Page last updated: 2024-12-05

folic acid

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Description

folcysteine: used to promote fertility in chickens [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

vitamin B9 : Any B-vitamin that exhibits biological activity against vitamin B9 deficiency. Vitamin B9 refers to the many forms of folic acid and its derivatives, including tetrahydrofolic acid (the active form), methyltetrahydrofolate (the primary form found in blood), methenyltetrahydrofolate, folinic acid amongst others. They are present in abundance in green leafy vegetables, citrus fruits, and animal products. Lack of vitamin B9 leads to anemia, a condition in which the body cannot produce sufficient number of red blood cells. Symptoms of vitamin B9 deficiency include fatigue, muscle weakness, and pale skin. [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 CID135398658
CHEMBL ID1622
CHEBI ID27470
SCHEMBL ID3876
SCHEMBL ID20791897
MeSH IDM0008658

Synonyms (261)

Synonym
BIDD:ER0563
folic
BIDD:GT0641
folcysteine
pteglu
usaf cb-13
folsan
cytofol
folettes
pteroyl-l-glutamic acid
nsc 3073
folvite
vitamin bc
folan
liver lactobacillus casei factor
folsav
incafolic
folacid
nsc-3073
pteroylmonoglutamic acid
foliamin
folsaure
folbal
facid
pteroyl-l-monoglutamic acid
folipac
folacin
millafol
vitamin m
pteroylmonoglutamate
vitamin be
acifolic
CHEBI:27470 ,
folsaeure
n-(4-{[(2-amino-4-oxo-3,4-dihydropteridin-6-yl)methyl]amino}benzoyl)-l-glutamic acid
n-[(4-{[(2-amino-4-oxo-1,4-dihydropteridin-6-yl)methyl]amino}phenyl)carbonyl]-l-glutamic acid
n-pteroyl-l-glutamic acid
DIVK1C_000494
KBIO1_000494
SDCCGMLS-0066738.P001
n-(4-{[(2-amino-4-oxo-1,4-dihydropteridin-6-yl)methyl]amino}benzoyl)-l-glutamic acid
n-(p-(((2-amino-4-hydroxy-6-pteridinyl)methyl)amino)benzoyl)-l-glutamic acid
nifolin [denmark]
l-glutamic acid, n-(4-(((2-amino-1,4-dihydro-4-oxo-6-pteridinyl)methyl)amino)benzoyl)-
l-glutamic acid, n-(4-(((2-amino-1,4-dihydro-4-oxo-6-pteridinyl)methyl)amino)benzo- yl)-
ai3-26387
novofolacid [canada]
einecs 200-419-0
n-(4-(((2-amino-1,4-dihydro-4-oxo-6-pteridinyl)methyl)amino)benzo- yl)-l-glutamic acid
hsdb 2002
mission prenatal
folcidin (van)
ccris 666
n-(4-((2-amino-1,4-dihydro-4-oxo-6-pteridinyl)methyl)amino)benzoyl)-l-glutamic acid
pga (van)
folicet (tn)
D00070
folic acid (jp17/usp/inn)
SPECTRUM4_001751
SPECTRUM_001381
BSPBIO_002338
SMP2_000137
PRESTWICK_230
cas-59-30-3
NCGC00016265-01
IDI1_000494
PRESTWICK3_000627
BPBIO1_000654
SPECTRUM5_000602
MLS001335861
folasic (australia)
kyselina listova [czech]
acido folico [inn-spanish]
foldine [france]
folina (italy)
acide folique [inn-french]
acidum folicum [inn-latin]
acfol (spain)
glutamic acid, pteroyl-, l-
folaemin [netherlands]
l-glutamic acid, n-(4-((2-amino-1,4-dihydro-4-oxo-6-pteridinyl)methyl)amino)benzoyl)-
folicet
FOL ,
antianemia factor
folico (italy)
4-pteridinol, 2-amino-6-((p-((1,3-dicarboxypropyl)carbamoyl)anilino)methyl)-
glutamic acid, n-(p-(((2-amino-4-hydroxypyrimido(4,5-b)pyrazin-6-yl)methyl)amino)benzoyl)-, l
glutamic acid, n-(p-(((2-amino-4-hydroxy-6-pteridinyl)methyl)amino)benzoyl)-, l-
l-glutamic acid, n-[4-[[(2-amino-4,8-dihydro-4-oxo-6-pteridinyl)methyl]amino]benzoyl]-
factor u
mittafol
pteroylglutamic acid
folate
59-30-3
FOLIC ACID ,
C00504
vitamin b9
folic acid, analytical standard
folic acid, meets usp testing specifications
folic acid, bioreagent, suitable for cell culture, suitable for insect cell culture, suitable for plant cell culture, >=97%
2D0K
DB00158
pteroyl-l-glutamate
NCGC00142391-01
KBIOGR_002222
KBIO2_001861
KBIO2_006997
KBIO3_001558
KBIO2_004429
KBIOSS_001861
NINDS_000494
SPECTRUM2_001459
SPECTRUM3_000749
SPBIO_001357
SPECTRUM1502020
BSPBIO_000594
smr000471860
MLS001304016
folic acid, >=97%
HMS2092N17
AC-11682
AKOS000503224
folic acid [ban:inn:jan]
BMSE000299
HMS501I16
b03bb01
foldine
acidum folicum
CHEMBL1622
F0043 ,
HMS1921D20
HMS3259A05
HMS2096N16
folico
folaemin
acide folique
megafol
acido folico
novofolacid
935e97boy8 ,
nifolin
l-glutamic acid, n-(4-(((2-amino-3,4-dihydro-4-oxo-6-pteridinyl)methyl)amino)benzoyl)-
kyselina listova
folina
neocepri
unii-935e97boy8
folic acid [usp:inn:ban:jan]
tox21_111559
dtxsid0022519 ,
NCGC00254203-01
tox21_300127
dtxcid102519
nsc-758158
MLS002548873
pharmakon1600-01502020
nsc758158
dosfolat b activ
HMS2270L05
S4605
AKOS016007919
CCG-38869
NCGC00016265-05
NCGC00016265-02
NCGC00016265-03
NCGC00016265-04
bdbm50367343
folic acid [who-dd]
folic acid component of folvron
folic acid [mi]
folic acid [who-ip]
folic acid [vandf]
folic acid [mart.]
folic acid [usp-rs]
calcium folinate impurity c [ep impurity]
n-(4-(((2-amino-4-oxo-1,4-dihydropteridin-6-yl)methyl)amino)benzoyl)-l-glutamic acid
folic acid [ep impurity]
folic acid [green book]
folic acid [orange book]
acidum folicum [who-ip latin]
folic acid [usp monograph]
folvron component folic acid
folic acid [fcc]
folic acid [jan]
folic acid [hsdb]
folic acid [inci]
folic acid [inn]
folic acid [dsc]
AKOS015895671
[3h]folic acid
gtpl4562
[3h]-folic acid
(2s)-2-[(4-{[(2-amino-4-oxo-1,4-dihydropteridin-6-yl)methyl]amino}phenyl)formamido]pentanedioic acid
gtpl4563
l-glutamic acid, n-[4-[[(2-amino-3,4-dihydro-4-oxo-6-pteridinyl)methyl]amino]benzoyl]-
NC00455
SCHEMBL3876
NCGC00016265-08
tox21_111559_1
pteroyglutamic acid
HY-16637
lexpec
bdbm50237629
folicare
bio science
preconceive
natur flow
folic acid, crystalline
(2s)-2-[[4-[(2-amino-4-oxo-3h-pteridin-6-yl)methylamino]benzoyl]amino]pentanedioic acid
GS-6860
(2s)-2-[(4-{[(2-amino-4-oxo-3,4-dihydropteridin-6-yl)methyl]amino}phenyl)formamido]pentanedioic acid
folic acid, tested according to ph.eur.
folic acid, united states pharmacopeia (usp) reference standard
folic acid, european pharmacopoeia (ep) reference standard
n-[4-[[(2-amino-4-oxo-1,4-dihydropteridin-6-yl)methyl]amino]benzoyl]-l-glutamic acid
.beta.-d-allopyranose, 1,6-anhydro-2,3-di-o-methyl-4-o-(phenylmethyl)-
.beta.-d-ribo-2-heptulopyranose, 2,7-anhydro-1,4-dideoxy-3-o-methyl-5-o-(phenylmethyl)-
folic acid, vetec(tm) reagent grade, >=97%
folic acid, pharmaceutical secondary standard; certified reference material
SBI-0051701.P002
HMS3713N16
pteroyl-l-monoglutamate
pteroylglutamate
folic acid, british pharmacopoeia (bp) reference standard
n-{p-[(2-amino-4-hydroxypteridin-6-yl)methylamino]benzoyl}glutamic acid
folic acid, usp grade
Z2042042504
BP-13474
folic acid,(s)
(s)-2-(4-((2-amino-4-oxo-1,4-dihydropteridin-6-yl)methylamino)benzamido)pentanedioic acid
112339-32-9
112339-08-9
Q127060
BRD-K18673820-001-07-2
SCHEMBL20791897
folic-acid
(2s)-2-[[4-[(2-amino-4-hydroxypteridin-6-yl)methylamino]benzoyl]amino]pentanedioic acid
cid 5280354
(2s)-2-[(4-{[(2-amino-4-hydroxypteridin-6-yl)methyl]amino}phenyl)formamido]pentanedioic acid
EN300-1667077
NCGC00016265-17
folaemin (netherlands)
folic acid (usp:inn:ban:jan)
nifolin (denmark)
folic acid (ep impurity)
folic acid (mart.)
folite
folvite(thomson.micromedex. drug information for the health care professional. 24th ed. volume 1. plus updates. content reviewed by the united states pharmacopeial convention, inc. greenwood village, co. 2004., p. 1422)
t-dol jiang suan bao
folic d3
folic acid (usp-rs)
(2s)-2-(4-(((2-amino-4-oxo-3,4-dihydropteridin-6-yl)methyl)amino)benzamido)pentanedioic acid
folic acid (usp monograph)
acfol
foldine (france)
v04cx02
novofolacid (canada)
2-amino-6-((p-((1,3-dicarboxypropyl)carbamoyl)anilino)methyl)-4-pteridinol
acidum folicum (inn-latin)
acide folique (inn-french)
2-(4-((2-amino-4-oxo-1h-pteridin-6-yl)methylamino)benzoyl)aminopentanedioic acid
acido folico (inn-spanish)

Research Excerpts

Toxicity

Oral folic acid (pteroylglutamic acid) is generally regarded as not toxic for normal humans. It may cause neurological injury when given to patients with undiagnosed pernicious anemia. The efficacy of antifolate drugs against Plasmodium is maximized in the absence of exogenous folic Acid.

ExcerptReferenceRelevance
"10-DAM appears to be as beneficial and as safe as MTX for the treatment of RA."( Efficacy and safety of 10-deazaaminopterin in the treatment of rheumatoid arthritis. A one-year continuation, double-blind study.
Alarcón, GS; Castañeda, O; Ferrándiz, M; Koopman, WJ; Krumdieck, CL, 1992
)
0.28
"Oral folic acid (pteroylglutamic acid) is generally regarded as not toxic for normal humans but it may cause neurological injury when given to patients with undiagnosed pernicious anemia."( Folic acid safety and toxicity: a brief review.
Butterworth, CE; Tamura, T, 1989
)
0.28
" Oral administration of CBZ as an aqueous suspension every 8 h at a dose of 250 mg/kg was continuously protective against HFDE-induced seizures and was minimally toxic as measured by weight gain over 8 weeks of treatment."( Chronic carbamazepine treatment in the rat: efficacy, toxicity, and effect on plasma and tissue folate concentrations.
Carl, GF; Smith, ML,
)
0.13
" The toxic effects of thymidylate synthase inhibition may be prevented by salvage of exogenous thymidine."( Potentiation of quinazoline antifolate (CB3717) toxicity by dipyridamole in human lung carcinoma, A549, cells.
Curtin, NJ; Harris, AL, 1988
)
0.27
" Both alcohols are metabolised via alcohol dehydrogenase to their toxic metabolites."( Methanol and ethylene glycol poisonings. Mechanism of toxicity, clinical course, diagnosis and treatment.
Jacobsen, D; McMartin, KE,
)
0.13
"Trimethoprim seems not to be a safe form of therapy in patients with a megaloblastic process; many of the toxic reactions reported with this drug may be on the basis of an unrecognized megaloblastic form of haemopoiesis."( Toxicity of trimethoprim-sulphamethoxazole in patients with megaloblastic haemopoiesis.
Chanarin, I; England, JM, 1972
)
0.25
" A serious chronic side effect of the drug is its hepatotoxicity, which may culminate in hepatic cirrhosis and death."( Methotrexate hepatotoxicity.
Barak, AJ; Beckenhauer, HC; Tuma, DJ, 1984
)
0.27
" Folate in excess of 1 mg daily can have adverse effects in patients with untreated cobalamin deficiency, usually undiagnosed pernicious anaemia (PA)."( Adverse effects of increased dietary folate. Relation to measures to reduce the incidence of neural tube defects.
Chanarin, I, 1994
)
0.29
"We attempted to develop a rodent model that exhibits characteristics of human methanol toxicities such as acidosis and visual dysfunction, which are correlated with an accumulation of formate, a toxic metabolite of methanol."( Animal model for the study of methanol toxicity: comparison of folate-reduced rat responses with published monkey data.
Garner, CD; Lee, EW; Terzo, TS, 1994
)
0.29
" However, the toxic effects of piritrexim and trimetrexate suggest that dihydrofolate reductase (DHFR) activity is essential for the parasite, most probably because of the role of this enzyme in the synthesis of thymidine nucleotides via thymidylate synthase."( The toxicity of antifolates in Babesia bovis.
Bagnara, AS; Nott, SE, 1993
)
0.29
" Methanol toxicity initially is not characterized by severe toxic manifestations."( Methanol toxicity. Agency for Toxic Substances and Disease Registry.
, 1993
)
0.29
" Thus, DDATHF did not inhibit the growth of IGROV1 cells depleted of folic acid after stripping FBP with phosphatidylinositol-phospholipase C, even at a dose toxic for cells constitutively expressing FBP."( Role of membrane folate-binding protein in the cytotoxicity of 5,10-dideazatetrahydrofolic acid in human ovarian carcinoma cell lines in vitro.
Bottero, F; Canevari, S; D'Incalci, M; Erba, E; Sen, S; Tomassetti, A, 1996
)
0.29
" Because no high-quality data exclude specific adverse effects, physicians should be vigilant in identifying detrimental effects when patients increase their consumption of folic acid."( How safe are folic acid supplements?
Campbell, NR,
)
0.13
" Although lower fat diets were related to lower self-reported intakes of several nutrients, no adverse effects were observed on blood biochemical measures of nutritional status."( Safety of a fat-reduced diet: the Dietary Intervention Study in Children (DISC).
Barton, BA; Franklin, FA; Hartmuller, VV; Hunsberger, SA; Kimm, SY; Kwiterovich, PO; Lasser, NL; Lauer, RM; Obarzanek, E; Simons-Morton, DG; Stevens, VJ; Van Horn, L, 1997
)
0.3
" The LD50 occurred at 60- and 250-fold lower doses of LY231514 in DBA/2 and CD1 nu/nu mice, respectively, maintained on low folate diet compared to standard diet."( Role of folic acid in modulating the toxicity and efficacy of the multitargeted antifolate, LY231514.
Schultz, RM; Shih, C; Worzalla, JF,
)
0.13
" Adverse effects in this group of patients included haematological ones (6%), asymptomatic elevations of liver enzymes (57%), gastrointestinal (6%) and dermatological side effects (3%)."( Toxicity profile of methotrexate in rheumatoid arthritis. A preliminary survey.
Coleiro, B; Mallia, C, 1999
)
0.3
" RTX induces proliferating tissue toxicities that are largely confined to the intestine, with diarrhea being a severe side effect in a small but significant minority of patients."( Balb/c mice as a preclinical model for raltitrexed-induced gastrointestinal toxicity.
Aherne, GW; Benstead, J; Clarke, SJ; Farrugia, DC; Jackman, AL; Pritchard, DM, 2000
)
0.31
" Haematologic side effects could not be analyzed, since details of each haematologic side effect by patients were not provided."( Folic acid and folinic acid for reducing side effects in patients receiving methotrexate for rheumatoid arthritis.
Moher, D; Ortiz, Z; Shea, B; Suarez Almazor, M; Tugwell, P; Wells, G, 2000
)
0.31
" The toxic syndrome in primates is characterized by formic acidemia, metabolic acidosis and blindness or serious visual impairment."( Development and characterization of a rodent model of methanol-induced retinal and optic nerve toxicity.
Eells, JT; Henry, MM; Lewandowski, MF; Murray, TG; Seme, MT, 2000
)
0.31
"It has been proposed that arsenic exerts its toxic effects, in part, by perturbing cellular methyl metabolism."( Folic acid protects SWV/Fnn embryo fibroblasts against arsenic toxicity.
Finnell, RH; Peterson, MH; Ruan, Y; Vorce, RL; Waes, JG; Wauson, EM, 2000
)
0.31
"To study the effect of folates on discontinuation of methotrexate (MTX) as single-drug antirheumatic treatment due to toxicity, to determine which type of adverse events are reduced, to study the effects on the efficacy of MTX, and to compare folic with folinic acid supplementation in a 48-week, randomized, double-blind, placebo-controlled trial."( Effect of folic or folinic acid supplementation on the toxicity and efficacy of methotrexate in rheumatoid arthritis: a forty-eight week, multicenter, randomized, double-blind, placebo-controlled study.
Breedveld, FC; de Boo, TM; de Rooij, DJ; Dijkmans, BA; Hartman, M; Huizinga, TW; Jacobs, MJ; Krabbe, PF; Laan, RF; Romme, TC; Rood, MJ; Severens, JL; van de Laar, MA; van de Putte, LB; van Denderen, CJ; van der Wilt, GJ; van Ede, AE; Westgeest, TA, 2001
)
0.31
" The primary end point was MTX withdrawal because of adverse events."( Effect of folic or folinic acid supplementation on the toxicity and efficacy of methotrexate in rheumatoid arthritis: a forty-eight week, multicenter, randomized, double-blind, placebo-controlled study.
Breedveld, FC; de Boo, TM; de Rooij, DJ; Dijkmans, BA; Hartman, M; Huizinga, TW; Jacobs, MJ; Krabbe, PF; Laan, RF; Romme, TC; Rood, MJ; Severens, JL; van de Laar, MA; van de Putte, LB; van Denderen, CJ; van der Wilt, GJ; van Ede, AE; Westgeest, TA, 2001
)
0.31
" No between-group differences were found in the frequency of other adverse events or in the duration of adverse events."( Effect of folic or folinic acid supplementation on the toxicity and efficacy of methotrexate in rheumatoid arthritis: a forty-eight week, multicenter, randomized, double-blind, placebo-controlled study.
Breedveld, FC; de Boo, TM; de Rooij, DJ; Dijkmans, BA; Hartman, M; Huizinga, TW; Jacobs, MJ; Krabbe, PF; Laan, RF; Romme, TC; Rood, MJ; Severens, JL; van de Laar, MA; van de Putte, LB; van Denderen, CJ; van der Wilt, GJ; van Ede, AE; Westgeest, TA, 2001
)
0.31
" Folates seem to have no effect on the incidence, severity, and duration of other adverse events, including gastrointestinal and mucosal side effects."( Effect of folic or folinic acid supplementation on the toxicity and efficacy of methotrexate in rheumatoid arthritis: a forty-eight week, multicenter, randomized, double-blind, placebo-controlled study.
Breedveld, FC; de Boo, TM; de Rooij, DJ; Dijkmans, BA; Hartman, M; Huizinga, TW; Jacobs, MJ; Krabbe, PF; Laan, RF; Romme, TC; Rood, MJ; Severens, JL; van de Laar, MA; van de Putte, LB; van Denderen, CJ; van der Wilt, GJ; van Ede, AE; Westgeest, TA, 2001
)
0.31
"Treatment of iron deficiency anaemia with conventional oral preparations is handicapped by unpredictable haematological response in addition to potential for irritating gastrointestinal adverse events."( Evaluation of efficacy and safety of iron polymaltose complex and folic acid (Mumfer) vs iron formulation (ferrous fumarate) in female patients with anaemia.
Adsul, BB; Desai, A; Gandewar, K; Korde, KM; Reddy, PS, 2001
)
0.31
" Of main concern are adverse effects of folic acid in cobalamin deficiency."( [Safety aspects of folic acid for the general population].
Eichholzer, M; Gutzwiller, F; Lüthy, J; Moser, U; Stähelin, HB, 2002
)
0.31
" Although severe folate deficiency may have adverse effects on NK-mediated cytotoxicity, moderate folate deficiency, a degree of depletion associated with an increased risk of several cancers, appears not to affect NK-mediated cytotoxicity in rats."( Severe folate deficiency impairs natural killer cell-mediated cytotoxicity in rats.
Hayek, M; Kim, YI; Mason, JB; Meydani, SN, 2002
)
0.31
" The LD50 for cyclophosphamide was significantly higher for the cereal diet than for the purified diets, but there was no difference among the purified diets."( Diet modulates the toxicity of cancer chemotherapy in rats.
Branda, RF; Brooks, EM; Chen, Z; McCormack, JJ; Naud, SJ; Trainer, TD, 2002
)
0.31
" Prior gastrointestinal (GI) events and younger age were related to the adverse event, diarrhoea."( Factors associated with toxicity, final dose, and efficacy of methotrexate in patients with rheumatoid arthritis.
Haagsma, CJ; Hoekstra, M; Huizinga, TW; Kruijsen, MW; Laan, RF; van de Laar, MA; van Ede, AE, 2003
)
0.32
" This work presents the use of a sample translation technique (STT) as a means to minimize these adverse effects."( Use of a sample translation technique to minimize adverse effects of laser irradiation in surface-enhanced Raman spectrometry.
De Jesús, MA; Giesfeldt, KS; Sepaniak, MJ, 2003
)
0.32
"A cross sectional study on 93 methotrexate treated patients with rheumatoid arthritis, comprising a clinical interview and physical examination to determine disease activity and methotrexate related adverse reactions."( Methotrexate related adverse effects in patients with rheumatoid arthritis are associated with the A1298C polymorphism of the MTHFR gene.
Aamar, S; Abou Atta, I; Ben-Yehuda, A; Berkun, Y; Friedman, G; Grenader, T; Levartovsky, D; Mevorach, D; Orbach, H; Rubinow, A, 2004
)
0.32
"1298CC polymorphism was more common in methotrexate treated rheumatoid patients than expected in the population, and was associated with a reduction in methotrexate related adverse effects."( Methotrexate related adverse effects in patients with rheumatoid arthritis are associated with the A1298C polymorphism of the MTHFR gene.
Aamar, S; Abou Atta, I; Ben-Yehuda, A; Berkun, Y; Friedman, G; Grenader, T; Levartovsky, D; Mevorach, D; Orbach, H; Rubinow, A, 2004
)
0.32
" Results of litter evaluation on GD18 showed that combined supplementation of FA and VB(12) ameliorated many of the adverse effects of ethanol."( The maternal combined supplementation of folic acid and Vitamin B(12) suppresses ethanol-induced developmental toxicity in mouse fetuses.
Li, Y; Long, Z; Shen, X; Tang, Y; Wang, J; Xu, Y; Zheng, X, 2006
)
0.33
"Among 214 patients enrolled at 4 study sites, a total of 67 patients (31%) presented with a side effect (gastrointestinal event, headache, lethargy, alopecia, cough, or dyspnea)."( Risk genotypes in folate-dependent enzymes and their association with methotrexate-related side effects in rheumatoid arthritis.
Caldwell, JR; Dervieux, T; Furst, DE; Kremer, JM; Park, GS; Smith, KM; Wallace, DJ; Weisman, MH, 2006
)
0.33
"To review the complementary medicines routinely encountered in psychiatric practice, their effectiveness, potential adverse effects and interactions."( Complementary medicines in psychiatry: review of effectiveness and safety.
Priebe, S; Turner, T; Werneke, U, 2006
)
0.33
" Grade 2/3 treatment-related adverse events were diarrhoea (34%), fatigue (27%), stomatitis (15%) and hand-foot syndrome (22%)."( A phase II study of fixed-dose capecitabine and assessment of predictors of toxicity in patients with advanced/metastatic colorectal cancer.
Beale, P; Clarke, SJ; Horvath, L; Ong, S; Rivory, L; Sharma, R, 2006
)
0.33
" Many of the components of leukemia therapy can contribute to adverse neurologic sequelae, including craniospinal irradiation, nucleoside analogs, corticosteroids, and antifolates."( Delayed neurotoxicity associated with therapy for children with acute lymphoblastic leukemia.
Cole, PD; Kamen, BA, 2006
)
0.33
" The frequency of adverse events was not increased in patients with C677T polymorphism with 11 patients experiencing adverse events as compared to 19 in the group without polymorphism (of whom 4 and 7 patients respectively discontinued treatment)."( Correlation between methotrexate efficacy & toxicity with C677T polymorphism of the methylenetetrahydrofolate gene in rheumatoid arthritis patients on folate supplementation.
Aggarwal, A; Aggarwal, P; Mishra, KP; Misra, R; Naik, S, 2006
)
0.33
" Therefore, an investigation was proposed in which it would be determined whether a general exemption could be granted for food fortification with a certain maximum safe amount per micronutrient."( Safe addition of vitamins and minerals to foods: setting maximum levels for fortification in the Netherlands.
de Stoppelaar, J; Fransen, HP; Kloosterman, J; Rompelberg, C; Verhagen, H, 2007
)
0.34
"To develop a risk assessment model to estimate maximum safe fortification levels (MSFLs) of vitamins and minerals to foods on the Dutch market, and to evaluate these levels to derive allowed fortification levels (AFLs), which can be used for a general exemption."( Safe addition of vitamins and minerals to foods: setting maximum levels for fortification in the Netherlands.
de Stoppelaar, J; Fransen, HP; Kloosterman, J; Rompelberg, C; Verhagen, H, 2007
)
0.34
" Whereas no definitive conclusion can yet be reached, evidence suggests that the improvement in side-effect profile is limited to fewer elevations of liver enzymes, but that this may be at the expense of decreased methotrexate efficacy."( Methods to enhance the safety of methotrexate prescribing.
Goldsmith, P; Roach, A, 2007
)
0.34
" This is usually associated with a lower incidence of adverse events related to the upper gastro intestinal tract."( Safety and efficacy of iron(III)-hydroxide polymaltose complex / a review of over 25 years experience.
Geisser, P, 2007
)
0.34
" Treatment of the toxic hepatitis with heptral increased the level of cytochrome P450, cytochrome b5, glutation activity of glutationetranspherase glutathione and reduced content of homocysteine."( [Efficacy and safety of heptral, vitamin B6 and folic acid during toxic hepatitis induced by CCL4].
Antelava, NA; Gogoluari, LI; Gogoluari, MI; Okudzhava, MV; Pirtskhalaĭshvili, NN, 2007
)
0.34
" Main adverse drug reactions of severity grade 3 or 4 were neutrophil count decreased (20."( Efficacy and safety of two doses of pemetrexed supplemented with folic acid and vitamin B12 in previously treated patients with non-small cell lung cancer.
Adachi, S; Fujimoto, T; Fukuoka, M; Ichinose, Y; Kubota, K; Nakagawa, K; Nambu, Y; Nishiwaki, Y; Ohe, Y; Saijo, N; Tamura, T; Yamamoto, N, 2008
)
0.35
", the safe limit."( Establishing safe and potentially efficacious fortification contents for folic acid and vitamin B12.
Dary, O, 2008
)
0.35
"Supplementation with folic acid is an effective measure to reduce hepatic adverse effects associated with methotrexate treatment."( Effect of folic or folinic acid supplementation on methotrexate-associated safety and efficacy in inflammatory disease: a systematic review.
Paul, C; Prey, S, 2009
)
0.35
"To review the adverse effects of methotrexate in the treatment of rheumatoid arthritis."( [The network of methotrexate toxicity].
Barcelos, A; Jorge, R; Neves, C,
)
0.13
" Cutaneous lesions, neurologic symptoms, changes in the bone metabolism, teratogenecity and hyperhomocysteinemia are other examples of the adverse effects of methotrexate."( [The network of methotrexate toxicity].
Barcelos, A; Jorge, R; Neves, C,
)
0.13
" However, the effective treatment conditions were severely toxic to human neutrophil progenitors called CFU-granulocyte/macrophage (CFU-GM), which could not tolerate > or =40 microM BCNU at any O4BF concentration."( In vitro comparison of O4-benzylfolate modulated, BCNU-induced toxicity in human bone marrow using CFU-GM and tumor cell lines.
Behrsing, HP; Furniss, MJ; Parchment, RE; Robillard, KA; Tomaszewski, JE, 2010
)
0.36
" We found no evidence, however, of the significant reduction in substantive maternal and neonatal adverse clinical outcomes (low birthweight, delayed development, preterm birth, infection, postpartum haemorrhage)."( Effects and safety of preventive oral iron or iron+folic acid supplementation for women during pregnancy.
Peña-Rosas, JP; Viteri, FE, 2009
)
0.35
" Several forms of folate appear to be safe and efficacious in some individuals with major depressive disorder, but more information is needed about dosage and populations most suited to folate therapy."( Folate in depression: efficacy, safety, differences in formulations, and clinical issues.
Fava, M; Mischoulon, D, 2009
)
0.35
" An understanding of structure-activity relationships (SARs) of chemicals can make a significant contribution to the identification of potential toxic effects early in the drug development process and aid in avoiding such problems."( Developing structure-activity relationships for the prediction of hepatotoxicity.
Fisk, L; Greene, N; Naven, RT; Note, RR; Patel, ML; Pelletier, DJ, 2010
)
0.36
" The frequency of any adverse effect was 29."( 677TT genotype is associated with elevated risk of methotrexate (MTX) toxicity in juvenile idiopathic arthritis: treatment outcome, erythrocyte concentrations of MTX and folates, and MTHFR polymorphisms.
Chládek, J; Dolezalová, P; Hoza, J; Hroch, M; Nemcová, D; Tuková, J, 2010
)
0.36
" These toxic effects were not persistent (reversible)."( Reproductive toxicity of methomyl insecticide in male rats and protective effect of folic acid.
El Zorba, HY; Shalaby, MA; Ziada, RM, 2010
)
0.36
" We examined whether folate supplementation before and during early pregnancy can reduce neural tube and other birth defects (including cleft palate) without causing adverse outcomes for mothers or babies."( Effects and safety of periconceptional folate supplementation for preventing birth defects.
De-Regil, LM; Dowswell, T; Fernández-Gaxiola, AC; Peña-Rosas, JP, 2010
)
0.36
"Ten specific examples of the underestimation of the efficacy, effectiveness and tolerability, and overestimation of adverse events of weekly, low-dose methotrexate, administered with folic acid, in treatment of rheumatic diseases are summarised."( Underestimation of the efficacy, effectiveness, tolerability, and safety of weekly low-dose methotrexate in information presented to physicians and patients.
Furer, V; Pincus, T; Sokka, T,
)
0.13
" Outcomes measured included adverse events (AEs), pharmacokinetics, and radiologic response."( Pralatrexate with vitamin supplementation in patients with previously treated, advanced non-small cell lung cancer: safety and efficacy in a phase 1 trial.
Azzoli, CG; Dunne, M; Ginsberg, M; Huntington, M; James, L; Kris, MG; Krug, LM; May, J; Miller, V; Patel, JD; Saunders, M; Sirotnak, FM; Subzwari, S; Tyson, L, 2011
)
0.37
" The use of folic acid supplements might reduce the adverse effects of smoking."( Folic acid supplements modify the adverse effects of maternal smoking on fetal growth and neonatal complications.
Bakker, R; Hofman, A; Jaddoe, VW; Steegers, EA; Timmermans, S, 2011
)
0.37
" Based on the above results, it could be concluded that Dol-PLA-PEG-FA polymer and its nanoparticles can be potentially used as a safe drug carrier with strong tumor cells targeting capability for tumor chemotherapy."( Dodecanol-poly(D,L-lactic acid)-b-poly (ethylene glycol)-folate (Dol-PLA-PEG-FA) nanoparticles: evaluation of cell cytotoxicity and selecting capability in vitro.
Liang, Z; Luo, C; Luo, Y; Wang, S; Wang, Y; Yang, L; Zeng, S, 2013
)
0.39
" The vitamin is generally regarded as a harmless nutrient based on studies evaluating the safe upper limits of folate intake."( Molecular mechanisms underlying the potentially adverse effects of folate.
Krupenko, NI; Krupenko, SA; Strickland, KC, 2013
)
0.39
" No adverse events were recorded."( Effectiveness and safety of citicoline in mild vascular cognitive impairment: the IDEALE study.
Castagna, A; Cotroneo, AM; Fantò, F; Gareri, P; Lacava, R; Malara, A; Monteleone, F; Putignano, S; Rocca, F, 2013
)
0.39
" PEG-L-Zol was more toxic than DPPG-L-Zol."( Liposome encapsulation of zoledronic acid results in major changes in tissue distribution and increase in toxicity.
Amitay, Y; Gabizon, A; Gorin, J; Shmeeda, H; Tzemach, D, 2013
)
0.39
" This strategy is under evaluation using liposomes carrying less toxic bisphosphonates."( Liposome encapsulation of zoledronic acid results in major changes in tissue distribution and increase in toxicity.
Amitay, Y; Gabizon, A; Gorin, J; Shmeeda, H; Tzemach, D, 2013
)
0.39
" Liabilities of entomophagy include the possible content of allergenic and toxic substances as well as antinutrients and the presence of pathogens."( Nutritional composition and safety aspects of edible insects.
Rumpold, BA; Schlüter, OK, 2013
)
0.39
" Folate supplementation can be used to reduce the adverse effects of MTX, though this may impact efficacy."( The effect of folate supplementation on methotrexate efficacy and toxicity in psoriasis patients and folic acid use by dermatologists in the USA.
Al-Dabagh, A; Davis, SA; Feldman, SR; Huang, K; Kinney, MA, 2013
)
0.39
" The literature confirms a reduction in the adverse effects of MTX but less strongly that there may be a reduction in efficacy too."( The effect of folate supplementation on methotrexate efficacy and toxicity in psoriasis patients and folic acid use by dermatologists in the USA.
Al-Dabagh, A; Davis, SA; Feldman, SR; Huang, K; Kinney, MA, 2013
)
0.39
" We examined whether single nucleotide polymorphisms (SNPs) in enzymes of the folic acid pathway (folylpoly-gamma-glutamate synthetase [FPGS], gamma-glutamyl hydrolase [GGH], and methylenetetrahydrofolate reductase [MTHFR]) associate with significant adverse events (SigAE)."( Folic acid pathway single nucleotide polymorphisms associated with methotrexate significant adverse events in United States veterans with rheumatoid arthritis.
Cannon, GW; Caplan, L; Davis, LA; Kerr, GS; Mann, A; Mikuls, TR; Polk, B; Reimold, AM; Wolff, RK,
)
0.13
" To define a safe dose of the supplement, the total folate (dietary + supplement) was compared with the tolerable upper intake level (UL = 1,000 mcg)."( [Evaluation of the safety of different doses of folic acid supplements in women in Brazil].
Marchioni, DM; Santos, Qd; Sichieri, R; Verly, E, 2013
)
0.39
" As psoriasis is an incurable disease, the goal of the MTX treatment is to suppress psoriasis, achieving long-term remissions with minimal treatment-related adverse events (AEs)."( Folate supplementation reduces the side effects of methotrexate therapy for psoriasis.
Baran, W; Batycka-Baran, A; Bieniek, A; Szepietowski, JC; Zychowska, M, 2014
)
0.4
" The use of methotrexate has been somewhat limited by concerns regarding its adverse effects, including its potential for hepatotoxicity."( A review of methotrexate-associated hepatotoxicity.
Bath, RK; Brar, NK; Forouhar, FA; Wu, GY, 2014
)
0.4
" However, toxicity is still a concern, with a significant proportion of patients interrupting long-term treatment due to the occurrence of MTX-related adverse drug reactions (ADRs), which are the main cause of drug withdrawal."( Three decades of low-dose methotrexate in rheumatoid arthritis: can we predict toxicity?
Bernardes, M; Canhão, H; Fonseca, JE; Lima, A; Romão, VC, 2014
)
0.4
"Kidney transplant recipients are at increased risk for adverse safety events related to their reduced renal function and many medications."( Safety events in kidney transplant recipients: results from the folic Acid for vascular outcome reduction in transplant trial.
Bostom, AG; Costa, N; Diamantidis, CJ; Gravens-Muller, L; Ivanova, A; Manitpisitkul, W; Weir, MR, 2015
)
0.42
"We determined the incidence of adverse safety events based on previously defined Agency for Healthcare and Research Quality (AHRQ) International Classification of Diseases-9 (ICD-9) code-derived patient safety indicators (PSI) in the Folic Acid for Vascular Outcome Reduction in Transplant trial participants who had a hospitalization stratified by tertiles of estimated glomerular filtration rate (GFR)."( Safety events in kidney transplant recipients: results from the folic Acid for vascular outcome reduction in transplant trial.
Bostom, AG; Costa, N; Diamantidis, CJ; Gravens-Muller, L; Ivanova, A; Manitpisitkul, W; Weir, MR, 2015
)
0.42
" Careful monitoring is necessary to prevent adverse outcomes."( Safety events in kidney transplant recipients: results from the folic Acid for vascular outcome reduction in transplant trial.
Bostom, AG; Costa, N; Diamantidis, CJ; Gravens-Muller, L; Ivanova, A; Manitpisitkul, W; Weir, MR, 2015
)
0.42
" Demographic characteristics were obtained and number of patients with MTX-related adverse affects, were recorded in the patient group."( Thymidylate synthase genetic polymorphism and plasma total homocysteine level in a group of Turkish patients with rheumatoid arthritis: relationship with disease activity and methotrexate toxicity.
Borman, P; Karabulut, H; Taşbaş, Ö; Tukun, A; Yorgancıoğlu, R,
)
0.13
" Thirty-six of the 64 patients showed adverse effects to MTX treatment."( Thymidylate synthase genetic polymorphism and plasma total homocysteine level in a group of Turkish patients with rheumatoid arthritis: relationship with disease activity and methotrexate toxicity.
Borman, P; Karabulut, H; Taşbaş, Ö; Tukun, A; Yorgancıoğlu, R,
)
0.13
" However, considering the potential significant drug-drug interactions between high doses of folic acid and some AEDs in patients with epilepsy and also with the emerging evidence from animal studies that high levels of folic acid throughout gestation may have adverse effects on fetal brain development, it is not suggested to advocate high dose folic acid supplementation in women with epilepsy until more information is available about its appropriate, safe and optimal dosing."( High dose folic acid supplementation in women with epilepsy: are we sure it is safe?
Asadi-Pooya, AA, 2015
)
0.42
" We analyzed adverse effects, such as myelosuppression, rash, and diarrhea, after 1 cycle of pemetrexed therapy."( [Safety of pemetrexed according to the duration of vitamin B12 and folic acid supplementation prior to the first dose of pemetrexed].
Chohnabayashi, N; Gotoh, K; Jinta, T; Kitamura, A; Koyama, K; Nishimura, N; Ohde, S; Okafuji, K; Takayama, S; Tomishima, Y; Tsuda, Y; Yagi, N, 2015
)
0.42
" The obtained results suggest that occurrence of 677T allele and coexistence of 677T and 1298C alleles may be associated with lower MTX clearance and elevated risk of adverse effects during MTX-treatment of pediatric ALL patients."( Functional variants of gene encoding folate metabolizing enzyme and methotrexate-related toxicity in children with acute lymphoblastic leukemia.
Fichna, M; Gowin, E; Januszkiewicz-Lewandowska, D; Kałużna, E; Mańkowski, P; Nowak, J; Strauss, E; Świątek-Kościelna, B; Zając-Spychała, O, 2015
)
0.42
" Interestingly the equivalent dose of free DOX was more toxic to 3T3 than to Caco2 cells, reducing the 3T3 viability to 72% and the Caco2 viability to 80%, which is likely due to the presence of the p-glycoprotein pumps in Caco2 cells."( Cytotoxicity of folic acid conjugated hollow silica nanoparticles toward Caco2 and 3T3 cells, with and without encapsulated DOX.
Chen, Y; Lou, X; Patel, K; Sundara Raj, B, 2016
)
0.43
" I have reviewed the Reports of four Expert Advisory Committees in Europe and the USA, which suggest that the safe upper tolerable limit (UL) for folic acid is 1 mg in adults."( What is the safe upper intake level of folic acid for the nervous system? Implications for folic acid fortification policies.
Reynolds, EH, 2016
)
0.43
" Herein, we presented a dual-functional glioma targeting delivery of doxorubicin based on the PAMAM G5 dendrimer, modified with folic acid (FA) to target tumor cell, also borneol (BO), a well known safe material derived from traditional Chinese medicine, to facilitate the BBB permeability and reduce the toxicity of naked PAMAM."( A novel doxorubicin loaded folic acid conjugated PAMAM modified with borneol, a nature dual-functional product of reducing PAMAM toxicity and boosting BBB penetration.
Fang, L; Han, S; Li, F; Li, J; Liang, Z; Sun, Y; Tao, C; Xu, X; Zhu, J, 2016
)
0.43
" To date, research on the potential for adverse effects of high intakes of folic acid has been limited."( Safe use of high intakes of folic acid: research challenges and paths forward.
Boyles, AL; Coates, PM; Thayer, KA; Yetley, EA, 2016
)
0.43
"Many adverse drug reactions are caused by the cytochrome P450 (CYP)-dependent activation of drugs into reactive metabolites."( Development of a cell viability assay to assess drug metabolite structure-toxicity relationships.
Jones, LH; Nadanaciva, S; Rana, P; Will, Y, 2016
)
0.43
"This exploratory analysis evaluated the incidence of adverse events (AEs) by folate receptor (FR) status in the randomized, multicenter, open-label PRECEDENT study in women with platinum-resistant ovarian cancer receiving pegylated liposomal doxorubicin (PLD) ± the small-molecule drug conjugate vintafolide."( Adverse Event Profile by Folate Receptor Status for Vintafolide and Pegylated Liposomal Doxorubicin in Combination, Versus Pegylated Liposomal Doxorubicin Alone, in Platinum-Resistant Ovarian Cancer: Exploratory Analysis of the Phase II PRECEDENT Trial.
Bidzińsk, M; Herzog, TJ; Kutarska, E; Naumann, RW; Nguyen, B; Rangwala, RA; Symanowski, J, 2016
)
0.43
" Although folate is believed to be non-toxic, the potential adverse effects of excessive intake of folic acid (synthetic form of folate) have not been highlighted well by authorities to people taking supplements; despite this, many studies have addressed this issue."( The adverse effects of an excessive folic acid intake.
Patel, KR; Sobczyńska-Malefora, A, 2017
)
0.46
"Aluminum sulphate has a significant toxic effects for humans."( Folic acid improve developmental toxicity induced by aluminum sulphates.
George, SM; Mohamed, HK; Yassa, HA, 2017
)
0.46
" We describe here the rationale and design of the CIRT-Adverse Events (CIRT-AE) ancillary study which aims to investigate adverse events within CIRT."( Investigating methotrexate toxicity within a randomized double-blinded, placebo-controlled trial: Rationale and design of the Cardiovascular Inflammation Reduction Trial-Adverse Events (CIRT-AE) Study.
Barbhaiya, M; Chasman, DI; Corrigan, CC; Karlson, EW; Lu, F; Paynter, NP; Raychaudhuri, S; Ridker, PM; Ritter, SY; Selhub, J; Solomon, DH; Sparks, JA, 2017
)
0.46
" The primary endpoints of CIRT include recurrent cardio vascular events, incident diabetes, and all-cause mortality, and the ancillary CIRT-AE study has been designed to adjudicate other clinically important adverse events including hepatic, gastrointestinal, respiratory, hematologic, infectious, mucocutaneous, oncologic, renal, neurologic, and musculoskeletal outcomes."( Investigating methotrexate toxicity within a randomized double-blinded, placebo-controlled trial: Rationale and design of the Cardiovascular Inflammation Reduction Trial-Adverse Events (CIRT-AE) Study.
Barbhaiya, M; Chasman, DI; Corrigan, CC; Karlson, EW; Lu, F; Paynter, NP; Raychaudhuri, S; Ridker, PM; Ritter, SY; Selhub, J; Solomon, DH; Sparks, JA, 2017
)
0.46
" We found nine studies evaluating the use and efficacy of MVMs in pregnant women and healthy adults and six studies in the elderly where adverse effects were explicitly addressed."( Multivitamin/mineral supplements: Rationale and safety.
Biesalski, HK; Tinz, J, 2017
)
0.46
" The efficacy of antifolate drugs against Plasmodium is maximized in the absence of exogenous folic acid, suggesting that there is no safe minimum dose of ingested folic acid."( Safety and benefits of interventions to increase folate status in malaria-endemic areas.
Mwangi, MN; Prentice, AM; Veenemans, J; Verhoef, H, 2017
)
0.46
" Of the various high throughput technologies available to detect global methylation profile, development of LINE-1 methylation index shall provide a cost effect-screening tool to detect epimutagenic events in the wake of toxic exposure in a large number of individuals."( Arsenic toxicity and epimutagenecity: the new LINEage.
Bhattacharjee, P; Giri, AK; Paul, S, 2017
)
0.46
" TEM showed the relatively uniform spherical structure for particles and in vitro MTT assay showed that EPI loaded micelles were more toxic on Hela cell line than MCF7 as expected."( Folic acid Targeted Polymeric Micelles Based on Tocopherol Succinate- Pulluan as an Effective Carrier for Epirubicin: Preparation, Characterization and In-vitro Cytotoxicity Assessment.
Hassanzadeh, F; Khodarahmi, GA; Mehdifar, M; Rostami, M; Varshosaz, J, 2018
)
0.48
"Metformin, first line medication in the treatment of type2 diabetes by millions of patients worldwide, causes gastrointestinal adverse effects (i."( "Metformin-resistant" folic acid producing probiotics or folic acid against metformin's adverse effects like diarrhea.
Olgun, A, 2017
)
0.46
"The minimal core data set included age, sex, severity of psoriasis, systemic interventions, monitoring, adverse events (AEs), and reason for discontinuation."( Safety of Systemic Agents for the Treatment of Pediatric Psoriasis.
Alexopoulos, A; Baselga, E; Belazarian, L; Bronckers, IMGJ; Cordoro, K; Hogeling, M; Holland, K; Kievit, W; Lambert, J; Lara-Corrales, I; Mahé, E; Mrowietz, U; Murphy, R; Paller, AS; Philipp, S; Seyger, MMB; Siegfried, E; Szalai, Z; Tollefson, M; Tom, WL; Vleugels, RA; West, DP; Zachariae, C, 2017
)
0.46
" In contrast, 5d-IV Act-D had the highest probability of being the least toxic regimen in terms of nausea and vomiting."( The efficacy and safety of first-line single-agent chemotherapy regimens in low-risk gestational trophoblastic neoplasia: A network meta-analysis.
Li, J; Li, S; Lu, X; Wang, J; Xu, C; Yu, H, 2018
)
0.48
" The aim of this study was to investigate the possibility of diminishing the side effect of mitomycin C by using pH-sensitive liposomes."( Diminishing the side effect of mitomycin C by using pH-sensitive liposomes: in vitro characterization and in vivo pharmacokinetics.
Fang, YP; Hu, PY; Huang, YB, 2018
)
0.48
" Marked toxic effects were observed in animals treated with cisplatin alone, while treatment with the nanoparticles functionalized with cisplatin showed no toxicity."( Europium(III)-doped yttrium vanadate nanoparticles reduce the toxicity of cisplatin.
de Oliveira, PF; de Souza, LDR; Ferreira, NH; Furtado, RA; Magalhães, GM; Miura, BA; Nassar, EJ; Neto, FR; Ozelin, SD; Ribeiro, AB; Tavares, DC, 2018
)
0.48
" In conclusion, these results suggested that NAC combined with FA can ameliorate the toxic effect of ASP on the rat's cerebral cortex."( The possible protective effect of N-acetyl-L-cysteine and folic acid in combination against aspartame-induced cerebral cortex neurotoxicity in adult male rats: a light and transmission electron microscopic study.
Abd-Ellah, HF; Abou-Zeid, NRA; Nasr, NM,
)
0.13
" The aim of this study was to investigate the mechanism by which folic acid can inhibit the toxic effects of BaP both in vivo and in vitro."( The intervention mechanism of folic acid for benzo(a)pyrene toxic effects in vitro and in vivo.
Chen, Y; Gong, Z; Wang, L; Wang, P; Wu, Y, 2019
)
0.51
" It appears that the toxic effects of BPA on testis might be minimized by FA treatment."( Effects of folic acid on testicular toxicity induced by bisphenol-A in male Wistar rats.
Gules, O; Naseer, Z; Tatar, M; Yildiz, M, 2019
)
0.51
"New targeted therapies are intended to minimize the toxic effects and maximize destruction of tumor cells."( Augmented cytotoxic effects of paclitaxel by curcumin induced overexpression of folate receptor-α for enhanced targeted drug delivery in HeLa cells.
Dhanasekaran, S, 2019
)
0.51
" All genetic polymorphisms, except for dihydropyrimidine dehydrogenase polymorphisms, were associated with hematological toxicities and did not appear to precipitate any non-hematological adverse events."( Folate pathway genetic polymorphisms modulate methotrexate-induced toxicity in childhood acute lymphoblastic leukemia.
Alshamaseen, D; Alsheikh, A; Farhad, R; Kadi, T; Yousef, AM; Zawiah, M, 2019
)
0.51
" The aim of the present paper is to review existing literature to assess risks of excessive intake in LMIC to then highlight programmatic changes required to maximise benefits of micronutrient interventions while minimising risks of adverse effects."( Maximising benefits and minimising adverse effects of micronutrient interventions in low- and middle-income countries.
Baye, K, 2019
)
0.51
" The pathogenicity of other iron-utilizing pathogens could also increase, causing inflammation leading to increased risk of adverse birth outcomes."( Excess risk of preterm birth with periconceptional iron supplementation in a malaria endemic area: analysis of secondary data on birth outcomes in a double blind randomized controlled safety trial in Burkina Faso.
Brabin, B; Brabin, L; Diallo, S; Gies, S; Kazienga, A; Lompo, OM; Ouedraogo, S; Roberts, SA; Tinto, H, 2019
)
0.51
"Methotrexate (MTX) increases the risk of alopecia and stomatitis, but the prevalence of these adverse events among rheumatic patients taking MTX is poorly defined."( Low-Dose Methotrexate and Mucocutaneous Adverse Events: Results of a Systematic Literature Review and Meta-Analysis of Randomized Controlled Trials.
Lalani, R; Lyu, H; Solomon, DH; Vanni, K, 2020
)
0.56
"This meta-analysis gives more precise estimates of mucocutaneous adverse events that occur in rheumatic disease patients taking MTX."( Low-Dose Methotrexate and Mucocutaneous Adverse Events: Results of a Systematic Literature Review and Meta-Analysis of Randomized Controlled Trials.
Lalani, R; Lyu, H; Solomon, DH; Vanni, K, 2020
)
0.56
" Early embryonic exposure to DTG is developmentally toxic in zebrafish, and supplemental folic acid can mitigate DTG developmental toxicity."( The antagonism of folate receptor by dolutegravir: developmental toxicity reduction by supplemental folic acid.
Cabrera, RM; Finnell, RH; Gorelick, DA; Souder, JP; Steele, JW; Tukeman, G; Yeo, L, 2019
)
0.51
" Both formulae were well accepted without differences in tolerance or occurrence of adverse events."( Suitability and safety of L-5-methyltetrahydrofolate as a folate source in infant formula: A randomized-controlled trial.
Demmelmair, J; Gimpfl, M; Hecht, C; Koletzko, B; Lakovic, G; Roehle, R; Schoop, R; Sipka, L; Trisic, B; Troesch, B; Vusurovic, M; Zdjelar, S, 2019
)
0.51
" Thymidine promotes microbial conversion of the prodrug FUdR into toxic 5-fluorouridine-5'-monophosphate (FUMP), leading to enhanced host death associated with mitochondrial RNA and DNA depletion, and lethal activation of autophagy."( Dietary serine-microbiota interaction enhances chemotherapeutic toxicity without altering drug conversion.
Benjamin, SB; Drangowska-Way, A; Hilzendeger, MA; Joshi, C; Ke, W; Lewis, N; Locasale, J; Mony, VK; O'Rourke, EJ; Patti, GJ; Saba, JA; Yao, CH; Zhang, S, 2020
)
0.56
" Using a modified WHO Safe Motherhood Assessment standard questionnaire, they recalled the total number of days of antenatal iron-folate intake and the attendant supplement-attributed undesirable experiences."( The Influence of Antenatal Oral Iron and Folic Acid Side Effects on Supplementation Duration in Low-Resource Rural Kenya: A Cross-Sectional Study.
Adan, F; Juma, M; Konyole, S; Oiye, S, 2020
)
0.56
" Our study demonstrated that potentially, more counselling on nausea as a side effect might be critical in advancing iron-folate supplementation compliance."( The Influence of Antenatal Oral Iron and Folic Acid Side Effects on Supplementation Duration in Low-Resource Rural Kenya: A Cross-Sectional Study.
Adan, F; Juma, M; Konyole, S; Oiye, S, 2020
)
0.56
"Both intravenous and oral treatments evaluated in this study, were effective and safe about the cardiovascular risk in "frailty" elderly patients, as resulted from non-linear HRV analysis."( A pilot study on secondary anemia in "frailty" patients treated with Ferric Sodium EDTA in combination with vitamin C, folic acid, copper gluconate, zinc gluconate and selenomethionine: safety of treatment explored by HRV non-linear analysis as predictive
Curcio, A; Iannarelli, N; Marchitto, N; Paparello, PT; Petrucci, A; Pironti, M; Raimondi, G; Romano, A, 2020
)
0.56
"Non-linear HRV evaluation confirmed that oral administration of Ferric Sodium EDTA, in combination with vitamin C, folic acid, copper gluconate, zinc gluconate and selenomethionine (Ferachel forte®) did not impact the cardiovascular risk, without causing adverse events typically reported with other iron supplementation therapies, both oral and intravenous."( A pilot study on secondary anemia in "frailty" patients treated with Ferric Sodium EDTA in combination with vitamin C, folic acid, copper gluconate, zinc gluconate and selenomethionine: safety of treatment explored by HRV non-linear analysis as predictive
Curcio, A; Iannarelli, N; Marchitto, N; Paparello, PT; Petrucci, A; Pironti, M; Raimondi, G; Romano, A, 2020
)
0.56
" This study examined whether maternal exercise during pregnancy and lactation mitigates the adverse effects of maternal obesity on offspring vascular endothelial function."( Exercise during pregnancy mitigates the adverse effects of maternal obesity on adult male offspring vascular function and alters one-carbon metabolism.
Aleliunas, RE; Bernatchez, P; Boonpattrawong, NP; Devlin, AM; Golbidi, S; Laher, I; Miller, JW; Tai, DC, 2020
)
0.56
" There were two mild to moderate infusion-related adverse events; and five serious adverse events (three in the intravenous iron group, two in the oral iron group), unrelated to the study medication."( Efficacy and safety of intravenous ferric carboxymaltose compared with oral iron for the treatment of iron deficiency anaemia in women after childbirth in Tanzania: a parallel-group, open-label, randomised controlled phase 3 trial.
Abdulla, S; Asilia, P; Daubenberger, C; Glass, TR; Issa, A; Kuemmerle, A; Lweno, O; Meyer-Monard, S; Mswata, S; Mwebi, KD; Schmidlin, S; Simon, B; Tanner, M; Vanobberghen, F, 2021
)
0.62
"Intravenous iron substitution with ferric carboxymaltose was safe and yielded a better haemoglobin response than oral iron."( Efficacy and safety of intravenous ferric carboxymaltose compared with oral iron for the treatment of iron deficiency anaemia in women after childbirth in Tanzania: a parallel-group, open-label, randomised controlled phase 3 trial.
Abdulla, S; Asilia, P; Daubenberger, C; Glass, TR; Issa, A; Kuemmerle, A; Lweno, O; Meyer-Monard, S; Mswata, S; Mwebi, KD; Schmidlin, S; Simon, B; Tanner, M; Vanobberghen, F, 2021
)
0.62
" Therefore, in this study sodium alginate and chitosan were used to synthesize the hydrogels that are known as biocompatible, hydrophilic and low toxic drug delivery systems."( Cytotoxicity Effects of Curcumin Loaded on Chitosan Alginate Nanospheres on the KMBC-10 Spheroids Cell Line.
Afzali, E; Ansari, M; Eslaminejad, T; Shahrokhi-Farjah, M; Yazdi Rouholamini, SE, 2021
)
0.62
" In this study, exosomes, a class of naturally occurring nanoparticles, were utilized as nanocarriers for safe and cancer-targeted delivery of a sonosensitizer, indocyanine green (ICG)."( Safe and Targeted Sonodynamic Cancer Therapy Using Biocompatible Exosome-Based Nanosonosensitizers.
Kang, HC; Kang, JH; Ko, YT; Nguyen Cao, TG; Rhee, WJ; Shim, MS; You, JY, 2021
)
0.62
" Exposure to arsenic (particularly its inorganic form) through contaminated food and drinking water is an important public health burden worldwide, and is associated with increased risk of neurotoxicity, congenital anomalies, cancer, and adverse neurodevelopment in children."( Provision of folic acid for reducing arsenic toxicity in arsenic-exposed children and adults.
Bae, S; Berry, RJ; Cassano, PA; Caudill, MA; Farinola, AF; Guetterman, HM; Kamynina, E; Stover, PJ, 2021
)
0.62
" Its use may associate with adverse effects presumably originating from folate deficiency."( Rescuing effect of folates on methotrexate cytotoxicity in human trophoblast cells.
Ravaei, A; Rubini, M, 2022
)
0.72
"Despite the general acceptance of administering FA to prevent adverse events of MTX therapy, our findings suggest that FA may not be optimal, and indicate FTHF or MTHF as a better choice."( Rescuing effect of folates on methotrexate cytotoxicity in human trophoblast cells.
Ravaei, A; Rubini, M, 2022
)
0.72
" Therefore, we constructed folate-modified triptolide liposomes (FA-TP-Lips) to target macrophages, thereby treating RA in a safe and effective way."( Folate-modified triptolide liposomes target activated macrophages for safe rheumatoid arthritis therapy.
Geng, HX; Guo, RB; Kong, L; Li, XT; Liu, Y; Wang, YJ; Wu, YN; Yan, DK; Yu, YJ; Zhang, XY, 2022
)
0.72
" The current experiment pertains to a comprehensive overview of the toxic effects of acetamiprid and the protective role of folic acid against reproductive, hematological, histopathological and biochemical toxicity induced by ACP during 5 weeks."( Protective effects of Folic acid against reproductive, hematological, hepatic, and renal toxicity induced by Acetamiprid in male Albino rats.
Ahmed, MAB; Ali, RA; Amin, YA; Fouad, SS; Saleh, SMM; Toghan, R, 2022
)
0.72
"In paediatric psoriasis, few studies have evaluated methotrexate effectiveness, adverse events and folic acid regimen."( Real-world Methotrexate Use in a Prospective Cohort of Paediatric Patients with Plaque Psoriasis: Effectiveness, Adverse Events and Folic Acid Regimen.
Bronckers, IMGJ; Bruins, FM; De Jong, EMGJ; Groenewoud, HMM; Seyger, MMB; Van Acht, MR, 2022
)
0.72
" Unfortunately, PTX has some drawbacks including low solubility, cell toxicity, adverse cell reaction, etc."( Design of surface tailored carboxymethyl dextran-protein based nanoconjugates for paclitaxel: Spectroscopical characterizations and cytotoxicity assay.
Girase, ML; Ige, PP; Jain, PD; Nangare, SN; Sugandhi, VV, 2022
)
0.72
" Adverse effects have been reported even at low doses (up to 25 mg/week), and there is risk of toxicity in the form of myelosuppression, hepatotoxicity, or pulmonary fibrosis."( Fatal low-dose methotrexate toxicity: A case report and literature review.
Ashforth, G; Ouellette, S; Razi, S; Shah, R; Wassef, C, 2022
)
0.72
" Specifically, our aim was to assess any adverse effects of EGCG alone or in combination with an ovarian stimulator on serum liver function tests (LFTs) and folate level."( Assessing the Hepatic Safety of Epigallocatechin Gallate (EGCG) in Reproductive-Aged Women.
Al-Hendy, A; Christman, GM; Flaminia, A; Flores, VA; González, F; Huang, H; Johnson, JJ; Segars, J; Siblini, H; Singh, B; Taylor, HS; Zhang, H, 2023
)
0.91
"We reported a patient with rheumatoid arthritis who received chronic methotrexate (MTX) therapy and experienced several adverse reactions like hemocytopenia and renal impairment."( Calcium Folate for Reducing the Side Effects of Low-dose Methotrexate in Rheumatoid Arthritis: A Case Report.
Hu, Y; Liu, R; Liu, X; Yan, Q, 2024
)
1.44
"A 66-year-old man with rheumatoid arthritis received MTX and developed adverse effects of bone marrow suppression, like pancytopenia."( Calcium Folate for Reducing the Side Effects of Low-dose Methotrexate in Rheumatoid Arthritis: A Case Report.
Hu, Y; Liu, R; Liu, X; Yan, Q, 2024
)
1.44
"Low-dose MTX has fewer adverse reactions but may cause bone marrow suppression- related side effects."( Calcium Folate for Reducing the Side Effects of Low-dose Methotrexate in Rheumatoid Arthritis: A Case Report.
Hu, Y; Liu, R; Liu, X; Yan, Q, 2024
)
1.44
" In addition, SpHL-DOX-Fol demonstrated a decrease in the systemic toxic effects of DOX, mainly in renal and cardiac parameters evaluation, even using a higher dose (20 mg/kg)."( Evaluation of acute toxicity and in vitro antitumor activity of a novel doxorubicin-loaded folate-coated pH-sensitive liposome.
Cassali, GD; de Alcântara Lemos, J; de Barros, ALB; de Oliveira Silva, J; de Paula Sabino, A; Fernandes, RS; Oliveira, MC; Townsend, DM, 2023
)
0.91

Pharmacokinetics

Study compared docetaxel-loaded folic acid-conjugated liposomes with those of dry powder prepared by co-spray-drying LPs-DTX-FA. No marked differences were evident in lometrexol plasma half-lives, plasma clearance, or the extent of plasma protein binding.

ExcerptReferenceRelevance
" The peak concentration of total folate in serum 1--2 min after administration of pteroylglutamate exceeded the sum of the endogenous stable and baseline serum folate, indicating that a reduced labile folate was released from the liver and perhaps from other tissues."( Radiochemical method for measuring plasma clearance and urinary excretion of pteroylglutamic acid.
da Costa, M; Rosenberg, Z; Rothenberg, SP, 1979
)
0.26
"Studies are described that sought the basis for a discrepancy in values for a key kinetic parameter of methotrexate transport (influx Vmax) in L1210 cells derived alternately from biochemical or pharmacokinetic measurements."( Enhancement of folate analogue transport inward in L1210 cells during methotrexate therapy of leukemic mice: evidence of the nature of the effect, possible host mediation, and pharmacokinetic significance.
Barrueco, JR; Poser, RE; Sirotnak, FM, 1987
)
0.27
" These pharmacokinetic studies have shown that, by analogy with experimental systems, cytotoxic plasma levels of CB 3717 are archieved in man."( The clinical pharmacokinetics of the novel antifolate N10-propargyl-5,8-dideazafolic acid (CB 3717).
Alison, DL; Calvert, AH; Harland, SJ; Harrap, KR; Hart, LI; Newell, DR; Sessa, C, 1985
)
0.27
" 1H and 13C are likely to be useful as non-perturbing NMR probes for future pharmacokinetic studies."( New techniques in the pharmacokinetic analysis of cancer drugs. III. Nuclear magnetic resonance.
Maxwell, RJ, 1993
)
0.29
" No marked differences were evident in lometrexol plasma half-lives, plasma clearance, or the extent of plasma protein binding, indicating that there is not a pronounced pharmacokinetic interaction between lometrexol and folic acid."( Clinical pharmacokinetics of the antipurine antifolate (6R)-5,10- dideaza-5,6,7,8-tetrahydrofolic acid (Lometrexol) administered with an oral folic acid supplement.
Boddy, A; Calvert, AH; Laohavinij, S; Newell, DR; Taylor, GA; Wedge, SR, 1995
)
0.29
" The pharmacokinetics of the classical antifolate methotrexate have been well-defined and pharmacokinetic data can be exploited to reduce the toxicity and enhance the activity of the drug."( Clinical pharmacokinetics of antitumor antifolates.
Newell, DR, 1999
)
0.3
" The study also sought to characterize the pharmacokinetic behavior of 1843U89 and to seek preliminary evidence of anticancer activity."( A phase I and pharmacokinetic study of 1843U89, a noncompetitive inhibitor of thymidylate synthase, in patients with advanced solid malignancies.
Burris, H; Goetz, A; Hohneker, JA; Johnson, TR; Lampkin, T; Rowinsky, EK; Sailstad, J; Schwartz, G; Smetzer, L; Von Hoff, DD, 2001
)
0.31
"The pharmacokinetic changes of diltiazem (DTZ) and its main metabolite, deacetyldiltiazem (DAD) were studied after oral administration of DTZ to normal rabbits and mild and medium folate-induced renal failure rabbits."( Pharmacokinetics of diltiazem and its major metabolite, deacetyidiltiazem after oral administration of diltiazem in mild and medium folate-induced renal failure rabbits.
Burm, JP; Choi, JS; Lee, JH, 2001
)
0.31
"The pharmacokinetic of tolbutamide was studied after the oral administration to normal rabbits or rabbits with mild to medium folate-induced renal failure."( Pharmacokinetics of tolbutamide after oral administration to rabbits with folate-induced renal failure.
Choi, JS; Shin, SC, 2003
)
0.32
" The aim of this study was to determine the pharmacokinetic properties of orally administered 6[R,S] 5-MTHF versus folic acid in cardiovascular patients with homozygosity for 677C --> T MTHFR."( Pharmacokinetic study on the utilisation of 5-methyltetrahydrofolate and folic acid in patients with coronary artery disease.
Aengevaeren, WR; Blom, HJ; Boers, GH; Verheugt, FW; Willems, FF, 2004
)
0.32
"The pharmacokinetic changes of tolbutamide were studied after oral administration to normal rabbits and mild and medium folate-induced renal failure rabbits."( Pharmacokinetics of tolbutamide after oral administration in rabbits with folate-induced renal failure.
Bae, HY; Choi, DH; Choi, JS, 2002
)
0.31
"The objectives of these analyses were to (1) develop a semimechanistic-physiologic population pharmacokinetic/pharmacodynamic (PK/PD) model to describe neutropenic response to pemetrexed and to (2) identify influential covariates with respect to pharmacodynamic response."( A semimechanistic-physiologic population pharmacokinetic/pharmacodynamic model for neutropenia following pemetrexed therapy.
Ghosh, A; Johnson, RD; Karlsson, MO; Latz, JE; Rusthoven, JJ, 2006
)
0.33
" Here, we present results from preclinical pharmacokinetic and tissue biodistribution studies using a radioactive folate-FITC conjugate and results from dose optimization studies done in tumor-bearing animals."( Preclinical pharmacokinetics, tissue distribution, and antitumor activity of a folate-hapten conjugate-targeted immunotherapy in hapten-immunized mice.
Leamon, CP; Low, PS; Lu, Y; Parker, N; Reddy, JA; Vetzel, M; Westrick, E; Xu, LC, 2006
)
0.33
"The purpose of this study was to investigate the utility of plasma pharmacokinetic and pharmacodynamic measures including plasma deoxynucleosides, homocysteine and methylmalonic acid concentrations in understanding the time course and extent of the inhibition of thymidylate synthase (TS) by pemetrexed in the context of a phase I/II combination study with vinorelbine."( Pemetrexed pharmacokinetics and pharmacodynamics in a phase I/II study of doublet chemotherapy with vinorelbine: implications for further optimisation of pemetrexed schedules.
Clarke, SJ; Li, KM; Rivory, LP, 2007
)
0.34
" The main purpose of the present study was to investigate a possible pharmacokinetic interaction between tea and folic acid in healthy volunteers."( Influence of green and black tea on folic acid pharmacokinetics in healthy volunteers: potential risk of diminished folic acid bioavailability.
Alemdaroglu, NC; Dietz, U; Langguth, P; Spahn-Langguth, H; Wolffram, S, 2008
)
0.35
" Standard pharmacokinetic parameters were determined and compared with Student's t-test, when appropriate."( Comparing folic acid pharmacokinetics among women of childbearing age: single dose ingestion of 1.1 versus 5 MG folic acid.
Boskovic, R; Kapur, B; Koren, G; Nguyen, P; Vandenberghe, H; Yazdani, P, 2008
)
0.35
"Concentrations of O(4)BF and the metabolite in CSF exceeded the ED(50) of AGT; however, recently reported lack of receptor specificity and pharmacokinetic data suggesting saturable elimination of both O(4)BF and its metabolite may limit dose-escalation and future clinical development of this agent."( Plasma and CNS pharmacokinetics of O4-benzylfolic acid (O4BF) and metabolite in a non-human primate model.
Balis, FM; Chuk, MK; Cole, DE; Fox, E; Loktionova, NA; McCully, C; Parker, RJ; Pauly, G; Pegg, AE; Widemann, BC, 2011
)
0.37
"The objectives of this study were (1) to develop a population pharmacokinetic model of high-dose methotrexate (HD-MTX) in children with acute lymphoblastic leukaemia (ALL) and malignant lymphoma (ML) in order to investigate the influence of common polymorphisms in SLC19A1, MTHFR and ABCB1 on plasma levels of MTX and (2) to estimate MTX exposure in individual patients to study the association of genetic variability in the folate metabolic pathway with MTX toxicity."( Association of genetic polymorphism in the folate metabolic pathway with methotrexate pharmacokinetics and toxicity in childhood acute lymphoblastic leukaemia and malignant lymphoma.
Bohanec Grabar, P; Dolžan, V; Faganel Kotnik, B; Grabnar, I; Jazbec, J, 2011
)
0.37
" Nonlinear mixed effects modelling was used for the pharmacokinetic analysis."( Association of genetic polymorphism in the folate metabolic pathway with methotrexate pharmacokinetics and toxicity in childhood acute lymphoblastic leukaemia and malignant lymphoma.
Bohanec Grabar, P; Dolžan, V; Faganel Kotnik, B; Grabnar, I; Jazbec, J, 2011
)
0.37
"A population pharmacokinetic model developed in this study implies only a limited influence of genetic factors on the systemic disposition of MTX."( Association of genetic polymorphism in the folate metabolic pathway with methotrexate pharmacokinetics and toxicity in childhood acute lymphoblastic leukaemia and malignant lymphoma.
Bohanec Grabar, P; Dolžan, V; Faganel Kotnik, B; Grabnar, I; Jazbec, J, 2011
)
0.37
" Folic acid was orally administered after a 6-hour fast, and blood samples were taken over a 10-hour period to evaluate pharmacokinetic parameters."( A comparison of folic acid pharmacokinetics in obese and nonobese women of childbearing age.
Kapur, B; Koren, G; Matok, I; Stern, SJ, 2011
)
0.37
" Pharmacokinetic study revealed that DOMC-FA/PTX micelles exhibited higher AUC values and a prolonged residence time of drug in the blood circulation than that of Taxol injection."( Tissue distribution and pharmacokinetics evaluation of DOMC-FA micelles for intravenous delivery of PTX.
Guo, H; Guo, S; Hao, L; Li, C; Wang, F; Zhang, D; Zhang, Q; Zheng, D, 2013
)
0.39
" Serum folate concentration may serve as a pharmacodynamic biomarker of intracellular nitrosylcobalamin activity following intravenous administration."( Serum folate: a pharmacodynamic biomarker of intracellular nitrosylcobalamin activity following intravenous administration in dogs.
Bauer, JA; Horne, WI; Steiner, JM; Suchodolski, JS; Sysel, AM, 2012
)
0.38
" The objective of this intervention study was to compare the relationship between BMI and the short-term pharmacokinetic response to an oral dose of folic acid."( Obesity affects short-term folate pharmacokinetics in women of childbearing age.
Bailey, LB; da Silva, VR; Hausman, DB; Kauwell, GP; Rathbun, SL; Sokolow, A; Tackett, RL, 2013
)
0.39
" Such formulations would serve to extend the drug half-life while improving the pharmacokinetic profile and biodistribution to reservoirs of human immunodeficiency virus (HIV) infection."( Pharmacokinetics, biodistribution, and toxicity of folic acid-coated antiretroviral nanoformulations.
Alnouti, Y; Balkundi, S; Fox, HS; Gautam, N; Gendelman, HE; Liu, XM; McMillan, J; Puligujja, P; Thakare, R, 2014
)
0.4
" The pharmacokinetic of DTX loaded FA-PF127-Chol micelles in comparison with Taxoter(®) was investigated in male Wistar rats."( Pharmacokinetics, Organ Toxicity and Antitumor Activity of Docetaxel Loaded in Folate Targeted Cholesterol Based Micelles.
Hassanzadeh, F; Javanmard, SH; Mahzouni, P; Taymouri, S; Varshosaz, J, 2016
)
0.43
" However, the unreliable pharmacokinetic characteristics of DM-NCTD could result in low bioavailability, hindering the clinical use of DM-NCTD in the treatment of diseases."( Liquid chromatography-tandem mass spectrometry evaluation of the pharmacokinetics of a diacid metabolite of norcantharidin loaded in folic acid-targeted liposomes in mice.
Gao, JQ; Han, M; Liu, MC; Ma, XQ; Peng, LH; Xu, Y, 2016
)
0.43
"The purpose of this study was to develop folic acid functionalized long-circulating co-encapsulated docetaxel (DTX) and curcumin (CRM) solid lipid nanoparticles (F-DC-SLN) to improve the pharmacokinetic and efficacy of DTX therapy."( Folic acid functionalized long-circulating co-encapsulated docetaxel and curcumin solid lipid nanoparticles: In vitro evaluation, pharmacokinetic and biodistribution in rats.
Burman, R; Gill, MS; Pawar, H; Singh, C; Surapaneni, SK; Suresh, S; Tikoo, K, 2016
)
0.43
" The main pharmacokinetic parameters were calculated (Cmax, tmax, AUC)."( Enhanced oral bioavailability of a novel folate salt: comparison with folic acid and a calcium folate salt in a pharmacokinetic study in rats.
Agostinetto, M; Bianchi, D; Miraglia, N; Valoti, E, 2016
)
0.43
"7 ng/mL), while tmax values were similar for the three folate forms."( Enhanced oral bioavailability of a novel folate salt: comparison with folic acid and a calcium folate salt in a pharmacokinetic study in rats.
Agostinetto, M; Bianchi, D; Miraglia, N; Valoti, E, 2016
)
0.43
" Because its half-life is 17 min after a 30 mg intravenous bolus administration, the suitability of mitomycin C for wide use in the clinical setting is limited."( Diminishing the side effect of mitomycin C by using pH-sensitive liposomes: in vitro characterization and in vivo pharmacokinetics.
Fang, YP; Hu, PY; Huang, YB, 2018
)
0.48
" PEGylated liposomes decorated with folic acid have been investigated for several anticancer agents not only to extend plasma half-life but also for tumor targeting via folic acid receptors which overexpressed on tumor cell surface."( Gemcitabine-loaded Folic Acid Tagged Liposomes: Improved Pharmacokinetic and Biodistribution Profile.
Muddana Eswara, BR; Panduragaiah, VM; Sidramappa, MA; Unnam, S, 2019
)
0.51
" The comparative in vivo pharmacokinetic and biodistribution characteristics of radiolabeled (99mTc-labeled) plain GEM solution, and all liposomal formulations (conventional:CLs; stealth: SLs; folate targeted: FTLs) were evaluated in mice model."( Gemcitabine-loaded Folic Acid Tagged Liposomes: Improved Pharmacokinetic and Biodistribution Profile.
Muddana Eswara, BR; Panduragaiah, VM; Sidramappa, MA; Unnam, S, 2019
)
0.51
" In this study, we compared the physicochemical property, anti-cancer activity, tumor targeting and pharmacokinetic behavior of docetaxel-loaded folic acid-conjugated liposomes (LPs-DTX-FA) with those of dry powder prepared by co-spray-drying LPs-DTX-FA."( Inhalable dry powder prepared from folic acid-conjugated docetaxel liposomes alters pharmacodynamic and pharmacokinetic properties relevant to lung cancer chemotherapy.
Chen, X; Kong, Y; Li, N; Liu, Q; Lu, X; Lu, Y; Xing, H; Xu, J; Yang, Y; Zhao, D; Zhu, X, 2019
)
0.51
" In this study, folic acid (FA) was used as a model drug and aimed at investigating a reliable method for its detailed pharmacokinetic evaluations."( Folic acid and its metabolite codetermination for pharmacokinetics with circadian rhythms and evaluation of oral bioavailability.
Chen, W; Li, H; Meng, F; Shakya, S; Wang, C; Wu, L; Xu, J; Zhang, G; Zhang, J; Zhu, R, 2019
)
0.51
" Prior to FDC development, pharmacokinetic properties of active pharmaceutical ingredients (APIs) have to be evaluated, as well as methods for their determination developed."( Pharmacokinetic Profiling and Simultaneous Determination of Thiopurine Immunosuppressants and Folic Acid by Chromatographic Methods.
Amidžić Klarić, D; Brusač, E; Jeličić, ML; Klarić, I; Mornar, A; Nigović, B; Turk, N, 2019
)
0.51
" The pharmacokinetic parameters were studied with high-performance liquid chromatography (HPLC) and atomic absorption spectroscopy (AAS)."( Building and behavior of a pH-stimuli responsive chitosan nanoparticles loaded with folic acid conjugated gemcitabine silver colloids in MDA-MB-453 metastatic breast cancer cell line and pharmacokinetics in rats.
Babu, D; Gautam, M; Karuppaiah, A; Natrajan, T; Nesamony, J; Rajan, R; Ranganathan, H; Sankar, V; Selvaraj, D; Siram, K, 2021
)
0.62

Compound-Compound Interactions

Intra-cerebral administrations of folic acid produce antidepressant-like effects. Folic acid or 17-β estradiol produces antidepressant effects, either alone or combined with several antidepressants.

ExcerptReferenceRelevance
"On a model of transplantable albeolar-mucous RS cancer it is shown that hydrocortisone, desoxycorticosteonre-acetate (DOCA), cyanocobalamine used in combination with folic and nicotinic acids does not lower the cytostatic activity of thiophosphamide and in a number cases even potentiates its action."( [Effect of corticosteroids, vitamins and their combination with thiophosphamide on the indicators of carbohydrate and electrolyte metabolism of animals with experimental tumors].
Butov, VI; Dunaev, VV,
)
0.13
"Analysis of the dynamics of changes in the end part of the ECG ventricular complex in 311 patients with rheumatic heart disease and stages IIA, IIB, and III circulatory insufficiency after treatment with preparations of digitalis and their combination with biologically active substances (orotic acid, vitamin B12, calcium pantothenate, ATP, methionine, inosi-F) is presented."( [Changes in the end part of the ECG ventricular complex under the effect of digitalis preparations and their combination with metabolic preparations].
Abbakumov, SA; Makolkin, VI; Masliuk, VI; Nedostup, AV; Popova, TA, 1977
)
0.26
" However, one study did demonstrate differences in the pharmacokinetics of 7-hydroxy-methotrexate, the active metabolite of MTX, when MTX was administered with aspirin."( Methotrexate and nonsteroidal antiinflammatory drug interactions.
Frenia, ML; Long, KS, 1992
)
0.28
"The presence of low concentrations of the lipophilic dihydrofolate reductase inhibitors metoprine or trimetrexate, which cause little inhibition in the growth of cultured hepatoma cells in combination with weakly inhibiting concentrations of 5,10-dideazatetrahydrofolate, exhibit greater activity than would be predicted by the activity of the individual components."( Antifolate drug interactions: enhancement of growth inhibition due to the antipurine 5,10-dideazatetrahydrofolic acid by the lipophilic dihydrofolate reductase inhibitors metoprine and trimetrexate.
Boschelli, D; Galivan, J; Kerwar, SS; Nimec, Z; Oronsky, AL; Rhee, M, 1988
)
0.27
" Drugs were administered with a programmable-in-time pump by continuous infusion for 5 days."( Spontaneous or imposed circadian changes in plasma concentrations of 5-fluorouracil coadministered with folinic acid and oxaliplatin: relationship with mucosal toxicity in patients with cancer.
Bastian, G; Brienza, S; Comisso, M; Etienne, MC; Lévi, F; Massari, C; Metzger, G; Milano, G; Misset, JL; Touitou, Y, 1994
)
0.29
" This observation prompted a Phase I clinical study of lometrexol given with folic acid supplementation which has confirmed that the toxicity of lometrexol can be markedly reduced by folic acid supplementation."( A phase I clinical study of the antipurine antifolate lometrexol (DDATHF) given with oral folic acid.
Bailey, N; Boddy, AV; Calvert, AH; Chapman, F; Gumbrell, L; Humphreys, A; Laohavinij, S; Lind, MJ; Newell, DR; Oakley, A; Proctor, M; Robson, L; Simmons, D; Taylor, GA; Thomas, HD; Wedge, SR, 1996
)
0.29
" Lometrexol pharmacokinetics were also examined in seven patients who received 45 or 60 mg/m2 lometrexol as part of a separate study of the drug given with folinic acid rescue 5-7 days after treatment."( Clinical pharmacokinetics of the antipurine antifolate (6R)-5,10- dideaza-5,6,7,8-tetrahydrofolic acid (Lometrexol) administered with an oral folic acid supplement.
Boddy, A; Calvert, AH; Laohavinij, S; Newell, DR; Taylor, GA; Wedge, SR, 1995
)
0.29
" Although the sample size is small, these findings suggest that daily administration of 400 microg/day folic acid combined with vitamin B12 and vitamin B6 may be equivalent to higher doses in reducing homocysteine levels in patients with CAD."( Reduction of homocysteine levels in coronary artery disease by low-dose folic acid combined with vitamins B6 and B12.
Abou-Ghazala, T; Alsous, F; Arheart, K; Gupta, A; Jacobsen, DW; Kruger, WD; Lobo, A; Moustapha, A; Nahlawi, M; Naso, A; Robinson, K; van Lente, F, 1999
)
0.3
"This study reports our first results of ambulant photodynamic treatment with 5-aminolevulinic acid (5-ALA) in combination with folic acid and subsequent illumination with a noncoherent light source."( Ambulant photodynamic therapy of superficial malignomas with 5-ALA in combination with folic acid and use of noncoherent light.
Alth, G; Dobrowsky, W; Jindra, RH; Kolbabek, H; Kubin, A, 1999
)
0.3
" The decrease in bioavailability of these nutrients when the multi-micronutrient supplement is combined with a milk-based cornstarch porridge is small."( Bioavailability of iron, zinc, folate, and vitamin C in the IRIS multi-micronutrient supplement: effect of combination with a milk-based cornstarch porridge.
Donangelo, CM; Gross, R; Hoenicke, I; Jandel, D; Kamp, F; Pietrzk, K; Trugo, NM, 2003
)
0.32
" Several phase I/II trials of pemetrexed as a single agent or in combination with a platinum drug have demonstrated considerable activity in mesothelioma."( Pemetrexed alone and in combination with platinum compounds in the management of malignant mesothelioma.
Green, MR; Meyer, ML; Suwanrusme, H, 2004
)
0.32
" It is our hope that the wide use of an appropriate procedure of the trienzyme-extraction method, in combination with a reasonable detection method, help in establishing accurate and reliable food-folate tables and that this, in turn, makes it possible to accurately assess folate intake in the general population."( Trienzyme extraction in combination with microbiologic assay in food folate analysis: an updated review.
Hyun, TH; Tamura, T, 2005
)
0.33
"To demonstrate the specific killing of folate receptor (FR)-positive tumor cells can be achieved by folate-targeted penicillin-G amidase (PGA) combined with its prodrug substrate N-(phenylacetyl) doxorubicin (DOXP)."( [Anticancer activity of N-(phenylacetyl) doxorubicin combined with folate-targeted PGA].
Lin, JL; Long, N; Xiang, GY; Zeng, FB; Zhang, Q, 2005
)
0.33
" This study therefore investigated if mild depletion of folate combined with depletion of riboflavin, vitamin B-6, and vitamin B-12 could induce alterations in the Wnt pathway in the colonic mucosa."( Mild depletion of dietary folate combined with other B vitamins alters multiple components of the Wnt pathway in mouse colon.
Bronson, R; Choi, SW; Crott, JW; Jang, H; Keyes, MK; Kim, M; Laird, PW; Liu, Z; Mason, JB; Smith, DE, 2007
)
0.34
"The goal of the present report is to compare several published methods of analyzing drug-drug interaction data."( Comparison of methods for evaluating drug-drug interaction.
Au, JL; Wientjes, MG; Zhao, L, 2010
)
0.36
"To investigate the efficacy of enalapril combined with folic acid in lowering both blood pressure and plasma total homocysteine (Hcy) in essential hypertensive patients."( [Efficacy of enalapril combined with folic acid in lowering blood pressure and plasma homocysteine level].
Fu, J; Mao, GY; Qin, XH; Tang, GF; Tang, HQ, 2009
)
0.35
"As compared to enalapril alone, enalapril combined with folic acid showed a better efficacy in reducing both blood pressure and plasma Hcy level in hypertensive subjects."( [Efficacy of enalapril combined with folic acid in lowering blood pressure and plasma homocysteine level].
Fu, J; Mao, GY; Qin, XH; Tang, GF; Tang, HQ, 2009
)
0.35
"The purpose of this work was to assess synergistic inhibitory responses of a novel chemopreventive combination regimen of drugs namely, aspirin in combination with calcium and folic acid on two human colon cancer cell lines, HT-29 and SW-480."( Nanoparticulate delivery of novel drug combination regimens for the chemoprevention of colon cancer.
Chaudhary, A; Kanthamneni, N; Prabhu, S; Wang, J, 2010
)
0.36
" The findings show that supplementation with Fe and particularly in combination with vitamins could improve the haematological status as well as oxidative stress and erythrocyte membrane fluidity."( Supplementation of iron alone and combined with vitamins improves haematological status, erythrocyte membrane fluidity and oxidative stress in anaemic pregnant women.
Han, XX; Jiang, DC; Kok, FJ; Ma, AG; Schouten, EG; Sun, YY; Yang, F; Zhang, FZ, 2010
)
0.36
"Folic acid or 17-β estradiol produces antidepressant effects, either alone or combined with several antidepressants."( The folic acid combined with 17-β estradiol produces antidepressant-like actions in ovariectomized rats forced to swim.
Jaramillo, MT; Molina-Hernández, M; Olivera-López, JI; Téllez-Alcántara, NP, 2011
)
0.37
"Intra-cerebral administrations of folic acid produce antidepressant-like effects; either alone or combined with several antidepressant drugs."( Intra-lateral septal infusions of folic acid alone or combined with various antidepressant drugs produce antidepressant-like actions in male Wistar rats forced to swim.
Jaramillo, MT; Molina-Hernández, M; Olivera-López, JI; Téllez-Alcántara, NP, 2012
)
0.38
"Folic acid is antidepressant, either alone or combined with several antidepressant drugs."( Fluoxetine, 17-β estradiol or folic acid combined with intra-lateral septal infusions of neuropeptide Y produced antidepressant-like actions in ovariectomized rats forced to swim.
Molina-Hernández, M; Téllez-Alcántara, NP, 2011
)
0.37
"This is the first phase I, open-label study to assess the safety, pharmacokinetics, and antitumor activity of a novel immunotherapeutic regimen known as Folate Immune (EC90 vaccine administered with GPI-0100 adjuvant followed by EC17, a folate-targeted hapten immunotherapy that targets folate receptor expressing cancer cells), which is designed to convert poorly immunogenic tumors to highly immunogenic tumors in patients with metastatic renal cell carcinoma."( A phase I study of folate immune therapy (EC90 vaccine administered with GPI-0100 adjuvant followed by EC17) in patients with renal cell carcinoma.
Amato, RJ; Ellis, R; Low, PS; Lu, Y; Shetty, A, 2013
)
0.39
" This study determined whether early-life exposure to supplemental folic acid (FA) - that may enhance DNA methylation of target genes - in combination with ISO provides greater benefits to male bone development than ISO alone."( Adequate but not supplemental folic acid combined with soy isoflavones during early life improves bone health at adulthood in male mice.
Kaludjerovic, J; Ward, WE, 2013
)
0.39
" Application of (177)Lu-EC0800 with PMXther resulted in a two- to four-fold enhanced tumor growth delay and a prolonged survival of KB and IGROV-1 tumor-bearing mice, as compared to the combination with PMXsubther or untreated control mice."( 177Lu-EC0800 combined with the antifolate pemetrexed: preclinical pilot study of folate receptor targeted radionuclide tumor therapy.
Haller, S; Leamon, CP; Müller, C; Reber, J, 2013
)
0.39
" It was found that transient folate deprivation combined with SMs was sufficient to permit reprogramming from mouse embryonic fibroblasts (MEFs) in the presence of transcription factors, Oct4 and Klf4, within 25 days, replacing Sox2 and c-Myc, and accelerated the generation of mouse iPSCs."( Transient folate deprivation in combination with small-molecule compounds facilitates the generation of somatic cell-derived pluripotent stem cells in mice.
Fang, Y; Hu, WT; Qiu, ZD; Yan, QY; Zhang, SM, 2014
)
0.4
"To evaluate efficacy and side effects of glycididazole sodium (CMNa) combined with chemotherapy (cisplatin plus 5-FU/folic acid, PLF) and radiotherapy in treating patients with locally advanced nasopharyngeal carcinoma."( Glycididazole sodium combined with radiochemotherapy for locally advanced nasopharyngeal carcinoma.
Chen, DP; Li, MY; Liang, YY; Liu, JQ; Qi, B; Yin, WJ, 2014
)
0.4
"To explore the effect of folic acid-modified magnetic nanoparticles (FA-MNPs) combined with a 100 Hz extremely low-frequency electromagnetic field (ELF-EMF) on the apoptosis of liver cancer BEL-7402 cells."( Apoptosis selectively induced in BEL-7402 cells by folic acid-modified magnetic nanoparticles combined with 100 Hz magnetic field.
Chen, B; Chen, Z; Jiang, S; Wen, J; Yang, R; Yi, Y; Zhao, W, 2014
)
0.4
"FA-MNPs combined with a 100 Hz magnetic field significantly inhibited cell proliferation and induced higher apoptosis compared to either the ELF-EMF alone or FA-MNPs alone."( Apoptosis selectively induced in BEL-7402 cells by folic acid-modified magnetic nanoparticles combined with 100 Hz magnetic field.
Chen, B; Chen, Z; Jiang, S; Wen, J; Yang, R; Yi, Y; Zhao, W, 2014
)
0.4
"These results suggest that FA-MNPs may induce apoptosis in a cellular iron uptake-dependent manner when combined with an ELF-EMF in BEL-7402 cells."( Apoptosis selectively induced in BEL-7402 cells by folic acid-modified magnetic nanoparticles combined with 100 Hz magnetic field.
Chen, B; Chen, Z; Jiang, S; Wen, J; Yang, R; Yi, Y; Zhao, W, 2014
)
0.4
" We analyzed if the effect of invitation to food supplementation early in pregnancy combined with multiple micronutrient supplements (MMS) on infant survival represented value for money compared to invitation to food supplementation at usual time in pregnancy combined with iron-folic acid."( Cost-effectiveness of invitation to food supplementation early in pregnancy combined with multiple micronutrients on infant survival: analysis of data from MINIMat randomized trial, Bangladesh.
Ahmed, S; Lindholm, L; Persson, LÅ; Shaheen, R; Streatfield, PK, 2015
)
0.42
"The aim of the present study was to examine the apoptosis of the hepatocellular carcinoma cell line, HepG2, induced by treatment with folic acid-conjugated silica-coated gold nanorods (GNRs@SiO2-FA) in combination with radiotherapy, and to determine the involvement of apoptosis-related proteins."( GNRs@SiO₂-FA in combination with radiotherapy induces the apoptosis of HepG2 cells by modulating the expression of apoptosis-related proteins.
Gao, B; He, KW; Shen, L; Xiao, WH, 2015
)
0.42
"In this study, we aimed to investigate the association of four single nucleotide polymorphisms (SNPs) (MTHFR 677 C > T, MTHFR 1298 A > C, MTR 2756 A > G and MTRR 66 A > G), gene-gene interaction and haplotype combination with pulmonary embolism (PE) risk based on Chinese Han population."( Association of folate metabolism gene polymorphisms and haplotype combination with pulmonary embolism risk in Chinese Han population.
Cha, L; Dai, Y; Han, B; Jin, E; Li, X; Weng, L; Yan, S, 2017
)
0.46
"To investigate the effects of folic acid combined with vitamin B12 on deep vein thrombosis (DVT) in patients with homocysteine cerebral infarction."( Effects of folic acid combined with vitamin B12 on DVT in patients with homocysteine cerebral infarction.
Chang, YW; Li, ZF; Liu, SY; Shu, XJ; Wang, WH, 2017
)
0.46
" In the present study, myricetin (Myr)-loaded mesoporous silica nanoparticles (MSN) combined with multidrug resistance protein (MRP-1) siRNA was prepared."( Folic acid (FA)-conjugated mesoporous silica nanoparticles combined with MRP-1 siRNA improves the suppressive effects of myricetin on non-small cell lung cancer (NSCLC).
Ai, Y; Du, X; Song, Y; Wang, Y; Xia, Z; Zhang, J; Zhao, G; Zhou, B, 2020
)
0.56
" More importantly, compared with the group of nsPEFs alone and gold nanorods without FA, treating cells with nsPEFs combined with GNR-PEG-FA resulted in a lower percentage of viable cells, higher percentages of necrosis and apoptosis and higher concentration of active caspase 3 and induced cell cycle arrest in S phase, effectively inhibiting the proliferation of A375 melanoma cells."( Targeted gold nanorods combined with low-intensity nsPEFs enhance antimelanoma efficacy in vitro.
Li, P; Liu, Q; Mi, Y; Tang, J; Xu, J; Yang, Q, 2020
)
0.56
" PER2 overexpression combined with the targeted and controlled release of nanoagents elevated chemotherapeutic efficacy in NPC, which has potential application value for the chronotherapy of tumours."( The circadian clock gene PER2 enhances chemotherapeutic efficacy in nasopharyngeal carcinoma when combined with a targeted nanosystem.
Hou, L; Li, H; Liu, J; Ma, D; Ma, L; Wang, F; Wang, H; Wang, Z; Xia, H; Yang, Z, 2020
)
0.56
" In a recent study we explored the effect and the tolerability of the administration of Ferric Sodium EDTA in combination with vitamin C, folic acid, copper gluconate, zinc gluconate and selenomethionine (Ferachel Forte®) in "frailty" patients with secondary anemia and low kidney failure, by analysing the HRV frequency domain."( A pilot study on secondary anemia in "frailty" patients treated with Ferric Sodium EDTA in combination with vitamin C, folic acid, copper gluconate, zinc gluconate and selenomethionine: safety of treatment explored by HRV non-linear analysis as predictive
Curcio, A; Iannarelli, N; Marchitto, N; Paparello, PT; Petrucci, A; Pironti, M; Raimondi, G; Romano, A, 2020
)
0.56
" The patients were divided in 2 groups: Group A (N=23 patients) received oral administration of Ferric Sodium EDTA in combination with vitamin C, folic acid, copper gluconate, zinc gluconate and selenomethionine (Ferachel Forte®) 2 tabs/day, containing 60 mg of Fe3+, for 24 days; Group B (N=29 patients) received intravenous administration of ferrous gluconate 63 mg/day added to saline solution, while they were hospitalized (15±5 days)."( A pilot study on secondary anemia in "frailty" patients treated with Ferric Sodium EDTA in combination with vitamin C, folic acid, copper gluconate, zinc gluconate and selenomethionine: safety of treatment explored by HRV non-linear analysis as predictive
Curcio, A; Iannarelli, N; Marchitto, N; Paparello, PT; Petrucci, A; Pironti, M; Raimondi, G; Romano, A, 2020
)
0.56
"Non-linear HRV evaluation confirmed that oral administration of Ferric Sodium EDTA, in combination with vitamin C, folic acid, copper gluconate, zinc gluconate and selenomethionine (Ferachel forte®) did not impact the cardiovascular risk, without causing adverse events typically reported with other iron supplementation therapies, both oral and intravenous."( A pilot study on secondary anemia in "frailty" patients treated with Ferric Sodium EDTA in combination with vitamin C, folic acid, copper gluconate, zinc gluconate and selenomethionine: safety of treatment explored by HRV non-linear analysis as predictive
Curcio, A; Iannarelli, N; Marchitto, N; Paparello, PT; Petrucci, A; Pironti, M; Raimondi, G; Romano, A, 2020
)
0.56
"This study aimed to assess the effects of folic acid (FA) combined with a docosahexaenoic acid (DHA) intervention on the cognitive function and inflammatory cytokines in elderly subjects with mild cognitive impairment (MCI)."( Effect of folic acid combined with docosahexaenoic acid intervention on mild cognitive impairment in elderly: a randomized double-blind, placebo-controlled trial.
Bai, D; Chen, Y; Du, Y; Gao, Y; Huang, G; Li, M; Li, W; Liu, H; Ma, F; Wang, X; Weng, J, 2021
)
0.62
"Potential safety concerns relative to impaired cognitive function may exist when high folic acid exposures are combined with low vitamin B-12 status."( High folic acid or folate combined with low vitamin B-12 status: potential but inconsistent association with cognitive function in a nationally representative cross-sectional sample of US older adults participating in the NHANES.
Bailey, RL; Dwyer, JT; Gahche, JJ; Green, R; Jun, S; McCabe, GP; Miller, JW; Murphy, L; Potischman, N, 2020
)
0.56
"In this study, we developed folate-conjugated active targeting olaparib nanoparticles (ATO) and investigated the anti-tumor effect of ATO combined with radiotherapy (RT) in nude mice using cervical cancer xenograft models."( Enhanced Anti-Cancer Effect of Folate-Conjugated Olaparib Nanoparticles Combined with Radiotherapy in Cervical Carcinoma.
Chen, Y; Fu, SZ; Hu, C; Li, D; Liao, Y; Wu, JB; Yang, J, 2020
)
0.56
"The results confirmed that ATO in combination with RT significantly inhibited tumor growth and prolonged survival time of tumor-bearing mice."( Enhanced Anti-Cancer Effect of Folate-Conjugated Olaparib Nanoparticles Combined with Radiotherapy in Cervical Carcinoma.
Chen, Y; Fu, SZ; Hu, C; Li, D; Liao, Y; Wu, JB; Yang, J, 2020
)
0.56
"This study aimed to assess the effect of folic acid combined with pravastatin on atherosclerosis-related indexes in elderly patients with hypertension complicated with lacunar cerebral infarction."( Effect of folic acid combined with pravastatin on arteriosclerosis in elderly hypertensive patients with lacunar infarction.
Bu, X; Li, C; Liu, Y, 2021
)
0.62
" Nonetheless, treatment with folic acid, either singly or when combined with L-citrulline, increases NO production and inhibits PH in chronically hypoxic newborn piglets."( Folic acid, either solely or combined with L-citrulline, improves NO signaling and ameliorates chronic hypoxia-induced pulmonary hypertension in newborn pigs.
Cunningham, G; Dikalova, A; Douglass, M; Fike, CD; Kaplowitz, MR; Summar, M; Zhang, Y, 2021
)
0.62
"This research aimed to study the optimization effects of the low-rank matrix denoising (LRMD) algorithm based on the Gaussian mixture model (GMM) on MRI images of stroke patients, aiming to evaluate the effects of atorvastatin combined with folic acid on poststroke cognitive impairment (PSCI) in patients with ischemic stroke."( Evaluation of the Effects of Folic Acid Combined with Atorvastatin on the Poststroke Cognitive Impairment by Low-Rank Matrix Denoising Algorithm-Based MRI Imaging.
Fang, F; Fang, Z; Li, J; Li, X; Li, Y; Wang, J; Wang, X, 2022
)
0.72
" The aim of this study was to evaluate the use of the new oral formulation based on ferric sodium EDTA in combination with vitamin C, folic acid, copper gluconate, zinc gluconate, and selenomethionine (Ferachel Forte®) in patients with moderate CKD and functional IDA, analyzing the inflammatory status in addition to iron blood parameters, in comparison with oral ferrous sulfate and liposomal iron therapies."( Comparison of Ferric Sodium EDTA in Combination with Vitamin C, Folic Acid, Copper Gluconate, Zinc Gluconate, and Selenomethionine as Therapeutic Option for Chronic Kidney Disease Patients with Improvement in Inflammatory Status.
Curcio, A; Di Lullo, L; Giliberti, A; Marchitto, N; Nano, F; Paolozzi, F; Pironti, M; Raimondi, G, 2022
)
0.72
"To investigate the diagnostic value of accessible fingertip mean corpuscular volume (MCV) combined with a visible "beefy red" patch in the diagnosis of vitamin B12 (VB12) deficiency in local clinics and hospitals without in-house clinical laboratories, especially in remote areas."( Diagnostic value of oral "beefy red" patch combined with fingertip blood mean corpuscular volume in vitamin B12 deficiency.
Hu, H; Jiang, X; Liu, Y; Meng, W; Xiong, X; Xu, X; Yao, Y, 2022
)
0.72
"815), and "MCV > 100 fL combined with beefy red patch" has maximal specificity (0."( Diagnostic value of oral "beefy red" patch combined with fingertip blood mean corpuscular volume in vitamin B12 deficiency.
Hu, H; Jiang, X; Liu, Y; Meng, W; Xiong, X; Xu, X; Yao, Y, 2022
)
0.72
"Visible oral "beefy red" patch combined with accessible fingertip blood MCV could improve the rate of diagnosis in VB12 deficiency, especially in the elderly in local clinics and hospitals without in-house clinical laboratories in China, which is conducive to early disease detection and treatment."( Diagnostic value of oral "beefy red" patch combined with fingertip blood mean corpuscular volume in vitamin B12 deficiency.
Hu, H; Jiang, X; Liu, Y; Meng, W; Xiong, X; Xu, X; Yao, Y, 2022
)
0.72
" A2A receptor antagonists are an emerging class of agents that treat cancers by enhancing immunotherapy, both as monotherapy and in combination with other therapeutic agents."( Caffeine-folic acid-loaded-chitosan nanoparticles combined with methotrexate as a novel HepG2 immunotherapy targeting adenosine A2A receptor downstream cascade.
Gaber, M; Ghareeb, D; Hamed, A; Hamed, M; Mohamed, TM; Nofal, MS, 2023
)
0.91
"This study suggests that CAF-FA-CS-NPs (D4) in combination with MTX may be a promising candidate for cancer immunotherapy, by inhibiting A2aR signaling and leading to improved immune activation and anti-tumor activity of MTX."( Caffeine-folic acid-loaded-chitosan nanoparticles combined with methotrexate as a novel HepG2 immunotherapy targeting adenosine A2A receptor downstream cascade.
Gaber, M; Ghareeb, D; Hamed, A; Hamed, M; Mohamed, TM; Nofal, MS, 2023
)
0.91

Bioavailability

Optimizing folic acid supplementation is complex and depends on factors including dosage, type of supplement and bioavailability of folate from food. In-vivo evaluation was carried out on eight Sprague-Dawley rats in a two-way crossover study.

ExcerptReferenceRelevance
" Pteroylglutamic acid, 10 microgram/ml, added to wines and given in doses of the beverages (4 ml/kg body weight that caused inebriation, was well absorbed by six normal human volunteers (mean maximal increment in serum folate concentration +/- SEM, 71 +/- 8 ng/ml) and by seven recently intoxicated chronic alcoholics (mean increment, 94 +/- 4 ng/ml)."( The bioavailability of folic acid added to wine.
Kaunitz, JD; Lindenbaum, J, 1977
)
0.26
" 5-Methyltetrahydrofolate is readily absorbed by normal human subjects and by patients with pernicious anaemia but poorly absorbed by patients with coeliac disease or leukaemia."( Serum folates in man.
Blair, JA; Cooke, WT; Leeming, RJ; Melikian, V; Thien, KR, 1977
)
0.26
" According to the urinary recovery data, both folates were poorly absorbed in untreated coeliac sprue, but were normally absorbed after treatment."( Availability of monoglutamyl and polyglutamyl folates in normal subjects and in patients with coeliac sprue.
Halsted, CH; Reisenauer, AM; Shane, B; Tamura, T, 1978
)
0.26
" Correlation between glucose absorption rate and xylose excretion was, however, significantly (P less than 0-02)."( Absorption of xylose, glucose, glycine, and folic (pteroylglutamic) acid in Zambian Africans with anaemia.
Cook, GC, 1976
)
0.26
" The rate of absorption of from two to six of the amino acids tested was lower in 7 of the patients than in the control subjects."( Malabsorption of essential amino acids in tropical sprue.
Corcino, JJ; Klipstein, FA, 1975
)
0.25
"Intraluminal perfusion of the human small intestine has not been used extensively to study comparative bioavailability of vitamins."( Comparative bioavailability of folate and vitamin C from a synthetic and a natural source.
Cerda, JJ; Nelson, EW; Streiff, RR, 1975
)
0.25
" Based on a parallel line assay, the relative bioavailability of folate in the brewers yeast diet (109) was significantly higher than in the standard diet (PGA = 100)."( Effect of nitrite ingestion on the bioavailability of folate in the rat.
Hoppner, K; Lampi, B, 1992
)
0.28
"The intestinal absorption and in vivo kinetics of (6S)-[3H]-5-methyl-tetrahydrofolate (5-methyl-H4folate), (6S)-[3H]-5-formyl-H4folate and [3H]folic acid were investigated to determine whether inherent differences exist in the overall bioavailability of these folates in rats."( Folic acid, 5-methyl-tetrahydrofolate and 5-formyl-tetrahydrofolate exhibit equivalent intestinal absorption, metabolism and in vivo kinetics in rats.
Bhandari, SD; Gregory, JF, 1992
)
0.28
" The RDA committee used the following types of data to estimate allowances: (a) the quantity of folate required to elicit established physiologic responses or replace daily losses corrected for bioavailability and individual variability and (b) dietary folate intake data related to prevalence of deficiency in population groups."( Evaluation of a new Recommended Dietary Allowance for folate.
Bailey, LB, 1992
)
0.28
"The bioavailability of orally administered monoglutamyl folic acid and various (6S)-tetrahydrofolates was examined in humans with stable-isotope methods."( Relative bioavailability of deuterium-labeled monoglutamyl tetrahydrofolates and folic acid in human subjects.
Bailey, LB; Baumgartner, TG; Bhandari, SD; Cerda, JJ; Gregory, JF; Toth, JP, 1992
)
0.28
" The bioavailability of 5FU (compared as the AUC0-60 values) is elevated to 80%."( [Pharmacokinetic aspects of the combination of interferon-alpha-2b and folic acid with fluorouracil].
Czejka, MJ; Fogl, U; Jäger, W; Schernthaner, G; Schüller, J, 1991
)
0.28
"), but its bioavailability following oral administration appeared to be low (approximately 10%-20%)."( The pharmacokinetics of the quinazoline antifolate ICI D 1694 in mice and rats.
Calvert, AH; Gibson, W; Hughes, LR; Jodrell, DI; Newell, DR, 1991
)
0.28
" Ingestion of cholestyramine significantly reduced the bioavailability of PGA versus brewers yeast folate in rats."( Bioavailability of folate following ingestion of cholestyramine in the rat.
Hoppner, K; Lampi, B, 1991
)
0.28
"The bioavailability of orally administered mono- and polyglutamyl folates was examined in humans by using stable-isotope methods."( Relative bioavailability of deuterium-labeled monoglutamyl and hexaglutamyl folates in human subjects.
Bailey, LB; Baumgartner, TG; Bhandari, SD; Cerda, JJ; Gregory, JF; Toth, JP, 1991
)
0.28
"Folate bioavailability of beef liver, lima beans, peas, spinach, mushrooms, collards, orange juice and wheat germ was estimated with a protocol of folate depletion-repletion using growth and liver, serum and erythrocyte folate of weanling male rats."( Bioavailability of food folates and evaluation of food matrix effects with a rat bioassay.
Bills, ND; Clifford, AJ; Heid, MK; Peerson, JM, 1991
)
0.28
"Two experiments were conducted to determine the feasibility of using a folate depletion/repletion protocol with rats fed an amino acid-based diet to measure the bioavailability of food folate."( Bioavailability of folates in selected foods incorporated into amino acid-based diets fed to rats.
Bills, ND; Clifford, AJ; Jones, AD, 1990
)
0.28
" Two deuterium-labeled forms of folic acid were evaluated for simultaneous in vivo use, with quantification of relative bioavailability by measurement of urinary excretion of labeled folates."( Stable-isotope methods for assessment of folate bioavailability.
Bailey, LB; Cerda, JJ; Gregory, JF; Toth, JP, 1990
)
0.28
"The present study was designed to determine the relative folate bioavailability from diets containing human, bovine or goat milk and the relative sensitivity of various response criteria used in assessing folate bioavailability."( Relative folate bioavailability from diets containing human, bovine and goat milk.
Andrews, J; O'Connor, DL; Picciano, MF; Swiatlo, N, 1990
)
0.28
" In practice, bioavailability studies are not generally performed on a standardized level."( [Bioavailability study of micronutrients].
Pietrzik, K; Remer, T, 1989
)
0.28
" The results also suggest a role for human milk FBP in regulating the nutritional bioavailability of folate."( Effect of human milk folate binding protein on folate intestinal transport.
Horne, DW; Said, HM; Wagner, C, 1986
)
0.27
" Absolute bioavailability of the 200-mg oral dose of leucovorin based on AUC was 31% compared with that of the iv dose (6,848 vs."( Absorption kinetics of orally administered leucovorin calcium.
Gutierrez, ML; Haynes, JD; Kisicki, JC; McGuire, BW; Sia, LL; Stokstad, EL, 1987
)
0.27
" The apparent bioavailability of endogenous folate in the dried orange juice and cabbage was 146 and 68%, respectively, relative to folic acid."( Determination of folate bioavailability with a rat bioassay.
Abad, AR; Gregory, JF, 1987
)
0.27
" After 40 wk, the bioavailability of oral 3H-folic acid was investigated and showed increased fecal and reduced urinary tritium excretion in alcohol-fed monkeys compared with controls while plasma uptake and liver and whole body tritium retention were similar in both groups."( Intestinal absorption, liver uptake, and excretion of 3H-folic acid in folic acid-deficient, alcohol-consuming nonhuman primates.
Blocker, DE; Thenen, SW, 1987
)
0.27
"4 or 176 micrograms of folate to test meals containing 13 micrograms Zn did not affect the bioavailability of Zn as measured by the retention of 65Zn by the liver and kidney."( Folic acid: effect on zinc absorption in humans and in the rat.
Keating, JN; King, JC; Stokstad, EL; Wada, L, 1987
)
0.27
"The Wernicke-Korsakoff syndrome is a rare neurological disorder which strikes primarily alcoholics and is caused, at least in part, by insufficient bioavailability of thiamin."( Current progress toward the prevention of the Wernicke-Korsakoff syndrome.
Bishai, DM; Bozzetti, LP, 1986
)
0.27
" This has place a greater emphasis on the bioavailability of nutrients in foods because the total intake of nutrients is generally closely linked with total caloric intake."( Bioavailability of vitamins.
Sauberlich, HE, 1985
)
0.27
" Generally speaking the absorption rate appeared to be inversely related to the length of the gamma glutamyl side chain."( Studies on the absorption and metabolism of folic acid. I. Folate absorption in the dog after exposure of isolated intestinal segments to synthetic pteroylpolyglutamates of various chain lengths.
Baker, HJ; Baugh, CM; Butterworth, CE; Krumdieck, CL, 1971
)
0.25
"Low bioavailability of folacin has been previously reported for a variety of foods of plant origin."( Effects of dietary fiber on the bioavailability of folic acid monoglutamate.
Damron, BL; Gregory, JF; Ristow, KA, 1982
)
0.26
"The oral bioavailability of zinc was studied in nonpregnant adults before and 24 hours after two weeks of oral supplementation with iron and folic acid."( Oral iron and the bioavailability of zinc.
Grainger, SL; Keeling, PW; Meadows, NJ; Ruse, W; Thompson, RP, 1983
)
0.27
"Biochemical investigations show a decreased bioavailability of 5-methyl-tetrahydrofolic acid in vitamin B12 deficient human cell cultures and bone marrow cells."( [Vitamin B12 as a regulator and methotrexate as an antagonist of folic acid metabolism. Pathophysiologic and clinical aspects].
Sauer, H, 1983
)
0.27
"The bioavailability of folic acid and trimethoprim was investigated from a combination preparation of folic acid (0."( Bioavailability of a combination preparation of trimethoprim and folic acid.
Kleimola, T; Soininen, K, 1983
)
0.27
"The drug diphenylhydantoin (phenytoin) (DPH) is thought to interfere with the bioavailability of dietary folate through an effect on intestinal folate deconjugation and/or monoglutamate folate transport."( The effect of diphenylhydantoin (phenytoin) on the sequential stages of intestinal folate absorption.
Cerda, JJ; Crick, WF; Nelson, EW; Streiff, RR; Wilder, BJ, 1983
)
0.27
" These results suggest that milk FBP has some nutritional effects on the bioavailability of folate in vivo."( Some nutritional effects of folate-binding protein in bovine milk on the bioavailability of folate to rats.
Iwai, K; Tani, M, 1984
)
0.27
" Further research is needed to clarify the biological significance of these findings with respect to potential differences in folacin bioavailability from breast milk, pasteurized cows' milk and infant formulas."( Denaturation of the folacin-binding protein in pasteurized milk products.
Gregory, JF, 1982
)
0.26
" The absorption rate constant was decreased for folic acid in the coeliac group, but increased for propranolol."( Altered jejunal surface pH in coeliac disease: its effect on propranolol and folic acid absorption.
Allan, RN; Bishop, H; Blair, JA; Kitis, G; Lucas, ML; Sargent, A; Schneider, RE, 1982
)
0.26
"In a study of apparently healthy volunteers (5 male, 5 female) the bioavailability of iron and folacin was calculated using Tardyferon¿ resp."( [Investigation or oral substitution of iron and folic acid (author's transl)].
Hötzel, D; Pietrzik, K, 1980
)
0.26
" The area under the curve (AUC) of the pre- and postprandial (1, 2, 3, 5 and 7 h) serum pteroylglutamate following ingestion of increasing levels of chemically pure pteroylmonoglutamic acid was used to derive a regression for the 100% bioavailability of dietary pteroylglutamic acid."( Pteroylglutamic (folic) acid in different feedstuffs: the pteroylglutamate content and an attempt to measure the bioavailability in pigs.
Girard, CL; Matte, JJ, 1994
)
0.29
" The individual bioavailability ratios of AUC(0-12) (A versus B) varied between 49."( [Absolute bioavailability of folic acid after oral administration of a folic acid tablet formulation in healthy volunteers].
Achtert, G; Menke, A; Menke, G; Schuster, O; Weimann, HJ, 1994
)
0.29
"This study was designed to assess the effect of succinylsulfathiazole on the apparent bioavailability of folate added to milk-containing diets."( Folate bioavailability from milk-containing diets is affected by altered intestinal biosynthesis of folate in rats.
Allen, OB; O'Connor, DL; Semchuk, GM, 1994
)
0.29
" As the bioavailability of folates is influenced by a variety of factors and different methods were employed for assessing bioavailability there is a considerable inconsistency in the results of these studies."( [Dietary folates--a timely review. Stability, physiological significance, bioavailability, analytical determination methods, effect of food handling].
Diehl, JF; Pfeiffer, C; Schwack, W, 1994
)
0.29
"The pharmacokinetics and the relative bioavailability of iron and of folic acid was investigated in a randomized, balanced 2-way cross-over study with 14 healthy male participants."( [Pharmacokinetics and relative bioavailability of iron and folic acid in healthy volunteers].
Menke, A; Menke, G; Müller, J; Schuster, O; Weimann, HJ, 1993
)
0.29
" These results indicate that zinc deficiency in pregnant rats decreases folate bioavailability of folinic acid, folate polyglutamates and, to a lesser extent, that of folate monoglutamate."( Zinc deficiency and dietary folate metabolism in pregnant rats.
Blache, D; Coudray, C; Faure, P; Favier, A; Favier, M; Roussel, AM, 1993
)
0.29
" Methanol is well absorbed following inhalation, ingestion or cutaneous exposure."( Methanol toxicity. Agency for Toxic Substances and Disease Registry.
, 1993
)
0.29
" Thus, heat processing of milk not only reduced the amount of 5-CH3 THF significantly, but also changed the concentration of FBP and the folate-binding capacity of FBP, which may have implications on the bioavailability of milk folates."( Effect of milk processing on the concentration of folate-binding protein (FBP), folate-binding capacity and retention of 5-methyltetrahydrofolate.
Hansen, I; Holm, J; Høier-Madsen, M; Jägerstad, M; Wigertz, K, 1996
)
0.29
" The results suggest that tumors can compensate for low folate bioavailability by up-regulation of a second FR with slightly lower affinity for folic acid."( The role of dietary folate in modulation of folate receptor expression, folylpolyglutamate synthetase activity and the efficacy and toxicity of lometrexol.
Gates, SB; Grindey, GB; Habeck, LL; Mendelsohn, LG; Shackelford, KA; Shih, C; Worzalla, J, 1996
)
0.29
" This study was conducted to evaluate in vivo the bioavailability of [2H4]folic acid (d4-PteGlu1) and [2H2]-pteroylhexaglutamate (d2-PteGlu6) administered in solution in water or citrate buffer or added to selected foods using a single-dose, dual-label protocol."( Bioavailability for humans of deuterium-labeled monoglutamyl and polyglutamyl folates is affected by selected foods.
Bailey, LB; Gregory, JF; Toth, JP; Wei, MM, 1996
)
0.29
" Data on bioavailability and distribution volume were obtained from two patients and two healthy controls by performing both intravenous and peroral Hcy loading."( Kinetic basis of hyperhomocysteinemia in patients with chronic renal failure.
Guttormsen, AB; Refsum, H; Svarstad, E; Ueland, PM, 1997
)
0.3
" To test these hypotheses, we determined the bioavailability of folate in serum and in ascitic/cystic fluids of ovarian carcinoma patients (n = 36)."( Homocysteine accumulation in human ovarian carcinoma ascitic/cystic fluids possibly caused by metabolic alteration of the methionine cycle in ovarian carcinoma cells.
Boiocchi, M; Corona, G; Donada, C; Fabris, M; Toffoli, G; Viel, A; Zarrelli, A, 1997
)
0.3
" However, research to establish the lowest effective dose of dietary folate/supplemental folic acid to optimise homocysteine levels and research on the bioavailability of folate is required."( Folate intake in Europe: recommended, actual and desired intake.
Brouwer, IA; de Bree, A; Steegers-Theunissen, RP; van Dusseldorp, M; van het Hof, KH, 1997
)
0.3
" pylori-induced gastritis, and the bioavailability of folates."( Coronary artery disease associated with Helicobacter pylori infection is at least partially due to inadequate folate status.
Markle, HV, 1997
)
0.3
" In view of this very limited short-term plasma response even with a relatively large oral dose, presumably due to hepatic first-pass uptake, these findings suggest that plasma kinetics would be of limited usefulness in assessing the relative bioavailability of nutritionally relevant oral doses of labeled folate."( A dual-label stable-isotopic protocol is suitable for determination of folate bioavailability in humans: evaluation of urinary excretion and plasma folate kinetics of intravenous and oral doses of [13C5] and [2H2]folic acid.
Bailey, LB; Gregory, JF; Pfeiffer, CM; Rogers, LM, 1997
)
0.3
" Estimation of dietary folate is difficult because nutrient data bases lack this nutrient in many countries and bioavailability is variable."( Quantitative responses of serum folate to increasing intakes of folic acid in healthy women.
Kounnavong, S; Truswell, AS, 1997
)
0.3
"We studied the effects of 5-MTHF on NO bioavailability in vivo in 10 patients with FH and 10 matched control subjects by venous occlusion plethysmography, using serotonin and nitroprusside as endothelium-dependent and -independent vasodilators."( 5-methyltetrahydrofolate, the active form of folic acid, restores endothelial function in familial hypercholesterolemia.
Kastelein, JJ; Koomans, HA; Rabelink, TJ; van Dam, T; Verhaar, MC; Wever, RM, 1998
)
0.3
"Fasting serum folate levels are commonly used in assessing folate status and also in estimating the bioavailability of synthetic folic acid and food folate."( The effects of fasting and refeeding healthy volunteers on serum folate levels.
Cahill, E; Gibney, MJ; McPartlin, J, 1998
)
0.3
"Numerous oral iron preparations are available for the treatment of iron deficiency anemia but only very few studies have been designed to measure the bioavailability of iron preparations."( Bioavailability of the iron formulated as natural ferric protein (TM/FMOA) and natural ferric protein + folic acid (TM/FMOA+FOL).
Coronel, P; Gimeno, M; González-Peñas, E; Martinez, P,
)
0.13
"The intestinal absorption of folate occurs at the monoglutamyl level, and an important measure of food folate bioavailability is how much folate from the food reaches the intestinal sites in forms that can readily be absorbed."( Properties of food folates determined by stability and susceptibility to intestinal pteroylpolyglutamate hydrolase action.
Selhub, J; Seyoum, E, 1998
)
0.3
" The bioavailability of key minerals such as iron, zinc and calcium is known to be significantly affected by the fiber, phytic acid, and tannin content of foods."( The impact of food processing on the nutritional quality of vitamins and minerals.
Love, M; Reddy, MB, 1999
)
0.3
" The aim of this study was to determine the relative bioavailability of natural folate from aleurone flour when ingested as a cereal."( Aleurone flour is a rich source of bioavailable folate in humans.
Clifton, P; Fenech, M; Noakes, M; Topping, D, 1999
)
0.3
" From the amount of additional folate (350 microgram/d) and folic acid (250 microgram/d) consumed, the relative bioavailability of dietary folate compared to folic acid was calculated to be 60-98%, depending on the endpoint used."( Dietary folate from vegetables and citrus fruit decreases plasma homocysteine concentrations in humans in a dietary controlled trial.
Brouwer, IA; Duran, M; Eskes, TK; Hautvast, JG; Meyboom, S; Steegers-Theunissen, RP; Thomas, CM; van Dusseldorp, M; van het Hof, KH; West, CE, 1999
)
0.3
"The design of targeted oral liposomes is anticipated to improve the systemic delivery of poorly absorbed agents, such as proteins and peptides."( Folic acid-PEO-labeled liposomes to improve gastrointestinal absorption of encapsulated agents.
Anderson, KE; Rogers, JA; Stevenson, BR, 1999
)
0.3
"Our objective was to update 2 national food consumption surveys to reflect folate intakes as a result of the recently initiated food fortification program and to correct folate intakes for the apparently higher bioavailability of synthetic folic acid (SFA; ie, folate added to foods or from dietary supplements) than of naturally occurring folate so as to express intakes as dietary folate equivalents."( Estimated folate intakes: data updated to reflect food fortification, increased bioavailability, and dietary supplement use.
Crane, NT; Lewis, CJ; Wilson, DB; Yetley, EA, 1999
)
0.3
" Currently, knowledge on the bioavailability of these compounds from vegetables is limited."( Influence of feeding different vegetables on plasma levels of carotenoids, folate and vitamin C. Effect of disruption of the vegetable matrix.
Pietrzik, K; Tijburg, LB; van het Hof, KH; Weststrate, JA, 1999
)
0.3
"In this crossover, single-blind study, the bioavailability of B12 and folate, fasting and postprandially, was measured in 30 pregnant women for two prenatal multivitamin/multimineral supplements (Stuartnatal Plus and Materna, Wyeth-Ayerst Pharmaceuticals, Philadelphia, PA) and a placebo."( Vitamin B12 and folate bioavailability from two prenatal multivitamin/multimineral supplements.
Conway, ME; Dawson, EB; Evans, DR; McGanity, WJ, 2000
)
0.31
"The effect of the food matrix and dietary fibre on the bioavailability of folate is not known."( Bioavailability of folate from processed spinach in humans. Effect of food matrix and interaction with carotenoids.
Brouwer, IA; Castenmiller, JJ; Thomas, CM; van de Poll, CJ; van Dusseldorp, M; West, CE, 2000
)
0.31
" The bioavailability of folate in the vitamin preparation is approximately double that of dietary folate."( The importance of folic acid.
Berg, MJ,
)
0.13
" Finally, one of the most important aspects of determining bioavailability in developing reference intakes is that as new information emerges, new complexities enter into the process."( National nutrition and public health policies: issues related to bioavailability of nutrients when developing dietary reference intakes.
Yates, AA, 2001
)
0.31
"Folate nutritional status depends on intake from food and supplements as well as on the bioavailability of the various ingested forms of this vitamin."( Case study: folate bioavailability.
Gregory, JF, 2001
)
0.31
" Homocysteine levels are regulated by folate bioavailability and also by the methyl donor S-adenosylmethionine (SAM) and its metabolite S-adenosylhomocysteine (SAH)."( Endothelial dysfunction and elevation of S-adenosylhomocysteine in cystathionine beta-synthase-deficient mice.
Arning, E; Bottiglieri, T; Dayal, S; Faraci, FM; Heistad, DD; Lentz, SR; Maeda, N; Malinow, MR; Sigmund, CD, 2001
)
0.31
" The folates in both DBCPs proved to have equally high bioavailability in the pigs."( Digested bacterial cell powder (DBCP) as a source of reduced-form folates for pigs: use of a trimethoprim-resistant strain and the bioavailability of folates in DBCP.
Kokue, E; Miyashiro, S; Mizuno, Y; Takeuchi, H; Tominaga, M; Toride, Y, 2001
)
0.31
"To demonstrate utility of folic acid-coated liposomes for enhancing the delivery of a poorly absorbed glycopeptide, vancomycin."( Formulation and evaluation of a folic acid receptor-targeted oral vancomycin liposomal dosage form.
Anderson, KE; Eliot, LA; Rogers, JA; Stevenson, BR, 2001
)
0.31
"5-fold increase in relative bioavailability for uncoated and FA-PEO-Chol-coated liposomes, respectively, compared with an oral solution."( Formulation and evaluation of a folic acid receptor-targeted oral vancomycin liposomal dosage form.
Anderson, KE; Eliot, LA; Rogers, JA; Stevenson, BR, 2001
)
0.31
" The recommendations should provide a margin of safety to allow for decreased intake, increased requirements, individual variability and bioavailability of natural food folates."( Importance of folate in human nutrition.
Krishnaswamy, K; Madhavan Nair, K, 2001
)
0.31
" The increased bioavailability of synthetic folic acid (SFA) was included in the analysis."( Folate fortification: potential impact on folate intake in an older population.
Bantick, JM; Flood, VM; Macintyre, R; Mitchell, P; Rubin, GL; Sindhusake, D; Smith, W; Webb, KL, 2001
)
0.31
"In healthy humans, continuous treatment with nitroglycerin (GTN) causes nitric oxide synthase dysfunction, probably through the reduced bioavailability of tetrahydrobiopterin."( Folic acid prevents nitroglycerin-induced nitric oxide synthase dysfunction and nitrate tolerance: a human in vivo study.
Ahmed, S; Al-Hesayen, A; Burstein, JM; Gori, T; Kelly, S; Miner, SE; Parker, JD, 2001
)
0.31
" We hypothesize that the reduced bioavailability of tetrahydrobiopterin is involved in the pathogenesis of both phenomena."( Folic acid prevents nitroglycerin-induced nitric oxide synthase dysfunction and nitrate tolerance: a human in vivo study.
Ahmed, S; Al-Hesayen, A; Burstein, JM; Gori, T; Kelly, S; Miner, SE; Parker, JD, 2001
)
0.31
" The supply of folate depends primarily on the quantity and bioavailability of ingested folate and the rate of loss by urinary and fecal routes and through catabolism."( Prevention of pathologies associated with oxidative stress and dietary intake deficiencies: folate deficiency and requirements.
Gaté, L; Machover, D; Tapiero, H; Tew, KD, 2001
)
0.31
"With the recent implementation of the folic-acid-fortification program, our objective was to estimate its benefits in adult women and account for the higher bioavailability of synthetic folic acid in fortification programs and supplements."( Estimates of the effects of folic-acid fortification and folic-acid bioavailability for women.
Boushey, CJ; Edmonds, JW; Welshimer, KJ, 2001
)
0.31
" Fortification was simulated with the use of fortification standards (140 microg/100 g of flour) and new bioavailability standards for synthetic folic acid."( Estimates of the effects of folic-acid fortification and folic-acid bioavailability for women.
Boushey, CJ; Edmonds, JW; Welshimer, KJ, 2001
)
0.31
" Endothelial dysfunction due to reduced nitric oxide bioavailability is an early feature of vascular pathology."( Folate, homocysteine, endothelial function and cardiovascular disease. What is the link?
Ashfield-Watt, PA; Doshi, SN; McDowell, IF; Moat, SJ, 2001
)
0.31
" The evaluation of dietary folate is complicated by data gaps in food composition tables, the unreliability of existing food data, variations between methods used for folate analysis and limited understanding of the bioavailability of food folate."( Evaluation of the significance of dietary folate from wild vegetables in Vietnam.
Johannesson, L; Johansson, M; Ogle, BM; Tuyet, HT, 2001
)
0.31
" Reduced endothelium-dependent relaxation in the coronary and systemic circulation due to decreased bioavailability of nitric oxide (NO) and increased release of oxygen-derived free radicals promotes the adhesion of leukocytes, thrombosis, inflammation, cell proliferation, and increases in vascular tone."( Endothelium and atherogenesis: endothelial therapy revisited.
Barton, M; Haudenschild, CC, 2001
)
0.31
"Folate depletion/repletion rat models are popular protocols for assessing the bioavailability of folate."( Plasma, liver and kidney folate and plasma homocysteine concentrations are poor response variables at very low dietary folate intakes, in a folate depletion/repletion rat model.
O'Leary, K; Sheehy, PJ, 2002
)
0.31
" The beneficial effect appears to be independent of its homocysteine-lowering capacity and is possibly related to an improved bioavailability of nitric oxide."( Is folate a promising agent in the prevention and treatment of cardiovascular disease in patients with renal failure?
De Vriese, AS; Lameire, NH; Schrijvers, BF; Verbeke, F, 2002
)
0.31
" The hypothesis that the matrix of some cereal-product vehicles may result in low fortificant bioavailability was tested using a dual oral/intravenous (i."( Use of an oral/intravenous dual-label stable-isotope protocol to determine folic acid bioavailability from fortified cereal grain foods in women.
Finglas, PM; Maunder, P; Mellon, FA; Ridge, B; Southon, S; Vahteristo, L; Witthöft, CM; Wright, AJ, 2002
)
0.31
" Folate acts directly to produce antioxidant effects, interactions with enzyme endothelial NO synthase (eNOS) and effects on cofactor bioavailability of NO."( Physiology of folic acid in health and disease.
Stanger, O, 2002
)
0.31
" This enzymatic deconjugation might limit the bioavailability of polyglutamate folate."( Dietary monoglutamate and polyglutamate folate are associated with plasma folate concentrations in Dutch men and women aged 20-65 years.
Bjørke-Monsen, AL; de Bree, A; Melse-Boonstra, A; Verhoef, P; Verschuren, WM, 2002
)
0.31
" Furthermore these studies would have to be targeted to individuals with common genetic polymorphisms that alter the bioavailability of specific micronutrients and the affinity of specific key enzymes involved in DNA metabolism for their micronutrient co-factor."( Micronutrients and genomic stability: a new paradigm for recommended dietary allowances (RDAs).
Fenech, M, 2002
)
0.31
" Further research is needed to clarify the role of choline and methionine concentration and the importance of the reduced folate carrier and the folate receptor in determining the relative bioavailability of 5-MeTHF and FA with regard to genome stability."( A comparison of folic acid and 5-methyltetrahydrofolate for prevention of DNA damage and cell death in human lymphocytes in vitro.
Fenech, M; Wang, X, 2003
)
0.32
" However, studies on bioavailability of endogenous folates, in particular of cereal sources, are scarce."( Functionality of endogenous folates from rye and orange juice using human in vivo model.
Bärlund, S; Kariluoto, S; Kärkkäinen, M; Lamberg-Allardt, C; Piironen, V; Salovaara, H; Vahteristo, L, 2002
)
0.31
" Folates from different rye products and orange juice showed good bioavailability that was similar to folic acid from fortified white bread."( Functionality of endogenous folates from rye and orange juice using human in vivo model.
Bärlund, S; Kariluoto, S; Kärkkäinen, M; Lamberg-Allardt, C; Piironen, V; Salovaara, H; Vahteristo, L, 2002
)
0.31
" This decision needs knowledge about the bioavailability of folic acid from fortified foods."( Study of wheat breakfast rolls fortified with folic acid. The effect on folate status in women during a 3-month intervention.
Bruce, A; Jägerstad, M; Johansson, M; Witthöft, CM, 2002
)
0.31
" Mechanisms responsible for endothelial dysfunction in hyperhomocyst(e)inemia may involve impaired bioavailability of NO, possibly secondary to accumulation of the endogenous NO synthase inhibitor asymmetric dimethylarginine (ADMA) and increased oxidative stress."( ADMA and oxidative stress are responsible for endothelial dysfunction in hyperhomocyst(e)inemia: effects of L-arginine and B vitamins.
Arakawa, N; Bode-Böger, SM; Böger, RH; Frölich, JC; Hornig, B; Schwedhelm, E; Sydow, K; Tsikas, D, 2003
)
0.32
" The processing of tomatoes may significantly affect the bioavailability of these nutrients."( Tomatoes and cardiovascular health.
Catignani, GL; Lazarus, S; Willcox, JK, 2003
)
0.32
"To provide a tool to study folate bioavailability under controlled conditions, a methodology was developed to produce extracts representative of natural food folates but removed from their matrix and sufficiently concentrated so as to elicit a response in biomarkers of folate status without distorting usual dietary intake patterns."( Protocol for the production of concentrated extracts of food folate for use in human bioavailability studies.
Alexander, J; Hughes, J; McCreedy, R; McKillop, DJ; McNulty, H; Patterson, K; Pentieva, KD; Scott, JM; Strain, JJ, 2003
)
0.32
": To determine the relative bioavailability of oral low-dose methotrexate administered with and without concomitant folic acid vs."( Bioavailability of oral vs. subcutaneous low-dose methotrexate in patients with Crohn's disease.
Almog, S; Bar-Meir, S; Chowers, Y; Fishbein, E; Halkin, H; Kurnik, D; Loebstein, R, 2003
)
0.32
"In patients with stable Crohn's disease, the oral bioavailability of methotrexate is highly variable and averages 73% of that of subcutaneous administration."( Bioavailability of oral vs. subcutaneous low-dose methotrexate in patients with Crohn's disease.
Almog, S; Bar-Meir, S; Chowers, Y; Fishbein, E; Halkin, H; Kurnik, D; Loebstein, R, 2003
)
0.32
"A pilot study was performed to prove the suitability of stable isotope dilution assays for assessing the bioavailability of endogenous folates in foods."( Application of stable isotope dilution assays based on liquid chromatography-tandem mass spectrometry for the assessment of folate bioavailability.
Bitsch, I; Frank, T; Netzel, M; Pfannebecker, I; Rychlik, M, 2003
)
0.32
" Discrepancies were observed in the evidence base for folate bioavailability, especially with regard to the relative bioavailability of natural folates compared with folic acid."( Folate bioavailability: UK Food Standards Agency workshop report.
Finglas, PM; Gregory, JF; Mastroiacovo, P; McDowell, IF; McNulty, H; Melse-Boonstra, A; Sanderson, P, 2003
)
0.32
" Oral bioavailability of these compounds is usually poor due to a combination of incompatible physicochemical properties, resulting in low cellular penetration, and high susceptibility to metabolic enzymes present within the gastrointestinal tract."( [Endocytosis mediated by receptors--function and participation in oral drug delivery].
Zuwała-Jagiełło, J, 2003
)
0.32
"The effect of combining a multi-micronutrient supplement with a milk-based cornstarch porridge on the bioavailability of iron, zinc, folate, and vitamin C was evaluated using the plasma curve response over time (8 hours) in healthy women."( Bioavailability of iron, zinc, folate, and vitamin C in the IRIS multi-micronutrient supplement: effect of combination with a milk-based cornstarch porridge.
Donangelo, CM; Gross, R; Hoenicke, I; Jandel, D; Kamp, F; Pietrzk, K; Trugo, NM, 2003
)
0.32
" The parameter used to quantify absorption was the absorption rate constant, determined in situ by means of a loop perfusion technique, performed in colon and in whole small intestine of rat at three pHs (5."( Kinetic modeling of triamterene intestinal absorption and its inhibition by folic acid and methotrexate.
Bermejo, M; García-Valcárcel, I; Garrigues, TM; Merino, V; Montalar, M; Nalda-Molina, R; Rodríguez-Ibáñez, M, 2003
)
0.32
" The effect of FBP on folate bioavailability has been widely discussed."( Bioaccessibility of folic acid and (6S)-5-methyltetrahydrofolate decreases after the addition of folate-binding protein to yogurt as studied in a dynamic in vitro gastrointestinal model.
Arkbåge, K; Havenaar, R; Verwei, M; Witthöft, C, 2003
)
0.32
" Endothelial dysfunction refers mainly to reduced bioavailability of nitric oxide (NO), which is involved in homocysteinemediated vascular damage."( Interactions of homocysteine, nitric oxide, folate and radicals in the progressively damaged endothelium.
Stanger, O; Weger, M, 2003
)
0.32
" Currently, examination of the relationships between common gene polymorphisms involved in C1 metabolism and folate bioavailability and folate status, morbidity, mortality and longevity is evaluated as a series of individual associations."( Is there more to folates than neural-tube defects?
Dainty, JR; Finglas, PM; Hart, DJ; Wolfe, CA; Wright, AJ; Wright, DM, 2003
)
0.32
" This could result in different bioavailability from folic acid- and 5-CH3-H4folate-fortified milk products."( The binding of folic acid and 5-methyltetrahydrofolate to folate-binding proteins during gastric passage differs in a dynamic in vitro gastrointestinal model.
Arkbåge, K; Groten, J; Havenaar, R; Mocking, H; Verwei, M, 2004
)
0.32
" In addition, we investigated the bioavailability of calcium added to mineral water by measuring urinary calcium excretion and serum alkaline phosphatase activity."( Mineral water fortified with folic acid, vitamins B6, B12, D and calcium improves folate status and decreases plasma homocysteine concentration in men and women.
Karvonen, HM; Niskanen, LK; Sarkkinen, ES; Tapola, NS, 2004
)
0.32
" All pharmacokinetic parameters demonstrate that the bioavailability of 5-MTHF is higher compared to folic acid."( Pharmacokinetic study on the utilisation of 5-methyltetrahydrofolate and folic acid in patients with coronary artery disease.
Aengevaeren, WR; Blom, HJ; Boers, GH; Verheugt, FW; Willems, FF, 2004
)
0.32
"The bioavailability of dietary folate has been estimated to be approximately 50% of that of synthetic folic acid."( Bioavailability of heptaglutamyl relative to monoglutamyl folic acid in healthy adults.
Katan, MB; Kok, FJ; Melse-Boonstra, A; Verhoef, P; West, CE, 2004
)
0.32
"Our goal was to quantify the bioavailability and bioefficacy of low doses of polyglutamyl folic acid relative to that of monoglutamyl folic acid."( Bioavailability of heptaglutamyl relative to monoglutamyl folic acid in healthy adults.
Katan, MB; Kok, FJ; Melse-Boonstra, A; Verhoef, P; West, CE, 2004
)
0.32
" The relative bioavailability of polyglutamyl folic acid was 64% (52%, 75%) on the basis of serum folate and was 68% (51%, 84%) on the basis of erythrocyte folate concentrations."( Bioavailability of heptaglutamyl relative to monoglutamyl folic acid in healthy adults.
Katan, MB; Kok, FJ; Melse-Boonstra, A; Verhoef, P; West, CE, 2004
)
0.32
"The natural folate derivative, 5-methyltetrahydrofolate ([6S]-5-MTHF), could be an option for supplementation and fortification but its bioavailability remains unclear."( The short-term bioavailabilities of [6S]-5-methyltetrahydrofolate and folic acid are equivalent in men.
Connolly, E; Krämer, K; McKillop, DJ; McNulty, H; McPartlin, JM; Molloy, A; Pentieva, K; Reichert, R; Scott, JM; Strain, JJ; Ward, M, 2004
)
0.32
" Endothelial nitric oxide bioavailability was assessed by flow-mediated dilatation."( Short-term high-dose folic acid does not alter markers of endothelial cell damage in patients with coronary heart disease.
Doshi, SN; Giddings, JC; Goodfellow, J; Lewis, MJ; McDowell, IF; Moat, SJ, 2004
)
0.32
"001) and nitric oxide bioavailability improved (47+/-35 vs."( Short-term high-dose folic acid does not alter markers of endothelial cell damage in patients with coronary heart disease.
Doshi, SN; Giddings, JC; Goodfellow, J; Lewis, MJ; McDowell, IF; Moat, SJ, 2004
)
0.32
"These data suggest that endothelial markers are not useful surrogates of endothelial nitric oxide bioavailability in coronary heart disease and may be a less sensitive marker of endothelial function than nitric oxide."( Short-term high-dose folic acid does not alter markers of endothelial cell damage in patients with coronary heart disease.
Doshi, SN; Giddings, JC; Goodfellow, J; Lewis, MJ; McDowell, IF; Moat, SJ, 2004
)
0.32
"It showed that the bioavailability and the expression of vitamin A, folate and vitamin E are very important to the analysis methods, the nutrition labeling, the food composition database and the determination of DRIs."( [Bioavailability and expression method of vitamin A, folate and vitamin E in foods].
Wen, X, 2004
)
0.32
"Dietary reference intakes for folate rely on a good estimate of folate bioavailability from the general diet."( Quantifying folate bioavailability: a critical appraisal of methods.
Melse-Boonstra, A; Verhoef, P; West, C, 2004
)
0.32
" Although many studies have been performed on the bioavailability of specific folate compounds and of folate from single foods, reliable data in which the bioavailability of folate from total diets have been measured are currently lacking."( Quantifying folate bioavailability: a critical appraisal of methods.
Melse-Boonstra, A; Verhoef, P; West, C, 2004
)
0.32
"A multiple oral dose design is the best approach for measuring folate bioavailability because there are several serious drawbacks to designs based on the use of a single oral dose."( Quantifying folate bioavailability: a critical appraisal of methods.
Melse-Boonstra, A; Verhoef, P; West, C, 2004
)
0.32
"Our aim was to study the bioavailability of polyglutamyl folic acid relative to that of monoglutamyl folic acid across GCPII 1561 genotypes."( Bioavailability of polyglutamyl folic acid relative to that of monoglutamyl folic acid in subjects with different genotypes of the glutamate carboxypeptidase II gene.
Blom, HJ; Lievers, KJ; Melse-Boonstra, A; Verhoef, P, 2004
)
0.32
" The bioavailability of heptaglutamyl folic acid relative to that of monoglutamyl folic acid was calculated by using the changes in serum folate concentration in the treatment groups, after correction for changes in the placebo group and for the administered dose."( Bioavailability of polyglutamyl folic acid relative to that of monoglutamyl folic acid in subjects with different genotypes of the glutamate carboxypeptidase II gene.
Blom, HJ; Lievers, KJ; Melse-Boonstra, A; Verhoef, P, 2004
)
0.32
" The bioavailability of heptaglutamyl folic acid relative to that of monoglutamyl folic acid was not significantly different between subjects with the CC (64%; 52%, 76%) and CT genotypes (70%; 49%, 91%)."( Bioavailability of polyglutamyl folic acid relative to that of monoglutamyl folic acid in subjects with different genotypes of the glutamate carboxypeptidase II gene.
Blom, HJ; Lievers, KJ; Melse-Boonstra, A; Verhoef, P, 2004
)
0.32
"The 1561T allele of the GCPII gene does not impair the bioavailability of polyglutamyl folic acid."( Bioavailability of polyglutamyl folic acid relative to that of monoglutamyl folic acid in subjects with different genotypes of the glutamate carboxypeptidase II gene.
Blom, HJ; Lievers, KJ; Melse-Boonstra, A; Verhoef, P, 2004
)
0.32
"The concept of dietary folate equivalents (DFEs) in the United States recognizes the differences in bioavailability between natural food folates and the synthetic vitamin, folic acid."( Determining bioavailability of food folates in a controlled intervention study.
Armstrong, NC; Bradbury, I; Dunn, AA; Hannon-Fletcher, MP; Kerr, MA; McNulty, H; Molloy, AM; Pentieva, K; Scott, JM; Strain, JJ; Ward, M, 2004
)
0.32
"We compared the bioavailability of food folates with that of folic acid under controlled conditions."( Determining bioavailability of food folates in a controlled intervention study.
Armstrong, NC; Bradbury, I; Dunn, AA; Hannon-Fletcher, MP; Kerr, MA; McNulty, H; Molloy, AM; Pentieva, K; Scott, JM; Strain, JJ; Ward, M, 2004
)
0.32
" Overall estimations of folate bioavailability relative to that of folic acid were found to be between 30% (spinach) and 59% (yeast)."( Determining bioavailability of food folates in a controlled intervention study.
Armstrong, NC; Bradbury, I; Dunn, AA; Hannon-Fletcher, MP; Kerr, MA; McNulty, H; Molloy, AM; Pentieva, K; Scott, JM; Strain, JJ; Ward, M, 2004
)
0.32
"Relative bioavailability estimates were consistent with the estimates from the metabolic study that were used as a basis to derive the US DFE value."( Determining bioavailability of food folates in a controlled intervention study.
Armstrong, NC; Bradbury, I; Dunn, AA; Hannon-Fletcher, MP; Kerr, MA; McNulty, H; Molloy, AM; Pentieva, K; Scott, JM; Strain, JJ; Ward, M, 2004
)
0.32
" Determination of the bioavailability of these nutrients is a critical step before commencing a fortification program."( Na2EDTA enhances the absorption of iron and zinc from fortified rice flour in Sri Lankan children.
Abrams, SA; Hettiarachchi, M; Hilmers, DC; Liyanage, C, 2004
)
0.32
"The objective was to evaluate whether cow milk enhances the bioavailability of food folate in humans."( Effect of cow milk on food folate bioavailability in young women.
Dirienzo, DB; Fishell, VK; Johnston, KE; Kris-Etherton, PM; Maddox, DH; Picciano, MF; Ruch, AL; Tamura, T; West, SG; Zhao, G, 2004
)
0.32
"The inclusion of cow milk in the diet enhanced the bioavailability of food folate as assessed by the changes in erythrocyte folate and plasma tHcy concentrations but not in plasma folate concentrations."( Effect of cow milk on food folate bioavailability in young women.
Dirienzo, DB; Fishell, VK; Johnston, KE; Kris-Etherton, PM; Maddox, DH; Picciano, MF; Ruch, AL; Tamura, T; West, SG; Zhao, G, 2004
)
0.32
" Because of the observed differential plasma response and the hypothesized difference in the site of initial metabolism, the historical use of PteGlu as a "reference folate" in studies of folate bioavailability is seriously questioned."( Differential kinetic behavior and distribution for pteroylglutamic acid and reduced folates: a revised hypothesis of the primary site of PteGlu metabolism in humans.
Dainty, JR; Finglas, PM; Gregory, JF; Hart, DJ; Wolfe, CA; Wright, AJ; Wright, DM, 2005
)
0.33
"The achievement of optimal folate status to prevent neural-tube defects, and possibly other diseases, is hindered by the well-recognised incomplete bioavailability of the natural folates found in foods compared with the synthetic vitamin, folic acid."( Folate bioavailability.
McNulty, H; Pentieva, K, 2004
)
0.32
"The presence of folic acid in enriched cereal grain products and the higher bioavailability of folic acid than food folate led to the expression of the 1998 folate RDA, 400 microg/d, as dietary folate equivalents (DFE)."( A long-term controlled folate feeding study in young women supports the validity of the 1.7 multiplier in the dietary folate equivalency equation.
Alamilla, A; Caudill, MA; Cogger, EA; Hata, H; Hung, J; Li, R; Perry, CA; Urrutia, TF; Yang, TL, 2005
)
0.33
"The aim of this study was to investigate whether milk fortified with folic acid enhances the folate status of humans and whether the presence of folate-binding proteins (FBP) in pasteurised milk affects the bioavailability of folic acid from fortified milk."( Bioavailability of folic acid from fortified pasteurised and UHT-treated milk in humans.
Castenmiller, JJ; de Jong, RJ; Siebelink, E; van den Berg, H; van Vliet, T; Verwei, M; West, CE, 2005
)
0.33
" The bioavailability of folic acid from pasteurised milk relative to that of folic acid from UHT milk was 74-94% (NS), depending on the parameter used."( Bioavailability of folic acid from fortified pasteurised and UHT-treated milk in humans.
Castenmiller, JJ; de Jong, RJ; Siebelink, E; van den Berg, H; van Vliet, T; Verwei, M; West, CE, 2005
)
0.33
" No significant effect of endogenous FBP was found on the bioavailability of folic acid from milk."( Bioavailability of folic acid from fortified pasteurised and UHT-treated milk in humans.
Castenmiller, JJ; de Jong, RJ; Siebelink, E; van den Berg, H; van Vliet, T; Verwei, M; West, CE, 2005
)
0.33
" Impaired flow-mediated dilatation (FMD) is a measure of endothelial dysfunction resulting from reduced bioavailability of nitric oxide (NO)."( Homocysteine and endothelial function in human studies.
McDowell, IF; Moat, SJ, 2005
)
0.33
" Such a relation is biologically plausible because ethanol impedes the bioavailability of dietary folate and is known to inhibit select folate-dependent biochemical reactions."( Effects of alcohol on folate metabolism: implications for carcinogenesis.
Choi, SW; Mason, JB, 2005
)
0.33
"To develop a statistical model for predicting zinc bioavailability from cereal-based vegetarian meals using relative proportion of nutrients, non-nutrients and their interactive effects."( Predicting bioavailable zinc from lower phytate forms, folic Acid and their interactions with zinc in vegetarian meals.
Agte, VV; Chiplonkar, SA, 2006
)
0.33
" Folate and vitamin B12 levels rose significantly, suggesting that the supplement was well absorbed and that participants adhered to the protocol."( Effects of short-term supplementation with ascorbate, folate, and vitamins B6 and B12 on inflammatory factors and estrogen levels in obese postmenopausal women.
Palmas, W, 2006
)
0.33
"Evidence is conflicting as to whether the bioavailability of food folates is influenced by the extent of their conjugation."( The rate of intestinal absorption of natural food folates is not related to the extent of folate conjugation.
Alexander, J; Bradbury, I; Girvan, J; Hannon-Fletcher, M; Hoey, L; McCreedy, R; McKillop, DJ; McNulty, H; McPartlin, JM; Patterson, BK; Pentieva, K; Scott, JM; Strain, JJ, 2006
)
0.33
"The objective was to compare the bioavailability of 3 representative food folate sources with various degrees of glutamylation-ie, egg yolk, spinach, and yeast, whose polyglutamyl folate content measured 0%, 50%, and 100%, respectively."( The rate of intestinal absorption of natural food folates is not related to the extent of folate conjugation.
Alexander, J; Bradbury, I; Girvan, J; Hannon-Fletcher, M; Hoey, L; McCreedy, R; McKillop, DJ; McNulty, H; McPartlin, JM; Patterson, BK; Pentieva, K; Scott, JM; Strain, JJ, 2006
)
0.33
" The significant and consistently higher serum values of these vitamins among salad consumers suggest that they are being well absorbed from salad."( Salad and raw vegetable consumption and nutritional status in the adult US population: results from the Third National Health and Nutrition Examination Survey.
Arab, L; Su, LJ, 2006
)
0.33
"The bioavailability of dietary folate may be hampered by the need of the glutamate moieties to be deconjugated before absorption."( A dual-isotope-labeling method of studying the bioavailability of hexaglutamyl folic acid relative to that of monoglutamyl folic acid in humans by using multiple orally administered low doses.
Garbis, SD; Katan, MB; Kok, FJ; Lasaroms, JJ; Melse-Boonstra, A; van Breemen, RB; van Rhijn, JA; Verhoef, P; West, CE, 2006
)
0.33
"The objective was to estimate the bioavailability of polyglutamyl relative to that of monoglutamyl folic acid by using a sensitive stable-isotope approach that allowed for the administration of multiple low doses in humans."( A dual-isotope-labeling method of studying the bioavailability of hexaglutamyl folic acid relative to that of monoglutamyl folic acid in humans by using multiple orally administered low doses.
Garbis, SD; Katan, MB; Kok, FJ; Lasaroms, JJ; Melse-Boonstra, A; van Breemen, RB; van Rhijn, JA; Verhoef, P; West, CE, 2006
)
0.33
" After correction for this ratio, the estimated bioavailability of hexaglutamyl relative to that of monoglutamyl folic acid was >/=78%."( A dual-isotope-labeling method of studying the bioavailability of hexaglutamyl folic acid relative to that of monoglutamyl folic acid in humans by using multiple orally administered low doses.
Garbis, SD; Katan, MB; Kok, FJ; Lasaroms, JJ; Melse-Boonstra, A; van Breemen, RB; van Rhijn, JA; Verhoef, P; West, CE, 2006
)
0.33
"Multiple dosing of low amounts of labeled folic acid is a sensitive, accurate, and efficient method of measuring the relative bioavailability of folic acid compounds, provided that the administered doses can be reliably assessed."( A dual-isotope-labeling method of studying the bioavailability of hexaglutamyl folic acid relative to that of monoglutamyl folic acid in humans by using multiple orally administered low doses.
Garbis, SD; Katan, MB; Kok, FJ; Lasaroms, JJ; Melse-Boonstra, A; van Breemen, RB; van Rhijn, JA; Verhoef, P; West, CE, 2006
)
0.33
"The nutritional quality of new functional or fortified food products depends on the bioavailability of the nutrient(s) in the human body."( Predicted serum folate concentrations based on in vitro studies and kinetic modeling are consistent with measured folate concentrations in humans.
Freidig, AP; Groten, JP; Havenaar, R; Verwei, M, 2006
)
0.33
" The use of a food supplement containing nutrients useful for improving the bioavailability of Fe and that is well tolerated can represent a valid alternative to iron therapy."( [Effect of treatment with a food supplement (containing: selected sea fish cartilage, vitamin C, vitamin E, folic acid, zinc, copper) in women with iron deficiency: double blind, randomized, placebo-controlled trial].
Andreoni, L; Opizzi, A; Rondanelli, M; Trotti, R, 2006
)
0.33
"This study has shown that, in patients with iron deficiency, the use of a food supplement, consisting of nutrients that improve the bioavailability of Fe, leads to a significant improvement in blood iron and blood ferritin levels."( [Effect of treatment with a food supplement (containing: selected sea fish cartilage, vitamin C, vitamin E, folic acid, zinc, copper) in women with iron deficiency: double blind, randomized, placebo-controlled trial].
Andreoni, L; Opizzi, A; Rondanelli, M; Trotti, R, 2006
)
0.33
" Evaluation of endothelial function seems to have a predictive role in humans, and therapeutic interventions improving nitric oxide bioavailability in the vasculature may improve the long-term outcome in healthy individuals, high-risk subjects, or patients with advanced atherosclerosis."( Novel therapies targeting vascular endothelium.
Antoniades, C; Koumallos, N; Latsios, G; Marinou, K; Stefanadi, E; Stefanadis, C; Tousoulis, D,
)
0.13
" The basal diet provided the 5 test vitamins at concentrations of total and estimated bioavailability equivalent to a minimum of 100 and 70%, respectively, of their estimated requirements (NRC, 1998) for 5- to 10-kg pigs."( Dietary B vitamin needs of strains of pigs with high and moderate lean growth.
Ewan, RC; Lutz, TR; Stahly, TS; Swenson, SG; Williams, NH, 2007
)
0.34
"The bioavailability of natural food folates is lower than that of synthetic folic acid, but no agreement exists as to the extent of the difference."( Bioavailability of food folates is 80% of that of folic acid.
Brouwer, IA; Katan, MB; Siebelink, E; Verhoef, P; Winkels, RM, 2007
)
0.34
"In a 4-wk dietary intervention study, we determined the aggregate bioavailability of food folates from fruit, vegetables, and liver relative to that of folic acid."( Bioavailability of food folates is 80% of that of folic acid.
Brouwer, IA; Katan, MB; Siebelink, E; Verhoef, P; Winkels, RM, 2007
)
0.34
"The aggregate bioavailability of folates from fruit, vegetables, and liver is approximately 80% of that of folic acid."( Bioavailability of food folates is 80% of that of folic acid.
Brouwer, IA; Katan, MB; Siebelink, E; Verhoef, P; Winkels, RM, 2007
)
0.34
" Vascular superoxide and nitric oxide bioavailability were determined in segments of saphenous vein and internal mammary artery."( Global improvement of vascular function and redox state with low-dose folic acid: implications for folate therapy in patients with coronary artery disease.
Antoniades, C; Channon, KM; Francis, JM; Jackson, CE; Lee, J; Moat, SJ; Neubauer, S; Pillai, R; Ratnatunga, C; Refsum, H; Robson, MD; Shirodaria, C, 2007
)
0.34
"Previous findings for the Texas Neural Tube Defects Project suggested that while maternal access to nutrients is adequate, bioavailability of nutrients to the fetus is compromised in NTD-affected pregnancies."( Neural tube defects, micronutrient deficiencies, and Helicobacter pylori: a new hypothesis.
Brender, JD; Canfield, M; Felkner, M; Liszka, B; Suarez, L, 2007
)
0.34
"In the absence of dietary modification, supplementation with the fruit and vegetable juice concentrate capsules proved to be a highly bioavailable source of phytonutrients."( Four week supplementation with mixed fruit and vegetable juice concentrates increased protective serum antioxidants and folate and decreased plasma homocysteine in Japanese subjects.
Kawashima, A; Koike, H; Komatsu, Y; Madarame, T; Wise, JA, 2007
)
0.34
"The natural folates are chemically unstable and poorly bioavailable in contrast to the chemical form, folic acid."( Reduced folate status is common and increases disease risk. It can be corrected by daily ingestion of supplements or fortification.
Scott, JM, 2007
)
0.34
"4 microg/d be met primarily with crystalline vitamin B12, which is believed to be well absorbed in individuals who have food-bound malabsorption."( If high folic acid aggravates vitamin B12 deficiency what should be done about it?
Johnson, MA, 2007
)
0.34
" The maximal daily dietary folate intake is considered to be 250 mg with a bioavailability of 50% to 70%."( Periconceptional folic acid use and the prevalence of positional plagiocephaly.
Bastiaenen, CH; Colla, CG; De Bie, RA; El Bakkali, N; Michels, A; Van der Hulst, RR, 2008
)
0.35
"Despite presenting bioavailability problems, tea catechins have emerged as promising chemopreventive agents because of their observed efficacy in various animal models."( Synthesis and biological activity of a 3,4,5-trimethoxybenzoyl ester analogue of epicatechin-3-gallate.
Cabezas-Herrera, J; Chazarra, S; Otón, F; Rodríguez-López, JN; Sánchez-del-Campo, L; Tárraga, A, 2008
)
0.35
" Natural food folates have a limited ability to enhance folate status as a result of their poor stability under typical cooking conditions and incomplete bioavailability when compared with the synthetic vitamin, folic acid (as found in supplements and fortified foods)."( Intake and status of folate and related B-vitamins: considerations and challenges in achieving optimal status.
McNulty, H; Scott, JM, 2008
)
0.35
"A crossover single-dose bioavailability study (n = 3) using gamma-tocopherol as exposure marker and a crossover unblinded dietary intervention study (5 weeks) in subjects at risk (n = 25)."( Consumption of restructured meat products with added walnuts has a cholesterol-lowering effect in subjects at high cardiovascular risk: a randomised, crossover, placebo-controlled study.
Blanco-Navarro, I; Blázquez-García, S; Granado-Lorencio, F; Herrero-Barbudo, C; Olmedilla-Alonso, B; Pérez-Sacristán, B, 2008
)
0.35
" The impact of these changes on the bioavailability of folate in infants requires further exploration."( Unmetabolized folic acid and total folate concentrations in breast milk are unaffected by low-dose folate supplements.
Houghton, LA; O'Connor, DL; Yang, J, 2009
)
0.35
"A liposome preparation that is amenable to receptor-mediated endocytosis has been developed to enhance the oral bioavailability of poorly absorbable peptidomimetic drugs by use of folic acid as the mediator of liposomal uptake."( Oral bioavailability enhancement of a hydrophilic drug delivered via folic acid-coupled liposomes in rats.
Barker, SA; Ling, SS; Magosso, E; Yuen, KH, 2009
)
0.35
" In-vivo evaluation was carried out on eight Sprague-Dawley rats in a two-way crossover study to compare the oral bioavailability of cefotaxime loaded in folic acid-free liposomes and folic acid-coupled liposomes."( Oral bioavailability enhancement of a hydrophilic drug delivered via folic acid-coupled liposomes in rats.
Barker, SA; Ling, SS; Magosso, E; Yuen, KH, 2009
)
0.35
"Enhanced oral bioavailability (AUC(0-infinity)) of cefotaxime was observed when administered via folic acid-coupled liposomes."( Oral bioavailability enhancement of a hydrophilic drug delivered via folic acid-coupled liposomes in rats.
Barker, SA; Ling, SS; Magosso, E; Yuen, KH, 2009
)
0.35
" It is well known that the microflora in the colon produce large quantities of folate that approach or exceed recommended dietary intakes; however, there is no direct evidence of the bioavailability of this pool in humans."( Folate is absorbed across the colon of adults: evidence from cecal infusion of (13)C-labeled [6S]-5-formyltetrahydrofolic acid.
Aufreiter, S; Fazili, Z; Gregory, JF; Kamalaporn, P; Kim, YI; Marcon, N; O'Connor, DL; Pencharz, PB; Pfeiffer, CM, 2009
)
0.35
" The bioavailability of polyglutamyl folate may be impaired in the subjects, even when their total folate intake was sufficient."( Relationship between genetic polymorphism, serum folate and homocysteine in Alzheimer's disease.
Hiraoka, M; Kagawa, Y; Kageyama, M, 2008
)
0.35
" However, before testing the efficacy of the supplement as an alternate choice for supplementation during pregnancy, the bioavailability of the iron needs to be determined."( Relative bioavailability of iron and folic acid from a new powdered supplement compared to a traditional tablet in pregnant women.
Christofides, A; Hartman-Craven, B; O'Connor, DL; Zlotkin, S, 2009
)
0.35
" Based on the differences in the area under the curve and doses, the relative bioavailability of iron from powdered supplement was lower than from the tablet (0."( Relative bioavailability of iron and folic acid from a new powdered supplement compared to a traditional tablet in pregnant women.
Christofides, A; Hartman-Craven, B; O'Connor, DL; Zlotkin, S, 2009
)
0.35
"The unexpected lower bioavailability of iron from the powdered supplement is contrary to previously published reports."( Relative bioavailability of iron and folic acid from a new powdered supplement compared to a traditional tablet in pregnant women.
Christofides, A; Hartman-Craven, B; O'Connor, DL; Zlotkin, S, 2009
)
0.35
" Furthermore, FA improved redox status of Ang II treated cells by increasing H(4)B and NO() bioavailability while decreasing superoxide (O(2)(-)) production."( Mechanistic insights into folic acid-dependent vascular protection: dihydrofolate reductase (DHFR)-mediated reduction in oxidant stress in endothelial cells and angiotensin II-infused mice: a novel HPLC-based fluorescent assay for DHFR activity.
Cai, H; Chalupsky, K; Gao, L; Stefani, E, 2009
)
0.35
" Reduced nitric oxide bioavailability and increased oxidative stress play a role in endothelial progenitor cell dysfunction in these patients."( Folic acid supplementation normalizes the endothelial progenitor cell transcriptome of patients with type 1 diabetes: a case-control pilot study.
de Kleijn, DP; Fledderus, JO; Lim, SK; Pescatori, M; Stubbs, A; Tuinenburg, A; van Oostrom, O; Verhaar, MC, 2009
)
0.35
" The resulting nanoparticle, HFT-T, is expected to retain the antitumor activity of paclitaxel and specifically target folate receptor (FR)-expressing tumors, thereby increasing the bioavailability and efficacy of paclitaxel."( HFT-T, a targeting nanoparticle, enhances specific delivery of paclitaxel to folate receptor-positive tumors.
Chen, ZG; Cho, KJ; Giannakakou, P; Gjyrezi, A; Kim, G; Koenig, L; Li, J; Nie, S; Shin, DM; Shin, HJ; Tighiouart, M; Wang, X; Wang, Y, 2009
)
0.35
"Folic acid (pteroylmonoglutamic acid) has historically been used as the reference folate in human intervention studies assessing the relative bioavailability of dietary folate."( Comparison of (6 S)-5-methyltetrahydrofolic acid v. folic acid as the reference folate in longer-term human dietary intervention studies assessing the relative bioavailability of natural food folates: comparative changes in folate status following a 16-we
Finglas, PM; King, MJ; Powers, HJ; Wolfe, CA; Wright, AJ, 2010
)
0.36
"The aim of this study was to establish the bioavailability of different folates produced by engineered Lactococcus lactis strains using a rodent depletion-repletion bioassay."( Supplementation with engineered Lactococcus lactis improves the folate status in deficient rats.
de Giori, GS; de Vos, WM; Hugenholtz, J; LeBlanc, JG; Sesma, F; Starrenburg, M; Sybesma, W,
)
0.13
"The folate produced by the engineered strains was able to compensate the folate depletion in the diet and showed similar bioavailability compared with commercial folic acid that is normally used for food fortification."( Supplementation with engineered Lactococcus lactis improves the folate status in deficient rats.
de Giori, GS; de Vos, WM; Hugenholtz, J; LeBlanc, JG; Sesma, F; Starrenburg, M; Sybesma, W,
)
0.13
" Inadequate dietary iron, folate intake due to low vegetable consumption, perhaps low B12 intake and poor bioavailability of dietary iron from the fibre, phytate rich Indian diets are the major factors responsible for high prevalence of anaemia."( Prevalence & consequences of anaemia in pregnancy.
Kalaivani, K, 2009
)
0.35
" Data analyzed will assist dietary studies to estimate and evaluate the adequacy of folate intakes of the population, to formulate experimental diets for folate bioavailability studies, and to revise dietary recommendations for the population."( Total folate: diversity within fruit varieties commonly consumed in India.
Akilanathan, L; Arcot, J; Ramachandran, S; Uthira, L; Vishnumohan, S, 2010
)
0.36
"Oat-bran helps to improve constipation management and B12 bioavailability in elderly, with multiple chronic diseases who live in nursing homes."( The status of vitamins B6, B12, folate, and of homocysteine in geriatric home residents receiving laxatives or dietary fiber.
Dietrich, A; Elmadfa, I; Gisinger, C; Sturtzel, B; Wagner, KH, 2010
)
0.36
"The addition of folic acid to the US food supply, along with the critical role of folate in certain health outcomes, has intensified worldwide interest in the bioavailability of folate."( Folate bioavailability: implications for establishing dietary recommendations and optimizing status.
Caudill, MA, 2010
)
0.36
" Although most of the data reviewed in the present paper refer to in vitro experiments with cell-culture systems, these studies raise a concern about possible changes in the bioavailability of substrates upon concomitant ingestion of polyphenols."( Effect of polyphenols on the intestinal and placental transport of some bioactive compounds.
Calhau, C; Martel, F; Monteiro, R, 2010
)
0.36
" Here, we present evidence that TMECG markedly reduces melanoma H(4)B and NO bioavailability and that TMECG action is abolished by the eNOS inhibitor N(omega)-nitro-L-arginine methyl ester or the H(2)O(2) scavenger catalase, which strongly suggests H(2)O(2)-dependent DHFR downregulation."( Mechanism of dihydrofolate reductase downregulation in melanoma by 3-O-(3,4,5-trimethoxybenzoyl)-(-)-epicatechin.
Cabezas-Herrera, J; Chazarra, S; Montenegro, MF; Rodríguez-López, JN; Sánchez-del-Campo, L, 2010
)
0.36
" They generate heat when an alternating current (AC) magnetic field is applied to them and have a specific absorption rate (SAR) of 132 W g(-1) at 230 kHz and 100 Oe."( High-frequency, magnetic-field-responsive drug release from magnetic nanoparticle/organic hybrid based on hyperthermic effect.
Hayashi, K; Moriya, M; Ono, K; Sakamoto, W; Sawada, M; Suzuki, H; Yogo, T, 2010
)
0.36
"The objective was to determine folate bioavailability after ingestion of breads or a breakfast meal fortified with either 5-CH(3)-H(4) folate or folic acid by using a stable-isotope area under the curve (AUC) and ileostomy model."( Folate bioavailability from breads and a meal assessed with a human stable-isotope area under the curve and ileostomy model.
Büttner, BE; Lundin, E; Ohrvik, VE; Rychlik, M; Witthöft, CM, 2010
)
0.36
" Stomal folate contents indicated almost complete bioavailability of labeled folate from the breads or breakfast meal."( Folate bioavailability from breads and a meal assessed with a human stable-isotope area under the curve and ileostomy model.
Büttner, BE; Lundin, E; Ohrvik, VE; Rychlik, M; Witthöft, CM, 2010
)
0.36
"A single-dose bioavailability study was performed using three commercially available milks (whole and skimmed milk fortified with folic acid and unfortified whole milk)."( Plasma folate concentrations after a single dose ingestion of whole and skimmed folic acid fortified milks in healthy subjects.
Achón, M; Alonso-Aperte, E; Arrate, A; Varela-Moreiras, G, 2011
)
0.37
" The IC(50) values were lowered by a factor of approximately 3 for FA-NanoGSE compared to the free drug, indicating substantially enhanced bioavailability to the tumor cells, sparing the normal ones."( Folate targeted polymeric 'green' nanotherapy for cancer.
Binulal, NS; Manzoor, K; Menon, D; Mony, U; Nair, S; Narayanan, S, 2010
)
0.36
" Studies comparing L-5-methyl-THF and folic acid have found that the two compounds have comparable physiological activity, bioavailability and absorption at equimolar doses."( Folic acid and L-5-methyltetrahydrofolate: comparison of clinical pharmacokinetics and pharmacodynamics.
Bailey, L; Pietrzik, K; Shane, B, 2010
)
0.36
" In addition, further research should evaluate the bioavailability of the vitamin from fortified flour by elderly people with food cobalamin malabsorption and gastric atrophy."( Considering the case for vitamin B12 fortification of flour.
Allen, LH; Oakley, GP; Omenn, GS; Rosenberg, IH, 2010
)
0.36
" These results demonstrate that the paclitaxel formulation not only exhibits a higher antitumor activity but also significantly reduces the toxicity and improves the bioavailability as compared to that of free paclitaxel for the treatment of nasopharyngeal carcinoma."( Preparation, characterization, and antitumor activity of paclitaxel-loaded folic acid modified and TAT peptide conjugated PEGylated polymeric liposomes.
Cao, S; Chang, J; Niu, R; Wang, H; Yu, M; Zhang, F; Zhao, P, 2011
)
0.37
"Chemotherapy is one of the most effective approaches to treat cancers in the clinic, but the problems, such as multidrug resistance (MDR), low bioavailability and toxicity, severely constrain the further application of chemotherapy."( PLGA/polymeric liposome for targeted drug and gene co-delivery.
Chang, J; Liao, Z; Niu, R; Su, W; Wang, H; Wang, S; Zhao, P, 2010
)
0.36
") supplemented diet administered to ethanol-exposed dams and male rats prevents the effects provoked by ethanol in Se bioavailability and in their glutathione peroxidase (GPx) activity, thus improving the health of their offspring."( Folic acid and selenite during reproduction, gestation and lactation protect against ethanol changed Se bioavailability.
Carreras, O; Delgado, MJ; Guerrero-León, MM; Jotty, K; Murillo, ML; Nogales, F; Ojeda, ML,
)
0.13
" GNMT expression in vivo improves folate retention and bioavailability in the liver."( GNMT expression increases hepatic folate contents and folate-dependent methionine synthase-mediated homocysteine remethylation.
Chen, YM; Chiang, EP; Lin, YJ; Liu, SP; Wang, YC,
)
0.13
" In order to achieve an optimal iron status, both an adequate amount of iron intake and its bioavailability should be considered."( The nutritional status of iron, folate, and vitamin B-12 of Buddhist vegetarians.
Krawinkel, M; Lee, Y, 2011
)
0.37
" This inhibition leads to disturbance of the folate metabolic pathway and to lower bioavailability of folate to cells; therefore, it may increase the risk of neural tube defects (NTDs) in a developing embryo."( Tea drinking as a risk factor for neural tube defects in northern China.
Li, Z; Liu, J; Pei, L; Ren, A; Ye, R; Zhang, L; Zheng, X, 2011
)
0.37
" However, little is known about the bioavailability of nutrients from fortified beverages relative to 100% fruit juices."( Absorption of folic acid and ascorbic acid from nutrient comparable beverages.
Carter, B; Drewnowski, A; Monsivais, P,
)
0.13
" The objective of the study, therefore, was to test the bioavailability of iron and zinc in 2 multiple micronutrient beverage premixes in the absence and presence of chapatti."( Bioavailability of iron and zinc from multiple micronutrient fortified beverage premixes in Caco-2 cell model.
Nair, KM; Pamini, H; Pullakhandam, R; Punjal, R, 2011
)
0.37
" Due to its lower bioavailability from natural foods, many countries have adopted mandatory folic acid food fortification programs."( Folic acid in obstetric practice: a review.
Arulkumaran, S; Talaulikar, VS, 2011
)
0.37
"Homocysteine is a cardiovascular risk factor, its metabolism is influenced by certain B vitamins and it is associated with endothelial dysfunction probably due to impaired bioavailability of NO caused by homocysteine-induced accumulation of asymmetric dimethylarginine (ADMA), an endogenous inhibitor of NO synthase."( Homocysteine and asymmetric dimethylarginine in relation to B vitamins in elderly people.
Elmadfa, I; Fabian, E; Kickinger, A; Wagner, KH, 2011
)
0.37
"The significant correlation between homocysteine and ADMA observed in this study may be an important mechanism decreasing NO bioavailability and so causing endothelial dysfunction."( Homocysteine and asymmetric dimethylarginine in relation to B vitamins in elderly people.
Elmadfa, I; Fabian, E; Kickinger, A; Wagner, KH, 2011
)
0.37
"0 mg/d) was explained by different assumed reference weights and bioavailability factors (10-18 %)."( Explaining the variability in recommended intakes of folate, vitamin B12, iron and zinc for adults and elderly people.
Cavelaars, AE; de Groot, LC; Dhonukshe-Rutten, RA; Doets, EL; van 't Veer, P, 2012
)
0.38
"For the harmonisation of approaches for setting recommended intakes of folate, vitamin B12, Fe and Zn across European countries, standardised methods are needed to (i) select health indicators and define adequate biomarker concentrations, (ii) make assumptions about inter-individual variation in requirements, (iii) derive bioavailability factors and (iv) collate, select, interpret and integrate evidence on requirements."( Explaining the variability in recommended intakes of folate, vitamin B12, iron and zinc for adults and elderly people.
Cavelaars, AE; de Groot, LC; Dhonukshe-Rutten, RA; Doets, EL; van 't Veer, P, 2012
)
0.38
" Folates interact with the endothelial enzyme NO synthase (eNOS) and, exert effects on the cofactor bioavailability of NO and thus, on peroxynitrite formation."( Enzymatic and non-enzymatic antioxidative effects of folic acid and its reduced derivates.
Stanger, O; Wonisch, W, 2012
)
0.38
" While the folate level of human milk is simulated in infant formula, data are lacking on the bioavailability and effect of folic acid in infants and on whether a tolerable upper intake level should be defined."( Folate recommendations for pregnancy, lactation, and infancy.
Lamers, Y, 2011
)
0.37
" Several national health authorities have therefore introduced mandatory food fortification with synthetic folic acid, which is considered a convenient fortificant, being cost-efficient in production, more stable than natural food folate, and superior in terms of bioavailability and bioefficacy."( Human folate bioavailability.
Ohrvik, VE; Witthoft, CM, 2011
)
0.37
" There is little published information about the bioavailability and bioequivalence of formulations containing both iron and folic acid."( In vitro dissolution profile of two commercially available iron preparations.
Cerdeira, R; Patrício, JP; Santos, C, 2012
)
0.38
" It is an important constituent of our organism, and its bioavailability is mainly dependent from the correct function of our gastrointestinal tract."( Folate in gastrointestinal health and disease.
Annicchiarico, BE; Cazzato, IA; D'Aversa, F; Danese, S; Fagiuoli, S; Gasbarrini, A; Gionchetti, P; Ponziani, FR, 2012
)
0.38
" This randomized crossover study was designed to evaluate the bioavailability of folic acid from a multivitamin softgel capsule vs a folic acid tablet in 16 premenopausal women (18 to 45 years of age)."( Absorption of folic acid from a softgel capsule compared to a standard tablet.
Brooks, JR; Dicklin, MR; Kelley, KM; Lawless, AL; Maki, KC; Ndife, LI; Shields, JM; Wright, SB, 2012
)
0.38
" The bioavailability and hypoglycemic activity of orally administered FA-insulin NPs were studied in diabetic rats."( Folate-decorated PLGA nanoparticles as a rationally designed vehicle for the oral delivery of insulin.
Das, M; Godugu, C; Jain, AK; Jain, S; Rathi, VV, 2012
)
0.38
"FA-PEG-PLGA NPs (50 U/kg) exhibited a twofold increase in the oral bioavailability (double hypoglycemia) without any hypoglycemic shock as compared to subcutaneously administered standard insulin solution."( Folate-decorated PLGA nanoparticles as a rationally designed vehicle for the oral delivery of insulin.
Das, M; Godugu, C; Jain, AK; Jain, S; Rathi, VV, 2012
)
0.38
"The oral absorption of drugs that have poor bioavailability can be enhanced by encapsulation in polymeric nanoparticles."( Folic acid functionalized nanoparticles for enhanced oral drug delivery.
Grill, AE; Guru, BR; Kalscheuer, S; Kirtane, A; Panyam, J; Roger, E; Whittum-Hudson, J, 2012
)
0.38
" Since the MTX is conjugated through an ester linkage, there were concerns that biological inconsistency could also result from serum esterase activity and differential bioavailability of the targeted conjugate."( Polyvalent dendrimer-methotrexate as a folate receptor-targeted cancer therapeutic.
Baker, JR; Choi, SK; Desai, AM; Gam, J; Huang, B; Joice, M; Kotlyar, A; Silpe, JE; Thomas, TP; Zong, H, 2012
)
0.38
"The bioavailability of EE and drospirenone was similar after administration of EE/drospirenone/levomefolate calcium and EE/drospirenone."( Bioequivalence evaluation of a folate-supplemented oral contraceptive containing ethinylestradiol/drospirenone/levomefolate calcium versus ethinylestradiol/drospirenone and levomefolate calcium alone.
Blode, H; Diefenbach, K; Eydeler, U; Richard, F; Rohde, B; Trummer, D; Wiesinger, H, 2012
)
0.38
"We investigated the effects of folate-enriched egg yolk powder on folate and homocysteine levels in plasma and liver of rats fed the folate- and choline-deficient diet to determine bioavailability in vivo."( The beneficial effect of folate-enriched egg on the folate and homocysteine levels in rats fed a folate- and choline-deficient diet.
Awaji, H; Horie, K; Kim, M; Nakata, R; Sugiyama, A, 2012
)
0.38
" This increase in needs is not satisfied by the regular diet, since it includes an insufficient amount and/or low bioavailability of iron."( [Review by expert group in the diagnosis and treatment of anemia in pregnant women. Federación Mexicana de Colegios de Obstetricia y Ginecología].
Castelazo Morales, E; Chávez Güitrón, LE; Escárcega Preciado, JA; Fajardo Dueñas, S; García Lee, T; García, A; Hernández de Morán, M; Jiménez Gutiérrez, C; Maldonado Aragón, A; Mondragón Galindo, CG; Montoya Cossío, J; Montoya Romero, Jde J; Nava Muñoz, DA; Pichardo Villalón, GM; Santana García, HR; Valerio Castro, E; Velázquez Cornejo, G, 2012
)
0.38
" This is because the recommendations are often not followed or because the bioavailability of food folate is variable."( Is 5-methyltetrahydrofolate an alternative to folic acid for the prevention of neural tube defects?
Holzgreve, W; Obeid, R; Pietrzik, K, 2013
)
0.39
" Nanoparticle-based drug delivery systems can provide an alternative approach for regulating the bioavailability of this and most other anticancer drugs."( Functionalized magnetic nanoparticles as vehicles for the delivery of the antitumor drug gemcitabine to tumor cells. Physicochemical in vitro evaluation.
Carazo, A; Delgado, AV; Gómez-Sotomayor, R; Munoz-Gamez, JA; Rudzka, K; Ruiz-Extremera, A; Salmerón, J; Viota, JL, 2013
)
0.39
" One of the major challenges in setting dietary reference values for folate, however, is the need to account for the differences in bioavailability between the natural forms of the vitamin and the synthetic form, folic acid, albeit to date, few countries in Europe take bioavailability into consideration."( EURRECA-Estimating folate requirements for deriving dietary reference values.
Duffy, ME; Hoey, L; Hughes, CF; McNulty, H; Strain, JJ, 2013
)
0.39
" After administration metafolin shows optimum absorption, comparable or higher bioavailability as well as physiological activity when compared to folic acid."( [Metafolin--alternative for folate deficiency supplementation in pregnant women].
Seremak-Mrozikiewicz, A, 2013
)
0.39
" Its oral bioavailability is low and its intestinal absorption mechanism is not clear."( Intestinal absorption of raltitrexed and evaluation of the effects of absorption enhancers.
Li, X; Lu, Y; Yin, Z; Yu, Y; Zhao, X, 2013
)
0.39
"The present study reports the folic acid (FA) functionalized insulin loaded stable liposomes with improved bioavailability following oral administration."( Improved stability and antidiabetic potential of insulin containing folic acid functionalized polymer stabilized multilayered liposomes following oral administration.
Agrawal, AK; Harde, H; Jain, S; Thanki, K, 2014
)
0.4
"Several strategies appear suitable to improve iron and zinc bioavailability from fortified maize, and fortification per se will increase the intake of bioavailable iron and zinc."( Bioavailability of iron, zinc, folic acid, and vitamin A from fortified maize.
Biebinger, R; Bruins, MJ; Hoeft, B; Kraemer, K; Moretti, D, 2014
)
0.4
" In this study, we evaluated short-term folate bioavailability in rats infused with this folate-biofortified fruit."( Natural folates from biofortified tomato and synthetic 5-methyl-tetrahydrofolate display equivalent bioavailability in a murine model.
Castorena-Torres, F; de la Garza, RI; García-Rivas, G; Hernández-Méndez, RV; Ramos-Parra, PA; Vargas-García, A, 2014
)
0.4
"Dual-label stable isotope dilution assays for the simultaneous quantification of isotopologic folates in clinical samples offer the perspective for differentiating between unlabeled folates from endogenous body pools and administered [13C5]-labeled folates from a test dose when performing bioavailability trials."( Quantification of isotope-labeled and unlabeled folates and folate catabolites in urine samples by stable isotope dilution assay.
Büttner, BE; Köhler, P; Ohrvik, VE; Rychlik, M; Witthöft, CM, 2013
)
0.39
" Naturally occurring 5-MTHF has important advantages over synthetic folic acid - it is well absorbed even when gastrointestinal pH is altered and its bioavailability is not affected by metabolic defects."( Folate, folic acid and 5-methyltetrahydrofolate are not the same thing.
Panzavolta, G; Scaglione, F, 2014
)
0.4
" Pharmacokinetic assessments showed advantages of systemic bioavailability of FTL-UA (AUC = 218."( In vitro and in vivo antitumor effects of folate-targeted ursolic acid stealth liposome.
Lu, M; Ma, X; Xiang, G; Yang, G; Yang, T; Zhang, W, 2014
)
0.4
" Information on the bioavailability of vitamins is important for a good estimation of the actual exposure to vitamins."( Bioaccessibility of vitamin A, vitamin C and folic acid from dietary supplements, fortified food and infant formula.
Alewijn, M; Bakker, MI; Bouwmeester, H; Brandon, EF; Kramer, E; Zuidema, T, 2014
)
0.4
" To minimize side effects and to enhance bioavailability of doxorubicin to cancer cells, a dual-targeted pH-sensitive biocompatible polymeric nanosystem was designed and developed."( AS1411 aptamer and folic acid functionalized pH-responsive ATRP fabricated pPEGMA-PCL-pPEGMA polymeric nanoparticles for targeted drug delivery in cancer therapy.
Aravind, A; Koul, V; Kumar, DS; Lale, SV; R G, A, 2014
)
0.4
" This reference value is expressed as dietary folate equivalents that take into account the difference in bioavailability between folic acid and all types of folates in food."( Revised D-A-CH intake recommendations for folate: how much is needed?
Bärlocher, K; Eichholzer, M; Elmadfa, I; Heseker, H; Krawinkel, MB; Leschik-Bonnet, E; Strohm, D; Watzl, B; Weissenborn, A, 2014
)
0.4
" Though foliates content in dairy products is lower than in vegetables and cereals, nevertheless their bioavailability and stability is much better."( [Dairy products as source of folates].
Cichosz, G; Kowalska, M, 2014
)
0.4
"If these data translate to the overall transport and subsequent bioavailability of folates, noncompetitive inhibition of the folate receptors by VPA may serve to lower the bioavailable folates in VPA treated mothers."( Brief report novel mechanism for valproate-induced teratogenicity.
Fathe, K; Finnell, RH; Palacios, A, 2014
)
0.4
" However, siRNA-based treatments targeting Bmi1 gene have been restricted to limited delivery, low bioavailability and hence relatively reduced efficacy."( Co-delivery of doxorubicin and Bmi1 siRNA by folate receptor targeted liposomes exhibits enhanced anti-tumor effects in vitro and in vivo.
Gai, Y; He, X; Li, B; Li, W; Liu, Y; Qi, S; Xiang, G; Xu, C; Yang, G; Yang, T; Ye, P; Zhang, P; Zhang, W; Zhang, Z, 2014
)
0.4
"Different sources of folate may have different bioavailability and hence may impact the standard definition of folate equivalents."( Folate bioavailability from foods rich in folates assessed in a short term human study using stable isotope dilution assays.
Frank, T; Mönch, S; Netzel, G; Netzel, M; Ott, U; Rychlik, M, 2015
)
0.42
" Different ways of food preparation influence the folate stability and its bioavailability varies from 25 to 50% from foods, 85% from enriched foods or 100% from supplements."( The question is whether intake of folic acid from diet alone during pregnancy is sufficient.
Banjari, I; Matoković, V; Škoro, V,
)
0.13
" And the in vivo results showed that FA-PEI-UMCS nanoparticles did not only improve the oral bioavailability of PTX, but also decrease the gastrointestinal toxicity of PTX."( Folate-polyethyleneimine functionalized mesoporous carbon nanoparticles for enhancing oral bioavailability of paclitaxel.
Jiang, T; Song, A; Sun, C; Wan, L; Wang, S; Wang, X; Zhang, C; Zhu, W, 2015
)
0.42
" The bioavailability of the many antioxidant ingredients a vitamin and trace element composition was investigated, to reveal the neuroprotective (preventive) potential of the composition."( Neuroprotective impact of a vitamin trace element composition - a randomized, double blind, placebo controlled clinical trial with healthy volunteers.
Endler, T; Mosgoeller, W; Muss, C, 2015
)
0.42
" We confirmed the bioavailability of ingredients, and determined metabolic parameters associated with the integrity of the blood brain barrier, mitochondrial deficiency (Q 10), neurodegeneration (homocystein), and antioxidative capacity (e."( Neuroprotective impact of a vitamin trace element composition - a randomized, double blind, placebo controlled clinical trial with healthy volunteers.
Endler, T; Mosgoeller, W; Muss, C, 2015
)
0.42
" This blended NP system can be achieved through a simple and effective nanoprecipitation technique, and possesses unique properties: i) improved long-term compatibility brought by PEG-based polymers; ii) reduced multidrug resistance mediated by P-glycoprotein (P-gp) in tumor cells and increased bioavailability of anticancer drugs by incorporation of TPGS; iii) the regulation of controlled release through polymer ratios and active targeting by FA."( Blended nanoparticle system based on miscible structurally similar polymers: a safe, simple, targeted, and surprisingly high efficiency vehicle for cancer therapy.
Huang, L; Liu, D; Liu, G; Liu, Y; Mei, L; Tao, W; Yu, Q; Zeng, X; Zhang, J; Zhu, X, 2015
)
0.42
" Bioavailability to the pool of nutrients might determine selectivity."( Association of folate and other one-carbon related nutrients with hypermethylation status and expression of RARB, BRCA1, and RASSF1A genes in breast cancer patients.
Atri, M; Mehdipour, P; Pirouzpanah, S; Taleban, FA, 2015
)
0.42
"To minimize cardiotoxicity and to increase the bioavailability of doxorubicin, polymersomes based on redox sensitive amphiphilic triblock copolymer poly(polyethylene glycol methacrylate)-poly(caprolactone)-s-s-poly(caprolactone)-poly(polyethylene glycol methacrylate) (pPEGMA-PCL-ss-PCL-pPEGMA) with disulfide linkage were designed and developed."( ROP and ATRP Fabricated Dual Targeted Redox Sensitive Polymersomes Based on pPEGMA-PCL-ss-PCL-pPEGMA Triblock Copolymers for Breast Cancer Therapeutics.
Choudhary, V; Koul, V; Kumar, A; Lale, SV; Mahajan, S, 2015
)
0.42
"Rifampicin is one of the frontline drugs for tuberculosis therapy but poor bioavailability of Rifampicin in combination with other anti-tuberculosis drugs is a subject of concern."( In vitro controlled release of Rifampicin through liquid-crystalline folate nanoparticles.
Misra, R; Mohanty, S; Parmar, R, 2015
)
0.42
" The pharmacokinetics, metabolism and bioavailability of EC0565 were studied in normal rats."( Antiinflammatory Activity of a Novel Folic Acid Targeted Conjugate of the mTOR Inhibitor Everolimus.
Cross, VA; Gehrke, MA; Hahn, SJ; Klein, PJ; Kleindl, PJ; Leamon, CP; Low, PS; Lu, Y; Parker, N; Santhapuram, HK; Stinnette, TW; Vaughn, JF; Vlahov, IR; Wang, K; Westrick, E; Wollak, K; You, F, 2015
)
0.42
" We hypothesized that increasing the capacity to recycle BH4 from BH2 would improve NO bioavailability as well as pulmonary vascular remodeling (PVR) and right ventricular hypertrophy (RVH) as indicators of pulmonary hypertension (PH) under hypoxic conditions."( Folic Acid Promotes Recycling of Tetrahydrobiopterin and Protects Against Hypoxia-Induced Pulmonary Hypertension by Recoupling Endothelial Nitric Oxide Synthase.
Bertram, K; Chalupsky, K; Görlach, A; Kanchev, I; Kračun, D, 2015
)
0.42
" Especially the bioavailability of natural compounds in complex mixtures, where the different ingredients may interfere with each other, is unknown."( Bioavailabilty of a liquid Vitamin Trace Element Composition in healthy volunteers.
Endler, T; Mosgoeller, W; Muss, C, 2015
)
0.42
"To learn more about the bioavailability of the ingredients in the complex compound LaVita® we examined blood levels of subjects, who ingested the multivitamin and trace element composition for 6 month continuously."( Bioavailabilty of a liquid Vitamin Trace Element Composition in healthy volunteers.
Endler, T; Mosgoeller, W; Muss, C, 2015
)
0.42
"Seasonings and condiments can be candidate vehicles for micronutrient fortification if consumed consistently and if dietary practices ensure bioavailability of the nutrient."( Bioavailability of iron, vitamin A, zinc, and folic acid when added to condiments and seasonings.
Degerud, EM; Dierkes, J; Manger, MS; Strand, TA, 2015
)
0.42
" Off-target effects and poor bioavailability of the FDA-approved antiobesity drug orlistat hinder its clinical translation as a repurposed new drug against TNBC."( Folate Receptor-Targeted Polymeric Micellar Nanocarriers for Delivery of Orlistat as a Repurposed Drug against Triple-Negative Breast Cancer.
Ananta, JS; Bhethanabotla, R; Devulapally, R; Foygel, K; Joy, A; Massoud, TF; Mishra, K; Paulmurugan, R; Sekar, TV, 2016
)
0.43
" GNMT expression in vivo improves folate retention and bioavailability in the liver."( Regulation of Folate-Mediated One-Carbon Metabolism by Glycine N-Methyltransferase (GNMT) and Methylenetetrahydrofolate Reductase (MTHFR).
Chiang, EP; Ko, HA; Lin, YJ; Tang, FY; Wang, YC; Wu, MT, 2015
)
0.42
" A liposomal drug delivery system could overcome the shortcomings of DM-NCTD by improving the relative bioavailability (Fr), reducing drug toxicity, and increasing the therapeutic efficacy."( Liquid chromatography-tandem mass spectrometry evaluation of the pharmacokinetics of a diacid metabolite of norcantharidin loaded in folic acid-targeted liposomes in mice.
Gao, JQ; Han, M; Liu, MC; Ma, XQ; Peng, LH; Xu, Y, 2016
)
0.43
" The aim of this study was to compare the bioavailability of Quatrefolic®, a novel patented (6S)5-MTHF glucosamine salt, with (6S)5-MTHF calcium salt and folic acid in Sprague Dawley rats."( Enhanced oral bioavailability of a novel folate salt: comparison with folic acid and a calcium folate salt in a pharmacokinetic study in rats.
Agostinetto, M; Bianchi, D; Miraglia, N; Valoti, E, 2016
)
0.43
"Quatrefolic® has demonstrated an enhanced oral bioavailability in comparison to other reduced folates and to folic acid in rats."( Enhanced oral bioavailability of a novel folate salt: comparison with folic acid and a calcium folate salt in a pharmacokinetic study in rats.
Agostinetto, M; Bianchi, D; Miraglia, N; Valoti, E, 2016
)
0.43
" The proposed approach has the capacity to utilize all relevant data available, including data from human studies, bioavailability data showing variability between specific forms of micronutrients and, in the case of animal studies, data on species comparability."( Quantifiable risk-benefit assessment of micronutrients: From theory to practice.
Kremer, BHA; Krul, L; Leeman, WR; Luijckx, NBL, 2017
)
0.46
" The obtained results point toward the potential use of MSPs as candidates to enhance stability and to improve the bioavailability of functional biomolecules."( Protective effect of mesoporous silica particles on encapsulated folates.
Amorós, P; Barat, JM; Daubenschüz, H; Marcos, MD; Martínez-Máñez, R; Pérez-Esteve, É; Ruiz-Rico, M, 2016
)
0.43
"As nanomedicines are gaining momentum in the therapy of cancer, new biomaterials emerge as alternative platforms for the delivery of anticancer drugs with bioavailability problems."( Design and optimization of novel paclitaxel-loaded folate-conjugated amphiphilic cyclodextrin nanoparticles.
Bilensoy, E; Erdoğar, N; Esendağlı, G; Nielsen, TT; Öner, L; Şen, M, 2016
)
0.43
" However, poor water solubility as well as less bioavailability has confined its use as a suitable anti-cancer drug."( Targeted delivery of quercetin loaded mesoporous silica nanoparticles to the breast cancer cells.
Chowdhury, S; Ghosh, S; Pandey, B; Sarkar, A; Sil, PC, 2016
)
0.43
"MSN-FA-Q facilitates higher cellular uptake and allows more drug bioavailability to the breast cancer cells with over-expressed folate receptors."( Targeted delivery of quercetin loaded mesoporous silica nanoparticles to the breast cancer cells.
Chowdhury, S; Ghosh, S; Pandey, B; Sarkar, A; Sil, PC, 2016
)
0.43
"The aim of the study was to measure the relative bioavailability of labeled pteroylglutamic acid (13C5-PteGlu) from a pectin-coated fortified rice in vivo to measure any effect of the edible coating on folic acid bioavailability."( Relative bioavailability of 13C5-folic acid in pectin-coated folate fortified rice in humans using stable isotope techniques.
Arcot, J; de Ambrosis, A; Haber, P; Paterson, J; Vishnumohan, S, 2017
)
0.46
"The bioavailability of folic acid in a pectin-coated rice premix was 68."( Relative bioavailability of 13C5-folic acid in pectin-coated folate fortified rice in humans using stable isotope techniques.
Arcot, J; de Ambrosis, A; Haber, P; Paterson, J; Vishnumohan, S, 2017
)
0.46
"This study is the first demonstration of the bioavailability of folate in pectin-coated fortified rice in humans."( Relative bioavailability of 13C5-folic acid in pectin-coated folate fortified rice in humans using stable isotope techniques.
Arcot, J; de Ambrosis, A; Haber, P; Paterson, J; Vishnumohan, S, 2017
)
0.46
" These studies, which are the focus of this review, suggest that folic acid and its active metabolite 5-methyl tetrahydrofolate improve nitric oxide (NO) bioavailability by increasing endothelial NO synthase coupling and NO production as well as by directly scavenging superoxide radicals."( Role of folic acid in nitric oxide bioavailability and vascular endothelial function.
Kenney, WL; Stanhewicz, AE, 2017
)
0.46
" In vivo pharmacokinetic study revealed noticeable enhancement of bioavailability and plasma circulation time of the drugs when encapsulated in the carrier system."( Folate receptor-targeted hybrid lipid-core nanocapsules for sequential delivery of doxorubicin and tanespimycin.
Choi, HG; Gautam, M; Gupta, B; Jeong, JH; Kim, JO; Lee, JS; Pathak, S; Poudel, BK; Regmi, S; Ruttala, HB; Yong, CS, 2017
)
0.46
"Targeted drug delivery systems have great potential to overcome the side effect and improve the bioavailability of conventional anticancer drugs."( Enhanced effect of folated pluronic F87-PLA/TPGS mixed micelles on targeted delivery of paclitaxel.
Cheng, F; Gong, YC; Li, YP; Li, ZL; Pan, X; Tao, L; Xiong, XY, 2017
)
0.46
" However, the low bioavailability and nonspecific tumor targeting restrict its further clinical application."( A smart pH-responsive nano-carrier as a drug delivery system for the targeted delivery of ursolic acid: suppresses cancer growth and metastasis by modulating P53/MMP-9/PTEN/CD44 mediated multiple signaling pathways.
Chen, S; Chen, X; Chi, T; Fan, L; Jia, L; Jiang, K; Li, T; Liu, Y; Shao, J; Zheng, G, 2017
)
0.46
" In this work, EGCG-loaded nanostructured lipid carriers (NLC) functionalized with folic acid were optimized through a Box-Behnken design intended to provide an enhanced oral absorption and increased bioavailability of EGCG."( Folate-targeted nanostructured lipid carriers for enhanced oral delivery of epigallocatechin-3-gallate.
Chaves, LL; Granja, A; Neves, AR; Nunes, C; Pinheiro, M; Reis, S; Vieira, AC, 2017
)
0.46
"Generating bioavailability data from in vivo studies is time-consuming and expensive."( Simulation of Food Folate Digestion and Bioavailability of an Oxidation Product of 5-Methyltetrahydrofolate.
Ringling, C; Rychlik, M, 2017
)
0.46
" FA-IONPs also displayed both high relaxivity for MRI detection and high specific absorption rate needed for hyperthermia treatment of tumors."( Folic acid on iron oxide nanoparticles: platform with high potential for simultaneous targeting, MRI detection and hyperthermia treatment of lymph node metastases of prostate cancer.
Bastiaansen, JAM; Bonvin, D; Hofmann, H; Mionić Ebersold, M; Stuber, M, 2017
)
0.46
" Resolving this problem will be significant in improving bioavailability and reducing side effects."( Effect of inhibitors of endocytosis and NF-kB signal pathway on folate-conjugated nanoparticle endocytosis by rat Kupffer cells.
Chen, H; Feng, X; Han, Z; Jia, Y; Li, X; Liu, Q; Liu, X; Tang, H; Wang, A, 2017
)
0.46
" The ADME properties of these active molecules were also predicted to enhance the knowhow of the oral bioavailability, indicating good bioavailability of the active entities."( Ionic liquid mediated stereoselective synthesis of alanine linked hybrid quinazoline-4(3H)-one derivatives perturbing the malarial reductase activity in folate pathway.
Bhatt, JD; Chudasama, CJ; Dixit, BC; Dixit, RB; Patel, BD; Patel, TS; Patel, UH; Vanparia, SF, 2017
)
0.46
"The differences in bioavailability and metabolism of synthetic folic acid and natural dietary folate as well as variation in the baseline characteristics of subjects and various methods of folate status assessment might be the main reasons for these controversies."( Folic acid intake and folate status and colorectal cancer risk: A systematic review and meta-analysis.
Alizadeh, BZ; Dastgiri, S; de Bock, GH; Dolatkhah, R; Moazzen, S; Shaarbafi, J; Tabrizi, JS, 2018
)
0.48
" Pharmacokinetic studies confirmed that Bacillus spore-based carriers could efficiently improve the oral bioavailability of curcumin."( Bacillus spore-based oral carriers loading curcumin for the therapy of colon cancer.
Chen, W; Guan, YQ; Han, K; Hu, K; Jin, Y; Li, CH; Meng, Z; Wu, BY; Yin, L; You, R; Zhang, Y, 2018
)
0.48
" The aim of the study was to develop FS loaded pluronic127 (PF)-folic acid (FA) conjugated micelles (FS-PF-FA) by the way of increasing solubility, bioavailability and active targetability of FS shall increase its therapeutic efficacy."( Development of fisetin-loaded folate functionalized pluronic micelles for breast cancer targeting.
Bothiraja, C; Pawar, A; Rajalakshmi, S; Shaikh, K; Singh, S, 2018
)
0.48
"A new family of biofunctionalized chitosan decorated nanocochleates-mediated drug delivery system was developed that involves uniquely combining nanocochleates with anticancer drug for controlled drug release, targeted delivery, improved bioavailability with reduced toxicity."( Development of novel biofunctionalized chitosan decorated nanocochleates as a cancer targeted drug delivery platform.
Bothiraja, C; Panda, B; Pawar, A; Poudel, I; Rajalakshmi, S; Rajput, N, 2018
)
0.48
" Cell viability of assay was implemented to determination of biocompatibility, bioavailability and therapeutic potency of nano-complexes on different cancer and normal cell lines."( Synthesis and in vitro study of modified chitosan-polycaprolactam nanocomplex as delivery system.
Bidaki, K; Mohammadnejad, J; Narmani, A; Rezvani, M, 2018
)
0.48
"Homeostasis around vascular endothelium is a function of the equilibrium between the bioavailability of nitric oxide (NO) and oxidizing reactive oxygen species (ROS)."( Endothelial dysfunction, endothelial nitric oxide bioavailability, tetrahydrobiopterin, and 5-methyltetrahydrofolate in cardiovascular disease. Where are we with therapy?
Ng, GA; Ng, LL; Yuyun, MF, 2018
)
0.48
"It has been shown that encapsulation of dietary polyphenols leads to increased solubility and bioavailability of these micronutrients."( Encapsulation of micronutrients resveratrol, genistein, and curcumin by folic acid-PAMAM nanoparticles.
Chanphai, P; Tajmir-Riahi, HA, 2018
)
0.48
" Micellized Dex demonstrated a 4 ∼ 5 fold longer elimination half-life and a 2 ∼ 3 folds higher bioavailability than commercial Dex injection."( Folate receptor-targeted mixed polysialic acid micelles for combating rheumatoid arthritis: in vitro and in vivo evaluation.
Chu, X; Fu, L; Hua, H; Li, N; Xu, C; Zeng, X; Zhang, N; Zhang, S; Zhao, Y, 2018
)
0.48
" The aim of this review was to assess the bioavailability of various forms of folate supplements in healthy populations and animal models."( The Bioavailability of Various Oral Forms of Folate Supplementation in Healthy Populations and Animal Models: A Systematic Review.
Agrawal, N; Bayes, J; Schloss, J, 2019
)
0.51
"A systematic literature review was conducted of original research, which assessed the bioavailability of different oral forms of folate in healthy adults or animal models."( The Bioavailability of Various Oral Forms of Folate Supplementation in Healthy Populations and Animal Models: A Systematic Review.
Agrawal, N; Bayes, J; Schloss, J, 2019
)
0.51
" Only three studies found a statistically significant difference in folate bioavailability when evaluating different supplement forms."( The Bioavailability of Various Oral Forms of Folate Supplementation in Healthy Populations and Animal Models: A Systematic Review.
Agrawal, N; Bayes, J; Schloss, J, 2019
)
0.51
" Quality absorption studies assessing the bioavailability of oral folate supplements are crucial if clinicians are to make effective evidence-based recommendations."( The Bioavailability of Various Oral Forms of Folate Supplementation in Healthy Populations and Animal Models: A Systematic Review.
Agrawal, N; Bayes, J; Schloss, J, 2019
)
0.51
" However, CH suffers from a drawback of poor aqueous solubility and in turn poor bioavailability limiting its clinical utility."( Chrysin-loaded folate conjugated PF127-F68 mixed micelles with enhanced oral bioavailability and anticancer activity against human breast cancer cells.
Baidya, D; Kushwaha, J; Mahadik, K; Patil, S, 2019
)
0.51
"To investigate the ingredients' bioavailability of the complex vitamin-mineral-trace element composition LaVita® we recruited healthy volunteers for six months and observed the changes of pregnancy relevant parameters by means of laboratory measures."( Potential of the multivitamin-mineral-trace element composition LaVita® before, during and after pregnancy.
Doerfler, D; Endler, TA; Mosgoeller, W; Muss, C, 2019
)
0.51
"Folic acid (FA) is an essential micronutrient but its delivery and bioavailability is a problem due to its inherent instability at various conditions."( Encapsulation of folic acid in copper-alginate hydrogels and it's slow in vitro release in physiological pH condition.
Cabrera, MJF; Camacho, DH; Fajardo, TJMC; Lobregas, MOS; Uy, SJY, 2019
)
0.51
" The % bioavailability in the unfortified parboiled rice was negligible as compared to Fe (14."( Effect of iron and folic acid fortification on in vitro bioavailability and starch hydrolysis in ready-to-eat parboiled rice.
Das, AJ; Green, BD; Hazarika, MK; Shooter, J; Wahengbam, ED, 2019
)
0.51
" On the other hand, nanoparticles (NPs) based therapies are remarkably progressing to solve several limitations of conventional drug delivery systems (DDSs) including nonspecific biodistribution and targeting, poor water solubility, weak bioavailability and biodegradability, low pharmacokinetic properties, and so forth."( Folic acid functionalized nanoparticles as pharmaceutical carriers in drug delivery systems.
Abdi Goushbolagh, N; Amini, B; Darkhor, P; Farhood, B; Mohammadnejad, J; Narmani, A; Refahi, S; Rezvani, M, 2019
)
0.51
" Achieving optimal nutritional status for preventing folate-related disease is challenging, however, primarily as a result of the poor stability and incomplete bioavailability of folate from natural food sources when compared with the synthetic vitamin form, folic acid."( Addressing optimal folate and related B-vitamin status through the lifecycle: health impacts and challenges.
Hoey, L; Hughes, CF; McNulty, H; Pentieva, K; Ward, M, 2019
)
0.51
" According to the results of this study, the system can serve as a promising non-spherical delivery vehicle for enhancing bioavailability and targeting of hydrophobic anticancer agents in the future."( Flower-like curcumin-loaded folic acid-conjugated ZnO-MPA- βcyclodextrin nanostructures enhanced anticancer activity and cellular uptake of curcumin in breast cancer cells.
Fakhroueian, Z; Ghaffari, SB; Khorramizadeh, MR; Sarrafzadeh, MH, 2019
)
0.51
" Ursolic acid (UA) as a natural product plays a pivotal role in anti-tumor field, although its performance is limited by low bioavailability and poor hydrophilicity."( Co-delivery of Bmi1 small interfering RNA with ursolic acid by folate receptor-targeted cationic liposomes enhances anti-tumor activity of ursolic acid
He, C; Khan, MW; Li, W; Liu, Y; Lu, Y; Xiang, G; Xu, C; Yan, R; Yang, T; Zhang, X, 2019
)
0.51
" In vivo pharmacokinetic studies in rats showed that oral PTX loaded in FA-F127-PLA polymersomes had a higher bioavailability than oral PTX loaded in PLA-F127-PLA polymersomes."( Folate-conjugated pluronic/polylactic acid polymersomes for oral delivery of paclitaxel.
Gong, YC; Li, YP; Li, ZL; Pan, XQ; Xiong, XY, 2019
)
0.51
" The increased demand of these nutrients is not meet through diet alone due to decreased bioavailability of nutrients during pregnancy."( Magnitude and factors associated with adherence to Iron and folic acid supplementation among pregnant women in Aykel town, Northwest Ethiopia.
Abebe, SM; Assefa, H; Sisay, M, 2019
)
0.51
" Hence, the pharmacokinetics of FA was conducted and showed that the administration of FA solution resulted in enhancing bioavailability of 5-methylTHF comparing with FA raw material suspension, whereas the free FA level in plasma was similar."( Folic acid and its metabolite codetermination for pharmacokinetics with circadian rhythms and evaluation of oral bioavailability.
Chen, W; Li, H; Meng, F; Shakya, S; Wang, C; Wu, L; Xu, J; Zhang, G; Zhang, J; Zhu, R, 2019
)
0.51
"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
"75-fold increase in the bioavailability of GEF delivered from GEF/ZnO-FCL@GPMs as compared to its trademarked drug (Iressa®)."( Novel β-1,3-d-glucan porous microcapsule enveloped folate-functionalized liposomes as a Trojan horse for facilitated oral tumor-targeted co-delivery of chemotherapeutic drugs and quantum dots.
Li, X; Liu, Z; Wang, J; Xu, Y; Yang, Y; Zhang, Y; Zhao, Z, 2020
)
0.56
"Owing to the widespread use of vitamin supplements to prevent and compensate for deficiencies, the equivalence of natural versus synthetic vitamins with respect to their bioavailability and metabolic influence is discussed controversially."( [Bioavailability of natural versus synthetic B vitamins and their effects on metabolic processes].
Cvirn, G; Fuchs, N; Lamont, E; Lindschinger, B; Lindschinger, M; Markolin, G; Schimetta, W; Schmid, I; Tatzber, F; Wonisch, W, 2020
)
0.56
"We examined the impact of matrix food structure on post-prandial folate bioavailability (and other macronutrients) in human volunteers using a randomized, controlled, crossover experimental design."( Food matrix structure (from Biscuit to Custard) has an impact on folate bioavailability in healthy volunteers.
Batisse, C; Buffière, C; Dupont, D; Hiolle, M; Meunier, N; Nau, F; Pereira, B; Peyron, MA; Rémond, D; Richard, R; Savary-Auzeloux, I, 2021
)
0.62
" The analysis of plasma kinetics of appearance of other nutrients/metabolites helps to understand/explain the lower bioavailability of folates in Custard and Biscuit."( Food matrix structure (from Biscuit to Custard) has an impact on folate bioavailability in healthy volunteers.
Batisse, C; Buffière, C; Dupont, D; Hiolle, M; Meunier, N; Nau, F; Pereira, B; Peyron, MA; Rémond, D; Richard, R; Savary-Auzeloux, I, 2021
)
0.62
" In-vivo pharmacokinetic study revealed better absorption and long circulation of FPS and FAS, which further leads to increased relative bioavailability of drugs(13."( Fabrication and in vivo evaluation of ligand appended paclitaxel and artemether loaded lipid nanoparticulate systems for the treatment of NSCLC: A nanoparticle assisted combination oncotherapy.
Badanthadka, M; Chokshi, N; Khatri, H; Patel, BM; Patel, MM; Rawal, S, 2020
)
0.56
" The FA-BSP-SA micelles distinctly improved the absolute bioavailability of Dox compared with the free Dox and the Dox/BSP-SA micelles (p < 0."( Doxorubicin-loaded folate-mediated pH-responsive micelle based on Bletilla striata polysaccharide: Release mechanism, cellular uptake mechanism, distribution, pharmacokinetics, and antitumor effects.
Guan, Q; Huang, L; Liu, Y; Wu, J; Zhang, G; Zhang, Z, 2020
)
0.56
" Therefore, the proposed drug delivery system demonstrates the potential of a multifunctional nano-platform to enhance bioavailability and reduce the side effects of chemotherapy agents."( Paclitaxel-loaded and folic acid-modified PLGA nanomedicine with glutathione response for the treatment of lung cancer.
Luo, T; Qian, F; Que, Z; Tian, J; Yao, J; Yao, W; Yu, P; Zhang, Z; Zheng, D, 2021
)
0.62
" However, low bioavailability restricts the clinical application of BA."( Activating caspase-8/Bid/ROS signaling to promote apoptosis of breast cancer cells by folate-modified albumin baicalin-loaded nanoparticles.
Cai, T; Cai, Y; Kong, Z; Lan, M; Li, L; Liu, F; Tian, H; Zou, T, 2022
)
0.72
" Remarkably, DPPE-FA-DOX micelles improved DOX bioavailability by 7 fold and diminished plasma elimination with no sign of tissue toxicity compared to free DOX."( 1, 2-Dihexadecanoyl-sn-glycero-3-phosphoethanolamin (DPPE), doxorubicin and folic acid conjugated micelles for cancer management in tumor bearing BALB/c mice.
Bhagwat, DA; Uttekar, PS; Yadav, VD, 2021
)
0.62
" In fortification of milk products, thermal processing, fermentation, and species differences in milk folate bioavailability are three additional factors that should be considered besides absolute difference in folate concentration between goat and human milk."( Role of fermented goat milk as a nutritional product to improve anemia.
Mirzaei, H; Sharafati Chaleshtori, R, 2022
)
0.72
" Triptolide (TP) has anti-inflammatory properties, and it can protect the cartilage matrix, but its clinical application has been limited due to poor solubility, low bioavailability and systemic toxicity."( Folate-modified triptolide liposomes target activated macrophages for safe rheumatoid arthritis therapy.
Geng, HX; Guo, RB; Kong, L; Li, XT; Liu, Y; Wang, YJ; Wu, YN; Yan, DK; Yu, YJ; Zhang, XY, 2022
)
0.72
"Baicalin (BAN) has attracted widespread attention due to its low-toxicity and efficient antitumor activity, but its poor water solubility and low bioavailability severely limit its clinical application."( Folic Acid Decorated Zeolitic Imidazolate Framework (ZIF-8) Loaded with Baicalin as a Nano-Drug Delivery System for Breast Cancer Therapy.
Chang, X; Chen, X; Dong, M; Hu, M; Lu, J; Mi, X; Yang, Z; Zhan, X, 2021
)
0.62
" Nanoparticles comprising antioxidant semi-conducting cores and encapsulated by biomaterials that are highly bioavailable can be promising therapeutic agents for inflammation and oxidative stress disorders studies."( In vitro cytotoxicity, macromolecular interaction and antioxidant potential of dual coated selenium nanoparticles.
Desai, K; Shinde, V, 2022
)
0.72
" However, its bioavailability is limited due to its inherent instability at several conditions."( Enhanced cellular uptake, transport and oral bioavailability of optimized folic acid-loaded chitosan nanoparticles.
Anand, T; Fathima, E; Khanum, F; Naika, M; Nallamuthu, I, 2022
)
0.72
"Optimizing folic acid supplementation is complex and depends on factors including dosage; type of supplement; bioavailability of folate from food, timing of initiating supplementation; and metabolic and genetic factors."( Guideline No. 427: Folic Acid and Multivitamin Supplementation for Prevention of Folic Acid-Sensitive Congenital Anomalies.
O'Connor, DL; Wilson, RD, 2022
)
0.72
" The upper tolerable limit of folic acid is 1000 mcg per day; however, this level was determined to avoid masking a vitamin B12 deficiency and not based on folic acid bioavailability and metabolism."( Women Taking a Folic Acid Supplement in Countries with Mandatory Food Fortification Programs May Be Exceeding the Upper Tolerable Limit of Folic Acid: A Systematic Review.
Ledowsky, C; Mahimbo, A; Scarf, V; Steel, A, 2022
)
0.72
" However, it has limited therapeutic application because of its low bioavailability and systemic toxicity if administered in free form."( Therapeutic potential of human serum albumin nanoparticles encapsulated actinonin in murine model of lung adenocarcinoma.
Ahlawat, P; Bal, A; Phutela, K; Sharma, S; Singh, N, 2022
)
0.72
" Although iron bioavailability and absorption inhibitors were not considered for the present analyses, the distribution of Tablets or MNP had several advantages in this context where micronutrient deficiency remains high among pregnant women, but macronutrient intake is generally adequate or even high."( Differential Effects of Three Nutritional Supplements on the Nutrient Intake of Pregnant Women Enrolled in a Conditional Cash Transfer Program in Mexico: A Cluster Randomized Trial.
Fernández-Gaxiola, AC; García-Feregrino, R; García-Guerra, A; Gómez-Humarán, IM; Mejía-Rodríguez, F; Neufeld, LM; Quezada-Sánchez, AD, 2022
)
0.72
" In vivo studies revealed that orally-administered INS/DFAN produced a significant reduction in blood glucose levels and further improved insulin bioavailability in type I diabetic rats compared to INS/FAN."( Dual crosslinking of folic acid-modified pectin nanoparticles for enhanced oral insulin delivery.
Cui, S; Fan, X; Gou, D; Pei, X; Peng, X; Song, C; Zhang, F; Zheng, X; Zhou, Y, 2022
)
0.72
" However, insufficient responses to oral MTX at lower doses as well as increased variation of drug bioavailability and a deteriorated safety profile during dose escalation are regularly observed in patients."( Subcutaneous injection of methotrexate: Advantages in the treatment of rheumatoid arthritis.
Tanaka, Y, 2023
)
0.91
" In conclusion, folic acid decorated chitosan nanoparticles improved the stability and bioavailability of proanthocyanidins in gastrointestinal digestion."( Synthesis, characterization and in vitro digestion of folate conjugated chitosan-loaded proanthocyanidins nanoparticles.
Bi, Y; Chen, W; Ding, Z; Jiang, F; Kong, F; Mo, M, 2023
)
0.91
"Curcumin (CUR) is a promising natural compound in ulcerative colitis (UC) treatment, but limited by its low oral bioavailability and poor targeting ability."( Folic acid-modified lactoferrin nanoparticles coated with a laminarin layer loaded curcumin with dual-targeting for ulcerative colitis treatment.
Ayue, S; Chang, D; Dai, L; Gao, F; He, H; Luo, R; Qi, S; Ye, N; Ye, Y; Zhao, P, 2023
)
0.91
"dietary diversity, consumption of intervention-promoted foods, practicing ways to enhance bioavailability and knowledge of iron-rich foods."( Study protocol for a randomised controlled trial of a virtual antenatal intervention for improved diet and iron intake in Kapilvastu district, Nepal: VALID.
Arjyal, A; Baral, SC; Bhattarai, S; Copas, A; Giri, S; Haghparast-Bidgoli, H; Harris-Fry, H; Hillman, S; Manandhar, S; Morrison, J; Saville, NM; Thapaliya, B, 2023
)
0.91
" These studies included information on dietary methyl donors, dietary components that potentially modulate the bioavailability of methyl groups, genetic variants of methyl metabolizing enzymes, and/or markers of CpG island methylator phenotype and/or microsatellite instability, and their possible interactions on CRC risk."( Influence of methyl donor nutrients as epigenetic regulators in colorectal cancer: A systematic review of observational studies.
Arroyo-Izaga, M; Chávez-Hidalgo, LP; M de Pancorbo, M; Martín-Fernández-de-Labastida, S, 2023
)
0.91
" Food preparation and processing operations affect contents and bioavailability of micronutrients in traditional dishes."( Nutrient retention in popular dishes based on Google Trends data in Hatay cuisine.
Güçlü, D; Öney, B; Yılmaz, SE, 2023
)
0.91
" However, its poor solubility in water, inappropriate pharmacokinetics, and low bioavailability limit its use as an antitumor drug."( Effect of folic acid-linked chitosan-coated PLGA-based curcumin nanoparticles on the redox system of glioblastoma cancer cells.
Ghahremanloo, A; Ghoreyshi, N; Hashemy, SI; Homayouni Tabrizi, M; Javid, H, 2023
)
0.91
"This investigation aimed to increase the bioavailability and anticancer effects of allicin (AC) by encapsulating it in solid lipid nanoparticles (SLN) decorated with chitosan (CS)-conjugated folic acid (FA)."( Preparation and Characterization of Allicin-Loaded Solid Lipid Nanoparticles Surface-Functionalized with Folic Acid-Bonded Chitosan:
Alyasiri, FJ; Ghobeh, M; Tabrizi, MH, 2023
)
0.91

Dosage Studied

A high dosage of folic acid supplements throughout pregnancy reduces Hcy concentrations at the time of delivery. Fertile-age women are not able to get enough folate from their diet.

ExcerptRelevanceReference
" During therapy with sulphasalazine, determination of acetylator phenotype and total sulphapyridine concentration can guide effective dosage and avoid side-effects."( Clinical pharmacokinetics of sulphasalazine.
Das, KM; Dubin, R,
)
0.13
" Clinically the diagnosis may be difficult with sub acute combined degenration secondary to the pernicious anaemia, and the dosage of the folate (in serum, in red-cells and in cerebrospinal fluid) is necessary."( [Folate and the nervous system (author's transl)].
Audebert, M; Gendre, JP; Le Quintrec, Y,
)
0.13
"4 ml and the folic acid to 200 microgram, and decreasing the ascorbic acid to 70 mg and vitamin B12 to 5 microgram/liter of TPN infusate, resulted in normal blood levels of all tested vitamins within two weeks after initiating TPN therapy, and normal blood levels were then maintained at this dosage for additional periods of time up to three weeks."( Vitamin requirements in patients receiving total parenteral nutrition.
Caldwell, MD; Meng, HC; Nichoalds, GE, 1977
)
0.26
" Additional dosage of vitamins compensated the biochemical B6 deficit and had an accelerating effect on heme synthesis."( [The treatment of anemia due to iron-deficiency with iron combined with vitamins (author's transl)].
Kurz, R; Reinken, L, 1978
)
0.26
" The dose-response curve for survival was used to determine the LC50 of the compound."( A method for detecting carcinogenic organic chemicals using mammalian cells in culture.
Styles, JA, 1977
)
0.26
" Although phenytoin dosage remained relatively constant, plasma phenytoin concentrations during pregnancy were significantly lower than nonpregnant concentrations."( Hematologic effects of phenytoin therapy during pregnancy.
Ramsay, RE; Strauss, RG; Wilder, BJ; Willmore, LJ, 1978
)
0.26
" At a dosage of 6 mg/kg q1d X 5 against solid tumors, the relative tumor volumes (treated/control X 100%) were 12%/41% for Sarcoma 180, 16%/31% for Taper liver tumor, and 20%/30% for Ehrlich ascites carcinoma."( Antitumor properties of a new folate analog, 10-deaza-aminopterin, in mice.
DeGraw, JI; Dorick, DM; Moccio, DM; Sirotnak, FM, 1978
)
0.26
" The parenteral administration of folic acid and vitamin B12 in adequate dosage did not alter these changes."( Nuclear abnormalities of marrow normoblasts as a normal occurrence in laboratory baboons in Kenya.
Davies, JD; Newson, J, 1975
)
0.25
" This combination showed at least equal efficiency as preparation ES in spite of a smaller iron dosage and was well tolerated without exception."( [Treatment of anemia in pregnancy].
Hilgarth, M; Steiner, H, 1977
)
0.26
" Results indicate that the method should be usful in the future in assisting individualization of dosage regimens and in the study of the pharmacokinetics and metabolism of MTX in cancer patients."( A radioimmunoassay for methotrexate and its comparison with spectrofluorimetric procedures.
Blum, MR; Loeffler, LJ; Nelsen, MA, 1976
)
0.26
"Cholestyramine in a mean dosage of 0-6 g/kg/day has been given to 18 children with familial hypercholesterolaemia for between one and two and a half years."( The effect of cholestyramine on intestinal absorption.
Lloyd, JK; West, RJ, 1975
)
0.25
" Although our findings do not provide clear evidence of a protective effect of folic acid supplementation they are consistent with those of the Medical Research Council (MRC) trial which demonstrated the efficacy of folic acid in preventing recurrence of NTDs and they raise the possibility that folic acid may be protective at a much lower dosage than that used in the MRC trial."( A randomised trial of low dose folic acid to prevent neural tube defects. The Irish Vitamin Study Group.
Daly, LE; Elwood, JH; Kirke, PN, 1992
)
0.28
" Direct pfxa3 diagnosis for the 135 females within these 222 additional cases was confirmed by dosage analysis with the control probe pS8."( Experience with direct molecular diagnosis of fragile X.
Chapman, CJ; Donnelly, A; Gardner, RJ; Gedeon, AK; Loesch, D; Mulley, JC; Richards, RI; Sutherland, GR; Turner, G; Yu, S, 1992
)
0.28
" Dosage must be adjusted to the results of blood counts."( [Usefulness of folinic acid in cytopenia induced by antiparasitic drugs in AIDS patients].
Leport, C; Niyongabo, T; Vildé, JL, 1991
)
0.28
" The syndrome appears to be associated with high dosage and slow acetylator status."( Sulphasalazine associated pancytopenia may be caused by acute folate deficiency.
Logan, EC; Ryrie, DR; Williamson, LM, 1986
)
0.27
" The increases in the requirement of 5-methyltetrahydrofolate (5-methyl-THF) by the resistant sublines were more pronounced than PGA requirement, moving the dose-response curve nearly 3 log orders in magnitude to the right."( Folate requirements of methotrexate-resistant human acute lymphoblastic leukemia cell lines.
Holland, JF; Kano, Y; Ohnuma, T, 1986
)
0.27
"5 microM at 5 hours, respectively, after termination of CF dosing in all subjects treated at the 800- and 1600-mg dose schedule."( Bioavailability of high-dose oral leucovorin.
Adelstein, DJ; Blum, MR; Giroski, P; Hines, JD; Rustum, YM; Zakem, MH, 1987
)
0.27
" Studies with various dose levels of ethanol in rats showed that there was a linear dose-response relationship between the total urinary folate excretion and the dose of ethanol."( Study of dose-dependence and urinary folate excretion produced by ethanol in humans and rats.
Collins, TD; McMartin, KE; Redetzki, HM; Shiao, CQ; Vidrine, L, 1986
)
0.27
" The results suggest a dose-response relationship among anticonvulsants, folate, and adverse pregnancy outcome."( Anticonvulsants, folate levels, and pregnancy outcome: a prospective study.
Andermann, E; Andermann, F; Dansky, LV; Rosenblatt, D; Sherwin, AL, 1987
)
0.27
" A significant positive trend for prevalence of cyanide-related symptoms measured against levels of exposure was demonstrated, supporting a dose-response effect."( Cyanide intoxication among silver-reclaiming workers.
Bernard, B; Blanc, P; Hessl, S; Hogan, M; Hryhorczuk, D; Mallin, K, 1985
)
0.27
" The patient relapsed after an erroneous iatrogenic tripling of the levothyroxine dosage, but her condition normalized after dosage correction."( Acute organic psychosis caused by thyrotoxicosis and vitamin B12 deficiency: case report.
Ewald, H; Lassen, E, 1985
)
0.27
" None of the dosing regimens caused toxicological manifestations other than hepatomegaly."( Alteration of bone marrow cell cycle kinetics by diphenylhydantoin: relationship to folate utilization and immune function.
Boorman, GA; Hong, L; Luster, MI; Pung, O; Tucker, AN, 1985
)
0.27
" In the dilution and dosage unit based on the continuous-flow principle, vitamin samples were diluted to two different dose levels at a rate of 40 per hr, mixed with the inoculated test broth, and dispensed into culture tubes."( Semiautomated method for microbiological vitamin assays.
Behagel, HA; Berg, TM, 1972
)
0.25
" Neither homovanillic acid nor 5-hydroxyindoleacetic acid concentrations changed significantly when 15 mg folic acid was given in divided dosage for one, two, and four weeks."( Effect of folic acid by mouth on cerebrospinal fluid homovanillic acid and 5-hydroxyindoleacetic acid concentration.
Barnes, J; Curzon, G; Duncan, C; Hunter, R; Kantamaneni, BD, 1971
)
0.25
" Fibroblast cultures from 10 retarded males expressed fra(X) in a dose-response relationship to increasing concentrations of FUdR."( Cytogenetic investigations in mentally retarded and normal males from 14 families with the fragile site at Xq28. Results of folic acid treatment on fra(X) expression.
Nielsen, KB; Tommerup, N, 1984
)
0.27
" Dose-response curves indicated that pectin, lignin and alginate significantly reduced chick growth at all levels of dietary folacin."( Effects of dietary fiber on the bioavailability of folic acid monoglutamate.
Damron, BL; Gregory, JF; Ristow, KA, 1982
)
0.26
" Patients are referred to the hematologist in the following situations: 1) Therapy is ineffective for one of the following reasons: the hypochromic anemia is not caused by iron deficiency (hemoglobinopathies); iron is less efficiently used because of transferrin deficiency or infectious, inflammatory or cancerous disease; iron therapy is inadequate either because of insufficient dosage or of suboptimal duration."( [Iron-deficiency anemia. Hematologist's viewpoint].
Cramer, P; Schaison, G; Tobelem, G, 1982
)
0.26
" The influence of trace-nutrient-binding proteins on the growth of coliforms, streptococci and lactobacilli in the gastrointestinal tract was examined in neonatal rabbits delivered germ-free and dosed with an artificial flora (ESL), or born conventionally and dosed with ESL or rabbit faeces."( Trace-nutrient-binding proteins in milk and the growth of bacteria in the gut of infant rabbits.
Coates, ME; Cole, CB; Ford, JE; Fuller, R; Henschel, MJ; Scott, KJ, 1983
)
0.27
" Due to the increase in tonic-clonic seizures after the initiation of folic acid (1 mg, orally) the sodium phenytoin dosage was increased by 130 mg until control was achieved."( Phenytoin and folic acid: individualized drug-drug interaction.
Berg, MJ; Fischer, LJ; Rivey, MP; Schottelius, DD; Vern, BA, 1983
)
0.27
" A cross-sectional analysis of items such as designs, patient sampling principles, recording of effect parameters and side effects, concomitant treatments, and statistical evaluations demonstrated that cross-over designs, investigating fixed dosage schedules, were extensively used."( Controlled trials in epilepsy: a review.
Bentsen, KD; Flachs, H; Gram, L; Parnas, J, 1982
)
0.26
" From these observations, we conclude that there is a predictable relationship between the dosage of folic acid and the abnormalities of morphologic features and function in this model of kidney injury."( Folic acid-induced renal injury and repair. Correlation of structural and functional abnormalities.
Anderson, RE; Evan, AP; Klingler, EL, 1980
)
0.26
"About 70% of the radioactivity retained in the livers of rats dosed 48 h earlier with radioactively labelled folate was incorporated into two folate conjugates."( The identification of the folate conjugates found in rat liver 48 h after the administration of radioactively labelled folate tracers.
Blair, JA; Connor, MJ, 1980
)
0.26
" Some investigators recommend givng this dosage to women, who experience abnormal tryptophan metabolism, while others warn that the long-term effects of such high dosages are unknown."( Nutritional effects of oral contraceptive use: a review.
Webb, JL, 1980
)
0.26
" In vitro exposure of fetal limbs to various doses of 9-mePGA resulted in a significant increase in the accumulation of labeled GAG by fetal forelimbs at the high and intermediate dosage levels."( In vitro effects of the teratogen and folic acid antagonist, 9-methyl pteroylglutamic acid, on glycosaminoglycan accumulation in fetal rat limbs.
Abbott, K; Cotler, JM; Schmidt, RR, 1982
)
0.26
" The methionine-supplemented group had significant decreases in FIGLU excretion after dosing with the folacin derivatives."( Utilization of administered folacin derivatives by rats fed a diet low in methionine and folacin.
Farnworth, ER; Hill, DC, 1980
)
0.26
"The effects of long term, low dosage anticonvulsant drug therapy on the vitamin D and folacin status of young children was studied."( Folic acid and vitamin D status of young children receiving minimal anticonvulsant drug therapy.
Bailey, LB; Enneking-Ivey, O; Gawley, L; Hananian, J; Hurd, R, 1981
)
0.26
"The metabolism of 2-[14C]-folic acid, 2-[14C]-5-methyltetrahydrofolate 5-[14C]-methyltetrahydrofolate, and a mixture of 2-[14C]-folic acid and 3',5',7,9-[3H]-folic acid has been studied in rats that were dosed with methotrexate (MTX) 24 h before receiving the radioactive folate."( The effect of methotrexate on folate metabolism in the rat.
Barford, PA; Blair, JA; Malghani, MA, 1980
)
0.26
" Haemoglobin concentration as well as haematocrit value and red blood cell count were highest in rats which received the full dosage of both riboflavin and folic acid."( Effect of riboflavin and folic acid supplementation on some haematopoietic parameters in the rat.
Dako, DY; Hill, DC, 1980
)
0.26
" Folates excreted in the urine of rats dosed previously with mixtures of 14C- and 3H-labelled folate derivatives are apparently 3H enriched, that is contain more 3H than 14C relative to the dosed compound."( Secondary isotope effects in studies using radiolabelled folate tracers.
Blair, JA; Connor, MJ; Said, H, 1980
)
0.26
"Using data from a recent case-control study, a woman's risk of having a child with a neural tube defect (NTD) was found to be associated with early pregnancy red cell folate levels in a continuous dose-response relationship."( Folate levels and neural tube defects. Implications for prevention.
Daly, LE; Kirke, PN; Molloy, A; Scott, JM; Weir, DG, 1995
)
0.29
" There was a strong dose-response relationship between midtrimester serum MMA level and the risk for an NTD-affected pregnancy, with the relative risk increasing 13-fold for women with MMA levels > 90th percentile."( Elevated midtrimester serum methylmalonic acid levels as a risk factor for neural tube defects.
Adams, MJ; Cheek, JE; Haddow, JE; Henry, JP; Khoury, MJ; Knight, GJ; Scanlon, KS; Stabler, SP; Stevenson, RE; Sylvester, GC, 1995
)
0.29
" Continuous subcutaneous infusion at the same total dosage over 3 days gave AUC (0-96 hr) values of 134 nmol/mg protein."( Leucovorin and folic acid regimens for selective expansion of murine 5,10-methylenetetrahydrofolate pools.
Alperin, W; Pardo, M; Rosowsky, A; Sayeed-Shah, U; Wright, JE, 1995
)
0.29
" Apart from determination of titre by indirect ELISA, dose-response behaviour and specificity of these antisera were also compared."( Antibody to folic acid: increased specificity and sensitivity in ELISA by using epsilon-aminocaproic acid modified BSA as the carrier protein.
Ali, E; Das Sarma, J; Dhar, TK; Duttagupta, C, 1995
)
0.29
" A possible explanation for the increased sensitivity to methotrexate which has been documented in patients with Down syndrome may be due to imbalances in nucleotide pools which result from a gene dosage effect and to greater methylation demands."( In vivo folic acid supplementation partially corrects in vitro methotrexate toxicity in patients with Down syndrome.
Lejeune, J; Peeters, MA; Rethore, MO, 1995
)
0.29
" An appropriate dosing regimen (consecutive doses of VPA on Day 9 of gestation) can also result in a low incidence of spina bifida aperta and a high incidence of spina bifida occulta in the mouse."( Valproic acid-induced neural tube defects.
Nau, H, 1994
)
0.29
" (4) Research is needed on the dose-response relationship between folic acid and neural tube defect prevention and the mechanism of action."( Folic acid and neural tube defects: the current evidence and implications for prevention.
Wald, NJ, 1994
)
0.29
" In spite of common gene dosage effects, unexpected and highly significant differences were noted between Down's syndrome patients without complications and those presenting with additional psychotic features."( Differences in purine metabolism in patients with Down's syndrome.
Cattaneo, F; Lejeune, J; Megarbane, A; Peeters, MA; Rethore, MO, 1993
)
0.29
" Specific risk factors include high maternal daily dosage or serum concentrations of AED, low folate levels, polytherapy, and generalized seizures during pregnancy."( Teratogenic effects of antiepileptic drugs: implications for the management of epilepsy in women of childbearing age.
Lindhout, D; Omtzigt, JG, 1994
)
0.29
" Changes in hepatic enzymes have been seen with both drugs, and are also seen with other anti-folates including MTX, but these changes settle with repeat dosing and with cessation of treatment."( The history of the development and clinical use of CB 3717 and ICI D1694.
Clarke, SJ; Jackman, AL; Judson, IR, 1993
)
0.29
" The recommended dosage of folic acid is not known to be associated with adverse effects."( Recommendations on the use of folic acid supplementation to prevent the recurrence of neural tube defects. Clinical Teratology Committee, Canadian College of Medical Geneticists.
Allanson, J; Andermann, E; Dallaire, L; Fraser, FC; Friedman, JM; McLeod, DR; Van Allen, MI, 1993
)
0.29
"The increased embryotoxicity of pyrimethamine (PYM) with concomitant oral dosing of folic acid (FA) was examined in rats."( Synergistic embryotoxicity of combination pyrimethamine and folic acid in rats.
Chung, MK; Han, SS; Roh, JK,
)
0.13
" In the dose-response range studied there was no apparent affinity for methotrexate."( Purification and characterization of folate binding proteins from rat placenta.
da Costa, M; Rothenberg, SP, 1996
)
0.29
" Even if serum concentrations are within the normal range, the administration of folic acid will enhance the effectiveness of rhEPO therapy so that the rhEPO dosage can be reduced."( Folic acid supplementation improves erythropoietin response.
Pronai, W; Riegler-Keil, M; Silberbauer, K; Stockenhuber, F, 1995
)
0.29
" We question the wisdom of fortifying foods with folate at this time, given a variety of uncertainties, which include the following: 1) the fact that neural tube defects seem to be a multifactorial group of disorders that are polygenic as well, so folate will not help in all or perhaps even in most cases; 2) the incidence of NTDs, which varies geographically, has been decreasing in the United States for years; 3) fortifying more food with folate may pose safety concerns for some not as risk for NTDs; 4) no dose-response relationship has been established between folate and NTDs; and 5) fortification in this case would represent a conceptually new intervention strategy for addressing what may be a metabolic abnormality where pharmacological doses of a nutrient may be required."( Fortification of the food supply with folic acid to prevent neural tube defects is not yet warranted.
Gaull, GE; Testa, CA; Thomas, PR; Weinreich, DA, 1996
)
0.29
" Optimization of the folic acid content in the diet and of the lometrexol dosage are predicted to have substantial impact on the clinical activity of this class of drugs."( Augmentation of the therapeutic activity of lometrexol -(6-R)5,10-dideazatetrahydrofolate- by oral folic acid.
Alati, T; Bewley, JR; Grindey, GB; Lewis, S; Moran, RG; Shih, C; Worzalla, JF, 1996
)
0.29
" However, the optimum dose and dosage regimen remains to be defined."( Autologous blood donation plus epoetin alfa in nonanemic orthopedic surgery patients.
Baudoux, E, 1996
)
0.29
"Although not statistically significant, the RR for folate supplementation on the risk of neoplasia is < 1 and shows a dose-response effect, consistent with previous studies."( The effect of folic acid supplementation on the risk for cancer or dysplasia in ulcerative colitis.
Brzezinski, A; Knesebeck, A; Lashner, BA; Provencher, KS; Seidner, DL, 1997
)
0.3
" We identified clear dose-response relationships for both plasma folate and homocysteine with increased quintile of breakfast cereal and of fruit and vegetable use."( Dietary intake pattern relates to plasma folate and homocysteine concentrations in the Framingham Heart Study.
Rosenberg, IH; Selhub, J; Tucker, KL; Wilson, PW, 1996
)
0.29
"RCF levels decrease during MTX treatment and relate to side effects, withdrawals, liver enzyme elevations and aberrant MTX dosage increase, but not to the therapeutic effect."( Prospectively measured red cell folate levels in methotrexate treated patients with rheumatoid arthritis: relation to withdrawal and side effects.
Andersen, LS; Hansen, EL; Hansen, GV; Hansen, TM; Knudsen, JB; Wester, JU, 1997
)
0.3
" The purpose of the study was to determine the dose-response effects of olestra on fat-soluble vitamins and selected water-soluble micronutrients."( Olestra dose response on fat-soluble and water-soluble nutrients in the pig.
Berry, DA; Cooper, DA; King, D; Kiorpes, AL; Peters, JC; Spendel, VA, 1997
)
0.3
" Serum creatinine concentrations increased significantly during trimethoprim therapy, began to decrease near day 10, and returned to baseline during the washout phase at both dosage levels."( Effects of moderate-dose versus high-dose trimethoprim on serum creatinine and creatinine clearance and adverse reactions.
Bertino, JS; Naderer, O; Nafziger, AN, 1997
)
0.3
" The dosage of these two substances help to differenciate between both carencies, but it is not determinant of any of them and is an expensive method."( [Megaloblastic anemia: rapid and economical study].
Cicchetti, G; Marín, GH; Tentoni, J, 1997
)
0.3
" Animals were sacrificed both early and late (7 days) after dosing to determine the long-term retention of these compounds."( Whole-body disposition and polyglutamate distribution of the GAR formyltransferase inhibitors LY309887 and lometrexol in mice: effect of low-folate diet.
Chay, SH; Habeck, LL; Mendelsohn, LG; Pohland, RC; Shih, C; Worzalla, JF, 1998
)
0.3
"High intake of folate may reduce risk for colon cancer, but the dosage and duration relations and the impact of dietary compared with supplementary sources are not well understood."( Multivitamin use, folate, and colon cancer in women in the Nurses' Health Study.
Colditz, GA; Fuchs, C; Giovannucci, E; Hunter, DJ; Rosner, BA; Speizer, FE; Stampfer, MJ; Willett, WC, 1998
)
0.3
"We discuss various statistical approaches useful in the analysis of nutritional dose-response data with a continuous response."( Statistical models for quantitative bioassay.
Clifford, AJ; Facer, MR; Müller, HG, 1998
)
0.3
"Data collected included mechanism of action, safety issues, dosing recommendations, compliance with recommendations, and economics."( Drug and environmental factors associated with adverse pregnancy outcomes. Part III: Folic acid: pharmacology, therapeutic recommendations, and economics.
Berg, MJ; Lewis, DP; Stumbo, PJ; Van Dyke, DC, 1998
)
0.3
" This study further shows that Chemiron has a better haematological effect than Ferrous Gluconate at the dosage used."( The effect of 61 days of combined iron (Chemiron) and single iron therapy on haemoglobin, packed cell volume, platelets and reticulocytes during pregnancy. Preliminary report.
Ajayi, GO; Fadiran, EO, 1998
)
0.3
" In this study, cells overexpressing the wild type Galpha4 gene, due to high copy gene dosage (Galpha4HC), were found to be defective in the ability to form the anterior prestalk cell region, express prespore- and prestalk-cell specific genes, and undergo spore formation."( Folic acid stimulation of the Galpha4 G protein-mediated signal transduction pathway inhibits anterior prestalk cell development in Dictyostelium.
Hadwiger, JA; Srinivasan, J, 1999
)
0.3
" We conclude that a supraphysiological dose of folic acid is superior to standard multivitamin dosing for the reduction of fasting tHcy levels in chronic RTRs."( Enhanced reduction of fasting total homocysteine levels with supraphysiological versus standard multivitamin dose folic acid supplementation in renal transplant recipients.
Beaulieu, AJ; Bostom, AG; Gohh, RY; Hakas, D; Han, H; Jacques, PF; Selhub, J, 1999
)
0.3
" A significant dose-response relationship between serum folate concentrations and risk of recurrent early pregnancy loss suggested a protective effect by high serum folate concentrations."( Homocysteine and folate levels as risk factors for recurrent early pregnancy loss.
Blom, HJ; den Heijer, M; Eskes, TK; Nelen, WL; Steegers, EA; Thomas, CM, 2000
)
0.31
" Urticaria developed during graded oral test dosing with leucovorin."( In vitro demonstration of IgE antibody to folate-albumin in anaphylaxis from folic acid.
Dykewicz, MS; Orfan, NA; Sun, W, 2000
)
0.31
" A wide variety of dosing regimens were used for folic acid supplementation."( The use of folic acid supplementation in psoriasis patients receiving methotrexate: a survey in the United Kingdom.
Chalmers, RJ; Griffiths, CE; Kirby, B; Lyon, CC, 2000
)
0.31
" Treatment of folate-replete or deficient WTK1 and TK6 cells with increasing concentrations (0-50microg/ml) of ethyl methanesulfonate (EMS) resulted in significantly different HPRT mutation dose-response relationships (P<0."( The effect of folate deficiency on the cytotoxic and mutagenic responses to ethyl methanesulfonate in human lymphoblastoid cell lines that differ in p53 status.
Branda, RF; Brooks, EM; Nicklas, JA; O'Neill, JP; Trombley, LM, 2001
)
0.31
" Homocysteine reduction is known to be maximal at a folic acid dosage of 1 mg/d, but the effect of lower doses (relevant to food fortification) is unclear."( Randomized trial of folic acid supplementation and serum homocysteine levels.
Bishop, L; Hennessy, E; Law, M; McPartlin, J; Scott, J; Wald, DS; Wald, NJ; Weir, D, 2001
)
0.31
" Food folate intake had an inverse dose-response relation with tHcy that was limited to nonusers of supplements."( Association of folate intake and serum homocysteine in elderly persons according to vitamin supplementation and alcohol use.
Allen, RH; Baumgartner, RN; Garry, PJ; Koehler, KM; Rimm, EB; Stabler, SP, 2001
)
0.31
" We evaluated prospectively the effect of increasing the folic acid dosage from 1 to 6 mg per dialysis on plasma total homocysteine levels of haemodialysis patients with and without a history of occlusive vascular artery disease (OVD)."( Difference in the homocysteine-lowering effect of folic acid in haemodialysis patients with and without occlusive vascular disease.
Bersier, LF; Boulat, O; Descombes, E; Fellay, G, 2001
)
0.31
" A placebo-controlled study with a dose-response suggests that based on the micronucleus index in lymphocytes, an RDI level of 700microgram/day for folic acid and 7microgram/day for Vitamin B12 would be appropriate for genomic stability in young adults."( The role of folic acid and Vitamin B12 in genomic stability of human cells.
Fenech, M, 2001
)
0.31
" Different shapes of the dose-response relationship were seen for the 3 vascular disease categories."( Plasma total cysteine as a risk factor for vascular disease: The European Concerted Action Project.
El-Khairy, L; Graham, IM; Refsum, H; Ueland, PM; Vollset, SE, 2001
)
0.31
" A curvilinear relationship exists between these cofactors and tHcy levels, with the dose-response relationship shifted to the right in the weight loss group."( Elevated homocysteine levels with weight loss after Lap-Band surgery: higher folate and vitamin B12 levels required to maintain homocysteine level.
Dixon, JB; Dixon, ME; O'Brien, PE, 2001
)
0.31
" There is an altered dose-response relationship with higher serum B(12) and folate levels required to maintain recommended tHcy levels."( Elevated homocysteine levels with weight loss after Lap-Band surgery: higher folate and vitamin B12 levels required to maintain homocysteine level.
Dixon, JB; Dixon, ME; O'Brien, PE, 2001
)
0.31
"05) with three vitamin dosages weekly, but not with one dosage weekly."( Homocyst(e)ine metabolism in hemodialysis patients treated with vitamins B6, B12 and folate.
Graefe, U; Henning, BF; Riezler, R; Tepel, M; Zidek, W, 2001
)
0.31
" Clinical signs of regression of the orbital inflammation, visual acuity, dosage and duration of methotrexate therapy, requirement for concurrent corticosteroid administration, and adverse drug reactions were recorded."( A role for methotrexate in the management of non-infectious orbital inflammatory disease.
Rosenbaum, JT; Smith, JR, 2001
)
0.31
" These results highlight the problems of dose uniformity and the potential health risks of slow dissolution and under-dosing in commercially available folic acid dosage forms."( Commercially available folic acid supplements and their compliance with the British Pharmacopoeia test for dissolution.
Allison, S; Ashton, T; Davies, B; Malhi, JS; McGuire, DN; Sculthorpe, NF, 2001
)
0.31
"0 micromol of HCY/per embryo could disturb their heart development and differentiation of blood vessels at fetal ages of two and four days, in a dose-response pattern, with 24."( [Effects of homocysteine on cardiovascular development in early chicken embryo].
Chen, X; Li, S; Li, Y; Li, Z; Qi, P, 1999
)
0.3
"This trial sought to examine the effects of high dosage of folic acid and vitamin C supplementation on red blood cell folate (RCF), serum folate (SF) and homocysteine (Hcy) levels in subjects who smoke more than 15 cigarettes per day."( Effect of folic acid and vitamin C supplementation on folate status and homocysteine level: a randomised controlled trial in Italian smoker-blood donors.
Cafolla, A; Costante, A; De Luca, AM; Dragoni, F; Funaro, D; Girelli, G; Scott, CS; Tosti, ME, 2002
)
0.31
" The results of preformulation studies enabled detection of drug-excipients interactions and selection of compatible excipient system to the given drug composition to formulate dosage form of required stability, processability and effectiveness."( [Formulation of tablets decreasing plasma homocysteine levels].
Budavári, Z, 2001
)
0.31
" In this report, we describe a woman with primary antiphospholipid antibody syndrome who developed extensive pulmonary embolism despite receiving a proven therapeutic dosage of low molecular weight heparin."( Low-molecular weight heparin: treatment failure in a patient with primary antiphospholipid antibody syndrome.
Ahmed, S; Karim, A; Mattana, J; Patel, D; Siddiqui, R, 2002
)
0.31
" Apart from recurrence prevention, where a dose of 4mg/day is recommended, no standard dosing guidelines exist."( [Folic acid and prevention of anomalies of foetal neural tube closing in women treated for epilepsy].
Dib, M; Weber, M, 2003
)
0.32
" Three divided doses of FA on GD 7 and continuous dosing of FA from GD 5 through GD 10 substantially reduced the VPA-induced exencephaly in the fetuses."( Amelioration of sodium valproate-induced neural tube defects in mouse fetuses by maternal folic acid supplementation during gestation.
Padmanabhan, R; Shafiullah, MM, 2003
)
0.32
" We conducted a long-term study to evaluate whether 15 mg is more effective than 5 mg oral folic acid as a daily dosage to decrease hyperhomocysteinemia, and to assess whether homocysteine-lowering treatment reduces the risk of cardiovascular disease in hemodialysis patients."( Effects of folic acid treatment on homocysteine levels and vascular disease in hemodialysis patients.
Ferrario, GM; La Rosa, L; Milani, S; Righetti, M; Serbelloni, P; Sessa, A; Uccellini, M, 2003
)
0.32
" From the dose-response curve, the adequate daily dose of folic acid was estimated to be 392 micro g, which decreased plasma homocysteine concentrations 22%."( Folic acid and reduction of plasma homocysteine concentrations in older adults: a dose-response study.
Brouwer, IA; Clarke, R; Katan, MB; Melse-Boonstra, A; van Oort, FV; Verhoef, P; West, CE, 2003
)
0.32
" Despite uncertainty about the efficacy of periconceptional folate supplementation in WWE, these women should receive such supplementation at dosage levels recommended for the general population of women of childbearing age."( Clinical care of pregnant women with epilepsy: neural tube defects and folic acid supplementation.
Yerby, MS, 2003
)
0.32
" Dosing schedules that include a nitrate-free period often fail to ameliorate the development of nitrate tolerance, and, in fact, can result in an increase in rebound ischemia."( Organic nitrate tolerance and endothelial dysfunction: role of folate therapy.
Leopold, JA; Loscalzo, J, 2003
)
0.32
" This complication is normally rare when small dosages of the drug are used, but a high incidence of the neuropathy has recently been observed in East Africa in a group of malnourished tuberculous patients receiving isoniazid in comparatively low dosage (4-6 mg/kg body-weight daily)."( Peripheral neuritis due to isoniazid.
ANDREWS, RH; DEVADATTA, S; FOX, W; GANGADHARAM, PR; RAMAKRISHNAN, CV; SELKON, JB; VELU, S, 1960
)
0.24
"The intestinal absorption of folic acid in patients with idiopathic steatorrhea was studied by the oral administration of tritium-labelled folic acid in a dosage of 15 mug."( INTESTINAL ABSORPTION OF TRITUM-LABELLED FOLIC ACID IN IDIOPATHIC STEATORRHEA: EFFECT OF A GLUTENFREE DIET.
BURGEN, AS; CAMERON, DG; JOHNS, DG; KINNEAR, DG; MACINTOSH, PC, 1963
)
0.24
" 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
)
0.24
" In addition, a significant dose-response relation between plasma folate concentrations and risk for schizophrenia suggested a protective effect by high plasma folate concentrations."( Homocysteine metabolism and B-vitamins in schizophrenic patients: low plasma folate as a possible independent risk factor for schizophrenia.
Blom, H; Ellenbroek, B; Eskes, T; Muntjewerff, JW; Steegers, E; van der Put, N; Zitman, F, 2003
)
0.32
"2 mg/kg, providing 360 microg daily per capita, an acceptable dosage for preventing the occurrence of some neural tube defect (NTD) cases."( Preliminary data on changes in neural tube defect prevalence rates after folic acid fortification in South America.
Castilla, EE; Dutra, Mda G; Lopez-Camelo, JS; Nazer-Herrera, J; Orioli, IM, 2003
)
0.32
" We apply our methods to new data regarding the analysis of the level of 14C-folate in plasma as a function of time since dosing of healthy adults with a small tracer dose of 14C-folic acid."( Shrinkage estimation for functional principal component scores with application to the population kinetics of plasma folate.
Buchholz, BA; Clifford, AJ; Dueker, SR; Follett, J; Lin, Y; Müller, HG; Vogel, JS; Yao, F, 2003
)
0.32
" Starting at a plasma homocysteine concentration of approximately 10 micromol/l, the risk increase follows a linear dose-response relationship with no specific threshold level."( DACH-LIGA homocystein (german, austrian and swiss homocysteine society): consensus paper on the rational clinical use of homocysteine, folic acid and B-vitamins in cardiovascular and thrombotic diseases: guidelines and recommendations.
Dierkes, J; Fowler, B; Geisel, J; Herrmann, W; Pietrzik, K; Stanger, O; Weger, M, 2003
)
0.32
" Therefore, these observations indicated that the dosage adjustment may be necessary for tolbutamide in patients with renal insufficiency."( Pharmacokinetics of tolbutamide after oral administration to rabbits with folate-induced renal failure.
Choi, JS; Shin, SC, 2003
)
0.32
" for 3 additional months, while the FOL dosage was constant."( Intravenous administration of vitamin B12 in the treatment of hyperhomocysteinemia associated with end-stage renal disease.
Alivanis, P; Arvanitis, A; Ganotakis, ES; Maliaraki, N; Margioris, AN; Papadakis, JA; Sratigis, S; Stilianou, K; Vardakis, KE; Vrentzos, GE,
)
0.13
" However, at 1 week after the administration of a single dosage 6[R,S] 5-MTHF, we detected 6[R] 5-MTHF following the administration of folic acid, indicating storage of this isomer in the body."( Pharmacokinetic study on the utilisation of 5-methyltetrahydrofolate and folic acid in patients with coronary artery disease.
Aengevaeren, WR; Blom, HJ; Boers, GH; Verheugt, FW; Willems, FF, 2004
)
0.32
" The other report is of anemia due to iron deficiency treated successfully with ferrous sulfate in a dosage twenty times that previously used prophylactically."( Treatment of nutritional anemia in infants.
STURGEON, P, 1952
)
0.23
" We recommend a pragmatic dosing schedule of 5 mg of oral folic acid given on the morning following the day of MTX administration."( Folate supplementation and methotrexate treatment in rheumatoid arthritis: a review.
Hughes, RA; Whittle, SL, 2004
)
0.32
" There was no difference in Hcy reduction following the administration of either high or low dosage of vitamins B6 and B12 utilized in the present study."( Comparative study of response to treatment with supraphysiologic doses of B-vitamins in hyperhomocysteinemic hemodialysis patients.
Abassi, Z; Brenner, B; Green, J; Khankin, E; Lanir, N; Nakhoul, F; Plawner, M; Ramadan, R, 2004
)
0.32
" The efficacy of a 30 days treatment with STRESSEN was evaluated through dosage of this amino acid and through a questionnaire on the general state of health."( ["STRESSEN" in the treatment of psycho-physical stress and hyperhomocysteinemia in patients with migraine without aura].
Di Sabato, F, 2004
)
0.32
" Starting at a plasma homocysteine concentration of approximately 10 micromol/l, the risk increase follows a linear dose-response relationship with no specific threshold level."( Clinical use and rational management of homocysteine, folic acid, and B vitamins in cardiovascular and thrombotic diseases.
Dierkes, J; Fowler, B; Geisel, J; Herrmann, W; Pietrzik, K; Stanger, O; Weger, M, 2004
)
0.32
" The investigation of the dose-response effects of B vitamin supplementation on cognition and mood in middle-aged men and women using objective measures of cognition and accounting for the influence of confounding factors such age and education would be informative."( Associations between dietary intake of folate and vitamins B-12 and B-6 and self-reported cognitive function and psychological well-being in Australian men and women in midlife.
Bryan, J; Calvaresi, E, 2004
)
0.32
" Dose-response relationships, a criterion for causality, were examined linking exposures to likelihood of case status."( Case-control study of multiple chemical sensitivity, comparing haematology, biochemistry, vitamins and serum volatile organic compound measures.
Baines, CJ; Cole, DE; Jazmaji, V; Loescher, B; Marshall, L; McKeown-Eyssen, GE; Riley, N, 2004
)
0.32
" Dietary folate intake reduced CLP risk independently in a dose-response manner."( Periconceptional folate intake by supplement and food reduces the risk of nonsyndromic cleft lip with or without cleft palate.
Merkus, HM; Ocké, MC; Steegers-Theunissen, RP; Straatman, H; van Rooij, IA; Zielhuis, GA, 2004
)
0.32
"In a 48 week randomised controlled trial of methotrexate, comparing folates with placebo, rheumatologists were advised on methotrexate dosage using a guideline reflecting daily practice."( Influence of guideline adherence on outcome in a randomised controlled trial on the efficacy of methotrexate with folate supplementation in rheumatoid arthritis.
Fransen, J; Huizinga, TW; Laan, RF; Van Der Laar, MA; Van Riel, PL, 2004
)
0.32
"There is an indication that adherence to guidelines on methotrexate dosage may benefit patients with rheumatoid arthritis by improving disease activity without increasing toxicity."( Influence of guideline adherence on outcome in a randomised controlled trial on the efficacy of methotrexate with folate supplementation in rheumatoid arthritis.
Fransen, J; Huizinga, TW; Laan, RF; Van Der Laar, MA; Van Riel, PL, 2004
)
0.32
" A dose of 6 g betaine/d has been used in the treatment of homocystinuria, but data on the dose-response are scarce."( The effect of low doses of betaine on plasma homocysteine in healthy volunteers.
Alfthan, G; Aro, A; Nissinen, K; Saarela, J; Tapani, K, 2004
)
0.32
" Notably, adjusted (for age and sex) dose-response curves for the postmethionine increase in homocysteine or fasting homocysteine versus betaine showed that the inverse associations were most pronounced at low serum folate, an observation that was confirmed by analyses of interaction."( Betaine and folate status as cooperative determinants of plasma homocysteine in humans.
Blom, HJ; den Heijer, M; Holm, PI; Keijzer, MB; Midttun, Ø; Ueland, PM; Vollset, SE, 2005
)
0.33
" The objective of this study was to investigate the effects of a daily dosage of 1000 mg vitamin C, 800 mg vitamin E, and 10 mg folate on markers of vascular function in 31 young healthy male adults."( Cardiovascular effects of oral Supplementation of vitamin C, E and folic acid in young healthy males.
Huisman, HW; Jerling, JC; Oosthuizen, W; Schutte, AE; van Rooyen, JM, 2004
)
0.32
" There was no dose-response relationship between homocysteine concentration and severity of preeclampsia."( Mapping the theories of preeclampsia: the role of homocysteine.
Carroli, G; Khan, KS; Kilby, MD; Latthe, PM; Mignini, LE; Villar, J, 2005
)
0.33
" However, because of a lack of consistency in data, dose-response relationship, and biologic plausibility, the observed association cannot be considered causal from the current literature."( Mapping the theories of preeclampsia: the role of homocysteine.
Carroli, G; Khan, KS; Kilby, MD; Latthe, PM; Mignini, LE; Villar, J, 2005
)
0.33
" Serum vitamin B12 was related to BMD in dose-response fashion up to about 200 pmol/L, and subjects with serum Hcy > or = 20 micromol/L had significantly lower BMD than subjects with serum Hcy < 10 micromol/L."( Relation between homocysteine and B-vitamin status indicators and bone mineral density in older Americans.
Jacques, PF; Morris, MS; Selhub, J, 2005
)
0.33
" These results are significant, since daily dosing of EC72 for more than 30 consecutive days yielded no evidence of myelosuppression or toxicity to major organs, including the FR-positive kidneys."( Synthesis and biological evaluation of EC72: a new folate-targeted chemotherapeutic.
Leamon, CP; Nicoson, JS; Parker, N; Reddy, JA; Vetzel, M; Vlahov, IR; Westrick, E; Xu, LC,
)
0.13
" Smoking frequency appeared to show negative dose-response effects on maternal and neonatal Zn concentrations, Zn/Pb molar concentration ratios, and birth weight."( Maternal and neonatal scalp hair concentrations of zinc, copper, cadmium, and lead: relationship to some lifestyle factors.
Ghribi, I; Razagui, IB, 2005
)
0.33
" Blockage of the platelet GpIIb/IIIa receptor by Integrilin (Schering-Plough A/S) did not abolish the FD-HH-induced increase in whole-blood coagulation velocity, irrespective of the dosage of Integrilin."( Folate deficiency-induced hyperhomocysteinemia attenuates, and folic acid supplementation restores, the functional activities of rat coagulation factors XII, X, and II.
Ebbesen, LS; Ingerslev, J, 2005
)
0.33
" The mean MTX dosage at week 52 was similar in the 2 RCTs."( Reduction of the efficacy of methotrexate by the use of folic acid: post hoc analysis from two randomized controlled studies.
Cohen, SB; Dorrier, C; Elashoff, D; Emery, P; Furst, DE; Khanna, D; Park, GS; Paulus, HE; Simpson, KM, 2005
)
0.33
" AC-Zn polymers provided a novel approach for enteric drug delivery as drug release from these matrices complied with the USP specifications for enteric dosage forms."( Synthesis of zinc-crosslinked thiolated alginic acid beads and their in vitro evaluation as potential enteric delivery system with folic acid as model drug.
Aiedeh, KM; Al-Hiari, Y; Al-Khatib, H; Taha, MO, 2005
)
0.33
"A significant dose-response relationship between the risk of orofacial clefts and a decrease in the intake of folates from diet was found, stronger for cleft palate without cleft lip."( [Periconceptional folates and the prevention of orofacial clefts: role of dietary intakes in France].
Bahuau, M; Cordier, S; Francannet, C; Herman, C; Monfort, C; Nelva, A; Robert-Gnansia, E; Rouget, F, 2005
)
0.33
" Decreased FIGLU might result from accelerated activity of one or more genes on chromosome 21, by a gene dosage effect."( A folate-dependent metabolite in amniotic fluid from pregnancies with normal or trisomy 21 chromosomes.
Baggot, PJ; Eliseo, AJ; Kalamarides, JA; Shoemaker, JD, 2006
)
0.33
" Additional studies are needed to define appropriate dosing for renally impaired patients receiving higher dose pemetrexed with vitamin supplementation."( Phase I and pharmacokinetic study of pemetrexed administered every 3 weeks to advanced cancer patients with normal and impaired renal function.
Baker, SD; Chaudhary, AK; Chaudhuri, T; Goetz, A; Hammond, LA; Johnson, RD; Latz, JE; Mita, AC; Molpus, K; Patnaik, A; Rowinsky, EK; Sandler, A; Simms, L; Sweeney, CJ; Takimoto, CH; Tolcher, AW; Villalona-Calero, M, 2006
)
0.33
" Four healthy adult volunteers undertook each dosing schedule 2 weeks apart."( Postprandial serum folic acid response to multiple doses of folic acid in fortified bread.
Daly, L; McPartlin, J; Scott, JM; Sweeney, MR; Weir, DG, 2006
)
0.33
" The business objective set for the Femina brand was to build the category of preventive iron-folic acid supplements in line with the Philippine Department of Health's advocacy on weekly supplementation as an alternate to daily dosing to reduce the prevalence of anemia in the country."( Industry experience in promoting weekly iron-folic acid supplementation in the Philippines.
Datol-Barrett, E; Dizon, M; Garcia, J, 2005
)
0.33
" The dosage of the preparation in group 1 was 1 tablet Ferro-Folgamma tid for 40 days, and 1 tablet Ferro-Folgamma bid for the same period."( [Ferro-folgamma--a good alternative in the treatment of iron deficiency anemia and depleted iron stores in pregnant women].
Ivanov, S; Sigridov, I, 2005
)
0.33
"Oral treatment with Ferro-Folgamma, according the described dosage regimen, demonstrates its fast and stable effect in treatment of moderate iron deficiency and recovery of depleted iron pool in pregnant patients as well."( [Ferro-folgamma--a good alternative in the treatment of iron deficiency anemia and depleted iron stores in pregnant women].
Ivanov, S; Sigridov, I, 2005
)
0.33
" Among all providers, 42% did not know the correct FA dosage (400 mug daily)."( Health care provider knowledge and practices regarding folic acid, United States, 2002-2003.
Abelman, SM; Damus, K; Fassett, EM; Mulinare, J; Petrini, JR; Stone, CE; Williams, JL, 2006
)
0.33
" Some reports support our observation that the dosage of folic acid required for tHcy decrease is 15-30 mg, and that the dosage higher than 60 mg does not significantly decrease tHcy concentration."( [The treatment of hyperhomocysteinemia in patients on dialysis: folic acid or the high-flow polysulphonic membrane?].
Kes, P; Kusec, V; Lovcić, V; Zeljko, R, 2006
)
0.33
" In contrast, treatment with the unconjugated DAVLBH drug produced nominal efficacy when dosed at its MTD."( Synthesis and biological evaluation of EC140: a novel folate-targeted vinca alkaloid conjugate.
Kleindl, PJ; Leamon, CP; Reddy, JA; Vetzel, M; Vlahov, IR; Westrick, E,
)
0.13
" There were no dose-response trends for either nutrient."( Prospective study of plasma folate, vitamin B12, and cognitive function and decline.
Grodstein, F; Irizarry, MC; Kang, JH, 2006
)
0.33
"Multiple dosing of low amounts of labeled folic acid is a sensitive, accurate, and efficient method of measuring the relative bioavailability of folic acid compounds, provided that the administered doses can be reliably assessed."( A dual-isotope-labeling method of studying the bioavailability of hexaglutamyl folic acid relative to that of monoglutamyl folic acid in humans by using multiple orally administered low doses.
Garbis, SD; Katan, MB; Kok, FJ; Lasaroms, JJ; Melse-Boonstra, A; van Breemen, RB; van Rhijn, JA; Verhoef, P; West, CE, 2006
)
0.33
" In the case of minor adverse effects the use of folic acid at a dosage of 1 mg/day is feasible."( Recommendations for the use of methotrexate in juvenile idiopathic arthritis.
Lankisch, P; Niehues, T, 2006
)
0.33
" Dietary vitamins E and C were statistically significantly protective for both colon and rectal cancer at all levels of consumption, and for both vitamins there was a dose-response effect of increasing protection, particularly so for colon cancer."( Colorectal cancer protective effects and the dietary micronutrients folate, methionine, vitamins B6, B12, C, E, selenium, and lycopene.
Kune, G; Watson, L, 2006
)
0.33
" The lack of impact of zinc on mortality and hospitalization rates in this study may have been due to the use of lower daily zinc dosing than used in some of the morbidity prevention trials or from an interaction between zinc and iron, where the addition of iron may have adversely affected potential effects of zinc on immune function and morbidity."( Adding zinc to supplemental iron and folic acid does not affect mortality and severe morbidity in young children.
Bahl, R; Bhan, MK; Bhandari, N; Fontaine, O; Mazumder, S; Taneja, S, 2007
)
0.34
" Nevertheless, several research gaps remain: identification of the mechanism by which the defect occurs and how folate ameliorates it; characterization of the relative efficacy of food folate, folic acid added to foods, and folic acid by itself; delineation of the dose-response relations of folate and NTD prevention; and more precise quantification of the dose needed to prevent recurrences."( Folate and neural tube defects.
Pitkin, RM, 2007
)
0.34
" We also performed a dose-response study with folinic acid and determined the impact of maternal folate supplementation on Folr1 nullizygous cardiac development."( Cardiovascular abnormalities in Folr1 knockout mice and folate rescue.
Finnell, RH; Gelineau-van Waes, J; Merriweather, M; Schwartz, RJ; Scott, M; Wlodarczyk, BJ; Yu, W; Zhu, H, 2007
)
0.34
" Dose-response analyses indicated a positive association between plasma tHcy and risk of fracture in both sexes and a negative association between plasma folate and risk of fracture among women only."( Plasma homocysteine, folate, and vitamin B 12 and the risk of hip fracture: the hordaland homocysteine study.
Gjesdal, CG; Meyer, HE; Refsum, H; Tell, GS; Ueland, PM; Vollset, SE, 2007
)
0.34
"Evidence of a dose-response relationship was found between BMI and inadequate servings of grains and vegetables, and iron and folate intake."( Pregravid body mass index is negatively associated with diet quality during pregnancy.
Bodnar, LM; Laraia, BA; Siega-Riz, AM, 2007
)
0.34
" To support this tentative relationship, more well designed, long-term follow-up studies are needed in places where fortification with FA has been introduced, focusing on dose-response and obtaining accurate data on infertility treatments."( Folic acid and risk of twinning: a systematic review of the recent literature, July 1994 to July 2006.
Halliday, JL; Muggli, EE, 2007
)
0.34
" However, in selected cases, depending on the effectiveness of the interventions, dosage reductions or discontinuation of medications may be possible."( Natural approaches to epilepsy.
Gaby, AR, 2007
)
0.34
" Oral [(13)C]formate or [2-(13)C]glycine dosing and urine collection can be used to study purine biosynthesis in humans."( 13C enrichment of carbons 2 and 8 of purine by folate-dependent reactions after [13C]formate and [2-13C]glycine dosing in adult humans.
Baggott, JE; Gorman, GS; Tamura, T, 2007
)
0.34
"to explore the use of folic acid and other vitamin supplements before and during pregnancy, including type, dosage and form; who recommended supplement use and for what reason; and women's understanding of why they took folic acid."( The use of folic acid and other vitamins before and during pregnancy in a group of women in Melbourne, Australia.
Bolger, M; Denning, A; Forster, DA; Wills, G, 2009
)
0.35
" Proteomic analysis indicated that, under the dosage of the present investigation, folic acid mainly reversed the alcohol-altered proteins involved in energy production, signal pathways and protein translation, which are all important for central nervous system development."( Effect of folic acid on prenatal alcohol-induced modification of brain proteome in mice.
Li, Y; Tang, Y; Xu, Y, 2008
)
0.35
" Post hoc analysis, which should be interpreted with caution, seemed to indicate a dose-response effect: the change in FMD was -0."( Folic acid improves vascular reactivity in humans: a meta-analysis of randomized controlled trials.
de Bree, A; Draijer, R; van Mierlo, LA, 2007
)
0.34
" EC0225 produced potent, dose-responsive activity in vitro, and curative activity was observed against FR-positive syngeneic and xenograft tumors following the administration of well-tolerated dosing regimens."( Preclinical antitumor activity of a novel folate-targeted dual drug conjugate.
Dawson, A; Dorton, R; Leamon, CP; Reddy, JA; Santhapuram, HK; Vetzel, M; Vlahov, IR; Wang, Y; Westrick, E,
)
0.13
"This preliminary study suggests that folic acid supplementation may contribute to higher MTX dosing in patients with RA."( Preliminary evidence shows that folic acid fortification of the food supply is associated with higher methotrexate dosing in patients with rheumatoid arthritis.
Arabelovic, S; Dallal, GE; Jacques, PF; Rosenberg, IH; Roubenoff, R; Sam, G; Selhub, J, 2007
)
0.34
" A more complete ascertainment and detailed timing and dosage of folic acid use in a prospective study is recommended."( Congenital malformations in infants whose mothers reported the use of folic acid in early pregnancy in Sweden. A prospective population study.
Källén, B, 2007
)
0.34
" Issues to be considered are the timing of the intervention during multistep carcinogenesis, baseline levels in a given individual or population, the complexity of dietary interactions, dose-response effects, and the duration of study."( Chemoprevention of colorectal cancer: why all the confusion?
Bresalier, RS, 2008
)
0.35
" A dose-response relationship was shown between plasma folate levels or methylation indices of arsenic species and UC risk in the respective quartile strata."( Plasma folate level, urinary arsenic methylation profiles, and urothelial carcinoma susceptibility.
Chen, CJ; Chung, CJ; Hsueh, YM; Huang, YK; Pu, YS; Shiue, HS; Yang, MH, 2008
)
0.35
" In line, we propose a risk-benefit model that consists of: (1) hazard and benefit identification, (2) hazard and benefit characterization through dose-response functions, (3) exposure assessment, and (4) risk-benefit integration."( Integrated risk-benefit analyses: method development with folic acid as example.
de Jong, N; Hoekstra, J; Rompelberg, C; van Kranen, H; Verhagen, H; Verkaik-Kloosterman, J; Zeilmaker, M, 2008
)
0.35
" Dosing of MTX was individualised with the help of pre-study evaluation of plasma MTX pharmacokinetics."( The effect of folic acid supplementation on the pharmacokinetics and pharmacodynamics of oral methotrexate during the remission-induction period of treatment for moderate-to-severe plaque psoriasis.
Beránek, M; Chládek, J; Chládkova, J; Hroch, M; Martínková, J; Simková, M; Vanecková, J; Vávrová, J, 2008
)
0.35
" The individual tailoring of MTX dosing needs further attention because the mean percent PASI improvement from baseline was 83% and the inter-patient variability in response was low after 16 weeks of monotherapy with MTX."( The effect of folic acid supplementation on the pharmacokinetics and pharmacodynamics of oral methotrexate during the remission-induction period of treatment for moderate-to-severe plaque psoriasis.
Beránek, M; Chládek, J; Chládkova, J; Hroch, M; Martínková, J; Simková, M; Vanecková, J; Vávrová, J, 2008
)
0.35
" In the first set, the inactiveness and mortality of the mussels in different drugs were studied through two different dosages and in subsequent tests the fixation of dosage was employed."( Differential growth of the freshwater mussel, Lamellidens marginalis in relation to certain drugs.
Mishra, RK; Mishra, S; Nayak, L; Sahu, BK; Senga, Y, 2008
)
0.35
" At level 1, 4/6 patients experienced DLTs; dosing decreased to level 0 and 4/5 patients experienced DLTs."( Phase I study of a 3-drug regimen of gemcitabine/cisplatin/pemetrexed in patients with metastatic transitional cell carcinoma of the urothelium.
Atienza, D; Awasthi, S; Berry, W; Delaune, R; Deutsch, M; Dien, PY; Gregory, TF; Hood, K; Hutson, TE; Ilegbodu, D; Kolodziej, MJ; Mull, S; Muscato, JJ; Nicol, S; Raju, RN; Ruxer, RL; Vukelja, S, 2008
)
0.35
" A total of 140 eligible women were randomly assigned to two dosage groups and followed up for 12 weeks."( Effect of different dosage and administration schedules of folic acid on blood folate levels in a population of Honduran women of reproductive age.
Barahona, F; Flores, A; Milla, G; Pfeiffer, C; Rosenthal, J; Skerrette, N; Umaña, E; Yon, M, 2008
)
0.35
" However, a differential effect on serum folate levels by dosage group and time was observed."( Effect of different dosage and administration schedules of folic acid on blood folate levels in a population of Honduran women of reproductive age.
Barahona, F; Flores, A; Milla, G; Pfeiffer, C; Rosenthal, J; Skerrette, N; Umaña, E; Yon, M, 2008
)
0.35
"Although both folate supplementation regimens increased serum and red blood cell folate levels significantly among the women studied, blood folate levels that are considered to be protective of NTD were reached faster with the daily dosage of 1 mg folic acid."( Effect of different dosage and administration schedules of folic acid on blood folate levels in a population of Honduran women of reproductive age.
Barahona, F; Flores, A; Milla, G; Pfeiffer, C; Rosenthal, J; Skerrette, N; Umaña, E; Yon, M, 2008
)
0.35
" Knowledge about the correct timing (12%) and dosage (47%) of folic acid preparations for average-risk women was also lacking."( Physicians' knowledge and attitudes regarding periconceptional folic acid supplementation: a survey in Southern Israel.
Abu-Hammad, T; Cohen, AD; Dreiher, J; Vardy, DA, 2008
)
0.35
"To study the prophylactic effect of folic acid supplementation with regard to spontaneous abortion and preterm delivery (fetal demise after week 20 of gestational age) in pregnant women receiving AED therapy, as well as benefits of most common dosage and preconceptional commencement."( Spontaneous abortion and the prophylactic effect of folic acid supplementation in epileptic women undergoing antiepileptic therapy.
Auckenthaler, A; Bauer, G; Brezinka, C; Dobesberger, J; Embacher, N; Jahn, B; Luef, G; Pittschieler, S; Trinka, E; Unterberger, I; Walser, G, 2008
)
0.35
"There are no large randomized trials of the effect of folic acid dosing regimens on blood folate and homocysteine concentrations."( Folate status and homocysteine response to folic acid doses and withdrawal among young Chinese women in a large-scale randomized double-blind trial.
Bailey, LB; Berry, RJ; Erickson, JD; Gindler, J; Hao, L; Hu, DJ; Li, S; Li, Z; Yang, QH; Zhang, BL; Zhang, L; Zhu, JH, 2008
)
0.35
"Changes in folate and homocysteine concentrations were unaffected by different dosing schedules."( Folate status and homocysteine response to folic acid doses and withdrawal among young Chinese women in a large-scale randomized double-blind trial.
Bailey, LB; Berry, RJ; Erickson, JD; Gindler, J; Hao, L; Hu, DJ; Li, S; Li, Z; Yang, QH; Zhang, BL; Zhang, L; Zhu, JH, 2008
)
0.35
" From these findings, we conclude that lowering the dietary intake of folates in mice has little impact on the biological activity of repetitively dosed folate-targeted agents but that low folate diet regimens will reduce serum and RBC folate levels down to levels that more closely approximate the normal human ranges."( Impact of high and low folate diets on tissue folate receptor levels and antitumor responses toward folate-drug conjugates.
Bloomfield, A; Dorton, R; Emsweller, K; Leamon, CP; Parker, N; Reddy, JA; Westrick, E, 2008
)
0.35
" These methods could be applied to determine DOX, PYR, and FA in their combined dosage forms."( Simultaneous determination of a ternary mixture of doxylamine succinate, pyridoxine hydrochloride, and folic acid by the ratio spectra-zero-crossing, double divisor-ratio spectra derivative, and column high-performance liquid chromatographic methods.
Pathak, A; Rajput, SJ,
)
0.13
" An increased risk of colon cancer was suggested for men in the middle quintile of serum folate, but without indication of a dose-response relationship."( One-carbon metabolism biomarkers and risk of colon and rectal cancers.
Albanes, D; Graubard, B; Lim, U; Selhub, J; Stolzenberg-Solomon, R; Taylor, PR; Virtamo, J; Weinstein, SJ, 2008
)
0.35
" Nine recommendations were specific for rheumatoid arthritis (RA), including the work-up before initiating methotrexate, optimal dosage and route, use of folic acid, monitoring, management of hepatotoxicity, long-term safety, mono versus combination therapy and management in the perioperative period and before/during pregnancy."( Multinational evidence-based recommendations for the use of methotrexate in rheumatic disorders with a focus on rheumatoid arthritis: integrating systematic literature research and expert opinion of a broad international panel of rheumatologists in the 3E
Bijlsma, JW; Bombardier, C; Boumpas, DT; Canhao, H; Carmona, L; Dougados, M; Edwards, CJ; Hamuryudan, V; Katchamart, W; Kvien, TK; Leeb, BF; Loza, E; Martín-Mola, EM; Martinez-Lopez, JA; Mielants, H; Müller-Ladner, U; Murphy, G; Pereira, IA; Ramos-Remus, C; Salliot, C; Trudeau, J; Valentini, G; van der Heijde, D; Visser, K; Zochling, J; Østergaard, M, 2009
)
0.35
" Collectively, these results show that this potent antiproliferative tubulysin compound can be specifically delivered to FR-positive tumors to provide substantial therapeutic benefit using well-tolerable dosing regimens."( Folate targeting enables durable and specific antitumor responses from a therapeutically null tubulysin B analogue.
Dorton, R; Leamon, CP; Parker, N; Reddy, JA; Vetzel, M; Vlahov, I; Wang, Y; Westrick, E, 2008
)
0.35
" The dosing regimen was continued up to 10 weeks."( Methotrexate-induced cytotoxicity and genotoxicity in germ cells of mice: intervention of folic and folinic acid.
Jena, GB; Padmanabhan, S; Ramarao, P; Tripathi, DN; Vikram, A, 2009
)
0.35
" We also tested the influence of folic acid dosage (5 mg OD) on the levels of homocysteine and the allied vitamin supplements, vitamin B12 and folate in smaller groups selected from the larger group."( Homocystine levels, polymorphisms and the risk of ischemic stroke in young Asian Indians.
Akhter, MS; Behari, M; Biswas, A; Meena, A; Munisamy, M; Ranjan, R; Saxena, R; Subbiah, V; Yadav, BK,
)
0.13
" There was an almost total response to folic acid dosage as all hyperhomocysteinemic patients showed lowering of homocysteine levels in response to the dosage."( Homocystine levels, polymorphisms and the risk of ischemic stroke in young Asian Indians.
Akhter, MS; Behari, M; Biswas, A; Meena, A; Munisamy, M; Ranjan, R; Saxena, R; Subbiah, V; Yadav, BK,
)
0.13
"Homocysteine (HCy), C-reactive protein (CRP), Folate, fibrinogen and alpha1 acid glycoprotein (alpha1AGP) were dosed before and after a 3-month course of high-dose folate (25 mg intravenous calcium laevofolinate pentahydride once weekly) and again after a one-month washout in 15 HD patients with established VOD (group A) and in 15 comparable HD patients with no diagnosis of VOD (group B)."( Treatment of hyperhomocysteinaemia in haemodialysis patients at high cardiovascular risk.
Athanasopoulou, E; Bernabei, E; Chamoun, G; Colarieti, G; De Francesco, M; Della Rovere, FR; Di Giandomenico, G; Lonzi, M; Manca di Villahermosa, S; Moscaritolo, E; Noce, A; Taccone-Gallucci, M; Tedesco, M, 2009
)
0.35
" Different folic acid supplementation approaches and dosage should be undertaken to improve folate status of women in different areas."( Plasma folate status and dietary folate intake among Chinese women of childbearing age.
Cao, Y; Deng, Y; Hao, L; Li, Z; Tian, Y; Wang, T; Xia, H; Yu, M; Zhang, L; Zhao, Y, 2009
)
0.35
" A single dosage of EtOH (3."( Exogenous folate ameliorates ethanol-induced brain hyperhomocysteinemia and exogenous ethanol reduces taurine levels in chick embryos.
Barnett, RK; Booms, SL; Gura, T; Gushrowski, M; Miller, RR, 2009
)
0.35
" Those subjects were randomized to receive either 5 mg/d of oral folic acid or an equivalent dosage of placebo."( Role of folic acid in atherosclerosis after kidney transplant: a double-blind, randomized, placebo-controlled clinical trial.
Einollahi, B; Farhangi, S; Farjad, R; Firouzan, A; Kalantar, A; Kardavani, B; Khatami, F; Nafar, M; Pour-Reza-Gholi, F, 2009
)
0.35
" The odds of a high total IgE level, atopy, and wheeze decreased across quintiles of serum folate levels, indicating a dose-response relationship between serum folate levels and these outcomes."( Higher serum folate levels are associated with a lower risk of atopy and wheeze.
Matsui, EC; Matsui, W, 2009
)
0.35
" Similarly, higher the frequency of dosing better was the impact- it being the best in daily IFA group."( Physical work capacity of young underprivileged school girls impact of daily vs intermittent iron folic acid supplementation: a randomized controlled trial.
Kanani, SJ; Sen, A, 2009
)
0.35
"Quantitative applications for pharmaceutical solid dosage forms using near-infrared (NIR) spectroscopy are central to process analytical technology (PAT) manufacturing designs."( Assessment of diffuse transmission mode in near-infrared quantification--part I: The press effect on low-dose pharmaceutical tablets.
Betz, G; Keller, H; Oelichmann, J; Saeed, M; Saner, S, 2009
)
0.35
" Future trials should examine the effect of different dosage and duration."( Folic acid supplementation for the prevention of recurrence of colorectal adenomas: metaanalysis of interventional trials.
Ibrahim, EM; Zekri, JM, 2010
)
0.36
"Insufficient knowledge about the correct dosage and potential implications of overdose have played an important role in recent accidents involving methotrexate (MTX)."( [Correct use of methotrexate].
Dijkmans, BA; Horikx, A; van den Bemt, BJ; van der Waal, RI; Verduijn, MM, 2009
)
0.35
" Further investigation of folic acid dosage is suggested."( Different doses of oral folic acid for homocysteine-lowering therapy in patients on hemodialysis: a randomized controlled trial.
Asgari, M; Farrokhi, F; Ossareh, S; Salimi, A; Shayan-Moghaddam, H, 2009
)
0.35
" The method was sensitive enough to detect pABG in plasma generally and unmetabolized folic acid in the plasma of a volunteer after oral dosage of an aqueous folic acid solution."( Quantitation of folates and their catabolites in blood plasma, erythrocytes, and urine by stable isotope dilution assays.
Mönch, S; Netzel, G; Netzel, M; Rychlik, M, 2010
)
0.36
" Several forms of folate appear to be safe and efficacious in some individuals with major depressive disorder, but more information is needed about dosage and populations most suited to folate therapy."( Folate in depression: efficacy, safety, differences in formulations, and clinical issues.
Fava, M; Mischoulon, D, 2009
)
0.35
" In contrast, no significant anti-tumor activity was observed in P-PEA treated mice which were co dosed with an excess of FR, thus demonstrating the target specific gene delivery."( The therapeutic efficiency of FP-PEA/TAM67 gene complexes via folate receptor-mediated endocytosis in a xenograft mice model.
Arote, RB; Cho, CS; Cho, MH; Hwang, SK; Jere, D; Jiang, HL; Kim, TH; Kim, YK; Lim, HT, 2010
)
0.36
" "Strong nonlinear blending" is a novel concept that provides a flexible paradigm for the assessment of combination drug synergy that is applicable to any shaped combination-drug dose-response surface; issues of varying relative potency, partial inhibitors, potentiation, or coalism pose no problems at all."( A review of synergy concepts of nonlinear blending and dose-reduction profiles.
Peterson, JJ, 2010
)
0.36
"Taking into account a continuous exposure in regression models by using categorization, when non-linear dose-response associations are expected, have been widely criticized."( Dose-response analyses using restricted cubic spline functions in public health research.
Desquilbet, L; Mariotti, F, 2010
)
0.36
"There are limited data suggesting that methotrexate polyglutamate (MTXGlu) concentrations can guide MTX dosing in patients with rheumatoid arthritis (RA)."( Methotrexate polyglutamate concentrations are not associated with disease control in rheumatoid arthritis patients receiving long-term methotrexate therapy.
Barclay, ML; Chapman, PT; Frampton, C; James, J; O'Donnell, JL; Stamp, LK; Zhang, M, 2010
)
0.36
"The MTX dosage was significantly higher in patients in whom the swollen joint count and DAS28 were higher."( Methotrexate polyglutamate concentrations are not associated with disease control in rheumatoid arthritis patients receiving long-term methotrexate therapy.
Barclay, ML; Chapman, PT; Frampton, C; James, J; O'Donnell, JL; Stamp, LK; Zhang, M, 2010
)
0.36
"Hc levels were significantly higher in patients taking levodopa and were not related to levodopa dosage or treatment duration."( [Homocysteine and cognitive impairment in Parkinson's disease].
Avilés, F; Cañizares, F; Carles-Díes, R; Fernández-Barreiro, A; Herrero, MT; Martín-Fernández, JJ; Morsi-Hassan, O; Parra, S; Villegas, I,
)
0.13
" In conclusion, an inverse association was evident between dietary folate intake and the prevalence of breathlessness for Japanese adults, together with a significant dose-response relationship for the COPD risk."( Folate intake associated with lung function, breathlessness and the prevalence of chronic obstructive pulmonary disease.
Hirayama, F; Kagawa, Y; Lee, AH; Terasawa, K, 2010
)
0.36
"The aim of this study was to determine whether folic acid supplementation increases the dosage requirement of the CYP2C9 substrate warfarin, and the formation clearance of the CYP2C9-mediated product, (S)-7-hydroxywarfarin."( Effects of folic acid supplementation on the pharmacokinetics and anticoagulant effect of warfarin: an open-label, prospective study of long-term administration in adults.
Adar, L; Bialer, O; Blotnick, S; Caraco, Y; Cascorbi, I; Muszkat, M; Ufer, M; Xie, HG, 2010
)
0.36
"Patients aged >or=18 years with folic acid deficiency who were receiving long-term treatment with a stable dosage of warfarin were studied prospectively, before and 30 to 60 days after the initiation of supplementation with folic acid."( Effects of folic acid supplementation on the pharmacokinetics and anticoagulant effect of warfarin: an open-label, prospective study of long-term administration in adults.
Adar, L; Bialer, O; Blotnick, S; Caraco, Y; Cascorbi, I; Muszkat, M; Ufer, M; Xie, HG, 2010
)
0.36
" Changes in warfarin dosage requirements and INR were nonsignificant."( Effects of folic acid supplementation on the pharmacokinetics and anticoagulant effect of warfarin: an open-label, prospective study of long-term administration in adults.
Adar, L; Bialer, O; Blotnick, S; Caraco, Y; Cascorbi, I; Muszkat, M; Ufer, M; Xie, HG, 2010
)
0.36
" The pregnant C57BL/6J mice were dosed with 24 microg TCDD/kg and/or 5 mg, 10 mg, 20 mg, 40 mg FA/kg body weight on gestation day (GD) 10."( Is it possible to antagonize 2, 3, 7, 8-tetrachlorodibenzo-p-dioxin- induced cleft palate by prenatal administration of folic acid? An experimental study.
He, W; Li, CH; Meng, T; Shi, B, 2010
)
0.36
" This paper reviews the findings of the main studies of the effects of folic acid on orofacial clefts, summarizes study limitations, and discusses research needs with a focus on studying the effects of high dosage folic acid on the recurrence of oral clefts using a randomized clinical trial design."( Folic acid and orofacial clefts: a review of the evidence.
Murray, JC; Wehby, GL, 2010
)
0.36
" However, no dose-response relation was observed."( Folate and other one-carbon metabolism-related nutrients and risk of postmenopausal breast cancer in the Cancer Prevention Study II Nutrition Cohort.
Gapstur, SM; McCullough, ML; Stevens, VL; Sun, J, 2010
)
0.36
" We retrospectively evaluated erythrocyte folate concentrations to examine if a recommended daily dosage of 5 mg folic acid is sufficient to balance the impact of antiepileptic drugs (AED) on folate metabolism in women with epilepsy."( [Evaluation of folate substitution in women with epilepsy. Determination of erythrocyte folic acid concentrations].
Bauer, J; Bös, M; Rück, J; Stoffel-Wagner, B, 2011
)
0.37
"03), although no significant dose-response relationship was found."( Serum folate, vitamin B-12, and homocysteine and their association with depressive symptoms among U.S. adults.
Beydoun, HA; Beydoun, MA; Shroff, MR; Zonderman, AB, 2010
)
0.36
" A randomized, double-blind, placebo-controlled, dose-response trial with a parallel-group design was conducted."( Effects of folic acid supplementation on serum folate and plasma homocysteine concentrations in older adults: a dose-response trial.
Anderson, CA; Appel, LJ; Charleston, J; Jee, SH; Narrett, M, 2010
)
0.36
" These examples include: 1) meta-analyses of clinical trials suggest that methotrexate has an efficacy similar to other disease-modifying anti-rheumatic drugs (DMARDs); 2) information in textbooks and websites may overstate adverse events and drug interactions associated with weekly low-dose methotrexate; 3) information presented to patients when filling a prescription for methotrexate understates 'side effects' of RA and overstates those of methotrexate; 4) an admonition to patients to refrain entirely from consumption of alcohol while taking methotrexate may be unnecessary; 5) frequent blood testing in patients who take methotrexate may be overused; 6) eligibility of only a small minority of patients for clinical trials to compare biologic agents and methotrexate; 7) Step-up design in most comparisons of biologic agents with methotrexate includes only patients who had experienced an incomplete response to methotrexate; 8) in parallel design trials, the efficacy of biologic agents is not substantially greater than that of methotrexate; 9) low, inflexible dosage schedules of methotrexate and requirement for withdrawal with minimal liver function abnormalities in many clinical trials may underestimate efficacy, effectiveness, tolerability and safety; 10) interpretation of clinical trial results may overstate the clinical significance of lower radiographic progression in patients treated with biologic agents versus patients treated with methotrexate."( Underestimation of the efficacy, effectiveness, tolerability, and safety of weekly low-dose methotrexate in information presented to physicians and patients.
Furer, V; Pincus, T; Sokka, T,
)
0.13
" Appropriate studies to determine optimal dosing to maximize efficacy and minimize toxicity, potentially utilizing pharmacogenetic principles, are clearly needed."( Assessment and management of methotrexate hepatotoxicity in psoriasis patients: report from a consensus conference to evaluate current practice and identify key questions toward optimizing methotrexate use in the clinic.
Barker, J; Horn, EJ; Lebwohl, M; Nast, A; Rosenberg, W; Smith, C; Warren, RB, 2011
)
0.37
"We assessed the dose-response relation between maternal hemoglobin and 2 prenatal iron supplements."( Randomized controlled trial of 2 prenatal iron supplements: is there a dose-response relation with maternal hemoglobin?
d'Alessandro, U; Habicht, JP; Henry, MC; Huybregts, L; Kolsteren, P; Lanou, H; Meda, N; Roberfroid, D, 2011
)
0.37
" 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
"The recommended daily dosage of folic acid in The Netherlands is 400 µg."( Positional plagiocephaly and excessive folic acid intake during pregnancy.
Michels, AC; Van den Elzen, ME; Van der Hulst, RR; Vles, JS, 2012
)
0.38
"In the PP group, 20% used double the recommended dosage of folic acid, compared with 6% in the CO group (p < ."( Positional plagiocephaly and excessive folic acid intake during pregnancy.
Michels, AC; Van den Elzen, ME; Van der Hulst, RR; Vles, JS, 2012
)
0.38
"After 4 or 8 weeks of treatment, increases in serum folate were seen across all genotypes and FA dosage groups."( Effect of folic acid intervention on the change of serum folate level in hypertensive Chinese adults: do methylenetetrahydrofolate reductase and methionine synthase gene polymorphisms affect therapeutic responses?
Cui, Y; Ge, J; Guan, D; Hu, J; Huo, Y; Li, J; Liu, Z; Qin, X; Wang, X; Wang, Y; Xu, X; Zhang, F; Zhao, Z, 2012
)
0.38
" Identification of genes with potential influence on cancer risk may help us to establish relevant laboratory studies on exposure and dose-response assessment and may help us to test the hypothesis in epidemiological studies."( Genetic variations in multiple myeloma I: effect on risk of multiple myeloma.
Klausen, TW; Vangsted, A; Vogel, U, 2012
)
0.38
" In subsequent in vivo studies in the folate receptor positive KB xenograft model, KO019 was as active as the free drug but significantly less toxic when dosed at twice the dose of the free drug whereas KO013 showed no anticancer efficacy."( Comparative evaluation of the biological properties of reducible and acid-sensitive folate prodrugs of a highly potent doxorubicin derivative.
Abu Ajaj, K; Azab, S; El-Abadla, N; Fichtner, I; Kratz, F; Welker, P; Zeisig, R, 2012
)
0.38
"2%) were treated by first generation antipsychotics with a mean daily dosage of 401."( [Hyperhomocysteinemia and schizophrenia: case control study].
Bouslama, A; Douki, W; Gaha, L; Mabrouk, H; Mechri, A; Najjar, MF; Omezzine, A; Younes, MK, 2011
)
0.37
" Concerning therapeutic features, plasma Hcys did not differ with type of antipsychotic and was not related to daily dosage of antipsychotics."( [Hyperhomocysteinemia and schizophrenia: case control study].
Bouslama, A; Douki, W; Gaha, L; Mabrouk, H; Mechri, A; Najjar, MF; Omezzine, A; Younes, MK, 2011
)
0.37
" The multifunctional nanorods were then used to target folate receptor expressing cancers cells for the delivery of a concentration dependent dosage of Doxorubicin (DOX)."( Multifunctional gold nanorod theragnostics probed by multi-photon imaging.
Book Newell, B; Irudayaraj, J; Wang, Y, 2012
)
0.38
" Specifically, mice were subjected to folic acid (FA)-induced AKI and then randomly assigned to sham operation or one of three dosage of CsA treatment groups."( One dose of cyclosporine A is protective at initiation of folic acid-induced acute kidney injury in mice.
Bishop, JV; Chedwick, LR; Kellum, JA; Li, Y; Peng, Z; Singbartl, K; Wang, H; Wen, X, 2012
)
0.38
"To determine folic acid dosage requirements for individuals across a broad range of BMI values, using dose per kilogram lean body weight (LBW) as a primary predictor of systemic exposure."( Dosage requirements for periconceptional folic acid supplementation: accounting for BMI and lean body weight.
Kapur, B; Koren, G; Matok, I; Stern, SJ, 2012
)
0.38
"A parallel, randomised, controlled, dose-response dietary intervention study."( Impact of the quantity and flavonoid content of fruits and vegetables on markers of intake in adults with an increased risk of cardiovascular disease: the FLAVURS trial.
Alimbetov, D; Chong, MF; George, TW; Gordon, MH; Jin, Y; Kennedy, OB; Lovegrove, JA; Macready, AL; Minihane, AM; Spencer, JP; Weech, M, 2013
)
0.39
" On such basis, we investigated the efficacy on insulin sensitivity and hormonal parameters of 8 weeks treatment with myo-inositol (MYO) (Inofert, ItalPharmaco, Milano, Italy) at the dosage of 2 g day in a group (n = 42) of obese PCOS patients,."( Differential insulin response to myo-inositol administration in obese polycystic ovary syndrome patients.
Artini, PG; Campedelli, A; Chierchia, E; Genazzani, AD; Prati, A; Rattighieri, E; Ricchieri, F; Santagni, S; Simoncini, T, 2012
)
0.38
"Our findings suggest that the addition of myo-inositol to folic acid in non PCOS-patients undergoing multiple follicular stimulation for in-vitro fertilization may reduce the numbers of mature oocytes and the dosage of rFSH whilst maintaining clinical pregnancy rate."( Pretreatment with myo-inositol in non polycystic ovary syndrome patients undergoing multiple follicular stimulation for IVF: a pilot study.
Carfagna, P; Caserta, D; Lisi, F; Lisi, R; Manna, C; Marci, R; Moscarini, M; Oliva, MM; Poverini, R; Rago, R; Raparelli, V; Vaquero, E, 2012
)
0.38
" The increase in the dosage of this gene results in an altered profile of metabolites involved in the folate pathway, including reduced homocysteine (Hcy), methionine, S-adenosylhomocysteine (SAH) and S-adenosylmethionine (SAM)."( Genetic polymorphisms modulate the folate metabolism of Brazilian individuals with Down syndrome.
Biselli, JM; Carvalho, VM; Eberlin, MN; Fonseca, MF; Goloni-Bertollo, EM; Haddad, R; Pavarino, EC; Vannucchi, H; Zampieri, BL, 2012
)
0.38
"Folate dose-response studies in women of childbearing age who consumed a folic acid (FA)-containing multivitamin in the era of FA fortification are lacking."( Folate-status response to a controlled folate intake in nonpregnant, pregnant, and lactating women.
Caudill, MA; Jiang, X; Malysheva, OV; Perry, CA; West, AA; Yan, J, 2012
)
0.38
" There was some evidence of an inverse dose-response during each time period."( Maternal use of folic acid and other supplements and risk of childhood brain tumors.
Armstrong, BK; Ashton, LJ; Bower, C; de Klerk, NH; Gottardo, NG; Greenop, KR; Miller, M; Milne, E; Scott, RJ; van Bockxmeer, FM, 2012
)
0.38
" Our aims were to systematically review randomized controlled trials (RCTs) investigating the effect of folate supplementation on birth weight, placental weight and length of gestation and to assess the dose-response relationship between folate intake (folic acid plus dietary folate) and health outcomes."( Effect of folate intake on health outcomes in pregnancy: a systematic review and meta-analysis on birth weight, placental weight and length of gestation.
Berti, C; Cetin, I; Decsi, T; Dullemeijer, C; Fekete, K; Lohner, S; Souverein, OW; Trovato, M, 2012
)
0.38
" These results suggested that the DOMC-FA micelles can prolong blood circulation time and modify the tissue distribution of PTX, and could provide a useful alternative dosage form for intravenous administration of PTX."( Tissue distribution and pharmacokinetics evaluation of DOMC-FA micelles for intravenous delivery of PTX.
Guo, H; Guo, S; Hao, L; Li, C; Wang, F; Zhang, D; Zhang, Q; Zheng, D, 2013
)
0.39
" Furthermore, a meta-regression analysis suggested a positive dose-response relationship between percent baseline diabetes and log-RR for CVD risk associated with folic acid supplementation (P = 0."( Homocysteine-lowering therapy with folic acid is effective in cardiovascular disease prevention in patients with kidney disease: a meta-analysis of randomized controlled trials.
Hou, F; Huo, Y; Qin, X; Wang, X; Xie, D; Xu, X, 2013
)
0.39
"To evaluate the lowest effective dose-response of folic acid on endothelial function in children with type 1 diabetes."( Folate fortification and supplementation do not provide vascular health benefits in type 1 diabetes.
Couper, J; Dowling, K; Gent, R; MacKenzie, K; Maftei, O; Peña, AS; Wiltshire, E, 2013
)
0.39
"The study is the first double-blinded randomized clinical trial (RCT) to study the effect of high dosage folic acid supplementation on isolated oral cleft recurrence."( High dosage folic acid supplementation, oral cleft recurrence and fetal growth.
Chakraborty, H; Félix, TM; Goco, N; Moretti-Ferreira, D; Murray, JC; Padovani, C; Pereira, R; Richieri-Costa, A; Souza, J; Wehby, GL, 2013
)
0.39
" In 6-59 months old children, instead of 100 days' continuous dosing with iron-folate syrup in a year, a directly supervised intermittent supplementation (biweekly; ~100 days per year) merits consideration."( Preventing childhood anemia in India: iron supplementation and beyond.
Gera, T; Sachdev, HP, 2013
)
0.39
" Patients included in the study underwent brain computed tomography or magnetic resonance imaging, and plasma dosage of vitamin B12, folate, and thyroid hormones."( Effectiveness and safety of citicoline in mild vascular cognitive impairment: the IDEALE study.
Castagna, A; Cotroneo, AM; Fantò, F; Gareri, P; Lacava, R; Malara, A; Monteleone, F; Putignano, S; Rocca, F, 2013
)
0.39
"Wheat flour and maize meal were sourced in Kenya, South Africa, and Tanzania, and the iron compound (sodium iron ethylenediaminetetraacetate [NaFeEDTA], ferrous fumarate, or ferrous sulfate) was varied and dosed at rates according to the WHO guidelines for consumption of 75 to 149 g/day of wheat flour and > 300 g/day of maize meal and tested again for 150 to 300 g/day for both."( Fortification of wheat flour and maize meal with different iron compounds: results of a series of baking trials.
Johnson, Q; Randall, P; Verster, A, 2012
)
0.38
"There were no significant dose-response relations between any plasma- or FFQ-measured dietary factors and relative telomere length in multivariate analyses."( One-carbon metabolism factors and leukocyte telomere length.
De Vivo, I; Giovannucci, E; Hankinson, SE; Liu, JJ; Prescott, J; Rosner, B, 2013
)
0.39
"Though encouraging evidence exists for the use of folic acid as an augmenting agent to antidepressants, evidence regarding its optimal dosage is lacking."( A randomized double-blind comparison of fluoxetine augmentation by high and low dosage folic acid in patients with depressive episodes.
Kumar, CN; Pandey, RS; Venkatasubramanian, R, 2013
)
0.39
" There are many conflicting opinions regarding dosage of iron folic acid supplementation for managing this simple nutritional deficiency disorder."( Weekly iron folate supplementation in adolescent girls--an effective nutritional measure for the management of iron deficiency anaemia.
Gumashta, R; Joshi, M, 2013
)
0.39
" The first patient did not receive any treatment for the corneal disease, and the second patient with bilateral intraocular lymphoma received 1 mg of oral folic acid daily, a commonly used dosage for patients on systemic methotrexate."( Toxic corneal epitheliopathy after intravitreal methotrexate and its treatment with oral folic acid.
Abia, M; Afshar, AR; Gorovoy, I; Prechanond, T; Stewart, JM, 2013
)
0.39
"In the first patient without treatment, there was a complete regression of the corneal epithelial disease only when the frequency of intravitreal methotrexate was reduced from weekly to monthly as per a commonly used dosage regimen for methotrexate."( Toxic corneal epitheliopathy after intravitreal methotrexate and its treatment with oral folic acid.
Abia, M; Afshar, AR; Gorovoy, I; Prechanond, T; Stewart, JM, 2013
)
0.39
" A linear regression analysis of the natural logarithm of the relative risk (RR) was carried out to assess a possible dose-response relationship between folate intake and pancreatic cancer risk."( Folate intake and pancreatic cancer risk: an overall and dose-response meta-analysis.
An, QZ; Lin, HL; Liu, CX; Wang, QZ, 2013
)
0.39
"125 - 25 μg/day) intervention dosed as to age and MTHFR genotypes."( A decreased micronucleus frequency in human lymphocytes after folate and vitamin B12 intervention: a preliminary study in a Yunnan population.
Cao, N; Liang, Z; Ni, J; Wang, X; Xia, X; Zhou, T, 2012
)
0.38
" We conducted a meta-analysis of case-control studies nested within prospective studies on circulating folate and colorectal cancer risk by using flexible meta-regression models to test the linear and nonlinear dose-response relationships."( Quantifying the dose-response relationship between circulating folate concentrations and colorectal cancer in cohort studies: a meta-analysis based on a flexible meta-regression model.
Chuang, SC; Eussen, SJ; Gunter, MJ; Norat, T; Rota, M; Ueland, PM; Vineis, P; Vollset, SE; Zeleniuch-Jacquotte, A; Ziegler, RG, 2013
)
0.39
"The objective of this study was to examine the dose-response relationship between As and global methylation of peripheral blood mononuclear cell (PBMC) DNA in apparently healthy Bangladeshi adults chronically exposed to a wide range of As concentrations in drinking water."( A dose-response study of arsenic exposure and global methylation of peripheral blood mononuclear cell DNA in Bangladeshi adults.
Alam, S; Gamble, MV; Graziano, JH; Hall, MN; Harper, KN; Ilievski, V; Levy, D; Liu, X; Mey, JL; Niedzwiecki, MM; Oka, J; Parvez, F; Siddique, AB; Slavkovich, V; van Geen, A,
)
0.13
"We conducted a dose-response meta-analysis in healthy adults to quantify the typical response of recognized folate biomarkers to a change in folic acid intake."( Biomarker responses to folic acid intervention in healthy adults: a meta-analysis of randomized controlled trials.
Collings, R; Duffy, ME; Dullemeijer, C; Hoey, L; Hooper, L; Hughes, CF; McNulty, H; Rankin, A; Souverein, OW; Strain, JJ, 2014
)
0.4
"Folate biomarkers (serum/plasma and red blood cell folate) increased in response to folic acid in a dose-response manner only up to an intake of 400 μg/d."( Biomarker responses to folic acid intervention in healthy adults: a meta-analysis of randomized controlled trials.
Collings, R; Duffy, ME; Dullemeijer, C; Hoey, L; Hooper, L; Hughes, CF; McNulty, H; Rankin, A; Souverein, OW; Strain, JJ, 2014
)
0.4
"Studies administering >400 μg folic acid/d show no dose-response relation and thus will not yield meaningful results for consideration when generating dietary folate recommendations."( Biomarker responses to folic acid intervention in healthy adults: a meta-analysis of randomized controlled trials.
Collings, R; Duffy, ME; Dullemeijer, C; Hoey, L; Hooper, L; Hughes, CF; McNulty, H; Rankin, A; Souverein, OW; Strain, JJ, 2014
)
0.4
" No dose-response relationship was observed."( Self-reported maternal cigarette smoke exposure during the periconceptional period and the risk for omphalocoele.
Botto, LD; Feldkamp, ML; Olney, RS; Richardson, SD; Romitti, PA; Srisukhumbowornchai, S, 2014
)
0.4
" Patients abstained from alcohol (46%) and took folic acid (91%, but with variable dosage regimens and doses)."( Perceptions of methotrexate use in rheumatoid arthritis by rheumatologists and their patients: an Australian survey study.
Nash, P; Nicholls, D, 2013
)
0.39
" With the introduction of multiple folate-targeted drugs into the clinic, the question has arisen regarding how frequently a patient can be dosed with a FR-targeted drug or antibody and whether dosing frequency exerts any impact on the availability of FR for subsequent rounds of FR-mediated drug uptake."( Effect of receptor occupancy on folate receptor internalization.
Bandara, NA; Hansen, MJ; Low, PS, 2014
)
0.4
" Although no clear dose-response relationship was observed, folic acid supplementation significantly promoted the progression of the sentinel mammary tumors and was associated with significantly higher sentinel mammary tumor weight and volume compared with the control diet."( Folic acid supplementation promotes mammary tumor progression in a rat model.
Croxford, R; Deghan Manshadi, S; Ishiguro, L; Kim, YI; Medline, A; Renlund, R; Sohn, KJ, 2014
)
0.4
" A dose-response relation exists between folate intake or plasma level and disease risk within the normal range."( Critical evaluation of lowering the recommended dietary intake of folate.
Koletzko, B; Obeid, R; Pietrzik, K, 2014
)
0.4
" This dosage was selected on the basis of its expected -20% efficacy in reducing low-density lipoprotein-cholesterol."( Nutraceutical approach to moderate cardiometabolic risk: results of a randomized, double-blind and crossover study with Armolipid Plus.
Arnoldi, A; Bosisio, R; Calabresi, L; Gomaraschi, M; Macchi, C; Magni, P; Mombelli, G; Pavanello, C; Pazzucconi, F; Ruscica, M; Sirtori, CR,
)
0.13
" The study was initiated with a dosing schedule of pralatrexate 190 mg/m(2) biweekly on a 4-week cycle with vitamin supplementation."( A phase II study of pralatrexate with vitamin B12 and folic acid supplementation for previously treated recurrent and/or metastatic head and neck squamous cell cancer.
Apollo, A; Cox, L; Fury, MG; Haque, S; Ho, AL; Lipson, BL; Lyo, JK; Pfister, DG; Sales, R; Seetharamu, N; Sherman, EJ; Sima, CS; Xiao, H, 2014
)
0.4
" Low CMC value indicates that the copolymers are suitable for preparation of stable micelles useful in parenteral dosage forms."( Uptake of etoposide in CT-26 cells of colorectal cancer using folate targeted dextran stearate polymeric micelles.
Firozian, F; Hassanzadeh, F; Sadeghi-Aliabadi, H; Varshosaz, J, 2014
)
0.4
" The purpose of this study was to summarize the evidence from prospective cohort studies regarding this relationship by using a dose-response meta-analytic approach."( Association between folate intake and the risk of lung cancer: a dose-response meta-analysis of prospective studies.
Gao, HF; Hou, AJ; Zhang, HW; Zhang, YF; Zhou, L; Zhou, YH, 2014
)
0.4
" Dose-response analysis showed that a 220 μg/day increment in dietary folate intake was not associated with the risk of breast cancer."( Lack of effects of dietary folate intake on risk of breast cancer: an updated meta-analysis of prospective studies.
Cui, LH; Li, N; Liu, M; Ma, AG; Piao, JM, 2014
)
0.4
" Prespecified stratified analyses, sensitivity analyses, and dose-response analysis were also carried out."( Folate intake and breast cancer prognosis: a meta-analysis of prospective observational studies.
Li, B; Lu, Y; Wang, L; Zhang, CX, 2015
)
0.42
" Furthermore, it makes it possible to reduce the dosage of concomitant medication."( Effect of the combination of uridine nucleotides, folic acid and vitamin B12 on the clinical expression of peripheral neuropathies.
Alcino, S; Almeida, P; Duro, H; Figueira, R; Gonçalves, S; Libório, T; Melo Silva, U; Negrão, L; Neto Parra, L, 2014
)
0.4
"The aqueous solubility and drug product dissolution are important factors that determine the rate and extent of drug absorption from immediate release solid oral dosage forms."( Folic acid: a biopharmaceutical evaluation.
Bellavinha, KR; Leite, JC; Silva-Barcellos, NM; Souza, JB; Souza, Jd, 2015
)
0.42
" Fertile-age women are not able to get enough folate from their diet, therefore right timing and proper dosing of folic acid is the object of numerous studies."( [Folic acid and prevention of the neural tube defects].
Doležálková, E; Unzeitig, V, 2014
)
0.4
" dosage should be individualized according to risk."( [Folic acid and prevention of the neural tube defects].
Doležálková, E; Unzeitig, V, 2014
)
0.4
" This study aimed to summarize the evidence regarding this relationship using a dose-response meta-analytic approach."( Folate intake and the risk of breast cancer: a dose-response meta-analysis of prospective studies.
Gao, HF; Hou, AJ; Shi, WW; Zhang, YF; Zhou, L; Zhou, YH, 2014
)
0.4
" Dose-response meta-analysis also suggested that a 100 µg/day increase in folate intake had no significant effect on the risk of breast cancer (RR = 0."( Folate intake and the risk of breast cancer: a dose-response meta-analysis of prospective studies.
Gao, HF; Hou, AJ; Shi, WW; Zhang, YF; Zhou, L; Zhou, YH, 2014
)
0.4
"Our study revealed that folate intake had little or no effect on the risk of breast cancer; moreover, a dose-response meta-analysis suggested a J-shaped association between folate intake and breast cancer."( Folate intake and the risk of breast cancer: a dose-response meta-analysis of prospective studies.
Gao, HF; Hou, AJ; Shi, WW; Zhang, YF; Zhou, L; Zhou, YH, 2014
)
0.4
" The TCDD group mice were dosed with TCDD 28 microg/kg body weight on gestation day 10 (GD 10) animals in folic acid group were respectively dosed with folic acid 15, 10, 5 mg/kg and TCDD 28 microg/kg; resveratrol treated mice were divided into 3 groups: resveratrol 50 mg/kg were orally administered for 6 consecutive days, from gestational day GD 8 to GD13 in resveratrol (GD8-13 ) group; resveratrol 50 mg/kg were orally administered for 6 consecutive days, from gestational day GD 8 to GD13, followed hy an oral administered with TCDD on GD10 in resveratrol (GD8-13) + TCDD group; resveratrol 50mg/kg and TCDD 28 microg/kg were used by gavage administration at GD10 in resveratrol (GD10) + TCDD group."( [The antagonistic effect of folic acid and resveratrol on cleft palate in mice induced by TCDD].
Fu, YX; Gan, LQ; He, XM; Liu, CP; Liu, Y; Qiu, L; Tian, XF; Wei, GH; Xiao, J; Yuan, XG, 2013
)
0.39
" The modeled dose-response relation was consistent with the existing literature."( Population red blood cell folate concentrations for prevention of neural tube defects: Bayesian model.
Berry, RJ; Crider, KS; Devine, O; Dowling, NF; Hao, L; Li, S; Li, Z; Molloy, AM; Zhu, J, 2014
)
0.4
" Doses can vary 20-fold between patients, and incorrect dosing can result in serious adverse events."( Genetic variant in folate homeostasis is associated with lower warfarin dose in African Americans.
Altman, RB; Burkley, B; Bustamante, CD; Cavallari, LH; Daneshjou, R; Gamazon, ER; Hillenmeyer, S; Johnson, JA; Karczewski, KJ; Klein, TE; Langaee, T; Limdi, N; Patel, SR; Percha, B; Perera, MA, 2014
)
0.4
" Because the half-life of low molecular weight folate conjugates in the vasculature is usually <1 h, these data suggest that targeting of folate conjugates to activated macrophages in vivo can be maximized by frequent dosing at conjugate concentrations that barely saturate FR (∼150 nmol/kg), thereby minimizing nonspecific binding to receptor-negative tissues and maximizing the probability that unoccupied cell surface receptors will be exposed to folate-drug conjugate."( Folate receptor-β in activated macrophages: ligand binding and receptor recycling kinetics.
Ayala Lopez, W; Low, PS; Paulos, CM; Reddy, J; Varghese, B; Vlashi, E; Xia, W; Xu, LC, 2014
)
0.4
" Taken together, our evaluations show that PTX/TS-CS-PEG-FA micelle is a potential drug delivery system of PTX for the effective treatment of the tumor and systematic toxicity reduction, thus, the micellar formulation can provide a useful alternative dosage form for intravenous administration of PTX."( In vivo pharmacokinetics, biodistribution and anti-tumor effect of paclitaxel-loaded targeted chitosan-based polymeric micelle.
Emami, J; Hasanzadeh, F; Lavasanifar, A; Minaiyan, M; Mostafavi, A; Rezazadeh, M; Rostami, M; Sadeghi, H, 2016
)
0.43
" The intake of folic acid among mothers of infants with severe IH was lower than among mothers of infants with mild IH, suggesting a dose-response relationship."( Possible preventive effect of high doses of folic acid for isolated hypospadias: a national population-based case-control study.
Ács, N; Czeizel, AE; Mavrogenis, S; Urban, R, 2014
)
0.4
"36) than children whose mothers used a recommended dosage of FA supplements (400-1000 μg/d)."( Folic acid supplements during pregnancy and child psychomotor development after the first year of life.
Fernandez-Somoano, A; Forns, J; García de la Hera, M; Ibarluzea, JM; Julvez, J; Lertxundi, N; Murcia, M; Navarrete-Muñoz, EM; Rebagliato, M; Tardón, A; Valera-Gran, D; Vioque, J, 2014
)
0.4
" The photo-killing effect increased with increasing dosage in the investigated concentration range of 50-100 μg ml(-1)."( A novel folic acid-conjugated TiO₂-SiO₂ photosensitizer for cancer targeting in photodynamic therapy.
Feng, X; Lou, X; Wu, H; Zhang, S, 2015
)
0.42
" This study sought to summarise the evidence regarding these relationships using a dose-response meta-analysis approach."( Folate intake, serum folate levels, and prostate cancer risk: a meta-analysis of prospective studies.
Huang, JY; Wang, JN; Wang, R; Zhang, AQ; Zheng, Y; Zhou, YH, 2014
)
0.4
"In the present study, pregnant mice were dosed with TCDD 24 µg/kg and with or without FA 5 mg/kg body weight on gestation day 10."( [Tetrachlorodibenzo-p-dioxin-induced cleft palate because of partial loss of cell polarity to interfere with apoptosis during early developmental stage].
He, W; Li, C; Lu, S; Meng, T; Shi, B, 2014
)
0.4
" A significant dose-response of duration of use was observed among women who used folic acid supplemention during pregnancy only (P-trend=0."( Folic acid supplementation and dietary folate intake, and risk of preeclampsia.
Bai, H; Chen, Y; Cui, H; Dang, Y; Ehrenkranz, RA; Han, X; He, X; Huang, H; Kim, C; Liang, J; Lin, R; Lin, X; Liu, Q; Liu, S; Liu, X; Lv, L; Ma, B; Qiu, J; Qiu, W; Su, J; Tang, Z; Wang, S; Wang, W; Wang, Y; Xu, R; Xu, X; Yao, T; Zhang, C; Zhang, H; Zhang, Y; Zhao, N; Zhou, M; Zhu, D, 2015
)
0.42
" To examine what is known about folate metabolism and the release of circulating UMFA, the Key Events Dose-Response Framework (KEDRF) was used to review each of the major key events, dose-response characteristics and homeostatic mechanisms of folate metabolism."( Application of the Key Events Dose-response Framework to Folate Metabolism.
Hu, J; Sahyoun, NR; Wang, B, 2016
)
0.43
"There is a range of methotrexate dosing regimens for psoriasis."( Methotrexate Dosing Regimen for Plaque-type Psoriasis: A Systematic Review of the Use of Test-dose, Start-dose, Dosing Scheme, Dose Adjustments, Maximum Dose and Folic Acid Supplementation.
Dekker, PM; Hooft, L; Limpens, J; Menting, SP; Spuls, PI, 2016
)
0.43
" The present study aimed to examine the dose-response curve between fruit and vegetable consumption and carotenoid (α-carotene, β-carotene, β-cryptoxanthin, lycopene, lutein and zeaxanthin), folate and vitamin C concentrations."( Prediction of fruit and vegetable intake from biomarkers using individual participant data of diet-controlled intervention studies.
Boshuizen, HC; Brazionis, L; Bub, A; Castenmiller, JJ; Chopra, M; de Vries, JH; Dragsted, LO; Freese, R; Itsiopoulos, C; Karlsen, A; Miller, ER; Naber, TH; O'Dea, K; Pasman, WJ; Souverein, OW; van der Voet, H; van Het Hof, K; van Loo-Bouwman, CA; Watzl, B; Winkels, R, 2015
)
0.42
" Folate intake impacts blood folate concentration; however, the dose-response between natural food folate and blood folate concentrations has not been well described."( Assessing the association between natural food folate intake and blood folate concentrations: a systematic review and Bayesian meta-analysis of trials and observational studies.
Berry, RJ; Cordero, AM; Crider, KS; Devine, OJ; Guo, J; Hamner, HC; Marchetta, CM; Mersereau, P; Mulinare, J; Qi, YP; Rosenthal, J; Tsang, BL, 2015
)
0.42
"Three DOX formulations were injected into the tail vein of the mice at a dosage of 5 mg/kg."( Quantification of DOX bioavailability in biological samples of mice by sensitive and precise HPLC assay.
Dong, Y; Wu, Y; Xu, H; Zhang, C; Zhao, L, 2016
)
0.43
" Moreover, fortification must be preceded by more research to elucidate the dose-response relation between intake and changes in serum 25(OH)D."( Use of Folate-Based and Other Fortification Scenarios Illustrates Different Shifts for Tails of the Distribution of Serum 25-Hydroxyvitamin D Concentrations.
Bailey, RL; Carriquiry, AL; Taylor, CL, 2015
)
0.42
" The dosing regimen improved treatment outcomes more than two fold from untargeted nanoATV/r."( Pharmacodynamics of folic acid receptor targeted antiretroviral nanotherapy in HIV-1-infected humanized mice.
Araínga, M; Dash, P; Gendelman, HE; Gorantla, S; McMillan, J; Mosley, RL; Palandri, D; Poluektova, L; Puligujja, P, 2015
)
0.42
" However, this is based on studies conducted with lower MTX dosage than used currently."( Comparison of two different folic acid doses with methotrexate--a randomized controlled trial (FOLVARI Study).
Dhir, V; Gupta, N; Kaur, J; Kaur, P; Kumar, P; Pinto, B; Sandhu, A; Sharma, A; Sharma, S; Sood, A, 2015
)
0.42
" Considerable decrease in genome-wide methylation rate was associated with elevated dosage of aluminum maltolate (0."( [Research of aluminum to the cognitive ability and genome-wide methylation in rats].
Kang, P; Li, Z; Niu, Q; Ren, P; Yang, X; Yuan, Y, 2015
)
0.42
"83) with a significant dose-response relationship (P for trend = 0."( Folic acid supplementation, dietary folate intake and risk of preterm birth in China.
Bai, H; Chen, Y; Cui, H; Dang, Y; Han, X; He, X; Huang, H; Lerro, C; Liang, J; Lin, R; Lin, X; Liu, Q; Liu, S; Liu, X; Lv, L; Ma, B; Qiu, J; Qiu, W; Su, J; Tang, Z; Wang, W; Wang, Y; Xu, R; Xu, X; Yao, T; Zhang, C; Zhang, H; Zhang, Y; Zhao, N; Zhou, M; Zhu, D, 2016
)
0.43
" With limited dosing regimens, the antiarthritic activity of EC0565 was found superior to that of etanercept, everolimus and a nontargeted everolimus analog."( Antiinflammatory Activity of a Novel Folic Acid Targeted Conjugate of the mTOR Inhibitor Everolimus.
Cross, VA; Gehrke, MA; Hahn, SJ; Klein, PJ; Kleindl, PJ; Leamon, CP; Low, PS; Lu, Y; Parker, N; Santhapuram, HK; Stinnette, TW; Vaughn, JF; Vlahov, IR; Wang, K; Westrick, E; Wollak, K; You, F, 2015
)
0.42
" We performed a review looking for the optimal dosage of folic acid that should be given to women of reproductive age who are planning or not avoiding conception to propose updated guidelines and thus help health care providers and patients."( Folic acid supplementation for pregnant women and those planning pregnancy: 2015 update.
Amitai, Y; Chitayat, D; Kennedy, D; Koren, G; Matsui, D; Rieder, M; Vohra, S, 2016
)
0.43
" This will help physicians, midwives, nurses, and other health care workers to assist in the education of women about the proper use and dosage of folic acid/multivitamin supplementation before and during pregnancy."( Pre-conception Folic Acid and Multivitamin Supplementation for the Primary and Secondary Prevention of Neural Tube Defects and Other Folic Acid-Sensitive Congenital Anomalies.
Audibert, F; Brock, JA; Carroll, J; Cartier, L; Deb-Rinker, P; Dodds, L; Gagnon, A; Johnson, JA; Langlois, S; Leon, JA; Lowel, HL; Luo, W; MacFarlane, A; McMillan, R; Moore, A; Mundle, W; Murphy-Kaulbeck, L; O'Connor, D; Okun, N; Pastuck, M; Ray, J; Van den Hof, M; Wilson, RD, 2015
)
0.42
"001 for high-FA] in a dose-response fashion (Ptrend < 0."( Protective Effect of Folic Acid on Oxidative DNA Damage: A Randomized, Double-Blind, and Placebo Controlled Clinical Trial.
Chen, Z; Cui, H; Guan, X; Guo, X; Jia, C; Mao, G; Qiu, W; Wu, J; Yang, H; Yang, Z; Zhang, C; Zhang, H; Zhang, Z, 2015
)
0.42
"Pregnant C57BL/6J mice were randomly assigned to eight groups dosed with corn oil (control group), ATRA (80 mg/kg), FA (40 mg/kg), or ATRA (80 mg/kg) + FA (2."( Dose-Dependent Antiteratogenic Effects of Folic Acid on All-Trans Retinoic Acid-Induced Cleft Palate in Fetal Mice.
Chen, W; Wang, H, 2016
)
0.43
"Among the pregnant mice dosed with ATRA+FA, those dosed with 5 mg/kg FA had fetuses with the lowest incidence of cleft palate."( Dose-Dependent Antiteratogenic Effects of Folic Acid on All-Trans Retinoic Acid-Induced Cleft Palate in Fetal Mice.
Chen, W; Wang, H, 2016
)
0.43
"68) were associated with high dosage use."( Use of high doses of folic acid supplements in pregnant women in Spain: an INMA cohort study.
García de la Hera, M; Gimenez-Monzo, D; Ibarluzea, J; Julvez, J; Morales, E; Murcia, M; Navarrete-Muñoz, EM; Rebagliato, M; Riaño, I; Santa-Marina, L; Tardón, A; Valera-Gran, D; Vioque, J, 2015
)
0.42
" Subgroup analyses suggest that the positive effect of folic acid on NTD incidence and recurrence is not affected by the explored daily folic acid dosage (400 µg (0."( Effects and safety of periconceptional oral folate supplementation for preventing birth defects.
De-Regil, LM; Fernández-Gaxiola, AC; Peña-Rosas, JP; Rayco-Solon, P, 2015
)
0.42
" Second, in vivo effect of different dosage patterns and concentrations in the development of hepatic metastasis was analyzed by intra-splenic inoculation of C26 colon carcinoma cells in Balb/c mice."( Ocoxin® oral solution slows down tumor growth in an experimental model of colorectal cancer metastasis to the liver in Balb/c mice.
Arteta, B; Benedicto, A; Hernandez-Unzueta, I; Márquez, J; Mena, J; Olaso, E; Sanz, E, 2016
)
0.43
" A recent study published in the British Medical Journal provides evidence for a generalizable dose-response relation between folate status and risk of NTD."( Folate and Prevention of Neural Tube Defects: New Insights from a Bayesian Model.
Bohn, T; Ströhle, A, 2015
)
0.42
" In addition, the homocysteine blood concentration just before the first cycle dosage of pemetrexed was significantly elevated relative to the 2-3 cycle."( Phase II study of oral vitamin B12 supplementation as an alternative to intramuscular injection for patients with non-small cell lung cancer undergoing pemetrexed therapy.
Hosomi, Y; Nagamata, M; Nakahara, Y; Okamura, T; Okuma, Y; Shimokawa, T; Sunami, K; Takagi, Y; Takahashi, S; Watanabe, K; Yomota, M, 2016
)
0.43
"2% completed their planned dosage within a 9-week feasibility time frame."( Reduced folate and serum vitamin metabolites in patients with rectal carcinoma: an open-label feasibility study of pemetrexed with folic acid and vitamin B12 supplementation.
Björkqvist, HG; Carlsson, GU; Gustavsson, BG; Kurlberg, GK; Odin, EA; Stoffregen, CC; Tångefjord, MT, 2016
)
0.43
" This method was successfully used to determine concentration of EC1456 and its metabolites tubulysin B hydrazide and tubulysin B in tumor homogenates in preliminary experiments with KB tumor bearing mice dosed intravenously with EC1456."( Development and validation of a UPLC-MS/MS method for the novel folate-targeted small molecule drug conjugate EC1456 and its metabolites in tumor homogenates from mice.
Klein, PJ; Leamon, CP; Nelson, M; Pugh, M; Rao, SI; Reddy, JA, 2016
)
0.43
" Multivitamin supplements were taken at a dosage of one pill every day for 12 weeks through the oral route."( Effects of Multivitamin Supplements on Cognitive Function, Serum Homocysteine Level, and Depression of Korean Older Adults With Mild Cognitive Impairment in Care Facilities.
Kim, SY; Lee, HK; Sok, SR, 2016
)
0.43
" Combining bioimaging of carbon dots, stimulus responsive property, gene silencing strategy, and active targeting motif, this multi-functionalized, integrated theranostic nanoagent may provide a useful tool and platform to benefit clinicians adjusting therapeutic strategy and administered drug dosage in real time response by monitoring the effect and tracking the development of carcinomatous tissues in diagnostic and therapeutic aspects."( Multi-functionalized carbon dots as theranostic nanoagent for gene delivery in lung cancer therapy.
Chang, CW; Kuan, CH; Lin, CJ; Wang, LW; Wang, TW; Wu, HC; Wu, YF, 2016
)
0.43
" Additional analyses assessing the effect of low RBC and serum folate and dose-response relationship were performed."( Folic Acid Supplementation in Pregnancy and the Risk of Pre-Eclampsia-A Cohort Study.
Guo, Y; Perkins, SL; Rodger, M; Smith, GN; Walker, MC; Wen, SW; White, RR; Yang, Q, 2016
)
0.43
" The association between B vitamins and survival might serve either as a tool for risk stratification or, if causative, as effective therapy, if optimal dosing of B vitamins is provided and on-treatment concentrations, including homocysteine and renal functions, are closely monitored."( B-Vitamin Serum Concentrations Predicting Long-Term Overall and Stroke-Free Survival after Carotid Endarterectomy.
Assadian, A; Basic, J; Duschek, N; Falkensammer, J; Taher, F, 2016
)
0.43
" For FA treatment, TCDD-treated mice were also dosed with 5, 10, and 15 mg/kg FA on GD 10, while for α-naphthoflavone treatment, the mice received a single dose of 50 μg/kg or 5 mg/kg α-naphthoflavone on GD 10."( Comparative Study of Folic Acid and α-Naphthoflavone on Reducing TCDD-Induced Cleft Palate in Fetal Mice.
Fu, Y; He, X; Liu, C; Pu, W; Qiu, L; Wang, C; Yuan, X; Zhang, X, 2017
)
0.46
" This study has provided evidence that a high dosage of folic acid supplements throughout pregnancy reduces Hcy concentrations at the time of delivery."( The Effect of High Dose Folic Acid throughout Pregnancy on Homocysteine (Hcy) Concentration and Pre-Eclampsia: A Randomized Clinical Trial.
Alizadeh, M; Bidadi, S; Ghojazadeh, M; Ghorbanihaghjo, A; Kazemi-Shishvan, M; Sayyah-Melli, M, 2016
)
0.43
"Higher levels of FR autoimmunity in maternal plasma are associated with elevated risk of NTDs in a dose-response manner."( Levels of folate receptor autoantibodies in maternal and cord blood and risk of neural tube defects in a Chinese population.
Cabrera, RM; Finnell, RH; Jin, L; Li, Z; Ren, A; Wang, L; Yang, N; Ye, R; Zhang, L, 2016
)
0.43
"Utilizing 1999-2010 National Health and Nutrition Examination Survey (NHANES) and linked mortality data, we performed a cohort study with 28,845 participants and used Cox proportional hazards models and restricted cubic spline plots to elucidate the dose-response relationships between serum folate status and all-cause, CVD and cancer mortality."( Serum folate concentrations and all-cause, cardiovascular disease and cancer mortality: A cohort study based on 1999-2010 National Health and Nutrition Examination Survey (NHANES).
Dong, B; Peng, Y; Wang, Z, 2016
)
0.43
" While many authorities believe that epidermal pigmentation evolved to protect against either ultraviolet B (UV-B) irradiation-induced mutagenesis or folic acid photolysis, we hypothesize that pigmentation augmented the epidermal barriers by shifting the UV-B dose-response curve from toxic to beneficial."( Basis for the gain and subsequent dilution of epidermal pigmentation during human evolution: The barrier and metabolic conservation hypotheses revisited.
Elias, PM; Williams, ML, 2016
)
0.43
"1 mg of folic acid in combination with vitamin B6 and B12 is less effective in reducing migraine associated symptoms compared to the previously tested dosage of 2 mg folic acid in combination with 25 mg of vitamin B6 and 400 μg of vitamin B12."( The effect of 1 mg folic acid supplementation on clinical outcomes in female migraine with aura patients.
Avgan, N; Ghassabian, S; Griffiths, L; Lea, R; Menon, S; Nasir, B; Oliver, C; Smith, M, 2016
)
0.43
" While there is a definite need for more research in all these supplements to determine true efficacy, dosage and target populations, they can be used as mono- or adjunctive therapies to good effect, and show superior safety profiles when compared with more traditional alternatives."( Does Diet Matter? The Use of Polyunsaturated Fatty Acids (PUFAs) and Other Dietary Supplements in Inflammation-Associated Depression.
Hastings, CN; Mondelli, V; Pariante, CM; Sheridan, H, 2017
)
0.46
" Subgroup analysis indicated that the follow-up time, the dosage of folic acid and vitamin B12 and B6, the history of diseases had no confounding effect on the incidence of cardio-cerebrovascular disease events."( [Meta-analysis on effect of combined supplementation of folic acid, vitamin B12 and B6 on risk of cardio-cerebrovascular diseases in randomized control trials].
Dang, SN; Lan, X; Yan, H; Zhao, YL, 2016
)
0.43
", serum retinol, RBP, breast-milk retinol, dose-response tests, isotope dilution methodology, and serum retinyl esters)."( Biomarkers of Nutrition for Development (BOND)-Vitamin A Review.
Craft, NE; Gannon, BM; Haskell, MJ; Lietz, G; Raiten, DJ; Russell, RM; Schulze, K; Stephensen, CB; Tanumihardjo, SA, 2016
)
0.43
"To provide accurate estimates of the commencement time, duration and dosage of folic acid (FA) supplementation taken by Irish women in the periconceptional period."( Duration of periconceptional folic acid supplementation in women booking for antenatal care.
Cawley, S; Farren, M; Kennedy, R; McCartney, D; Mullaney, L; Turner, MJ, 2017
)
0.46
" A dose-response relation between the number of capsules taken and concentrations of folate and ferritin was observed for all micronutrient supplements."( A Prenatal Multiple Micronutrient Supplement Produces Higher Maternal Vitamin B-12 Concentrations and Similar Folate, Ferritin, and Zinc Concentrations as the Standard 60-mg Iron Plus 400-μg Folic Acid Supplement in Rural Bangladeshi Women.
Ekström, EC; Lönnerdal, B; Rahman, A; Raqib, R; Ziaei, S, 2016
)
0.43
" The findings of the present study provided an ideal drug delivery system for breast cancer therapy due to the advanced chemo-photothermal synergistic targeted therapy and good drug release properties of DOX-FA-PEG-ZnO NS, which could effectively avoid frequent and invasive dosing and improve patient compliance."( Synergistic effect of chemo-photothermal for breast cancer therapy using folic acid (FA) modified zinc oxide nanosheet.
Kannan, S; Shanthi, K; Sundarraj, S; Vimala, K, 2017
)
0.46
" This study aims to summarize the evidence regarding these relationships using a dose-response meta-analysis approach."( Folate intake, serum folate levels and esophageal cancer risk: an overall and dose-response meta-analysis.
Guo, C; Hu, H; Jiang, L; Li, H; Ma, J; Zhao, E; Zhao, Y; Zheng, L, 2017
)
0.46
" HT was administered at a daily dosage of 45mg for 8 weeks to volunteers with mild hyperlipidemia (n=14)."( Hydroxytyrosol supplementation increases vitamin C levels in vivo. A human volunteer trial.
Fonolla, J; Lopez-Huertas, E, 2017
)
0.46
"Targeted drug delivery has long been extensively researched since drug delivery and release at the diseased site with minimum dosage realizes the effective therapy without adverse side effects."( Synergistically enhanced selective intracellular uptake of anticancer drug carrier comprising folic acid-conjugated hydrogels containing magnetite nanoparticles.
Baek, S; Cho, SK; Chung, JW; Jo, A; Kim, H; Lim, D; Park, SY; Yoon, J, 2017
)
0.46
" We propose that changes in dosing procedures could improve the delivery and therapeutic index for methotrexate and other folic acid-targeted drug conjugates and imaging agents."( Folate binding protein: therapeutic natural nanotechnology for folic acid, methotrexate, and leucovorin.
Banaszak Holl, MM; Boutom, SM; Chen, J; Frey, C; Marsh, EN; Merzel, RL; Shedden, K, 2017
)
0.46
" For dosage forms containing 5 mg folic acid, the highest dose strength on the World Health Organization Essential Medicines List, the dose/solubility ratio calculated from solubility studies was higher than 250 mL, corresponding to a classification as "not highly soluble."( Biowaiver Monographs for Immediate-Release Solid Oral Dosage Forms: Folic Acid.
Abrahamsson, B; Bellavinha, KR; Cristofoletti, R; Dressman, JB; Groot, DW; Hofsäss, MA; Langguth, P; Mehta, MU; Parr, A; Polli, JE; Shah, VP; Silva-Barcellos, NM; Souza, J; Tajiri, T, 2017
)
0.46
"Dams dosed with excessive folate (HFol group) delivered low birth weight (LBW) offsprings (p<0."( Combination of vitamin B12 active forms improved fetal growth in Wistar rats through up-regulation of placental miR-16 and miR-21 levels.
Apte, K; Joshi, K; Mishra, S; More, A; Otiv, S; Shah, T, 2017
)
0.46
" Hence, a comprehensive and dose-response meta-analysis was performed to clarify the association between folate intake and HNSCC risk."( Association between folate intake and risk of head and neck squamous cell carcinoma: An overall and dose-response PRISMA meta-analysis.
Cheng, Z; Ding, X; Fan, C; Su, J; Yu, S; Zhang, S, 2017
)
0.46
" Points of intervention may include pre-conception initiation of folic acid, optimization of dosing of AEDs with contraceptives, guidelines for peripartum seizure treatment, and establishment of a prospective registry for WWE and their offspring."( Contraception, pregnancy, and peripartum experiences among women with epilepsy in Bhutan.
Bui, E; Clark, SJ; Dema, U; Dorji, C; Grundy, SJ; Halani, S; Lhamo, S; Mateen, FJ; Nirola, DK; Pem, T; Tshering, L, 2017
)
0.46
"Higher intake of food folate and fortified folic acid in foods was associated with a decreasing HNC risk in a dose-response manner."( The impact of folate intake on the risk of head and neck cancer in the prostate, lung, colorectal, and ovarian cancer screening trial (PLCO) cohort.
Buys, SS; Gren, LH; Hashibe, M; Kawakita, D; La Vecchia, C; Lee, YA, 2018
)
0.48
"Our findings suggest that a high dosage of FA (≥ 1000 µg/day) may be associated with an increased risk of SGA-w at birth."( High doses of folic acid in the periconceptional period and risk of low weight for gestational age at birth in a population based cohort study.
Amiano, P; Garcia-de-la-Hera, M; Gonzalez-Palacios, S; Guxens, M; Lertxundi, A; Murcia, M; Navarrete-Muñoz, EM; Rebagliato, M; Riaño, I; Tardón, A; Valera-Gran, D; Vioque, J; Vrijheid, M, 2019
)
0.51
" Our data suggest that compared with never smokers, ever smokers may require a higher dosage of folic acid to achieve a greater beneficial effect on stroke."( Effect of Smoking and Folate Levels on the Efficacy of Folic Acid Therapy in Prevention of Stroke in Hypertensive Men.
Cai, Y; Cheng, X; Dong, Q; He, M; Hou, FF; Huang, X; Huo, Y; Li, J; Li, Y; Liu, L; Qin, X; Song, Y; Tang, G; Wang, B; Wang, X; Wang, Y; Xu, X; Yin, D; Yu, Y; Zhang, Y; Zhao, M; Zhou, Z, 2018
)
0.48
" There is little agreement about the proper dosing or frequency of folate supplementation as many believe that daily folate supplementation can reduce methotrexate efficacy."( Does daily folic acid supplementation reduce methotrexate efficacy?
Cline, A; Jorizzo, JL, 2017
)
0.46
" Patients and methods In an open, prospective, non-blinded, non-comparative observational study, 3602 infertile women used myo-inositol and folic acid between 2 and 3 months in a dosage of 2 × 2000 mg myo-inositol +2 × 200 μg folic acid per day."( Management of women with PCOS using myo-inositol and folic acid. New clinical data and review of the literature.
Druckman, R; Lesoine, B; Regidor, PA; Schindler, AE, 2018
)
0.48
" Additional studies should be conducted to confirm these findings and refine the optimal dosing regimen."( A Randomized Trial of a Novel Chewable Multivitamin and Mineral Supplement Following Roux-en-Y Gastric Bypass.
Furtado, M; Papas, K; Perin, J; Prokopowicz, G; Steele, KE, 2018
)
0.48
"The dose-response relationship between folate and the risk of esophageal cancer (EC) is not clear."( Folate intake, serum folate, and risk of esophageal cancer: a systematic review and dose-response meta-analysis.
Du, J; Lu, M; Ni, Y; Yin, X, 2019
)
0.51
" Therefore, DSPE-PEG-FA is considered as a proper stabilizer with active targeting effect for ACGs-NSps to reduce toxicity, enlarge the safe dosage range and apply in clinic for the treatment of folate-positive tumors."( Folate-targeting annonaceous acetogenins nanosuspensions: significantly enhanced antitumor efficacy in HeLa tumor-bearing mice.
Ao, H; Bi, D; Guo, Y; Han, M; Li, H; Li, Y; Wang, X, 2018
)
0.48
" These dose-response estimates may be used to derive folate intake reference values."( Systematic Review of Observational Studies with Dose-Response Meta-Analysis between Folate Intake and Status Biomarkers in Adults and the Elderly.
de Groot, LCPGM; Duffy, M; Dullemeijer, C; Geelen, A; Glibetić, M; Gurinović, M; Hoey, L; McNulty, H; Nikolić, M; Novaković, R; Renkema, JMS; Ristić-Medić, D; Souverein, OW; Van't Veer, P, 2018
)
0.48
" However, the severe side effect during long term and high dosage usage limit its application."( Dual-functional lipid polymeric hybrid pH-responsive nanoparticles decorated with cell penetrating peptide and folate for therapy against rheumatoid arthritis.
Lee, RJ; Li, Y; Sun, F; Sun, X; Teng, L; Yu, C; Zhang, X; Zhao, J; Zhao, M; Zhou, Y, 2018
)
0.48
" Further investigations are necessary to increase the reliability of the results and estimate the relationship between dose-response and the best outcome."( Maternal Folate Intake and Risk of Childhood Brain and Spinal Cord Tumors: A Systematic Review and Meta-Analysis.
Chiavarini, M; Fabiani, R; Naldini, G, 2018
)
0.48
"To review the evidence for benefits and harms of folate (folic acid or folinic acid) supplementation on methotrexate (MTX) treatment for rheumatoid arthritis (RA), to assess whether or not folate supplementation would reduce MTX toxicity or reduce MTX benefits, and to decide whether a higher MTX dosage is essential."( Folate Supplementation for Methotrexate Therapy in Patients With Rheumatoid Arthritis: A Systematic Review.
Guan, W; He, Y; Hu, W; Li, T; Liu, L; Liu, S; Liu, X; Lu, J; Wang, C; Wang, P; Xuan, Y; Zhang, L; Zhang, Y, 2019
)
0.51
" Additional studies are required to determine both the dosage of folic acid and the timing of folic acid intake needed for optimal neurodevelopment in humans."( Maternal oversupplementation with folic acid and its impact on neurodevelopment of offspring.
Jadavji, NM; Murray, LK; Smith, MJ, 2018
)
0.48
"The goal of this study was to evaluate the dose-response association of serum folate with the risk of CIN, and the potential for HPV to modify the risk of CIN."( Interactions between serum folate and human papillomavirus with cervical intraepithelial neoplasia risk in a Chinese population-based study.
Hao, M; Li, D; Li, L; Liu, H; Lv, W; Mason, TG; Ran, J; Song, J; Truong, A; Wang, C; Wang, J; Wang, W; Wang, Y; Wang, Z; Yang, A; Yang, J; Zhao, W; Zheng, T, 2018
)
0.48
" Both categoric and spline analyses were used to evaluate the dose-response relation between serum folate and CIN risk."( Interactions between serum folate and human papillomavirus with cervical intraepithelial neoplasia risk in a Chinese population-based study.
Hao, M; Li, D; Li, L; Liu, H; Lv, W; Mason, TG; Ran, J; Song, J; Truong, A; Wang, C; Wang, J; Wang, W; Wang, Y; Wang, Z; Yang, A; Yang, J; Zhao, W; Zheng, T, 2018
)
0.48
"CSF 5MTHF dosage should be considered in patients with mitochondrial diseases, primary brain calcifications and unexplained complex neurological disorders especially if associated with WMA, since folinic acid supplementation in patients with sCFD is frequently efficient."( Cerebral folate deficiency in adults: A heterogeneous potentially treatable condition.
Benoist, JF; Lubetzki, C; Masingue, M; Moussa, F; Nadjar, Y; Roze, E; Sedel, F, 2019
)
0.51
"The threshold for population-level optimal red blood cell (RBC) folate concentration among women of reproductive age for the prevention of neural tube defects has been estimated at 906 nmol/L; however, the dose-response relationship between folic acid intake and blood folate concentrations is uncharacterized."( Systematic Review and Bayesian Meta-analysis of the Dose-response Relationship between Folic Acid Intake and Changes in Blood Folate Concentrations.
Berry, RJ; Crider, KS; Devine, O; Qi, YP; Rose, CE; Sekkarie, A; Wong, E; Yeung, LF; Zaganjor, I, 2019
)
0.51
" A randomized trial has recently been published evaluating a single weekly dosage (17."( Methotrexate efficacy and tolerance in plaque psoriasis. A prospective real-life multicentre study in France.
Amy de la Breteque, M; Avenel-Audran, M; Bastien, M; Beauchet, A; Bégon, E; Beneton, N; Boyé, T; Fougerousse, AC; Girard, C; Khemis, A; Maccari, F; Mahé, E; Pallure, V; Parier, J; Perrot, JL; Reguiai, Z; Tournier, A, 2019
)
0.51
" The impact of demographic data, psoriasis characteristics (duration, topography, rheumatism), dosage (W12/16 dosage, cumulative dose after 4 weeks), and mode of administration (subcutaneous vs."( Methotrexate efficacy and tolerance in plaque psoriasis. A prospective real-life multicentre study in France.
Amy de la Breteque, M; Avenel-Audran, M; Bastien, M; Beauchet, A; Bégon, E; Beneton, N; Boyé, T; Fougerousse, AC; Girard, C; Khemis, A; Maccari, F; Mahé, E; Pallure, V; Parier, J; Perrot, JL; Reguiai, Z; Tournier, A, 2019
)
0.51
" The initial dosage (high dose in the first month) appears to be associated with superior efficacy for W12/W16."( Methotrexate efficacy and tolerance in plaque psoriasis. A prospective real-life multicentre study in France.
Amy de la Breteque, M; Avenel-Audran, M; Bastien, M; Beauchet, A; Bégon, E; Beneton, N; Boyé, T; Fougerousse, AC; Girard, C; Khemis, A; Maccari, F; Mahé, E; Pallure, V; Parier, J; Perrot, JL; Reguiai, Z; Tournier, A, 2019
)
0.51
" Future preclinical studies are needed to help us characterize the behavioral effects, understand the underlying mechanisms, and to establish an optimal dosage and time window of folate supplementation."( The Importance of Maternal Folate Status for Brain Development and Function of Offspring.
Brouwer-Brolsma, EM; Naninck, EFG; Stijger, PC, 2019
)
0.51
" Liver biopsy was considered when the total cumulative dosage (TCD) of MTX was ≥3."( "Hepatic toxicity by methotrexate with weekly single doses associated with folic acid in rheumatoid and psoriatic arthritis. What is its real frequency?"
Abritta, G; Ascimani-Peña, C; Cravero, A; García, DS; Martínez-Artola, Y; Poncino, D; Rosenberg, S; Saturansky, EI,
)
0.13
" We also adopted generalized least-squares trend (GLST) estimation for the dose-response analysis."( Association of maternal folate intake during pregnancy with infant asthma risk.
Cao, Y; Hu, C; Kong, J; Li, W; Shao, Y; Tan, X; Wu, J; Wu, W; Wu, X; Xie, K; Xu, B; Zhou, J, 2019
)
0.51
" These patterns can be compared with secular trends of usual medical practice for the treatment of pernicious anemia and with the changes in usage of folic acid preparations, including recommended therapeutic dosage and precautions for its usage surrounding the synthesis of folic acid in 1945 and vitamin B12 in 1948."( Lack of historical evidence to support folic acid exacerbation of the neuropathy caused by vitamin B12 deficiency.
Berry, RJ, 2019
)
0.51
" By controlling the concentration and dosing schedule of adapter administration, we document two methods that can rapidly terminate (<3 h) a pre-existing CRS-like toxicity and two unrelated methods that can pre-emptively prevent a CRS-like toxicity that would have otherwise occurred."( Regulation of CAR T cell-mediated cytokine release syndrome-like toxicity using low molecular weight adapters.
Chu, H; Leamon, CP; Lee, YG; Low, PS; Lu, Y; Putt, KS; Srinivasarao, M, 2019
)
0.51
" Our variables were demographic data, folate levels before and 8 weeks after treatment and cumulative dosage of UVA during 8 weeks of treatment."( Evaluation of serum folate level before and after bath PUVA therapy in patients referred to Razi Hospital, Rasht, Iran.
Alizadeh, N; Darjani, A; Eftekhari, H; Gharaei Nejad, K; Rafiee, B; Rafiei, E; Rafiei, R; Yousefkhani, L, 2019
)
0.51
" However, its dosing should be carefully considered because of possible renal damage."( The effect of folic acid administration on cardiac tissue matrix metalloproteinase activity and hepatorenal biomarkers in diabetic rats
Djuric, D; Gopcevic, K; Jakovljevic Uzelac, J; Labudovic Borovic, M; Mutavdzin, S; Stankovic, S, 2019
)
0.51
" In this experimental animal study of early chick embryo model, we would like to determine if there is any dose-response relationship between VA and NTDs and if there is any protective effect of FA on this relationship in early chick embryo period."( Valproic acid effect on neural tube defects is not prevented by concomitant folic acid supplementation: Early chick embryo model pilot study.
Cakin, H; Kazan, S; Ozak, A; Turgut, U, 2019
)
0.51
"The dose-response relationship between folate levels and cognitive impairment among individuals with vitamin B12 deficiency is an essential component of a risk-benefit analysis approach to regulatory and policy recommendations regarding folic acid fortification."( Assessment of the Dose-Response Relationship Between Folate Exposure and Cognitive Impairment: Synthesizing Data from Documented Studies.
Clarke, J; Dutta, E; Sahyoun, NR; Shao, K; Wang, B, 2020
)
0.56
" A low dosage of loaded DTX in FA-CD@PP-CpG can promote infiltration of CTLs to improve efficacy of anti-PD-L1 antibody (aPD-L1), suppress MDSCs, and effectively polarize MDSCs toward M1 phenotype to reduce tumor burden, further to enhance the antitumor efficacy."( Tumor-Targeted Drug and CpG Delivery System for Phototherapy and Docetaxel-Enhanced Immunotherapy with Polarization toward M1-Type Macrophages on Triple Negative Breast Cancers.
Chen, L; Dong, C; Han, Y; Hu, X; Liang, S; Lin, Y; Liu, J; Lu, Y; Shi, S; Wang, C; Yao, T; Zhou, L, 2019
)
0.51
"In light of the recommendation of folic acid supplementation in chronic hemolytic anemia, with possible supratherapeutic dosing and associated side effects, we performed this study to investigate serum folate levels in children with chronic hemolytic anemia."( Serum Folate Levels in Patients with Chronic Hemolytic Anemia on Regular Folic Acid Supplementation Before and After Dose Modification.
Attalla, S; Azzam, M, 2019
)
0.51
"Phase 1 was a cross-sectional study of 134 patients in the Pediatric Hematology service, documenting daily dosage and performing serum folate levels."( Serum Folate Levels in Patients with Chronic Hemolytic Anemia on Regular Folic Acid Supplementation Before and After Dose Modification.
Attalla, S; Azzam, M, 2019
)
0.51
"Dual-targeted drug delivery is a new drug dosing strategy that is frequently used to enhance the therapeutic efficacy of anticancer drugs."( New Folate-Modified Human Serum Albumin Conjugated to Cationic Lipid Carriers for Dual Targeting of Mitoxantrone against Breast Cancer.
Azandaryani, AH; Kashanian, S; Mahdavian, E; Rafipour, R; Ridha, AA, 2020
)
0.56
" These targeting moieties can be recognized by specific integrin/receptors that are overexpressed specifically on the tumor cell surface, resulting in minimizing dosage and reducing off-target effects."( Targeting strategies for superparamagnetic iron oxide nanoparticles in cancer therapy.
Fu, S; Yang, J; Yang, T; Zhang, S; Zhi, D, 2020
)
0.56
"This study has provided evidence that a high dosage of FA supplement from 3 months before pregnancy until the entire pregnancy reduces the recurrent pre-eclampsia."( The effect of folic acid throughout pregnancy among pregnant women at high risk of pre-eclampsia: A randomized clinical trial.
Huang, J; Kong, H; Su, Y; Wang, F; Xin, H; Zheng, L, 2020
)
0.56
" Further clinical research is advisable to identify the dosage and timing of the supplementation, the group of women that might benefit the most from this approach, and the nutraceuticals with the best cost-effectiveness and risk-benefit ratio for widespread use in clinical practice."( Nutraceuticals and Hypertensive Disorders in Pregnancy: The Available Clinical Evidence.
Cicero, AFG; Fogacci, F; Fogacci, S, 2020
)
0.56
" In this review, we summarized the link across DNA methylation, maternal FAS, and offspring health to provide more evidence for clinical guidance in terms of precise FAS dosage and time point."( Maternal Folic Acid Supplementation Mediates Offspring Health via DNA Methylation.
Liu, HY; Liu, SM; Zhang, YZ, 2020
)
0.56
"Preparing a controlled release dosage form for specific locations within the body is one of the most challenging tasks in the present times."( Folic acid modified gold nanoparticle for targeted delivery of Sorafenib tosylate towards the treatment of diabetic retinopathy.
Dave, V; Gupta, C; Sharma, R; Sur, S, 2020
)
0.56
" The exploration of the different cellular uptake mechanisms could improve treatment efficacy or allow a decrease in dosage of anticancer drugs."( Folate and Pegylated Aliphatic Polyester Nanoparticles for Targeted Anticancer Drug Delivery.
Agianian, B; Angelou, E; Avgoustakis, K; Bikiaris, D; Didaskalou, S; Koffa, MD; Tsolou, A, 2020
)
0.56
" Pooled relative risks (RR) and dose-response analysis were used to examine dietary folate intake and cancers risks among Chinese population."( Association between Dietary Intake of Folate and the Risks of Multiple Cancers in Chinese Population: A Dose-Response Meta-Analysis of Observational Studies.
Chen, S; Chen, Y; Wang, Y; Zhan, J, 2021
)
0.62
" Dose-response analysis revealed that those maintaining 250 μg daily intake of dietary folate had the lowest risk of cancers events among Chinese."( Association between Dietary Intake of Folate and the Risks of Multiple Cancers in Chinese Population: A Dose-Response Meta-Analysis of Observational Studies.
Chen, S; Chen, Y; Wang, Y; Zhan, J, 2021
)
0.62
" The restricted cubic spline model was used for the dose-response analysis."( Red blood cell folate and severe abdominal aortic calcification: Results from the NHANES 2013-2014.
Guo, M; Peng, Y; Wen, X; Zhao, L; Zhou, L, 2021
)
0.62
" Despite women experiencing challenges with midday dosing and stigma, using simple home-based strategies and being counseled on the purpose of supplementation were more effective than reducing dosage for mitigating barriers and improving adherence."( Integrating Calcium Into Antenatal Iron-Folic Acid Supplementation in Ethiopia: Women's Experiences, Perceptions of Acceptability, and Strategies to Support Calcium Supplement Adherence.
Birhanu, Z; Dickin, KL; Kebede, Y; Klemm, GC; Mamo, G; Martin, SL; Ortolano, SE, 2020
)
0.56
" The results indicated a non-linear dose-response relationship between vitamin B6 intake and pancreatic risk."( Vitamin B6, vitamin B12 and methionine and risk of pancreatic cancer: a meta-analysis.
Mao, QQ; Wei, DH, 2020
)
0.56
" Hence, we conducted a dose-response meta-analysis of observational studies to obtain more reliable conclusions."( Association of folate intake and plasma folate level with the risk of breast cancer: a dose-response meta-analysis of observational studies.
Dai, Z; Hao, Q; Kang, H; Li, N; Liu, K; Ren, X; Song, D; Wu, Y; Xu, P; Yang, S; Zhai, Z; Zhang, D; Zheng, Y, 2020
)
0.56
"Multiple variable logistic regression failed to demonstrate any statistically significant effect of folic acid dosage in reducing overall fetal malformation rates in women taking folic acid either before and during pregnancy (P = 0."( Folic acid dose, valproate, and fetal malformations.
Eadie, MJ; Graham, JE; Hitchcock, AA; Lander, CM; O'Brien, TJ; Perucca, P; Vajda, FJE, 2021
)
0.62
" Knowledge of IFA supplement dosage and benefits also increased among frontline health care workers and pregnant women."( Training healthcare workers increases IFA use and adherence: Evidence and cost-effectiveness analysis from Bangladesh.
Busch-Hallen, J; Cotton, CS; Kashi, B; Kurzawa, Z; Mazurkewich, N; Verney, A, 2021
)
0.62
" Results for A-549 showed a weaker dose-response effect than for colon cancer ones."( Methotrexate Gold Nanocarriers: Loading and Release Study: Its Activity in Colon and Lung Cancer Cells.
Álvarez, MA; Álvarez-González, B; Fernández-Perales, M; Rozalen, M; Sánchez-Polo, M, 2020
)
0.56
" We also found two L-shaped dose-response curves among total folate intake, natural folate intake with depressive symptoms, respectively."( Total folate, natural folate and synthetic folic acid intake associations with adult depressive symptoms.
Jiang, W; Yu, X; Zhang, D; Zheng, L, 2020
)
0.56
" And, it was suggested that the dosage of metformin should be less than 1700 mg/days."( The effect of metformin on homocysteine levels in patients with polycystic ovary syndrome: A systematic review and meta-analysis.
Bai, Y; Fang, Z; Li, X; Pan, H; Wang, F; Yang, X; Zhang, C, 2021
)
0.62
"Based on the optimization of particle size and embedding rate of PTX-loaded mixed NPs, the appropriate dosage ratio of FA-F87-PLGA to TPGS was finally determined to be 5:3."( Preparation and In Vitro/Vivo Evaluation of Folate-conjugated Pluronic F87-PLGA/TPGS Mixed Nanoparticles for Targeted Drug Delivery.
Gong, Y; Li, Y; Li, Z; Wu, T; Xiong, X, 2021
)
0.62
" Further approaches taken to improve the efficacy of 5-FU chemotherapy regimens have focused on optimising the route and dosing schedules and regulating folate metabolism."( Metastatic colorectal cancer: Advances in the folate-fluoropyrimidine chemotherapy backbone.
de Gramont, A; Glimelius, B; Marshall, J; Stintzing, S; Yoshino, T, 2021
)
0.62
"Associations and dose-response relationships between serum total folate, 5-methyltetrahydrofolate, and grip strength in general adults were unknown."( The relationship between serum folate and grip strength in American adults.
Li, Z; Sun, J; Zhang, D; Zhang, L, 2021
)
0.62
" Non-linear positive dose-response relationships between serum folate and grip strength were also found only in females, not in males."( The relationship between serum folate and grip strength in American adults.
Li, Z; Sun, J; Zhang, D; Zhang, L, 2021
)
0.62
"Our study suggested a positive association between serum folate and grip strength, while this positive association was only found in females; besides, the dose-response relationships were in a non-linear trend."( The relationship between serum folate and grip strength in American adults.
Li, Z; Sun, J; Zhang, D; Zhang, L, 2021
)
0.62
" Cox regression model was used to calculate the hazard ratio (HR) and 95 % confidence intervals (95 % CIs), and restricted cubic spline function was further modelled to investigate their dose-response associations."( Association between serum vitamin B12 and risk of all-cause mortality in elderly adults: a prospective cohort study.
Ding, X; Li, L; Liu, J; Liu, X; Sun, J; Xu, K; Zhang, Y, 2021
)
0.62
"Development of dosage form comprising of Capecitabine loaded carbon nanotubes for its targeted delivery to the colon."( Colon targeted dosage form of Capecitabine using folic acid anchored modified carbon nanotube:
Bhinge, SD; Bhutkar, MA; Gavade, AS; Jadhav, NR; Randive, DS; Shejawal, KP, 2021
)
0.62
" Higher total antioxidant intake was significantly associated with lower odds of depression and an inverse dose-response effect between total antioxidant intake and clinical severity of depression was observed among women, in adjusted models."( Associations of depression and intake of antioxidants and vitamin B complex: Results of the Brazilian Longitudinal Study of Adult Health (ELSA-Brasil).
Barreto, SM; Benseñor, IM; Brunoni, AR; da Fonseca, MJM; de Aguiar, OB; Ferriani, LO; Mill, JG; Molina, MDCB; Moreno, AB; Silva, DA; Viana, MC, 2022
)
0.72
" Pooled effect sizes were calculated based on the random effects model, and dose-response analysis was modeled by using a fractional polynomial model."( The Effects of Folic Acid Supplementation on Pro-inflammatory Mediators: a Systematic Review and Dose-Response Meta-Analysis of Randomized Controlled Trials.
Mousavi, SM; Persad, E; Pizarro, AB; Severo, JS; Zargarzadeh, N, 2021
)
0.62
" Categoric and spline analyses were used to evaluate the dose-response relations."( Associations of RBC and Serum Folate Concentrations with Cervical Intraepithelial Neoplasia and High-Risk Human Papillomavirus Genotypes in Female Chinese Adults.
Hao, M; Li, L; Li, Y; Liang, T; Lou, H; Lv, W; Song, J; Su, X; Wang, C; Wang, J; Wang, W; Wang, Z; Yang, A; Yang, J; Zhang, H; Zhang, L; Zhao, C; Zhao, W, 2022
)
0.72
" Sensitivity, subgroup and dose-response analyses were also performed."( Effects of maternal folate and vitamin B12 on gestational diabetes mellitus: a dose-response meta-analysis of observational studies.
Guo, L; Jiang, J; Li, N, 2022
)
0.72
"A clear dosing regimen for methotrexate in psoriasis is lacking, and this might lead to a suboptimal treatment."( International eDelphi Study to Reach Consensus on the Methotrexate Dosing Regimen in Patients With Psoriasis.
Abad, ME; Akman-Karakas, A; Appelen, D; Araujo, RR; Ayanlowo, O; Azimi, SZ; Babic, LT; Balak, D; Barber, K; Boonen, HPJ; Brajac, I; Bylaite-Bucinskiene, M; Calzavara-Pinton, P; Cárdenas Rojas, PJ; Carija, A; Carretero, G; Castro, C; Castro-Ayarza, JR; Ceovic, R; Cetkovska, P; Chandrashekar, L; Choon, SE; Chosidow, O; Claréus, BW; Colombo, EP; Conrad, C; Correa, CC; Csányi, I; da Cruz Costa, SA; Damiani, G; Danespazhooh, M; de Jong, EMGJ; de la Cruz, C; de la Cueva, P; de Oliveira, MFSP; de Rie, MA; de Souza Sittart, JA; Del-Río, R; Doss, N; Drvar, DL; Dutil, M; Echeverría, CM; Egeberg, A; El Gamal, E; El-Sayed, MH; Fábos, B; Fardet, L; Félix, PAO; Fernandez-Peñas, P; Ferran, M; Ferrándiz, C; Firooz, A; Fougerousse, AC; Foulkes, A; Franco, MD; Frez, ML; García-Doval, I; Gebauer, KA; Ghislain, PD; Gisondi, P; Gomez, LC; Gómez-Flores, M; Gonçalo, M; Gonzalez, C; Gonzalez, GO; Gooderham, MJ; Goujon, C; Grewal, P; Griffiths, CEM; Grozdev, I; Gulin, SJ; Gulliver, W; Gyulai, R; Handa, S; Handjani, F; Holló, P; Hong, CH; Horváth, B; Hsiao, JP; Huldt-Nystrøm, T; Hunter, HJA; Hurtová, T; Ingram, JR; Iversen, L; Janmohamed, SR; Jullien, D; Kaštelan, M; Khobzei, K; Kim, DH; Kolalapudi, SA; Krisztián, G; Krnjevic-Pezic, G; Kui, R; Kumar, AS; Laffitte, E; Lafuente-Urrez, RF; Lambert, JLW; le Cleach, L; Lebwohl, M; Lecluse, L; Leonidze, T; Liu, TY; Llamas-Velasco, M; Luna, PC; Mahé, E; Mahil, SK; Maldonado-García, C; Mälkönen, T; Marchesi, C; Margasin, SM; Marrón, SE; Massari, LP; Matlock, BH; Maul, JT; Maul, LV; Menting, SP; Middelkamp-Hup, MA; Misery, L; Moussa, IO; Muresanu, LI; Nicolopoulos, J; Novoa, FD; Oakley, A; Olszewska, M; Oon, HH; Pellerano, G; Polic, MV; Prinz, JC; Puig, L; Rademaker, M; Ramam, M; Ramos, AMC; Reciné, TR; Reich, K; Riad, H; Romiti, R; Salleras I Redonnet, M; Sanchez, JL; Sator, P; Schejtman, AA; Schram, ME; Seyger, MMB; Sharma, VK; Sikora, M; Silverberg, NB; Skov, L; Sonkoly, E; Spuls, PI; Törocsik, D; Torres, T; Trcko, K; Turchin, I; Urbancek, S; Valenzuela, F; van den Reek, JMPA; van der Kraaij, GE; van Doorn, M; van Huizen, AM; Varela, P; Velásquez-Lopera, MM; Veldkamp, W; Vender, R; Vestergaard, C; Vilarrasa, E; Vílchez-Márquez, F; Warren, RB; Weightman, W; Weinberg, JM; Wells, J; Willaert, F; Wiseman, MC; Wong, TW; Yawalkar, N; Zargari, O; Zheng, M, 2022
)
0.72
"To reach international consensus among psoriasis experts on a uniform dosing regimen for treatment with methotrexate in adult and pediatric patients with psoriasis and identify potential future research topics."( International eDelphi Study to Reach Consensus on the Methotrexate Dosing Regimen in Patients With Psoriasis.
Abad, ME; Akman-Karakas, A; Appelen, D; Araujo, RR; Ayanlowo, O; Azimi, SZ; Babic, LT; Balak, D; Barber, K; Boonen, HPJ; Brajac, I; Bylaite-Bucinskiene, M; Calzavara-Pinton, P; Cárdenas Rojas, PJ; Carija, A; Carretero, G; Castro, C; Castro-Ayarza, JR; Ceovic, R; Cetkovska, P; Chandrashekar, L; Choon, SE; Chosidow, O; Claréus, BW; Colombo, EP; Conrad, C; Correa, CC; Csányi, I; da Cruz Costa, SA; Damiani, G; Danespazhooh, M; de Jong, EMGJ; de la Cruz, C; de la Cueva, P; de Oliveira, MFSP; de Rie, MA; de Souza Sittart, JA; Del-Río, R; Doss, N; Drvar, DL; Dutil, M; Echeverría, CM; Egeberg, A; El Gamal, E; El-Sayed, MH; Fábos, B; Fardet, L; Félix, PAO; Fernandez-Peñas, P; Ferran, M; Ferrándiz, C; Firooz, A; Fougerousse, AC; Foulkes, A; Franco, MD; Frez, ML; García-Doval, I; Gebauer, KA; Ghislain, PD; Gisondi, P; Gomez, LC; Gómez-Flores, M; Gonçalo, M; Gonzalez, C; Gonzalez, GO; Gooderham, MJ; Goujon, C; Grewal, P; Griffiths, CEM; Grozdev, I; Gulin, SJ; Gulliver, W; Gyulai, R; Handa, S; Handjani, F; Holló, P; Hong, CH; Horváth, B; Hsiao, JP; Huldt-Nystrøm, T; Hunter, HJA; Hurtová, T; Ingram, JR; Iversen, L; Janmohamed, SR; Jullien, D; Kaštelan, M; Khobzei, K; Kim, DH; Kolalapudi, SA; Krisztián, G; Krnjevic-Pezic, G; Kui, R; Kumar, AS; Laffitte, E; Lafuente-Urrez, RF; Lambert, JLW; le Cleach, L; Lebwohl, M; Lecluse, L; Leonidze, T; Liu, TY; Llamas-Velasco, M; Luna, PC; Mahé, E; Mahil, SK; Maldonado-García, C; Mälkönen, T; Marchesi, C; Margasin, SM; Marrón, SE; Massari, LP; Matlock, BH; Maul, JT; Maul, LV; Menting, SP; Middelkamp-Hup, MA; Misery, L; Moussa, IO; Muresanu, LI; Nicolopoulos, J; Novoa, FD; Oakley, A; Olszewska, M; Oon, HH; Pellerano, G; Polic, MV; Prinz, JC; Puig, L; Rademaker, M; Ramam, M; Ramos, AMC; Reciné, TR; Reich, K; Riad, H; Romiti, R; Salleras I Redonnet, M; Sanchez, JL; Sator, P; Schejtman, AA; Schram, ME; Seyger, MMB; Sharma, VK; Sikora, M; Silverberg, NB; Skov, L; Sonkoly, E; Spuls, PI; Törocsik, D; Torres, T; Trcko, K; Turchin, I; Urbancek, S; Valenzuela, F; van den Reek, JMPA; van der Kraaij, GE; van Doorn, M; van Huizen, AM; Varela, P; Velásquez-Lopera, MM; Veldkamp, W; Vender, R; Vestergaard, C; Vilarrasa, E; Vílchez-Márquez, F; Warren, RB; Weightman, W; Weinberg, JM; Wells, J; Willaert, F; Wiseman, MC; Wong, TW; Yawalkar, N; Zargari, O; Zheng, M, 2022
)
0.72
" More research is needed, especially for the proposals on folic acid and the dosing of methotrexate for treating subpopulations such as children and vulnerable patients."( International eDelphi Study to Reach Consensus on the Methotrexate Dosing Regimen in Patients With Psoriasis.
Abad, ME; Akman-Karakas, A; Appelen, D; Araujo, RR; Ayanlowo, O; Azimi, SZ; Babic, LT; Balak, D; Barber, K; Boonen, HPJ; Brajac, I; Bylaite-Bucinskiene, M; Calzavara-Pinton, P; Cárdenas Rojas, PJ; Carija, A; Carretero, G; Castro, C; Castro-Ayarza, JR; Ceovic, R; Cetkovska, P; Chandrashekar, L; Choon, SE; Chosidow, O; Claréus, BW; Colombo, EP; Conrad, C; Correa, CC; Csányi, I; da Cruz Costa, SA; Damiani, G; Danespazhooh, M; de Jong, EMGJ; de la Cruz, C; de la Cueva, P; de Oliveira, MFSP; de Rie, MA; de Souza Sittart, JA; Del-Río, R; Doss, N; Drvar, DL; Dutil, M; Echeverría, CM; Egeberg, A; El Gamal, E; El-Sayed, MH; Fábos, B; Fardet, L; Félix, PAO; Fernandez-Peñas, P; Ferran, M; Ferrándiz, C; Firooz, A; Fougerousse, AC; Foulkes, A; Franco, MD; Frez, ML; García-Doval, I; Gebauer, KA; Ghislain, PD; Gisondi, P; Gomez, LC; Gómez-Flores, M; Gonçalo, M; Gonzalez, C; Gonzalez, GO; Gooderham, MJ; Goujon, C; Grewal, P; Griffiths, CEM; Grozdev, I; Gulin, SJ; Gulliver, W; Gyulai, R; Handa, S; Handjani, F; Holló, P; Hong, CH; Horváth, B; Hsiao, JP; Huldt-Nystrøm, T; Hunter, HJA; Hurtová, T; Ingram, JR; Iversen, L; Janmohamed, SR; Jullien, D; Kaštelan, M; Khobzei, K; Kim, DH; Kolalapudi, SA; Krisztián, G; Krnjevic-Pezic, G; Kui, R; Kumar, AS; Laffitte, E; Lafuente-Urrez, RF; Lambert, JLW; le Cleach, L; Lebwohl, M; Lecluse, L; Leonidze, T; Liu, TY; Llamas-Velasco, M; Luna, PC; Mahé, E; Mahil, SK; Maldonado-García, C; Mälkönen, T; Marchesi, C; Margasin, SM; Marrón, SE; Massari, LP; Matlock, BH; Maul, JT; Maul, LV; Menting, SP; Middelkamp-Hup, MA; Misery, L; Moussa, IO; Muresanu, LI; Nicolopoulos, J; Novoa, FD; Oakley, A; Olszewska, M; Oon, HH; Pellerano, G; Polic, MV; Prinz, JC; Puig, L; Rademaker, M; Ramam, M; Ramos, AMC; Reciné, TR; Reich, K; Riad, H; Romiti, R; Salleras I Redonnet, M; Sanchez, JL; Sator, P; Schejtman, AA; Schram, ME; Seyger, MMB; Sharma, VK; Sikora, M; Silverberg, NB; Skov, L; Sonkoly, E; Spuls, PI; Törocsik, D; Torres, T; Trcko, K; Turchin, I; Urbancek, S; Valenzuela, F; van den Reek, JMPA; van der Kraaij, GE; van Doorn, M; van Huizen, AM; Varela, P; Velásquez-Lopera, MM; Veldkamp, W; Vender, R; Vestergaard, C; Vilarrasa, E; Vílchez-Márquez, F; Warren, RB; Weightman, W; Weinberg, JM; Wells, J; Willaert, F; Wiseman, MC; Wong, TW; Yawalkar, N; Zargari, O; Zheng, M, 2022
)
0.72
"In this eDelphi consensus study, consensus was reached on 20 of 21 proposals involving methotrexate dosing in patients with psoriasis."( International eDelphi Study to Reach Consensus on the Methotrexate Dosing Regimen in Patients With Psoriasis.
Abad, ME; Akman-Karakas, A; Appelen, D; Araujo, RR; Ayanlowo, O; Azimi, SZ; Babic, LT; Balak, D; Barber, K; Boonen, HPJ; Brajac, I; Bylaite-Bucinskiene, M; Calzavara-Pinton, P; Cárdenas Rojas, PJ; Carija, A; Carretero, G; Castro, C; Castro-Ayarza, JR; Ceovic, R; Cetkovska, P; Chandrashekar, L; Choon, SE; Chosidow, O; Claréus, BW; Colombo, EP; Conrad, C; Correa, CC; Csányi, I; da Cruz Costa, SA; Damiani, G; Danespazhooh, M; de Jong, EMGJ; de la Cruz, C; de la Cueva, P; de Oliveira, MFSP; de Rie, MA; de Souza Sittart, JA; Del-Río, R; Doss, N; Drvar, DL; Dutil, M; Echeverría, CM; Egeberg, A; El Gamal, E; El-Sayed, MH; Fábos, B; Fardet, L; Félix, PAO; Fernandez-Peñas, P; Ferran, M; Ferrándiz, C; Firooz, A; Fougerousse, AC; Foulkes, A; Franco, MD; Frez, ML; García-Doval, I; Gebauer, KA; Ghislain, PD; Gisondi, P; Gomez, LC; Gómez-Flores, M; Gonçalo, M; Gonzalez, C; Gonzalez, GO; Gooderham, MJ; Goujon, C; Grewal, P; Griffiths, CEM; Grozdev, I; Gulin, SJ; Gulliver, W; Gyulai, R; Handa, S; Handjani, F; Holló, P; Hong, CH; Horváth, B; Hsiao, JP; Huldt-Nystrøm, T; Hunter, HJA; Hurtová, T; Ingram, JR; Iversen, L; Janmohamed, SR; Jullien, D; Kaštelan, M; Khobzei, K; Kim, DH; Kolalapudi, SA; Krisztián, G; Krnjevic-Pezic, G; Kui, R; Kumar, AS; Laffitte, E; Lafuente-Urrez, RF; Lambert, JLW; le Cleach, L; Lebwohl, M; Lecluse, L; Leonidze, T; Liu, TY; Llamas-Velasco, M; Luna, PC; Mahé, E; Mahil, SK; Maldonado-García, C; Mälkönen, T; Marchesi, C; Margasin, SM; Marrón, SE; Massari, LP; Matlock, BH; Maul, JT; Maul, LV; Menting, SP; Middelkamp-Hup, MA; Misery, L; Moussa, IO; Muresanu, LI; Nicolopoulos, J; Novoa, FD; Oakley, A; Olszewska, M; Oon, HH; Pellerano, G; Polic, MV; Prinz, JC; Puig, L; Rademaker, M; Ramam, M; Ramos, AMC; Reciné, TR; Reich, K; Riad, H; Romiti, R; Salleras I Redonnet, M; Sanchez, JL; Sator, P; Schejtman, AA; Schram, ME; Seyger, MMB; Sharma, VK; Sikora, M; Silverberg, NB; Skov, L; Sonkoly, E; Spuls, PI; Törocsik, D; Torres, T; Trcko, K; Turchin, I; Urbancek, S; Valenzuela, F; van den Reek, JMPA; van der Kraaij, GE; van Doorn, M; van Huizen, AM; Varela, P; Velásquez-Lopera, MM; Veldkamp, W; Vender, R; Vestergaard, C; Vilarrasa, E; Vílchez-Márquez, F; Warren, RB; Weightman, W; Weinberg, JM; Wells, J; Willaert, F; Wiseman, MC; Wong, TW; Yawalkar, N; Zargari, O; Zheng, M, 2022
)
0.72
" However, it requires complicated dosing regimens and is accompanied by increased toxicity."( Co-Delivery of Daunorubicin and Homoharringtonine in Folic Acid Modified-Liposomes for Enhancing Therapeutic Effect on Acute Myeloid Leukemia.
Feng, X; Gao, X; Li, H; Liu, Q; Luo, L; Mao, S; Yang, P; Zhang, D, 2023
)
0.91
"Methotrexate cutaneous ulceration is commonly preceded by dosage mistakes, absence of folic acid supplementation, and concurrent use of nephrotoxic medications."( Methotrexate Cutaneous Ulceration: A Systematic Review of Cases.
Baumrin, E; Berna, R; Margolis, DJ; Mitra, N; Rosenbach, M, 2022
)
0.72
" Besides individual positive associations of maternal Hg and Pb exposure with offspring OWO, BKMR clearly indicated a positive dose-response association between in-utero co-exposure to the three toxic metals and childhood OWO."( In-utero co-exposure to toxic metals and micronutrients on childhood risk of overweight or obesity: new insight on micronutrients counteracting toxic metals.
Bind, E; Buckley, JP; Haltmeier, D; Hong, X; Hou, W; Huang, W; Igusa, T; Ji, Y; Mukherjee, J; Steffens, A; Tina Fan, Z; Wang, G; Wang, X; Xu, R, 2022
)
0.72
"This study strove to investigate the hypothesis that a low dosage of myo-inositol supplementation might decrease the likelihood of gestational diabetes in overweight, pregnant women."( The effect of myo-inositol supplementation on the prevention of gestational diabetes in overweight pregnant women: a randomized, double-blind, controlled trial.
Basirat, Z; Delavar, MA; Esmaeilzadeh, S; Ghadimi, R; Mashayekh-Amiri, S, 2023
)
0.91
" For all women who could become pregnant, a low daily dosage of folic acid is recommended before conception and throughout pregnancy and breastfeeding."( Guideline No. 427: Folic Acid and Multivitamin Supplementation for Prevention of Folic Acid-Sensitive Congenital Anomalies.
O'Connor, DL; Wilson, RD, 2022
)
0.72
" However, with the emergence of conditions where folate metabolism and transport are disrupted, such as folate receptor alpha autoantibody (FRαAb)-induced folate deficiency, it is critical to find a folate form that is effective and safe for pharmacologic dosing for prolonged periods."( Absorption and Tissue Distribution of Folate Forms in Rats: Indications for Specific Folate Form Supplementation during Pregnancy.
Arning, E; Bobrowski-Khoury, N; Bottiglieri, T; Quadros, EV; Sequeira, JM, 2022
)
0.72
" Exposure to each of the intervention components had a dose-response relationship with self-reported IFA use."( How does a social norms-based intervention affect behaviour change? Interim findings from a cluster randomised controlled trial in Odisha, India.
Bingenheimer, J; Ganjoo, R; Mohanty, S; Pant, I; Patro, L; Rimal, R; Sedlander, E; Yilma, H, 2022
)
0.72
" Maternal exposure to ETS in first trimester was associated with increased risk of CHDs in a dose-response gradient, with the AORs (95% CI) were1."( Association between maternal smoke exposure and congenital heart defects from a case-control study in China.
Dai, L; Deng, C; Deng, Y; Guo, X; Liu, H; Liu, L; Pu, J; Sandin, S; Xie, L; Yu, L, 2022
)
0.72
" However, larger studies of folic acid dosing and timing, with consideration for childhood asthma, are needed."( Periconceptional folic acid supplementation and child asthma: a
Adgent, MA; Carroll, KN; Hartmann, KE; Jones, SH; McCullough, A; Torstenson, E; Velez Edwards, DR; Vereen, S, 2022
)
0.72
"To determine the long-term impact of periconceptional folic acid supplementation on DNA methylation patterns, we examined the association of the recommended dosage (400 μg/d) and time period (periconceptional before pregnancy through first trimester) of folic acid supplementation with the DNA methylation patterns in the offspring at age 14-17 y compared with offspring with no supplementation."( Maternal Periconceptional Folic Acid Supplementation and DNA Methylation Patterns in Adolescent Offspring.
Bailey, RL; Berry, RJ; Crider, KS; Killian, JK; Lichen, Y; Linet, M; Ling, H; Pfeiffer, CM; Potischman, N; Rose, C; Sampson, J; Su, LJ; Wang, A; Yu, W; Zhu, L, 2023
)
0.91
"Overall, there were no differences in DNA methylation between adolescents who were exposed during the critical developmental window and those not exposed to the recommended periconceptional/first-trimester dosage of folic acid."( Maternal Periconceptional Folic Acid Supplementation and DNA Methylation Patterns in Adolescent Offspring.
Bailey, RL; Berry, RJ; Crider, KS; Killian, JK; Lichen, Y; Linet, M; Ling, H; Pfeiffer, CM; Potischman, N; Rose, C; Sampson, J; Su, LJ; Wang, A; Yu, W; Zhu, L, 2023
)
0.91
" However, there is no consensus as to the appropriate dosage of folate supplements and their advantages and disadvantages for patients with ESKD."( Supplementation with Folic Acid and Cardiovascular Outcomes in End-Stage Kidney Disease: A Multi-Institution Cohort Study.
Chang, CH; Chen, YC; Chu, PH; Fan, PC; Fang, JT; Lee, CC; Tu, KH; Tu, YR; Wu, VC; Yen, CL, 2022
)
0.72
" Restricted cubic splines were plotted to evaluate the dose-response relationship between dietary OCM-related nutrient intake and the risk of PE."( One-carbon metabolism-related nutrients intake is associated with lower risk of preeclampsia in pregnant women: a matched case-control study.
Bo, Y; Cao, Y; Dou, W; Duan, D; Fu, W; Liu, Y; Lyu, Q; Ma, S; Zeng, F; Zhao, X, 2022
)
0.72
" There was no evidence for temporality, coherence, or a biologically meaningful dose-response relationship between plasma vitamin B12 concentrations and cancer."( High Plasma Vitamin B12 and Cancer in Human Studies: A Scoping Review to Judge Causality and Alternative Explanations.
Obeid, R, 2022
)
0.72
" These findings may provide guidance for monitoring serum folate level and controlling oral folate dosage in clinic, so as to prevent liver steatosis more effectively."( The association between serum folate and ultrasound - defined hepatic steatosis.
Chen, B; Chen, X; Lu, J; Shen, L; Xu, Q, 2023
)
0.91
" Significant nonlinear dose-response relationships were observed for the associations of folate with anemia, vitamin B12 with vitamin B-complex deficiencies, anemia and cholelithiasis, and homocysteine with cerebrovascular disease."( Phenome-wide association study of genetically predicted B vitamins and homocysteine biomarkers with multiple health and disease outcomes: analysis of the UK Biobank.
Bennett, D; Campbell, H; Duthie, S; Eguiagaray, IM; Li, X; Little, J; MacFarlane, AJ; McNulty, H; Momoli, F; Montazeri, A; Munger, R; Rubini, M; Senekal, M; Theodoratou, E; Wang, L, 2023
)
0.91
" A random-effects model was used for meta-analysis, and linear Meta-regression and non-linear dose-response analysis were performed to assess whether the effect of folic acid supplementation was affected by the dose and duration of intervention."( The effects of folic acid supplementation on endothelial function in adults: a systematic review and dose-response meta-analysis of randomized controlled trials.
Asbaghi, O; Ashtary-Larky, D; Clark, CCT; Golalipour, E; Naseri, K; Rastgoo, S; Rezaiian, F; Saadati, S; Yousefi, M; Zamani, M, 2023
)
0.91
" Notwithstanding, studies have shown that, like other bioactive substances, its efficacy can be affected by dosage and delivery routes."( An investigation of the effect of folic acid and its delivery routes on broiler chickens' hatch and growth performance, blood biochemistry, anti-oxidant status, and intestinal morphology.
Adewole, D; Oladokun, S, 2023
)
0.91
" Dose-response analysis indicated a negative linear correlation between DFE intake and NAFLD risk."( Folate intake and non-alcoholic fatty liver disease in US adults.
Cao, JC; Chen, CJ; Deng, Z; Liu, FR; Sun, YY; Zhang, B, 2023
)
0.91
" Non-linear dose-response relationships between dietary intake of folate and niacin and diabetes risk were also evaluated using adjusted restricted cubic splines."( Dose-response association between dietary folate and niacin intakes with diabetes among Chinese adults: a cross-sectional study.
Chai, Y; Jiang, Y; Xie, H; Zhang, Z; Zhu, Y, 2023
)
0.91
", vitamin C (VC), vitamin B9 (VB9), and vitamin B12 (VB12)) with co-exposure to MetS, as well as the dose-response relationships among them."( Association of serum water-soluble vitamin exposures with the risk of metabolic syndrome: results from NHANES 2003-2006.
Lu, H; Pei, X; Ran, S; Shi, H; Tan, A; Wang, M; Yang, S; Yao, J; Zhang, Y, 2023
)
0.91
" Restricted cubic splines were performed to explore the dose-response relationships among them."( Association of serum water-soluble vitamin exposures with the risk of metabolic syndrome: results from NHANES 2003-2006.
Lu, H; Pei, X; Ran, S; Shi, H; Tan, A; Wang, M; Yang, S; Yao, J; Zhang, Y, 2023
)
0.91
" The incidence of congenital malformations in women taking a recommended dosage (e."( Initiation and duration of folic acid supplementation in preventing congenital malformations.
Deng, XD; Dong, J; Ji, CY; Pan, Q; Peng, T; Wu, JN; Yang, Z; Yin, LL, 2023
)
0.91
" Hence, the developed PNP formulation sticks out as a plausible substitute for the intravenous dosage forms of IRI which have been conventionally prevailing."( Folic acid-chitosan functionalized polymeric nanocarriers to treat colon cancer.
Bhaskar, KV; Bhaskaran, NA; Birangal, SR; Gourishetti, K; Hari, G; Jitta, SR; Kulkarni, OP; Kumar, L; Sharma, P; Verma, R, 2023
)
0.91
" Knowing the pleiotropic negative impact of Hcy on gametes, embryos and pregnancy in general, we strongly recommend a Hcy dosage in both members of couples seeking treatment for pregnancy."( The importance of preconception Hcy testing: identification of a folate trap syndrome in a woman attending an assisted reproduction program.
Clément, A; Clément, P; Menezo, YJR; Viot, G, 2023
)
0.91
" For each period, the average daily dosage of FAs was categorised into (i) <400 μg/d, (ii) ≥400 to 999 μg/d, (iii) ≥1000 to 4999 μg/d, and (iv) ≥5000 μg/d."( Folic Acid Supplementation during Pregnancy and Its Association with Telomere Length in Children at Four Years: Results from the INMA Birth Cohort Study.
Gonzalez-Palacios, S; Irizar, A; Julvez, J; Martens, DS; Murcia, M; Navarrete-Muñoz, EM; Nawrot, T; Petermann-Rocha, F; Prieto-Botella, D; Riaño-Galán, I; Santa-Marina, L; Sunyer, J; Tardón, A; Valera-Gran, D; Vioque, J, 2023
)
0.91
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Occurs in Manufacturing (983 Product(s))

Product Categories

Product CategoryProducts
Vitamins & Supplements327
Pet Supplies110
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Active Lifestyle & Fitness148
Food & Beverages143
Weight Management79
Baby & Kids Products72
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Beauty & Personal Care3

Products

ProductBrandCategoryCompounds Matched from IngredientsDate Retrieved
1Life Science NAD+ Longevity Cardiovascular Support -- 60 Veggie Caps1Life ScienceVitamins & SupplementsApigenin, Fisetin, Vitamin B9, NAD +, Vitamin B3, NMN, Vitamin B6, Quercetin, Vitamin B62024-11-29 10:47:42
8Greens Daily Greens Gummies Apple -- 50 Vegan Gummies8GreensVitamins & SupplementsVitamin C, Folate, Pantothenic Acid, Vitamin B6, Riboflavin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Abound Grain Free Wet Cat Food Pate Chicken Dinner -- 2.6 ozAboundPet SuppliesD-calcium pantothenate, choline chloride, ferrous sulfate, folic acid, potassium chloride, potassium iodide, pyridoxine hydrochloride, sodium sulfate, taurine, zinc oxide2024-11-29 10:47:42
Abound Grain Free Wet Cat Food Pate Roast Turkey Dinner -- 2.6 ozAboundPet Suppliesbiotin, D-calcium pantothenate, choline chloride, ferrous sulfate, folic acid, magnesium sulfate, potassium chloride, potassium iodide, pyridoxine hydrochloride, sodium selenite, taurine, zinc oxide2024-11-29 10:47:42
Abound Grain Free Wet Cat Food Pate Salmon Dinner -- 2.6 ozAboundPet Suppliesbiotin, D-calcium pantothenate, choline, ferrous sulfate, folic acid, magnesium sulfate, potassium chloride, potassium iodide, pyridoxine hydrochloride, sodium selenite, taurine, zinc oxide2024-11-29 10:47:42
Abound Grain Free Wet Cat Food Pate Whitefish & Tuna Dinner -- 2.6 ozAboundPet Suppliesbiotin, D-calcium pantothenate, choline chloride, ferrous sulfate, folic acid, magnesium sulfate, potassium chloride, potassium iodide, pyridoxine hydrochloride, sodium selenite, zinc oxide2024-11-29 10:47:42
Allergy Research Group Multi-Vi-Min -- 150 CapsulesAllergy Research GroupProfessional SupplementsBiotin, Boron, Vitamin D3, Chromium, Vitamin E, Folic Acid, Vitamin E, Glutamic Acid, Manganese, Molybdenum, Niacin, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Allergy Research Group Multi-Vi-Min without Copper & Iron -- 150 Vegetarian CapsulesAllergy Research GroupProfessional SupplementsPABA, Vitamin C, Biotin, Boron, Vitamin D3, Chromium, Vitamin E, Folic Acid, Vitamin E, Glutamic Acid, Manganese, Molybdenum, Niacin, PABA, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vanadium, Vitamin B12, Vitamin B62024-11-29 10:47:42
Allergy Research Group Super Vitamin B Complex -- 120 Vegetarian CapsulesAllergy Research GroupProfessional SupplementsPABA, Biotin, Folic Acid, Inositol, Niacin, PABA, Pantothenic Acid, Vitamin B6, Riboflavin, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
ALLMAX Nutrition Impact Igniter Sport Blue Raspberry -- 50 ServingsALLMAX NutritionActive Lifestyle & FitnessBeta-Alanine, Caffeine, Folate, Niacin, Vitamin B6, Taurine, Tyrosine, Vitamin B12, Vitamin B62024-11-29 10:47:42
Amazing Grass Greens Blend Energy Powder Watermelon -- 30 ServingsAmazing GrassVitamins & SupplementsVitamin C, Chlorophyll, Folic Acid, Iodine, Manganese, Niacin, Vitamin B6, Vitamin A, Riboflavin, Selenium, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Amazing Grass Greens Blend Superfood Original -- 15 ServingsAmazing GrassVitamins & SupplementsVitamin C, Chlorophyll, Folic Acid, Iodine, Manganese, Niacin, Vitamin B6, Vitamin A, Riboflavin, Selenium, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Amazing Grass Greens Blend Superfood Powder Berry -- 30 ServingsAmazing GrassVitamins & SupplementsVitamin C, Chlorophyll, Folic Acid, Iodine, Manganese, Niacin, Vitamin B6, Vitamin A, Riboflavin, Selenium, Vitamin B6, Vitamin K2024-11-29 10:47:42
Amazing Muscle Max Boost- Advanced Pre-Workout Formula Cherry Lemonade -- 60 ServingsAmazing MuscleActive Lifestyle & FitnessCaffeine Anhydrous, Folic Acid, L-Glutamine, Huperzine A, N-Acetyl-L-Tyrosine, Niacin, Vitamin B6, Vitamin B12, Vitamin B62024-11-29 10:47:42
Amazing Muscle Max Boost- Advanced Pre-Workout Formula Fruit Punch -- 60 ServingsAmazing MuscleActive Lifestyle & FitnessCaffeine Anhydrous, Folic Acid, L-Glutamine, Huperzine A, N-Acetyl-L-Tyrosine, Niacin, Vitamin B6, Vitamin B12, Vitamin B62024-11-29 10:47:42
Amazing Nutrition Amazing Formulas Daily Multivitamin -- 500 TabletsAmazing NutritionVitamins & SupplementsVitamin C, Biotin, Boron, Chloride, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Lutein, Lycopene, Manganese, Molybdenum, Niacin, Nickel, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vanadium, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Amberen Advanced Perimenopause Relief -- 60 CapsulesAmberenVitamins & SupplementsVitamin E, Vitamin B9, Vitamin E, Glycine, Vitamin B6, Vitamin B2, Vitamin B1, Vitamin B12, Vitamin B62024-11-29 10:47:42
AMEN Biotin Collagen Peptides - Vitamins C & E Folate Keratin Hyaluronic Acid -- 90 Vegetable CapsulesAMENVitamins & SupplementsVitamin C, Biotin, Vitamin E, Folate, Vitamin E2024-11-29 10:47:42
AMEN Iron Ultra Supplement + Copper Folate Vitamin C & B12 Ferrous Sulfate -- 65 mg - 60 Vegetable CapsulesAMENVitamins & SupplementsVitamin C, Folate, Vitamin B122024-11-29 10:47:42
American Health Ester-C Effervescent Plus Electrolytes Natural Orange -- 1000 mg - 21 PacketsAmerican HealthVitamins & SupplementsVitamin C, Chloride, Chromium, Folic Acid, Calcium Carbonate, Manganese, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Riboflavin, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Amy Myers MD Methylation Suppor -- 60 CapsulesAmy Myers MDProfessional SupplementsTrimethylglycine, Trimethylglycine, Folate, Vitamin B6, Vitamin B2, Vitamin B12, Vitamin B62024-11-29 10:47:42
Amy Myers MD The Myers Way Multivitamin -- 180 CapsulesAmy Myers MDProfessional SupplementsVitamin C, Biotin, Boron, Choline, Chromium, Vitamin E, Folate, Vitamin E, myo-Inositol, Iodine, Manganese, Molybdenum, Niacin, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamine, Vanadium, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Ancient Nutrition Ancient Nutrients B-Complex -- 60 CapsulesAncient NutritionVitamins & SupplementsFolate, Niacin, Vitamin B6, Riboflavin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Ancient Nutrition Multi Prenatal -- 90 CapsulesAncient NutritionVitamins & SupplementsVitamin E, Folate, Vitamin E, Niacin, Vitamin B6, Vitamin A, Riboflavin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Animal PAK - The Ultimate Training Pack -- 30 PacksAnimalActive Lifestyle & FitnessLipase, Alanine, Arginine, Vitamin C, Aspartic Acid, Biotin, Carnitine, Choline, Chromium, Coenzyme Q10, Cystine, Vitamin E, Folate, Vitamin E, Glutamic Acid, Glutamine, Glycine, Histidine, Hydroxyproline, Inositol, Iodine, Isoleucine, Leucine, Lutein, Lycopene, Lysine, Manganese, menaquinone-4, Methionine, Niacin, Ornithine, Pantothenic Acid, Phenylalanine, Phosphorus, Proline, Vitamin B6, Vitamin A, Riboflavin, Selenium, Serine, L-Taurine, Thiamin, Alpha Lipoic Acid, Threonine, Tryptophan, Tyrosine, Valine, Vitamin B12, Vitamin B6, phytonadione, Vitamin K2024-11-29 10:47:42
Animal PAK - The Ultimate Training Pack -- 44 PacksAnimalActive Lifestyle & FitnessLipase, Alanine, Arginine, Vitamin C, Aspartic Acid, Biotin, Carnitine, Choline, Chromium, Coenzyme Q10, Cystine, Vitamin E, Folate, Vitamin E, Glutamic Acid, Glutamine, Glycine, Histidine, Hydroxyproline, Inositol, Iodine, Isoleucine, Leucine, Lutein, Lycopene, Lysine, Manganese, menaquinone-4, Methionine, Niacin, Ornithine, Pantothenic Acid, Phenylalanine, Phosphorus, Proline, Vitamin B6, Vitamin A, Riboflavin, Selenium, Serine, L-Taurine, Thiamin, Alpha Lipoic Acid, Threonine, Tryptophan, Tyrosine, Valine, Vitamin B12, Vitamin B6, phytonadione, Vitamin K2024-11-29 10:47:42
Animal Pak Ultimate Foundation Powder Cherry Bomb -- 30 ServingsAnimalActive Lifestyle & FitnessLipase, Vitamin C, Betaine Anhydrous, Biotin, dicalcium phosphate, Choline, Chromium, Coenzyme Q10, Vitamin E, Folate, Vitamin E, L-Glutamine, L-Histidine, Inositol, Iodine, L-Isoleucine, calcium carbonate, Lutein, Lycopene, Manganese, menaquinone-4, Niacin, Pantothenic Acid, L-Phenylalanine, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Selenium, L-Taurine, Thiamin, L-Valine, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Animal Pak Ultimate Foundation Powder Fruit Punch -- 14.7 ozAnimalActive Lifestyle & FitnessLipase, Vitamin C, Betaine Anhydrous, Biotin, dicalcium phosphate, Choline, Chromium, Coenzyme Q10, Vitamin E, Folate, Vitamin E, L-Glutamine, L-Histidine, Inositol, Iodine, L-Isoleucine, calcium carbonate, Lutein, Lycopene, Manganese, menaquinone-4, Niacin, Pantothenic Acid, L-Phenylalanine, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Selenium, L-Taurine, Thiamin, L-Valine, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Animal Pak Ultimate Foundation Powder Orange Crushed -- 14.5 ozAnimalActive Lifestyle & FitnessLipase, Vitamin C, Betaine Anhydrous, Biotin, dicalcium phosphate, Choline, Chromium, Coenzyme Q10, Vitamin E, Folate, Vitamin E, L-Glutamine, L-Histidine, Inositol, Iodine, L-Isoleucine, calcium carbonate, Lutein, Lycopene, Manganese, menaquinone-4, Niacin, Pantothenic Acid, L-Phenylalanine, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Selenium, L-Taurine, Thiamin, L-Valine, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Animal Power Balance -- 30 PacksAnimalActive Lifestyle & FitnessDiindolylmethane, Biotin, Chromium, Folate, phytonadione, Vitamin K2024-11-29 10:47:42
Arrowhead Mills Gluten Free Organic Chickpeas -- 16 ozArrowhead MillsFood & BeveragesFolate, Niacin, Phosphorus, Riboflavin, Thiamin2024-11-29 10:47:42
Arrowhead Mills Organic Red Lentils Gluten Free -- 16 ozArrowhead MillsFood & BeveragesFolate, Niacin, Thiamin2024-11-29 10:47:42
Arrowhead Mills Organic Whole Wheat Flour -- 22 ozArrowhead MillsFood & BeveragesVitamin C, Folate, Niacin, Vitamin A, Riboflavin, Thiamin2024-11-29 10:47:42
Arthur Andrew Medical Inc. Femesse Breast and Balance -- 240 CapsulesArthur Andrew Medical Inc.Professional SupplementsVitamin E, Folate, Vitamin E, Vitamin B6, Selenium, Vitamin B62024-11-29 10:47:42
Atkins Iced Coffee Protein Shake Vanilla Latte -- 11 fl oz Each / Pack of 4AtkinsWeight ManagementVitamin C, Biotin, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Molybdenum, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Atkins Peanut Butter Granola Bar Meal Peanut Butter -- 5 BarsAtkinsWeight ManagementVitamin C, Biotin, Chromium, Vitamin E, Folate, Vitamin E, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Atkins Protein Meal Bar Chocolate Chip Cookie Dough -- 5 BarsAtkinsWeight ManagementVitamin C, Biotin, Vitamin E, Folate, Vitamin E, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Atkins Protein Plus RTD Creamy Milk Chocolate -- 4 BottlesAtkinsWeight ManagementVitamin C, Biotin, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Manganese, Molybdenum, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Atkins Protein Plus RTD Creamy Vanilla -- 4 BottlesAtkinsWeight ManagementVitamin C, Biotin, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Manganese, Molybdenum, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Atkins Protein Rich Shake Cafe Caramel -- 4 ShakesAtkinsWeight ManagementVitamin C, Biotin, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Manganese, Molybdenum, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Atkins Protein Rich Shake Creamy Caramel -- 4 Bottles Each / Pack of 4AtkinsWeight ManagementVitamin C, Biotin, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Manganese, Molybdenum, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Atkins Protein Shake Chai Tea Latte -- 11 fl oz Each / Pack of 4AtkinsWeight ManagementVitamin C, Biotin, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Molybdenum, Niacin, Pantothenic Acid, Vitamin B6, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Atkins Protein-Rich Shake Dark Chocolate Royale -- 8 ShakesAtkinsWeight ManagementVitamin C, Biotin, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Manganese, Molybdenum, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Atkins RTD Protein Shake Creamy Vanilla -- 8 ShakesAtkinsWeight ManagementVitamin C, Biotin, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Manganese, Molybdenum, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Atkins RTD Protein-Rich Meal Shake Creamy Chocolate -- 16.9 fl oz Each / Pack of 4AtkinsWeight ManagementVitamin C, Biotin, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Manganese, Molybdenum, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Atkins RTD Shake Creamy Root Beer Float -- 4 ShakesAtkinsWeight ManagementVitamin C, Biotin, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Manganese, Molybdenum, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Atkins RTD Shake Milk Chocolate Delight -- 8 ShakesAtkinsWeight ManagementVitamin C, Biotin, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Manganese, Molybdenum, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Atkins RTD Shake Mocha Latte -- 11 fl oz Each / Pack of 4AtkinsWeight ManagementVitamin C, Biotin, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Manganese, Molybdenum, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Atkins RTD Shake Pumpkin Spice Latte -- 11 fl oz Each / Pack of 4AtkinsActive Lifestyle & FitnessVitamin C, Biotin, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Manganese, Molybdenum, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Atkins RTD Shake Strawberry -- 11 fl oz Each / Pack of 4AtkinsWeight ManagementVitamin C, Biotin, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Manganese, Molybdenum, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Atkins Snack Bar Caramel Chocolate Nut Roll -- 5 BarsAtkinsWeight ManagementVitamin C, Biotin, Chromium, Vitamin E, Folate, Vitamin E, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Atkins Snack Bar Caramel Chocolate Peanut Nougat -- 5 BarsAtkinsWeight ManagementVitamin C, Biotin, Chromium, Vitamin E, Folate, Vitamin E, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamine, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Aussie Bubs Australian Grass Fed Nutritional Milk-Based Toddler Formula -- 28.2 ozAussie BubsBaby & Kids ProductsVitamin C, Vitamin E, Folate, Vitamin E, Iodine, Niacin, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Balanced Breed Cat L-Lysine Immune Support Supplement + Krill Oil Vet Pharmacist Approved Chicken -- 60 Soft ChewsBalanced BreedPet SuppliesFolic Acid, Vitamin B122024-11-29 10:47:42
Balanced Breed Dog All-in-1 Canine Multivitamin Vet Pharmacist Approved Peanut & Butter Banana -- 60 Soft ChewsBalanced BreedPet SuppliesVitamin C, Vitamin E, Folic Acid, Vitamin E, Vitamin B6, Vitamin B2, Taurine, Vitamin B1, Vitamin B12, Vitamin B62024-11-29 10:47:42
Balanced Greens Plant Protein Chocolate -- 34 ServingsBalanced GreensWeight ManagementVitamin C, Vitamin E, Folate, Vitamin E, Niacin, Vitamin B6, Vitamin A, Riboflavin, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Balanced Greens Plant Protein Unflavored -- 34 ServingsBalanced GreensWeight ManagementVitamin C, Vitamin E, Folate, Vitamin E, Niacin, Vitamin B6, Vitamin A, Riboflavin, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Balanced Greens Plant Protein Vanilla -- 34 ServingsBalanced GreensWeight ManagementVitamin C, Vitamin E, Folate, Vitamin E, Niacin, Vitamin B6, Vitamin A, Riboflavin, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Balanced Greens Total Health Superfood Blend with Probiotics Unflavored -- 60 ServingsBalanced GreensVitamins & SupplementsVitamin C, Folate, Niacin, Vitamin B, Vitamin A, Riboflavin, Thiamin, Vitamin B12, Vitamin K2024-11-29 10:47:42
Bark & Whiskers Organic Vitamin B Complex for Dogs & Cats -- 0.84 ozBark & WhiskersPet SuppliesBiotin, Folic Acid, Niacin, Pantothenic Acid, Pyridoxine, Riboflavin, Thiamine, Vitamin B122024-11-29 10:47:42
Beech-Nut Mini Waffles with Hidden Veggies 12+ Months Butternut Berry -- 3.2 ozBeech-NutBaby & Kids ProductsVitamin E, Folate, Vitamin E, Niacin, Thiamin2024-11-29 10:47:42
Beech-Nut Whole Grain Baby Cereal Oatmeal -- 6 PackBeech-NutBaby & Kids ProductsVitamin E, Folate, Vitamin E, Niacin, Vitamin B, Pantothenic Acid, Phosphorus, Riboflavin, Thiamin2024-11-29 10:47:42
Best Naturals B-100 Complex -- 120 TabletsBest NaturalsVitamins & SupplementsPABA, Biotin, Choline, Folate, Inositol, Niacin, PABA, Pantothenic Acid, Vitamin B6, Vitamin B2, Vitamin B1, Vitamin B12, Vitamin B62024-11-29 10:47:42
Best Naturals Folic Acid -- 1000 mcg - 240 TabletsBest NaturalsVitamins & SupplementsFolate2024-11-29 10:47:42
Best Naturals L-Methyl Folate -- 15000 mcg - 60 TabletsBest NaturalsVitamins & SupplementsFolate2024-11-29 10:47:42
Beverly International Super Pak -- 30 PacketsBeverly InternationalActive Lifestyle & FitnessPara-Aminobenzoic Acid, Vitamin C, Betaine HCl, Biotin, Chloride, Vitamin D3, Choline, Chromium, Vitamin E, Folate, Vitamin E, L-Glutamic Acid, Pepsin, Inositol, Iodine, Manganese, Niacin, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, Rutin, Selenium, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Bio Nutrition Urilow -- 60 Vegetarian CapsulesBio NutritionVitamins & SupplementsVitamin C, Folate, Vitamin B6, Vitamin B1, Vitamin B12, Vitamin B62024-11-29 10:47:42
Bio360 Probiotics Cognitive Support Formula -- 30 Vegetarian CapsulesBio360Vitamins & SupplementsFolate, Pantothenic Acid, Vitamin B6, Vitamin B12, Vitamin B62024-11-29 10:47:42
Biocare Dietary GLP-1 Beverage - Pack of 14 Chocolate -- 14 PacketsBiocareProfessional SupplementsVitamin C, Biotin, L-Carnosine, Choline, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Leucine, Manganese, Vitamin K2, Vitamin K2, Molybdenum, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Biocare Dietary GLP-1 Beverage - Pack of 14 Chocolate Salted Caramel -- 14 PacketsBiocareProfessional SupplementsVitamin C, Biotin, L-Carnosine, Choline, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Leucine, Manganese, Vitamin K2, Vitamin K2, Molybdenum, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Biocare Dietary GLP-1 Beverage - Pack of 14 Mixed Fruit -- 14 PacketsBiocareProfessional SupplementsVitamin C, Biotin, L-Carnosine, Choline, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Leucine, Manganese, Vitamin K2, Vitamin K2, Molybdenum, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Biocare Dietary GLP-1 Beverage - Pack of 14 Strawberries & Cream -- 14 PacketsBiocareProfessional SupplementsVitamin C, Biotin, L-Carnosine, Choline, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Leucine, Manganese, Vitamin K2, Vitamin K2, Molybdenum, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
BioSchwartz Advanced B-Complex -- 60 Veggie CapsBioSchwartzVitamins & Supplements ascorbyl palmitate, Vitamin C, Biotin, calcium ascorbate, Choline, Folate, Inositol, Niacin, Pantothenic Acid, pyridoxal-5-phosphate, pyridoxine HCl, Vitamin B6, Riboflavin, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Bluebonnet Nutrition B-Complex 100 -- 100 Vegetable CapsulesBluebonnet NutritionVitamins & SupplementsPABA, Biotin, Choline, Folate, Inositol, Vitamin B3, PABA, Pantothenic Acid, Vitamin B6, Vitamin B2, Vitamin B1, Vitamin B12, Vitamin B62024-11-29 10:47:42
Bluebonnet Nutrition B-Complex 50 -- 100 Vegetable CapsulesBluebonnet NutritionVitamins & SupplementsPABA, Biotin, Choline, Folate, Inositol, Vitamin B3, PABA, Pantothenic Acid, Vitamin B6, Vitamin B2, Vitamin B1, Vitamin B12, Vitamin B62024-11-29 10:47:42
Bluebonnet Nutrition EarthSweet® Chewables Vitamin B12 & Folic Acid Natural Raspberry -- 180 Chewable TabletsBluebonnet NutritionVitamins & SupplementsFolate, Vitamin B122024-11-29 10:47:42
Bluebonnet Nutrition Liquid Vitamin B12 & Folic Acid Natural Raspberry -- 2 fl ozBluebonnet NutritionVitamins & SupplementsFolate, Vitamin B122024-11-29 10:47:42
Bluebonnet Nutrition Maxi ONE® Whole Food-Based Multiple -- 90 Vegetable CapsulesBluebonnet NutritionVitamins & SupplementsVitamin C, Biotin, Boron, Vitamin D3, Choline, Chromium, Vitamin E, riboflavin 5' phosphate, Folate, Vitamin E, Iodine, Manganese, Molybdenum, Vitamin B3, Pantothenic Acid, pyridoxine 5' phosphate, pyridoxine HCl, Vitamin B6, Vitamin A, Vitamin B2, Selenium, citrate, citrate, Vitamin B1, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Bluebonnet Nutrition Multi One Single Daily Multiple -- 120 Vegetable CapsulesBluebonnet NutritionVitamins & SupplementsPABA, Vitamin C, Biotin, Vitamin D3, Choline, Chromium, Vitamin E, Folate, Vitamin E, Inositol, Iodine, Lutein, Manganese, Molybdenum, Vitamin B3, PABA, Pantothenic Acid, Vitamin B6, Vitamin A, Vitamin B2, Selenium, Vitamin B1, Vitamin B12, Vitamin B62024-11-29 10:47:42
C2O Gluten Free Pure Coconut Water with Pulp -- 17.5 fl ozC2OFood & BeveragesVitamin C, Folic Acid, Manganese, Niacin, Phosphorus, Vitamin A2024-11-29 10:47:42
California Natural B Complex Raspberry -- 1 fl ozCalifornia NaturalVitamins & SupplementsBiotin, Folic Acid, Niacin, Pantothenic Acid, Vitamin B6, Vitamin B2, Vitamin B1, Vitamin B12, Vitamin B62024-11-29 10:47:42
Carlson B-50 Gel Vitamin B Complex -- 100 SoftgelsCarlsonVitamins & SupplementsBiotin, Folate, Niacin, Pantothenic Acid, Vitamin B6, Riboflavin, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
CeliAct Optimizing Nutrition for People with Celiac Disease -- 180 TabletsCeliActVitamins & Supplements Lipase, Para Aminobenzoic Acid, Vitamin C, Biotin, Boron, Chromium, Vitamin E, Folic Acid, Vitamin E, L-Glutamic Acid, Inositol, Manganese, Molybdenum, Niacin, Pantothenic Acid, Vitamin B6, Vitamin A, Vitamin B2, Selenium, Vitamin B1, Vanadium, Vitamin B12, Vitamin B6, Vitamin K12024-11-29 10:47:42
Cellucor C4 Sport - Pre-Workout - NSF Certified for Sport Hawaiian Punch Fruit Juicy Red -- 20 ServingsCellucorActive Lifestyle & FitnessCaffeine Anhydrous, Chloride, Folate, Phosphorus, Potassium Citrate, Vitamin B6, Taurine, Vitamin B12, Vitamin B62024-11-29 10:47:42
Cellucor C4 Sport - Pre-Workout - NSF Certified for Sport Icy Blue Razz -- 20 ServingsCellucorActive Lifestyle & FitnessCaffeine Anhydrous, Chloride, Folate, Phosphorus, Potassium Citrate, Vitamin B6, Taurine, Vitamin B12, Vitamin B62024-11-29 10:47:42
Cellucor C4 Sport - Pre-Workout - NSF Certified for Sport Watermelon -- 20 ServingsCellucorActive Lifestyle & FitnessCaffeine Anhydrous, Chloride, Folate, Phosphorus, Potassium Citrate, Vitamin B6, Taurine, Vitamin B12, Vitamin B62024-11-29 10:47:42
Cellucor C4 Sport Ripped - Pre-Workout - NSF Certified for Sport Artic Snow Cone -- 20 ServingsCellucorActive Lifestyle & FitnessCaffeine Anhydrous, Chloride, Folate, Phosphorus, Vitamin B6, Taurine, Vitamin B12, Vitamin B62024-11-29 10:47:42
Cento All Purpose Crushed Tomatoes -- 28 ozCentoFood & BeveragesVitamin C, Folate, Vitamin A2024-11-29 10:47:42
Centrum Adult Multivitamin and Multimineral Supplement -- 60 TabletsCentrumVitamins & SupplementsVitamin C, Biotin, Chloride, Vitamin D3, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Manganese, Molybdenum, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Centrum Men Multi-Vitamin Tablets -- 200 TabletsCentrumVitamins & SupplementsVitamin C, Biotin, Chloride, Vitamin D3, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Lycopene, Manganese, Molybdenum, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Centrum MultiGummies Men 50 Plus Multivitamin Supplement Assorted Natural Fruit -- 140 GummiesCentrumVitamins & SupplementsVitamin C, Biotin, Vitamin D3, Vitamin E, Folate, Vitamin E, Iodine, Pantothenic Acid, Vitamin B6, Vitamin A, Vitamin B12, Vitamin B62024-11-29 10:47:42
Centrum MultiGummies Men 50 Plus Multivitamin Supplement Assorted Natural Fruit -- 80 GummiesCentrumVitamins & SupplementsVitamin C, Biotin, Vitamin D3, Vitamin E, Folate, Vitamin E, Iodine, Pantothenic Acid, Vitamin B6, Vitamin A, Vitamin B12, Vitamin B62024-11-29 10:47:42
Centrum MultiGummies Women 50 Plus Multivitamin Supplement Assorted Fruit -- 140 GummiesCentrumVitamins & SupplementsVitamin C, Biotin, Vitamin D3, Vitamin E, Folate, Vitamin E, Iodine, Pantothenic Acid, Vitamin B6, Vitamin A, Vitamin B12, Vitamin B62024-11-29 10:47:42
Centrum MultiGummies Women 50 Plus Multivitamin Supplement Assorted Fruit -- 80 GummiesCentrumVitamins & SupplementsVitamin C, Biotin, Vitamin D3, Vitamin E, Folate, Vitamin E, Iodine, Pantothenic Acid, Vitamin B6, Vitamin A, Vitamin B12, Vitamin B62024-11-29 10:47:42
Centrum Multivitamin for Men Multivitamin/Multimineral Supplement -- 120 TabletsCentrumVitamins & SupplementsVitamin C, Biotin, Chloride, Vitamin D3, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Lycopene, Manganese, Molybdenum, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Centrum Multivitamin for Men Multivitamin/Multimineral Supplement -- 65 TabletsCentrumVitamins & SupplementsVitamin C, Biotin, Chloride, Vitamin D3, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Lycopene, Manganese, Molybdenum, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Centrum Silver Adults 50 Plus Multivitamin Tablets -- 220 TabletsCentrumVitamins & SupplementsVitamin C, Biotin, Chloride, Vitamin D3, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Lutein, Lycopene, Manganese, Molybdenum, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Centrum Silver Men 50 Plus Multivitamin-Multimineral Tablets -- 200 TabletsCentrumVitamins & SupplementsVitamin C, Biotin, Chloride, Vitamin D3, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Lutein, Lycopene, Manganese, Molybdenum, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Centrum Silver Women 50 Plus Multivitamin-Multimineral Tablets -- 100 TabletsCentrumVitamins & SupplementsVitamin C, Biotin, Chloride, Vitamin D3, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Lutein, Manganese, Molybdenum, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Centrum Women MultiVitamin -- 65 TabletsCentrumVitamins & SupplementsVitamin C, Biotin, Chloride, Vitamin D3, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Manganese, Molybdenum, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Centrum Women Multivitamin-Multimineral -- 200 TabletsCentrumVitamins & SupplementsVitamin C, Biotin, Chloride, Vitamin D3, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Manganese, Molybdenum, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Centrum Women Multivitamin-Multimineral Tablets -- 120 TabletsCentrumVitamins & SupplementsVitamin C, Biotin, Chloride, Vitamin D3, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Manganese, Molybdenum, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Cerebelly Organic Baby Food Dairy Free Smoothie Celery Apple Kiwi -- 6 PouchesCerebellyBaby & Kids ProductsVitamin C, Choline, Vitamin E, Folate, Vitamin E, Iodine, Manganese, Vitamin B6, Selenium, Vitamin B12, Vitamin B62024-11-29 10:47:42
Cerebelly Organic Baby Food Dairy Free Smoothie Purple Carrot Blueberry -- 6 PackCerebellyBaby & Kids ProductsVitamin C, Choline, Vitamin E, Folate, Vitamin E, Iodine, Manganese, Vitamin B6, Vitamin A, Selenium, Vitamin B12, Vitamin B62024-11-29 10:47:42
Cerebelly Organic Baby Food Dairy Free Smoothie Sweet Potato Peach -- 6 PouchesCerebellyBaby & Kids ProductsVitamin C, Choline, Vitamin E, Folate, Vitamin E, Iodine, Manganese, Niacin, Vitamin B6, Vitamin A, Selenium, Vitamin B12, Vitamin B62024-11-29 10:47:42
Cerebelly Organic Baby Food Purees Black Bean Sweet Potato with Avocado Oil -- 6 PouchesCerebellyBaby & Kids ProductsCholine, Vitamin E, Folate, Vitamin E, Iodine, Niacin, Vitamin B6, Vitamin A, Selenium, Vitamin B12, Vitamin B62024-11-29 10:47:42
Cerebelly Organic Baby Food Purees Butternut Squash White Bean -- 6 PouchesCerebellyBaby & Kids ProductsCholine, Vitamin E, Folate, Vitamin E, Iodine, Niacin, Vitamin B6, Vitamin A, Selenium, Vitamin B12, Vitamin B62024-11-29 10:47:42
Cerebelly Organic Baby Food Purees Beet Carrot Blueberry -- 6 PouchesCerebellyBaby & Kids ProductsCholine, Vitamin E, Folate, Vitamin E, Iodine, Niacin, Vitamin B6, Vitamin A, Selenium, Vitamin B12, Vitamin B62024-11-29 10:47:42
Cerebelly Organic Baby Food Purees Broccoli Pear -- 6 PouchesCerebellyBaby & Kids ProductsVitamin C, Choline, Vitamin E, Folate, Vitamin E, Iodine, Manganese, Niacin, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Selenium, Vitamin B12, Vitamin B62024-11-29 10:47:42
Cerebelly Organic Baby Food Purees Butternut Squash Chicken Broth -- 6 PouchesCerebellyBaby & Kids ProductsCholine, Vitamin E, Folate, Vitamin E, Iodine, Niacin, Vitamin B6, Vitamin A, Selenium, Vitamin B12, Vitamin B62024-11-29 10:47:42
Cerebelly Organic Baby Food Purees Carrot Beef Broth -- 6 PouchesCerebellyBaby & Kids ProductsCholine, Vitamin E, Folate, Vitamin E, Iodine, Niacin, Vitamin B6, Vitamin A, Selenium, Vitamin B12, Vitamin B62024-11-29 10:47:42
Cerebelly Organic Baby Food Purees Carrot Chickpea with Ginger -- 6 PouchesCerebellyBaby & Kids ProductsCholine, Folate, Iodine, Niacin, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Cerebelly Organic Baby Food Purees Carrot Pumpkin -- 6 PouchesCerebellyBaby & Kids ProductsCholine, Vitamin E, Folate, Vitamin E, Iodine, Niacin, Vitamin B6, Vitamin A, Selenium, Vitamin B12, Vitamin B62024-11-29 10:47:42
Cerebelly Organic Baby Food Purees Green Bean Pumpkin -- 6 PouchesCerebellyBaby & Kids ProductsCholine, Vitamin E, Folate, Vitamin E, Iodine, Niacin, Vitamin B6, Vitamin A, Selenium, Vitamin B12, Vitamin B62024-11-29 10:47:42
Cerebelly Organic Baby Food Purees Kale Sweet Potato Apple -- 6 PouchesCerebellyBaby & Kids ProductsCholine, Vitamin E, Folate, Vitamin E, Iodine, Niacin, Vitamin B6, Vitamin A, Selenium, Vitamin B12, Vitamin B62024-11-29 10:47:42
Cerebelly Organic Baby Food Purees Spinach Apple Sweet Potato -- 6 PouchesCerebellyBaby & Kids ProductsVitamin C, Choline, Vitamin E, Folate, Vitamin E, Iodine, Manganese, Niacin, Vitamin B6, Vitamin A, Riboflavin, Selenium, Vitamin B12, Vitamin B62024-11-29 10:47:42
Cerebelly Organic Baby Food Purees Sweet Potato Mango -- 6 PouchesCerebellyBaby & Kids ProductsVitamin C, Choline, Vitamin E, Folate, Vitamin E, Iodine, Manganese, Niacin, Vitamin B6, Vitamin A, Riboflavin, Selenium, Vitamin B12, Vitamin B62024-11-29 10:47:42
Cerebelly Organic Baby Food Purees Sweet Potato Pinto Bean -- 6 PouchesCerebellyBaby & Kids ProductsCholine, Vitamin E, Folate, Vitamin E, Iodine, Niacin, Vitamin B6, Vitamin A, Selenium, Vitamin B12, Vitamin B62024-11-29 10:47:42
Cerebelly Organic Baby Food Purees White Bean Pumpkin Apple -- 6 PouchesCerebellyBaby & Kids ProductsVitamin C, Choline, Vitamin E, Folate, Vitamin E, Iodine, Manganese, Niacin, Vitamin B6, Vitamin A, Riboflavin, Selenium, Vitamin B12, Vitamin B62024-11-29 10:47:42
Cerebelly Organic Smart Toddler Snack Bars Strawberry Beet -- 5 BarsCerebellyBaby & Kids ProductsCholine, Vitamin E, Folate, Vitamin E, Iodine, Niacin, Vitamin B6, Vitamin A, Selenium, Vitamin B12, Vitamin B62024-11-29 10:47:42
Chapter One One Multi Gummies -- 60 GummiesChapter OneVitamins & SupplementsVitamin C, Biotin, Choline, Vitamin E, Folic Acid, Vitamin E, Inositol, Iodine, Pantothenic Acid, Vitamin B6, Vitamin A, Vitamin B12, Vitamin B62024-11-29 10:47:42
Chapter Six Prenatal -- 60 GummiesChapter SixVitamins & SupplementsVitamin C, Biotin, Vitamin D3, Vitamin E, Folate, Vitamin E, Iodine, Niacin, Vitamin B6, Vitamin A, Vitamin B12, Vitamin B62024-11-29 10:47:42
Chickapea Non-GMO Organic Elbows Pasta -- 8 ozChickapeaFood & BeveragesFolate, Niacin, Phosphorus, Vitamin B6, Riboflavin, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Chickapea Non-GMO Organic Lasagna Pasta -- 8 ozChickapeaFood & BeveragesFolate, Niacin, Phosphorus, Vitamin B6, Riboflavin, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Childlife Multi Vitamin and Mineral Natural Orange Mango -- 8 fl ozChildlifeVitamins & SupplementsVitamin C, Biotin, Vitamin D3, Chromium, Vitamin E, Folic Acid, Vitamin E, Inositol, Iodine, Manganese, Niacin, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Childlife Multi Vitamin SoftMelts Natural Orange -- 27 GummiesChildlifeVitamins & SupplementsVitamin C, Biotin, Vitamin D3, Vitamin E, Folate, Vitamin E, Niacin, Vitamin B6, Vitamin A, Riboflavin, Selenium, Vitamin B12, Vitamin B62024-11-29 10:47:42
Childlife MultiVitamin Gummy Gluten Free Sugar Free Strawberry Lemon -- 90 GummiesChildlifeVitamins & SupplementsVitamin C, Biotin, Boron, Vitamin D3, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Lutein, Niacin, Pantothenic Acid, Vitamin B6, Vitamin A, Selenium, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Clif Bar Builders Plant-Based Protein Bars Cookies and Cream -- 12 BarsClifActive Lifestyle & FitnessVitamin C, Biotin, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Manganese, Molybdenum, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Clif Bar Organic Kid ZBar Chocolate Chip -- 6 BarsClifFood & BeveragesVitamin C, Folate, Niacin, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Codeage Hair Vitamins - Biotin 10000 mcg Keratin Collagen Zinc Inositol Supplement -- 120 CapsulesCodeageProfessional SupplementsVitamin C, Biotin, Omega-3, Vitamin D3, Vitamin E, Folate, Vitamin E, Inositol, Iodine, Niacin, Pantothenic Acid, Vitamin B6, Vitamin A, Selenium, Vitamin B12, Vitamin B62024-11-29 10:47:42
Codeage Methylfolate B Complex 5-MTHF Methylcobalamin Methylated Vitamin B B2 B6 B12 -- 120 CapsulesCodeageProfessional SupplementsBetaine, Folate, Vitamin B6, Riboflavin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Codeage Raw Vitamin B-Complex-Essential B Vitamins-Probiotics- Enzymes-Fruits & Vegetables -- 60 Vegetable CapsulesCodeageProfessional SupplementsBiotin, Folate, Niacin, Pantothenic Acid, Vitamin B6, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Comforts Advantage Premium Milk-Based Infant Formula -- 34 ozComfortsBaby & Kids ProductsVitamin C, Biotin, Chloride, Choline, Vitamin E, Folic Acid, Vitamin E, Inositol, Iodine, Linoleic Acid, Manganese, Niacin, Fat, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamine, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Comforts Gentle Premium Milk Based Infant Formula -- 33.2 ozComfortsBaby & Kids ProductsVitamin C, Biotin, Chloride, Choline, Vitamin E, Folic Acid, Vitamin E, Inositol, Iodine, Linoleic Acid, Manganese, Niacin, Fat, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamine, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Comforts Infant Premium Milk Based Formula with Iron -- 34 ozComfortsBaby & Kids ProductsVitamin C, Biotin, Chloride, Choline, Vitamin E, Folic Acid, Vitamin E, Inositol, Iodine, Linoleic Acid, Manganese, Niacin, Fat, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamine, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Comforts Pediatric Shake Chocolate -- 6 ShakesComfortsBaby & Kids ProductsVitamin C, Biotin, Chloride, Choline, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Manganese, Molybdenum, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Comforts Pediatric Shake Strawberry -- 6 ShakesComfortsBaby & Kids ProductsVitamin C, Biotin, Chloride, Choline, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Manganese, Molybdenum, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Comforts Pediatric Shake Vanilla -- 16 ShakesComfortsBaby & Kids ProductsVitamin C, Biotin, Chloride, Choline, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Manganese, Molybdenum, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Comforts Pediatric Shake Vanilla -- 6 ShakesComfortsBaby & Kids ProductsVitamin C, Biotin, Chloride, Choline, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Manganese, Molybdenum, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Country Life Chewable Adult Multi -- 60 WafersCountry LifeVitamins & SupplementsPABA, Vitamin C, Biotin, calcium ascorbate, calcium citrate, Choline, Chromium, Vitamin E, riboflavin 5' phosphate, Folic Acid, Vitamin E, Inositol, Manganese, Niacin, niacinamide, PABA, Pantothenic Acid, pyridoxal 5' phosphate, pyridoxine hydrochloride, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Country Life Coenzyme B-Complex -- 120 Vegan CapsulesCountry LifeVitamins & SupplementsPABA, Biotin, d-calcium pantothenate, Choline, dibencozide, riboflavin 5' phosphate, Folate, Inositol, Niacin, PABA, pantethine, Pantothenic Acid, pyridoxal 5' phosphate, pyridoxine hydrochloride, Vitamin B6, Riboflavin, thiamine hydrochloride, Thiamin, alpha-Lipoic Acid, Vitamin B12, Vitamin B62024-11-29 10:47:42
Country Life Coenzyme B-Complex -- 60 Vegan CapsulesCountry LifeVitamins & SupplementsPABA, Biotin, Choline, dibencozide, riboflavin 5' phosphate, Folate, Inositol, Niacin, PABA, pantethine, Pantothenic Acid, pyridoxal 5' phosphate, pyridoxine hydrochloride, Vitamin B6, Riboflavin, thiamine hydrochloride, Thiamin, Alpha-Lipoic Acid, Vitamin B12, Vitamin B62024-11-29 10:47:42
Country Life Core Daily-1 for Men 50 + -- 60 TabletsCountry LifeVitamins & SupplementsLipase, Vitamin C, beta carotene, Betaine, Biotin, Calcium fructoborate, d-calcium pantothenate, Cellulase, Choline, Chromium, Vitamin E, riboflavin 5' phosphate, Folic Acid, Vitamin E, inositol hexanicotinate, Inositol, Lactose, Manganese, Molybdenum, Niacin, pantethine, Pantothenic Acid, Phosphorus, pyridoxal 5' phosphate, pyridoxine hydrochloride, Vitamin B6, Vitamin A, Riboflavin, Selenium, citrate, citrate, thiamine hydrochloride, Thiamin, cyanocobalamin, Vitamin B6, Vitamin K2024-11-29 10:47:42
Country Life Core Daily™ 1 for Women 50 Plus -- 60 TabletsCountry LifeVitamins & SupplementsLipase, Vitamin C, beta carotene, Betaine, Biotin, Calcium fructoborate, d-calcium pantothenate, Cellulase, Choline, Chromium, Vitamin E, riboflavin 5' phosphate, Folic Acid, Vitamin E, inositol hexanicotinate, Inositol, Lactose, Manganese, Molybdenum, Niacin, pantethine, Pantothenic Acid, Phosphorus, pyridoxal 5' phosphate, pyridoxine hydrochloride, Vitamin B6, Vitamin A, Riboflavin, Selenium, citrate, citrate, thiamine hydrochloride, Thiamin, cyanocobalamin, Vitamin B6, Vitamin K2024-11-29 10:47:42
Country Life Daily Total One™ Iron Free -- 60 Vegetarian CapsulesCountry LifeVitamins & Supplements ascorbyl palmitate, Vitamin C, beta carotene, Betaine, Biotin, Boron, calcium ascorbate, calcium citrate, d-calcium pantothenate, di-calcium phosphate, Chromium, Vitamin E, riboflavin 5' phosphate, Folate, Vitamin E, inositol hexanicotinate, Inositol, magnesium citrate, Manganese, Molybdenum, Niacin, niacinamide, pantethine, Pantothenic Acid, Phosphorus, pyridoxal 5' phosphate, pyridoxine hydrochloride, Vitamin B6, retinyl palmitate, Vitamin A, Riboflavin, Selenium, thiamine hydrochloride, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Country Life Folate -- 800 mcg - 250 TabletsCountry LifeVitamins & SupplementsFolate2024-11-29 10:47:42
Culturelle Kids Probiotic Plus Multivitamin Chewables Natural Fruit Punch -- 30 Chewable TabletsCulturelleVitamins & SupplementsVitamin C, Biotin, Vitamin E, Folate, Vitamin E, Iodine, Pantothenic Acid, Vitamin B6, Vitamin A, Vitamin B12, Vitamin B62024-11-29 10:47:42
Culturelle Kids Probiotics Multivitamin Plus Probiotic -- 60 GummiesCulturelleVitamins & SupplementsVitamin C, Biotin, Vitamin E, Folate, Vitamin E, Iodine, Lutein, Vitamin B6, Vitamin A, Vitamin B12, Vitamin B62024-11-29 10:47:42
Cymbiotika B12 + B6 Liposomal Delivery Wild Berry -- 30 ServingsCymbiotikaVitamins & SupplementsFolate, Vitamin B6, Vitamin B12, Vitamin B62024-11-29 10:47:42
DaVinci Laboratories 5-MTHF -- 1 mg - 60 CapsulesDaVinci LaboratoriesProfessional SupplementsFolate2024-11-29 10:47:42
DaVinci Laboratories Active Folate B12 Chewable -- 60 Chewable WaferDaVinci LaboratoriesProfessional SupplementsFolate, Vitamin B122024-11-29 10:47:42
DaVinci Laboratories B Complex-75 -- 60 CapsulesDaVinci LaboratoriesProfessional SupplementsPABA, Biotin, Choline, Folic Acid, Inositol, Niacinamide, PABA, Pantothenic Acid, Vitamin B6, Riboflavin, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
DaVinci Laboratories B-12 MC Liquid -- 1000 mcg - 1 fl ozDaVinci LaboratoriesProfessional SupplementsFolate, Vitamin B6, Vitamin B12, Vitamin B62024-11-29 10:47:42
DaVinci Laboratories Benefits Line™ Adrenal Benefits™ -- 120 CapsulesDaVinci LaboratoriesProfessional SupplementsFolate, Pantothenic Acid, Vitamin B6, Vitamin B12, Vitamin B62024-11-29 10:47:42
DaVinci Laboratories Chewable B12-MC -- 100 TabletsDaVinci LaboratoriesProfessional SupplementsFolic Acid, Vitamin B122024-11-29 10:47:42
DaVinci Laboratories Daily Best™ Ultra Multivitamin -- 60 CapsulesDaVinci LaboratoriesProfessional SupplementsVitamin C, Biotin, Boron, Vitamin D3, Choline, Chromium, Coenzyme Q10, Vitamin E, Folate, Vitamin E, Inositol, Iodine, Lutein, Lycopene, Manganese, Vitamin K2, Vitamin K2, Molybdenum, Niacin, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Alpha-Lipoic Acid, Vitamin B12, Vitamin B6, Zeaxanthin2024-11-29 10:47:42
DaVinci Laboratories Hair Skin and Nails -- 60 CapsulesDaVinci LaboratoriesProfessional SupplementsVitamin C, Biotin, Vitamin D3, Methylsulfonylmethane, Folate, Iodine, Niacin, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B62024-11-29 10:47:42
DaVinci Laboratories Iron Bis-Glycinate -- 60 CapsulesDaVinci LaboratoriesProfessional SupplementsVitamin C, Folate, Vitamin B122024-11-29 10:47:42
DaVinci Laboratories Prostate Health -- 60 CapsulesDaVinci LaboratoriesProfessional SupplementsVitamin C, R-Alpha-Lipoic Acid, Vitamin E, Folate, Vitamin E, Lycopene, Vitamin B6, Resveratrol, Vitamin B62024-11-29 10:47:42
DaVinci Laboratories Spectra Man Multi -- 120 TabletsDaVinci LaboratoriesProfessional Supplements Lipase, Octacosanol, PABA, Vitamin C, L-Aspartic Acid, Betaine HCl, Biotin, Boron, Vitamin D3, Choline, Chromium, L-Cysteine, Vitamin E, Folic Acid, Gamma Linolenic Acid, Vitamin E, L-Glutamine, Hesperidin, Inositol, Iodine, Lycopene, Manganese, Molybdenum, Niacin, PABA, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, Rutin, Selenium, Silicon, Thiamin, Alpha-Lipoic Acid, Vanadium, Vitamin B12, Vitamin B6, Vitamin K12024-11-29 10:47:42
DaVinci Laboratories Spectra™ Multivitamins for Adults -- 240 TabletsDaVinci LaboratoriesProfessional Supplements Lipase, Octacosanol, PABA, Vitamin C, L-Aspartic Acid, Betaine HCl, Biotin, Boron, Vitamin D3, Choline, Chromium, L-Cysteine, Vitamin E, Folic Acid, Vitamin E, L-Glutamine, Hesperidin, Inositol, Iodine, Linoleic Acid, Manganese, Molybdenum, Niacin, Nickel, PABA, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, Rutin, Selenium, Silicon, Thiamin, Vanadium, Vitamin B12, Vitamin B6, Vitamin K12024-11-29 10:47:42
DaVinci Laboratories Spectra™ Senior Multi -- 180 TabletsDaVinci LaboratoriesProfessional Supplements lipase, Octacosanol, PABA, Vitamin C, L-Aspartic Acid, Betaine HCl, Biotin, Boron, Vitamin D3, Choline, Chromium, Coenzyme Q10, L-Cysteine, Vitamin E, Folic Acid, Gamma Linolenic Acid, Vitamin E, Glutamic Acid, Hesperidin, Inositol, Iodine, Lutein, Lycopene, Manganese, Molybdenum, Niacin, PABA, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, Rutin, Selenium, Silicon, Thiamin, Alpha-Lipoic Acid, Vanadium, Vitamin B12, Vitamin B6, Vitamin K12024-11-29 10:47:42
DaVinci Laboratories Spectra™ Woman -- 120 TabletsDaVinci LaboratoriesProfessional Supplements lipase, Octacosanol, PABA, Vitamin C, L-Aspartic Acid, Biotin, Boron, Vitamin D3, Choline, Chromium, L-Cysteine, Vitamin E, Folic Acid, Gamma Linolenic Acid, Vitamin E, L-Glutamine, Hesperidin, Inositol, Iodine, Manganese, Molybdenum, Niacin, Nickel, PABA, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, Rutin, Selenium, Silicon, Thiamin, Vanadium, Vitamin B12, Vitamin B6, Vitamin K12024-11-29 10:47:42
DaVinci Laboratories Ultimate Prenatal Multi -- 150 TabletsDaVinci LaboratoriesProfessional Supplements lipase, Octacosanol, PABA, Vitamin C, L-Aspartic Acid, Betaine HCl, Biotin, Boron, Vitamin D3, Choline, Chromium, L-Cysteine, Vitamin E, Folic Acid, Vitamin E, L-Glutamine, Hesperidin, Inositol, Iodine, Linoleic Acid, Manganese, Molybdenum, Niacin, PABA, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, Rutin, Selenium, Silicon, Thiamin, Vitamin B12, Vitamin B6, Vitamin K12024-11-29 10:47:42
De Cecco 12 Spaghetti -- 1 lbDe CeccoFood & BeveragesVitamin C, Folic Acid, Niacin, Vitamin A, Riboflavin, Thiamin2024-11-29 10:47:42
De Cecco Linguine No 7 -- 16 ozDe CeccoFood & BeveragesFolate, Niacin, Riboflavin, Thiamin2024-11-29 10:47:42
Delallo Organic Pasta Capellini No 1 Whole Wheat -- 1 lbDelalloFood & BeveragesVitamin C, Folic Acid, Niacin, Vitamin A, Riboflavin, Thiamin2024-11-29 10:47:42
Delallo Organic Spaghetti Pasta Whole Wheat No 4 -- 1 lbDelalloFood & BeveragesVitamin C, Folic Acid, Niacin, Vitamin A, Riboflavin, Thiamin2024-11-29 10:47:42
Designer Wellness Designer Whey - Meal Replacement Protein Powder Milk Chocolate -- 1.72 lbsDesigner WellnessWeight ManagementVitamin C, Biotin, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Manganese, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Designer Wellness Designer Whey - Meal Replacement Protein Powder Vanilla Bean -- 1.72 lbsDesigner WellnessWeight ManagementVitamin C, Biotin, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Manganese, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Designs for Sport Multi + Phyto - NSF Certified for Sport -- 120 Vegetarian CapsulesDesigns for SportProfessional SupplementsVitamin C, Benfotiamine, Biotin, Boron, Chromium, Folate, Lycopene, Manganese, MK-7, MK-9, Molybdenum, Niacin, Pantothenic Acid, Vitamin B6, Quercetin, Trans-Resveratrol, Vitamin A, Riboflavin, Selenium, Thiamin, Vanadium, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Designs for Sport Power Pack - NSF Certified for Sport -- 30 PacketsDesigns for SportProfessional SupplementsVitamin C, Benfotiamine, Biotin, Boron, Chromium, Folate, Lycopene, Manganese, MK-7, MK-9, Molybdenum, Niacin, Pantothenic Acid, Vitamin B6, Quercetin, Trans-Resveratrol, Vitamin A, Riboflavin, Selenium, Thiamin, Vanadium, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Deva Vegan B12 Fast Dissolve -- 90 TabletsDevaVitamins & SupplementsFolate, Vitamin B122024-11-29 10:47:42
Deva Vegan Hair Nails and Skin -- 90 TabletsDevaVitamins & SupplementsPABA, Vitamin C, Biotin, Choline, L-cysteine, Vitamin E, Folate, Vitamin E, Inositol, Iodine, Vitamin B3, PABA, Vitamin B5, Vitamin B6, Vitamin B2, Beta Sitosterol, Vitamin B1, Alpha Lipoic Acid, Vitamin B12, Vitamin B6, Vitamin D22024-11-29 10:47:42
Deva Vegan Multivitamin & Mineral Supplement -- 90 Coated TabletsDevaVitamins & SupplementsVitamin C, Beta Carotene, Betaine HCL, Biotin, Boron, Choline, Chromium, Vitamin E, Folic Acid, Vitamin E, Inositol, Iodine, Calcium Carbonate, Lutein, Manganese, Molybdenum, Vitamin B3, Vitamin B5, Vitamin B6, Vitamin A, Vitamin B2, Rutin, Selenium, Vitamin B1, Vitamin B12, Vitamin B6, Vitamin D22024-11-29 10:47:42
Deva Vegan Multivitamin & Mineral Tiny Tablets -- 90 TabletsDevaVitamins & SupplementsVitamin C, Biotin, Boron, Choline, Chromium, Vitamin E, Folate, Vitamin E, Inositol, Iodine, Manganese, Molybdenum, Vitamin B3, Vitamin B5, Vitamin B6, Vitamin A, Vitamin B2, Selenium, Vitamin B1, Vitamin B12, Vitamin B6, Vitamin D22024-11-29 10:47:42
Deva Vegan Multivitamin and Mineral Supplement Iron Free -- 90 Coated TabletsDevaVitamins & SupplementsVitamin C, Beta Carotene, Biotin, Boron, Choline, Chromium, Vitamin E, Folic Acid, Vitamin E, Inositol, Iodine, Lutein, Manganese, Molybdenum, Vitamin B3, Vitamin B5, Vitamin B6, Vitamin A, Vitamin B2, Rutin, Selenium, Vitamin B1, Vitamin B12, Vitamin B6, Vitamin D22024-11-29 10:47:42
Deva Vegan Prenatal One Daily Multivitamin and Mineral -- 90 Coated TabletsDevaVitamins & SupplementsChamomile, Vitamin C, Biotin, Boron, Choline, Chromium, Vitamin E, Folate, Vitamin E, Inositol, Iodine, Lutein, Manganese, Molybdenum, Vitamin B3, Vitamin B5, Vitamin B6, Vitamin A, Vitamin B2, Selenium, Vitamin B1, Vitamin B12, Vitamin B6, Vitamin D2, Vitamin K2024-11-29 10:47:42
Divine Health Brain Zone Basic -- 120 CapsulesDivine HealthVitamins & SupplementsTrimethylglycine, Trimethylglycine, Curcumin, Folate, Vitamin B6, Vitamin B2, Vitamin B12, Vitamin B62024-11-29 10:47:42
Douglas Laboratories B-Complex with Metafolin L-5-MTHF -- 60 Vegetarian CapsulesDouglas LaboratoriesProfessional SupplementsBiotin, Folate, Niacin, Pantothenic Acid, Vitamin B6, vitamin B2, Thiamin, vitamin B1, Vitamin B12, Vitamin B62024-11-29 10:47:42
Douglas Laboratories Methyl B12 Plus -- 90 LozengesDouglas LaboratoriesProfessional SupplementsL-methylfolate, Folate, Vitamin B122024-11-29 10:47:42
Douglas Laboratories Ultra Preventive® Kids Natural Grape -- 60 TabletsDouglas LaboratoriesProfessional SupplementsVitamin C, Biotin, Boron, Vitamin D3, Choline, Vitamin E, Folic Acid, Vitamin E, Iodine, Lutein, Manganese, Molybdenum, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamine, beta, Vanadium, Vitamin B12, Vitamin B62024-11-29 10:47:42
Douglas Laboratories Ultra Preventive® Kids Natural Orange -- 60 TabletsDouglas LaboratoriesProfessional SupplementsVitamin C, Biotin, Boron, Vitamin D3, Choline, Vitamin E, Folic Acid, Vitamin E, Iodine, Manganese, Molybdenum, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamine, beta, Vanadium, Vitamin B12, Vitamin B62024-11-29 10:47:42
Dr. Mercola Kids Chewable Multivitamin Fruit -- 60 TabletsDr. MercolaProfessional SupplementsVitamin C, Biotin, Boron, Calcium Ascorbate, Calcium Citrate, Vitamin D3, Chromium, Folate, Iodine, Manganese, Molybdenum, Niacin, Niacinamide, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vanadium, Vitamin B12, Vitamin B62024-11-29 10:47:42
Dr. Mercola Vitamin B Complex with Benfotiamine -- 180 CapsulesDr. MercolaProfessional SupplementsBenfotiamine, Biotin, Folate, Niacin, Pantothenic Acid, Vitamin B6, Riboflavin, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Dr. Mercola Vitamin B Complex with Benfotiamine -- 60 CapsulesDr. MercolaProfessional SupplementsBenfotiamine, Biotin, Folate, Niacin, Pantothenic Acid, Vitamin B6, Riboflavin, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Dr. Mercola Whole Food Multivitamin Plus -- 240 TabletsDr. MercolaProfessional SupplementsPABA, Ascorbyl Palmitate, Vitamin C, Betaine, Biotin, Boron, Vitamin D3, Choline, Chromium, Folate, Glutamic Acid, Hesperidin, Inositol, Iodine, Manganese, Molybdenum, Niacin, Niacinamide, PABA, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, Rutin, Selenium, Strontium, Thiamin, Vanadium, Vitamin B12, Vitamin B62024-11-29 10:47:42
Dr. Mercola Whole-Food Multivitamin for Women -- 240 TabletsDr. MercolaProfessional SupplementsPABA, Ascorbyl Palmitate, Vitamin C, Betaine, Biotin, Boron, Vitamin D3, Choline, Chromium, Folate, Glutamic Acid, Hesperidin, Inositol, Iodine, Manganese, Molybdenum, Niacin, PABA, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, Rutin, Selenium, Strontium, Thiamin, Vanadium, Vitamin B12, Vitamin B62024-11-29 10:47:42
Dymatize Super Mass Gainer Gourmet Vanilla -- 6 lbsDymatizeActive Lifestyle & FitnessVitamin C, Vitamin E, Folate, Vitamin E, Iodine, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Dymatize Super Mass Gainer Rich Chocolate -- 6 lbsDymatizeActive Lifestyle & FitnessVitamin C, Vitamin E, Folate, Vitamin E, Iodine, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Eclectic Institute Lemon Greens Whole Food Powder -- 3.2 ozEclectic InstituteVitamins & SupplementsVitamin C, Folic Acid, Vitamin A2024-11-29 10:47:42
Eden Foods Organic Black Beans -- 29 ozEden FoodsFood & BeveragesFolate, Niacin, Phosphorus, Riboflavin, Thiamin2024-11-29 10:47:42
Eden Foods Organic Black Beans Dry -- 16 ozEden FoodsFood & BeveragesVitamin C, Folate, Manganese, Phosphorus, Pyridoxine Hydrochloride, Vitamin A, Riboflavin, Thiamin2024-11-29 10:47:42
Eden Foods Organic Black Eyed Peas -- 15 ozEden FoodsFood & BeveragesFolate, Phosphorus, Riboflavin, Thiamin2024-11-29 10:47:42
Eden Foods Organic Brown Rice Green Lentils -- 15 ozEden FoodsFood & BeveragesFolate, Niacin, Phosphorus, Riboflavin, Thiamin2024-11-29 10:47:42
Eden Foods Organic Cannellini White Kidney Beans -- 15 ozEden FoodsFood & BeveragesFolate, Phosphorus, Riboflavin, Thiamin2024-11-29 10:47:42
Eden Foods Organic Cannellini White Kidney Beans -- 29 ozEden FoodsFood & BeveragesFolate, Phosphorus, Riboflavin, Thiamin2024-11-29 10:47:42
Eden Foods Organic EdenSoy Extra Soy Milk Vanilla -- 32 fl ozEden FoodsFood & BeveragesBiotin, Omega-3, Vitamin E, Folate, Vitamin E, Iodine, Niacin, Pantothenic Acid, Phosphorus, Pyridoxine, Vitamin A, Riboflavin, Thiamin, Vitamin B122024-11-29 10:47:42
Eden Foods Organic EdenSoy Soymilk Dairy Free Unsweetened -- 32 fl ozEden FoodsFood & BeveragesBiotin, Folate, Niacin, Pantothenic Acid, Vitamin B6, Riboflavin, Thiamin, Vitamin B6, Vitamin K2024-11-29 10:47:42
Eden Foods Organic EdenSoy® Extra Soymilk Dairy Free Original -- 32 fl ozEden FoodsFood & BeveragesBiotin, Omega-3, Folate, Iodine, Niacin, Pantothenic Acid, Phosphorus, Pyridoxine, Vitamin A, Riboflavin, Thiamin, Vitamin B122024-11-29 10:47:42
Eden Foods Organic EdenSoy® Soymilk Dairy Free Carob -- 32 fl ozEden FoodsFood & BeveragesBiotin, Omega-3, Folate, Iodine, Niacin, Pantothenic Acid, Phosphorus, Pyridoxine, Riboflavin, Thiamin2024-11-29 10:47:42
Eden Foods Organic EdenSoy® Soymilk Dairy Free Original -- 32 fl ozEden FoodsFood & BeveragesBiotin, Omega-3, Folate, Iodine, Niacin, Pantothenic Acid, Phosphorus, Pyridoxine, Riboflavin, Thiamin2024-11-29 10:47:42
Eden Foods Organic Garbanzo Beans -- 15 ozEden FoodsFood & BeveragesFolate, Niacin, Phosphorus, Riboflavin, Thiamin2024-11-29 10:47:42
Eden Foods Organic Garbanzo Beans -- 29 ozEden FoodsFood & BeveragesFolate, Niacin, Phosphorus, Riboflavin, Thiamin2024-11-29 10:47:42
Eden Foods Organic Great Northern Beans -- 15 ozEden FoodsFood & BeveragesFolate, Phosphorus, Riboflavin, Thiamin2024-11-29 10:47:42
Eden Foods Organic Kidney Beans -- 15 ozEden FoodsFood & BeveragesFolate, Niacin, Phosphorus, Riboflavin, Thiamin2024-11-29 10:47:42
Eden Foods Organic Kidney Beans -- 29 ozEden FoodsFood & BeveragesFolate, Niacin, Phosphorus, Riboflavin, Thiamin2024-11-29 10:47:42
Eden Foods Organic Mexican Rice and Beans -- 15 ozEden FoodsFood & BeveragesFolate, Niacin, Phosphorus, Riboflavin, Thiamin2024-11-29 10:47:42
Eden Foods Organic Millet Whole Grain Gluten Free -- 16 ozEden FoodsFood & BeveragesFolate, Manganese, Niacin, Phosphorus, Riboflavin, Thiamin2024-11-29 10:47:42
Eden Foods Organic Navy Beans -- 29 ozEden FoodsFood & BeveragesFolate, Niacin, Phosphorus, Riboflavin, Thiamin2024-11-29 10:47:42
Eden Foods Organic Pasta Kamut Elbows -- 14 ozEden FoodsFood & BeveragesVitamin C, Folate, Niacin, Phosphorus, Vitamin A, Riboflavin, Thiamin2024-11-29 10:47:42
Eden Foods Organic Pasta Kamut Spirals -- 12 ozEden FoodsFood & BeveragesVitamin C, Folate, Niacin, Phosphorus, Vitamin A, Riboflavin, Thiamin2024-11-29 10:47:42
Eden Foods Organic Pinto Beans -- 16 ozEden FoodsFood & BeveragesFolate, Phosphorus, Pyridoxine Hydrochloride, Thiamin2024-11-29 10:47:42
Eden Foods Organic Pinto Beans -- 29 ozEden FoodsFood & BeveragesFolate, Niacin, Phosphorus, Riboflavin, Thiamin2024-11-29 10:47:42
Eden Foods Organic Pistachios Shelled and Dry Roasted -- 4 ozEden FoodsFood & BeveragesVitamin C, Folate, Niacin, Vitamin A, Riboflavin, Thiamin2024-11-29 10:47:42
Eden Foods Organic Small Red Beans -- 15 ozEden FoodsFood & BeveragesFolate, Phosphorus, Riboflavin, Thiamin2024-11-29 10:47:42
Else Kids Complete Nutrition Shake RTD Plant Powered 2+ Years Chocolate -- 4 PackElseBaby & Kids ProductsVitamin C, Biotin, Chloride, Choline, Vitamin E, Folate, Vitamin E, Inositol, Iodine, Manganese, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamine, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Else Kids Nutritional Shake Plant Protein Powder 2+ Year Vanilla -- 16 ozElseBaby & Kids ProductsVitamin C, Biotin, Choline, Vitamin E, Folate, Vitamin E, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Thiamine, Vitamin B12, Vitamin B62024-11-29 10:47:42
Else Kids Nutritional Shake Plant Protein Powder 2+ Years Chocolate -- 16 ozElseBaby & Kids ProductsVitamin C, Biotin, Choline, Vitamin E, Folate, Vitamin E, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Thiamine, Vitamin B12, Vitamin B62024-11-29 10:47:42
Else Organic Plant-Powered Super Cereal 6+ Months Banana -- 7 ozElseBaby & Kids ProductsVitamin C, Biotin, Choline, Vitamin E, Folate, Vitamin E, Iodine, Manganese, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Thiamine, Vitamin B12, Vitamin B62024-11-29 10:47:42
Else Organic Plant-Powered Super Cereal Baby 6+ Months Mango -- 7 ozElseBaby & Kids ProductsVitamin C, Biotin, Choline, Vitamin E, Folate, Vitamin E, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Thiamine, Vitamin B12, Vitamin B62024-11-29 10:47:42
Else Organic Plant-Powered Super Cereal Baby 6+ Months Original -- 7 ozElseBaby & Kids ProductsVitamin C, Biotin, Choline, Vitamin E, Folate, Vitamin E, Manganese, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Thiamine, Vitamin B12, Vitamin B62024-11-29 10:47:42
Else Organic Plant-Powered Super Cereal Baby 6+ Months Vanilla -- 7 ozElseBaby & Kids ProductsVitamin C, Biotin, Choline, Vitamin E, Folate, Vitamin E, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Thiamine, Vitamin B12, Vitamin B62024-11-29 10:47:42
Else Toddler Omega 3&6 Complete Nutrition Formula Plant-Based 12+ Months -- 22 ozElseBaby & Kids ProductsVitamin C, Biotin, Chloride, Choline, Vitamin E, Folate, Vitamin E, Iodine, Manganese, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Thiamine, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Else Toddler Organic Complete Nutrition Formula Plant-Based 12+ Months -- 22 ozElseBaby & Kids ProductsVitamin C, Biotin, Choline, Vitamin E, Folate, Vitamin E, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Thiamine, Vitamin B12, Vitamin B62024-11-29 10:47:42
Emerald Cove Organic Toasted Shushi Nori -- 50 SheetsEmerald CoveFood & BeveragesVitamin C, Biotin, Vitamin E, Folate, Vitamin E, Iodine, Manganese, Molybdenum, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Emergen-C Immune Plus Triple Action Immune Support Super Orange -- 30 PacketsEmergen-CVitamins & SupplementsVitamin C, calcium pantothenate, monobasic calcium phosphate, Vitamin D3, Chromium, tribasic calcium phosphate, Folate, calcium carbonate, magnesium carbonate, Manganese, Niacin, Pantothenic Acid, Phosphorus, potassium carbonate, Vitamin B6, Riboflavin, sodium bicarbonate, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Emergen-C Vitamin C Fizzy Drink Mix Pink Lemonade -- 1000 mg - 30 PacketsEmergen-CVitamins & SupplementsVitamin C, calcium pantothenate, monobasic calcium phosphate, Chromium, tribasic calcium phosphate, Folate, calcium carbonate, magnesium carbonate, Manganese, Niacin, Pantothenic Acid, Phosphorus, potassium bicarbonate, potassium carbonate, Riboflavin, sodium bicarbonate, Thiamin, Vitamin B122024-11-29 10:47:42
Ener-C Vitamin C Raspberry -- 1000 mg - 30 PacketsEner-CVitamins & SupplementsVitamin C, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Manganese, Vitamin B3, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Vitamin B12, Vitamin B62024-11-29 10:47:42
Ener-C Vitamin C Multivitamin Drink Mix Lemon Lime -- 1000 mg - 30 PacketsEner-CVitamins & SupplementsVitamin C, Chromium, Vitamin E, Folic Acid, Vitamin E, Iodine, Manganese, Vitamin B3, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Vitamin B12, Vitamin B62024-11-29 10:47:42
Ener-C Vitamin C Multivitamin Drink Mix Orange -- 1000 mg - 30 PacketsEner-CVitamins & SupplementsVitamin C, Beta Carotene, Chromium, Vitamin E, Folic Acid, Vitamin E, Iodine, Manganese, Vitamin B3, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Vitamin B12, Vitamin B62024-11-29 10:47:42
Ener-C Vitamin C Multivitamin Drink Mix Peach Mango -- 1000 mg - 30 PacketsEner-CVitamins & SupplementsVitamin C, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Vitamin B3, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Vitamin B12, Vitamin B62024-11-29 10:47:42
Ener-C Vitamin C Multivitamin Drink Mix Tangerine Grapefruit -- 1000 mg - 30 PacketsEner-CVitamins & SupplementsVitamin C, Chromium, Vitamin E, Folic Acid, Vitamin E, Iodine, Manganese, Vitamin B3, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Vitamin B12, Vitamin B62024-11-29 10:47:42
Ener-C Vitamin C Multivitamin Drink Mix Variety Pack -- 1000 mg - 30 PacketsEner-CVitamins & SupplementsVitamin C, Chromium, Vitamin E, Folic Acid, Vitamin E, Iodine, Manganese, Vitamin B3, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Vitamin B12, Vitamin B62024-11-29 10:47:42
Ener-C Vitamin C Multivitamin Drink Mix Sugar Free Mixed Berry -- 1000 mg - 30 PacketsEner-CVitamins & SupplementsVitamin C, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Manganese, Niacinamide, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin B12, Vitamin B62024-11-29 10:47:42
Ener-C Vitamin C Multivitamin Drink Mix Sugar Free Orange -- 1000 mg - 30 PacketsEner-CVitamins & SupplementsVitamin C, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Manganese, Niacinamide, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin B12, Vitamin B62024-11-29 10:47:42
Ensure Clear Nutrition Drink Mixed Fruit -- 4 PackEnsureWeight ManagementVitamin C, Biotin, Chromium, Vitamin E, Folic Acid, Vitamin E, Iodine, Manganese, Molybdenum, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Ensure Complete Nutrition Shake Milk Chocolate -- 4 ShakesEnsureWeight ManagementVitamin C, Biotin, Chloride, Choline, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Manganese, Molybdenum, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Ensure Complete Nutrition Shake Vanilla -- 4 ShakesEnsureWeight ManagementVitamin C, Biotin, Chloride, Choline, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Manganese, Molybdenum, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Ensure High Protein Nutrition Shake Milk Chocolate -- 8 fl oz Each / Pack of 6EnsureWeight ManagementVitamin C, Biotin, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Molybdenum, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Ensure High Protein Nutrition Shake Vanilla 8 fl oz -- 6 BottlesEnsureWeight ManagementVitamin C, Biotin, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Molybdenum, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Ensure Max Protein Nutrition Shake Cafe Mocha -- 11 fl ozEnsureWeight ManagementVitamin C, Biotin, Chloride, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Manganese, Molybdenum, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Ensure Max Protein Nutrition Shake French Vanilla -- 4 ShakesEnsureWeight ManagementVitamin C, Biotin, Chloride, Choline, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Manganese, Molybdenum, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Ensure Max Protein Nutrition Shake Milk Chocolate -- 11 fl ozEnsureWeight ManagementVitamin C, Biotin, Chloride, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Manganese, Molybdenum, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Ensure Original Nutrition Shake Strawberry -- 8 fl oz Each / Pack of 6EnsureWeight ManagementVitamin C, Biotin, Chloride, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Molybdenum, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Ensure Plus Nutrition Shake Strawberry -- 6 BottlesEnsureWeight ManagementVitamin C, Biotin, Chloride, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Molybdenum, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Ensure Plus Nutrition Shake Milk Chocolate -- 6 BottlesEnsureWeight ManagementVitamin C, Biotin, Chloride, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Molybdenum, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Ensure Plus Nutrition Shake Vanilla 8oz -- 6 BottlesEnsureWeight ManagementVitamin C, Biotin, Chloride, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Molybdenum, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Ensure Original Milk Chocolate Ready-to-Drink Nutrition Shakes -- Pack of 6EnsureWeight ManagementVitamin C, Biotin, Chloride, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Manganese, Molybdenum, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Ensure Original Vanilla Ready-to-Drink Nutrition Shakes -- Pack of 6EnsureWeight ManagementVitamin C, Biotin, Chloride, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Molybdenum, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Equazen VitaSpectrum Powder Unflavored -- 5.04 ozEquazenProfessional SupplementsVitamin C, Trimethylglycine, Trimethylglycine, Biotin, Boron, Vitamin D3, Choline, Chromium, Vitamin E, Folate, Vitamin E, Inositol, Iodine, Manganese, Vitamin K2, Vitamin K2, Molybdenum, Niacin, Pantothenic Acid, Vitamin B6, vitamin A acetate, Vitamin A, Riboflavin, Selenium, Thiamin, Vanadium, Vitamin B12, Vitamin B62024-11-29 10:47:42
Evlution Nutrition ENGN Focus Pre-Workout Engine Watermelon -- 9.52 oz - 30 ServingsEvlution NutritionActive Lifestyle & FitnessBeta-Alanine, Betaine Anhydrous, Caffeine Anhydrous, Chloride, Choline, Folate, Huperzine A, N-Acetyl L-Tyrosine, Vitamin B1, Vitamin B122024-11-29 10:47:42
Evlution Nutrition ENGN Pre-Workout Engine Furious Grape -- 30 ServingsEvlution NutritionActive Lifestyle & FitnessFolic Acid, Niacin, Vitamin B6, Vitamin B12, Vitamin B62024-11-29 10:47:42
Evlution Nutrition ENGN Pump Pre-Workout Engine Cherry Limeade -- 9.52 oz - 30 ServingsEvlution NutritionActive Lifestyle & FitnessBeta-Alanine, Betaine Anhydrous, Caffeine Anhydrous, Folate, Vitamin B6, Resveratrol, Vitamin B1, Vitamin B12, Vitamin B62024-11-29 10:47:42
Evlution Nutrition ENGN Shred Pre-Workout Pink Lemonade -- 30 ServingsEvlution NutritionActive Lifestyle & FitnessBeta-Alanine, Choline, Folic Acid, Niacin, Vitamin B6, Vitamin B12, Vitamin B62024-11-29 10:47:42
Evlution Nutrition ENGN Test Pre-Workout Testosterone Fruit Punch -- 10.05 oz - 30 ServingsEvlution NutritionActive Lifestyle & FitnessBeta-Alanine, Caffeine Anhydrous, Chloride, Folate, Vitamin B6, Vitamin B1, Vitamin B12, Vitamin B62024-11-29 10:47:42
Evlution Nutrition ENGN® Shred Pre-Workout Shred Engine Blue Raz -- 30 ServingsEvlution NutritionActive Lifestyle & FitnessFolic Acid, Niacin, Vitamin B6, Vitamin B12, Vitamin B62024-11-29 10:47:42
Evlution Nutrition TRANS4ORM Thermogenic Energizer -- 120 CapsulesEvlution NutritionActive Lifestyle & FitnessCholine, Folic Acid, Niacin, Vitamin B6, Vitamin B12, Vitamin B62024-11-29 10:47:42
Evlution Nutrition VitaMode -- 120 TabletsEvlution NutritionActive Lifestyle & Fitness Lipase, PABA, Vitamin C, Biotin, Boron, Choline, Chromium, Vitamin E, Folic Acid, Vitamin E, Inositol, Iodine, Lutein, Lycopene, Manganese, Molybdenum, Niacin, PABA, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Alpha-Lipoic Acid, Vanadium, Vitamin B12, Vitamin B6, Vitamin K, Zeaxanthin2024-11-29 10:47:42
Evlution Nutrition Z-Matrix -- 240 CapsulesEvlution NutritionActive Lifestyle & FitnessVitamin D3, Folic Acid, Vitamin B6, Vitamin B62024-11-29 10:47:42
Fearn Lecithin Granules -- 16 ozFearnVitamins & SupplementsLinolenic Acid, Choline, Vitamin E, Folic Acid, Vitamin E, Linoleic Acid, Niacin, Fat, Phosphorus, Riboflavin, Thiamine, Vitamin B122024-11-29 10:47:42
Fitcode Energycode - 30 Servings Watermelon -- 9.8 ozFitcodeActive Lifestyle & FitnessBeta-Alanine, Betaine Anhydrous, Caffeine Anhydrous, Choline, Folic Acid, N-Acetyl L-Tyrosine, Niacinamide, Vitamin B6, Vitamin B1, Vitamin B12, Vitamin B62024-11-29 10:47:42
Fitcode Fit Multi Complete Multivitamin Complex -- 90 TabletsFitcodeVitamins & SupplementsVitamin C, Biotin, Chloride, Choline, Vitamin E, Folate, Vitamin E, Inositol, Lutein, Lycopene, Manganese, Niacin, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B6, Zeaxanthin2024-11-29 10:47:42
Fitcode LeanPre - 30 Servings Blue Raz -- 8.5 ozFitcodeActive Lifestyle & FitnessBeta-Alanine, Betaine Anhydrous, Choline, Folic Acid, Niacin, Vitamin B6, Vitamin B1, Vitamin B12, Vitamin B62024-11-29 10:47:42
Flora Stressveda with KSM-66 Ashwagandha + Plant-Sourced B-Complex -- 30 Vegetarian CapsulesFloraHerbs, Botanicals & HomeopathyVitamin C, Biotin, Vitamin E, Folate, Vitamin E, Niacin, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, Thiamin, Vitamin B6, Vitamin K2024-11-29 10:47:42
Floradix Iron + Herbs - Iron and Vitamin Tablets Gluten-free Yeast-free Support Healthy Iron Levels -- 80 TabletsFloradixVitamins & SupplementsVitamin C, Folic Acid, Niacin, Vitamin B6, Riboflavin, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Floradix Iron + Herbs - Iron and Vitamin Tablets, Gluten-free Yeast-free Support Healthy Iron Levels -- 120 TabletsFloradixVitamins & SupplementsVitamin C, Folic Acid, Niacin, Vitamin B6, Riboflavin, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Food For Life Organic Ezekiel 4:9 Sprouted Crunchy Cereal Almond -- 16 ozFood For LifeFood & BeveragesVitamin C, Folic Acid, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Thiamin, Vitamin B62024-11-29 10:47:42
Food For Life Organic Ezekiel 4:9 Sprouted Crunchy Cereal Golden Flax -- 16 ozFood For LifeFood & BeveragesFolate, Manganese, Niacin, Phosphorus, Vitamin B6, Selenium, Thiamin, Vitamin B62024-11-29 10:47:42
Food For Life Organic Ezekiel 4:9 Sprouted Crunchy Cereal Original -- 16 ozFood For LifeFood & BeveragesFolate, Manganese, Niacin, Phosphorus, Vitamin B6, Selenium, Thiamin, Vitamin B62024-11-29 10:47:42
Foods Alive Organic Black Sesame Seeds Superfood -- 12 ozFoods AliveFood & BeveragesVitamin C, Vitamin E, Folate, Vitamin E, Manganese, Niacin, Phosphorus, Vitamin A, Riboflavin, Thiamin2024-11-29 10:47:42
Foods Alive Organic Sprouted Crisps Everything -- 4 ozFoods AliveFood & BeveragesVitamin C, Omega-3, Folate, Niacin, Riboflavin2024-11-29 10:47:42
Foods Alive Organic Sprouted Crisps Lemonly Lemon -- 4 ozFoods AliveFood & BeveragesVitamin C, Folate, Manganese, Phosphorus, Vitamin B6, Vitamin A, Selenium, Vitamin B62024-11-29 10:47:42
Foods Alive Organic Sprouted Crisps Original -- 4 ozFoods AliveFood & BeveragesVitamin C, Folate, Manganese, Phosphorus, Vitamin B6, Vitamin A, Selenium, Vitamin B62024-11-29 10:47:42
Foods Alive Organic Sprouted Crisps Rosemary -- 4 ozFoods AliveFood & BeveragesVitamin C, Folate, Manganese, Phosphorus, Vitamin B6, Vitamin A, Selenium, Vitamin B62024-11-29 10:47:42
Foods Alive Organic Sprouted Crisps Salsa Fresca -- 4 ozFoods AliveFood & BeveragesVitamin C, Omega-3, Folate, Niacin, Vitamin A, Riboflavin2024-11-29 10:47:42
Foods Alive Organic Sprouted Crisps Tomato & Herb -- 4 ozFoods AliveFood & BeveragesOmega-3, Folate, Niacin, Vitamin A, Riboflavin, Thiamin2024-11-29 10:47:42
Foods Alive Organic Superfoods Hemp Protein Powder Raw -- 8 ozFoods AliveActive Lifestyle & FitnessVitamin C, Folate, Manganese, Niacin, Phosphorus, Vitamin A, Thiamin2024-11-29 10:47:42
Foods Alive Organic Tart Cherries - Dried -- 10 ozFoods AliveFood & BeveragesVitamin C, Folate, Niacin, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Thiamin, Vitamin B6, Vitamin K2024-11-29 10:47:42
Force Factor ProbioSlim® Apple Cider Vinegar -- 60 GummiesForce FactorActive Lifestyle & FitnessVitamin B9, Vitamin B6, Vitamin B12, Vitamin B62024-11-29 10:47:42
Force Factor Test X180 Multivitamin Daily Testosterone Booster + Male Vitality Enhancer -- 120 TabletsForce FactorActive Lifestyle & FitnessVitamin C, Biotin, Choline, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Manganese, Molybdenum, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Frontier Co-Op Natural Products Nutritional Yeast Powder -- 16 ozFrontier Co-OpFood & BeveragesVitamin C, Biotin, Folate, Niacin, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, Thiamin, Vitamin B62024-11-29 10:47:42
Futurebiotics Chill Pill® -- 60 Vegetarian TabletsFuturebioticsVitamins & Supplementsdicalcium phosphate, Folic Acid, Niacin, Phosphorus, Vitamin B6, Riboflavin, Thiamin, Vitamin B62024-11-29 10:47:42
Futurebiotics EstroComfort™ -- 56 Vegetarian CapsulesFuturebioticsVitamins & SupplementsFolic Acid, Gamma Oryzanol, Gamma Oryzanol, Vitamin B6, Vitamin B12, Vitamin B62024-11-29 10:47:42
Futurebiotics Hair Skin & Nails -- 135 TabletsFuturebioticsVitamins & SupplementsVitamin C, Biotin, Vitamin D3, Choline, Vitamin E, Folate, Vitamin E, Iodine, Manganese, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Futurebiotics Hair Skin & Nails® for Men -- 135 TabletsFuturebioticsVitamins & Supplementspara-Aminobenzoic Acid, Vitamin C, Biotin, Vitamin D3, Choline, Vitamin E, Folate, Vitamin E, Inositol, Iodine, Manganese, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Futurebiotics Hair, Skin and Nails® -- 75 TabletsFuturebioticsVitamins & SupplementsPara Aminobenzoic Acid, Vitamin C, Betaine, Biotin, Vitamin E, Folic Acid, Vitamin E, Inositol, Iodine, Manganese, Methionine, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Rutin, Selenium, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Futurebiotics Hi-Energy Multi For Men™ -- 120 TabletsFuturebioticsVitamins & SupplementsPara Aminobenzoic Acid, Vitamin C, Biotin, Chloride, Chromium, Vitamin E, Folate, Vitamin E, Inositol, Iodine, Manganese, Molybdenum, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Futurebiotics Hi-Energy Multi For Men™ -- 60 TabletsFuturebioticsVitamins & SupplementsVitamin C, Biotin, Chloride, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Manganese, Molybdenum, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Futurebiotics M.V. Teen™ Multi-Vitamin and Mineral Formula for Teens -- 180 CapsulesFuturebioticsVitamins & SupplementsVitamin C, Biotin, Vitamin D3, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Manganese, Niacin, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Futurebiotics M.V. Teen™ Multivitamin -- 90 CapsulesFuturebioticsVitamins & SupplementsVitamin C, Biotin, Vitamin D3, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Manganese, Niacin, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Futurebiotics Multi Vitamin Energy Plus® For Women -- 60 TabletsFuturebioticsVitamins & SupplementsPara Aminobenzoic Acid, Vitamin C, Biotin, Choline, Chromium, Vitamin E, Folate, Vitamin E, Inositol, Iodine, Niacin, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Futurebiotics Organic Folic Acid -- 800 mcg - 120 Vegetarian TabletsFuturebioticsVitamins & SupplementsFolic Acid2024-11-29 10:47:42
Futurebiotics StressAssist™ -- 60 Vegetarian CapsulesFuturebioticsVitamins & SupplementsBiotin, Folic Acid, Niacin, Pantothenic Acid, Vitamin B6, Riboflavin, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Garden of Life Mykind Organics Kids Multi Gummies Organic Cherry -- 120 Vegan GummiesGarden of LifeVitamins & SupplementsVitamin C, Biotin, Chromium, Vitamin E, Folate, Vitamin E, Manganese, Niacin, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Garden of Life Raw Organic Meal Plant-Based Chocolate -- 38.03 ozGarden of LifeActive Lifestyle & FitnessVitamin C, Biotin, Chromium, Vitamin E, Folate, Vitamin E, Niacin, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Garden of Life Raw Organic Meal Plant-Based Vanilla -- 37.04 ozGarden of LifeActive Lifestyle & FitnessVitamin C, Biotin, Chromium, Vitamin E, Folate, Vitamin E, Niacin, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Garden of Life RAW Organic Protein & Greens Real Raw Vanilla -- 19.3 ozGarden of LifeActive Lifestyle & FitnessAlanine, Arginine, Vitamin C, Aspartic Acid, Biotin, Chromium, Cystine, Folate, Glutamic Acid, Glycine, Histidine, Manganese, Molybdenum, Phosphorus, Proline, Vitamin A, Selenium, Serine, Tyrosine, Vitamin K2024-11-29 10:47:42
Garden of Life RAW Probiotics Women 50 and Wiser -- 85 billion - 90 Vegetarian CapsulesGarden of LifeVitamins & SupplementsChromium, Folate, Iodine, Manganese, Molybdenum, Pantothenic Acid, Vitamin B6, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Garden of Life Vitamin Code RAW B-Complex -- 120 Vegan CapsulesGarden of LifeVitamins & SupplementsBiotin, Folate, Niacin, Pantothenic Acid, Vitamin B6, Riboflavin, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Garden of Life Vitamin Code RAW B-Complex -- 60 Vegan CapsulesGarden of LifeVitamins & SupplementsBiotin, Folate, Niacin, Pantothenic Acid, Vitamin B6, Riboflavin, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Garden of Life Vitamin Code Raw Iron -- 22 mg - 30 Vegan CapsulesGarden of LifeVitamins & SupplementsVitamin C, Folate, Vitamin B122024-11-29 10:47:42
Garden of Life Vitamin Code RAW One Multivitamin for Women -- 75 Vegetarian CapsulesGarden of LifeVitamins & SupplementsVitamin C, Biotin, Chromium, Vitamin E, Folate, Vitamin E, Manganese, Molybdenum, Niacin, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Garden of Life Vitamin Code® 50 & Wiser Women Whole Food Multivitamin -- 120 Vegetarian CapsulesGarden of LifeVitamins & SupplementsVitamin C, Biotin, Boron, Vitamin D3, Chromium, CoQ10, Vitamin E, Folate, Vitamin E, Iodine, Manganese, Vitamin K2, Vitamin K2, Molybdenum, Niacin, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vanadium, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Garden of Life Vitamin Code® 50 & Wiser Women Whole Food Multivitamin -- 240 Vegetarian CapsulesGarden of LifeVitamins & SupplementsVitamin C, Biotin, Boron, Vitamin D3, Chromium, CoQ10, Vitamin E, Folate, Vitamin E, Iodine, Manganese, Vitamin K2, Vitamin K2, Molybdenum, Niacin, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vanadium, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Garden of Life Vitamin Code® 50 and Wiser Men -- 240 Vegetarian CapsulesGarden of LifeVitamins & SupplementsVitamin C, Biotin, Boron, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Lycopene, Manganese, Vitamin K2, Vitamin K2, Molybdenum, Niacin, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vanadium, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Garden of Life Vitamin Code® RAW One™ Multivitamin for Men -- 75 Vegetarian CapsulesGarden of LifeVitamins & SupplementsVitamin C, Biotin, Chromium, Vitamin E, Folate, Vitamin E, Manganese, Molybdenum, Niacin, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
GEM Calm Essentials Bites Banana Cinnamon -- 28 BitesGEMVitamins & SupplementsVitamin E, Folate, Vitamin E, Vitamin B122024-11-29 10:47:42
Gerber Cereal for Baby Supported Sitter First Foods Oatmeal -- 16 ozGerberBaby & Kids ProductsVitamin C, Vitamin E, Folate, Vitamin E, Niacin, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Gerber Cereal for Baby Supported Sitter First Foods Rice -- 8 ozGerberBaby & Kids ProductsVitamin C, Vitamin E, Folate, Vitamin E, Niacin, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Gerber Grain & Grow Stage 3 Hearty Bits MultiGrain Non-GMO Cereal Banana Apple Strawberry -- 8 ozGerberBaby & Kids ProductsVitamin C, Vitamin E, Folate, Vitamin E, Niacin, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Glucerna Hunger Smart Shake Homemade Vanilla -- 6 BottlesGlucernaWeight ManagementVitamin C, Biotin, Chloride, Choline, Chromium, Vitamin E, Folate, Vitamin E, Glycerin, Iodine, Manganese, Molybdenum, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Glucerna Hunger Smart Shake Rich Chocolate -- 6 BottlesGlucernaWeight ManagementFolic Acid2024-11-29 10:47:42
Glucerna Nutritional Shake Creamy Strawberry -- 6 BottlesGlucernaWeight ManagementVitamin C, Biotin, Chloride, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Molybdenum, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Glucerna Nutritional Shake Homemade Vanilla -- 6 BottlesGlucernaWeight ManagementVitamin C, Biotin, Chloride, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Molybdenum, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Glucerna Protein Smart Shakes Chocolate -- 4 ShakesGlucernaWeight ManagementVitamin C, Biotin, Chloride, Choline, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Manganese, Molybdenum, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Glucerna Protein Smart Shakes Vanilla -- 4 ShakesGlucernaWeight ManagementVitamin C, Biotin, Chloride, Choline, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Manganese, Molybdenum, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Glucerna Shake Rich Chocolate -- 8 fl ozGlucernaWeight ManagementVitamin C, Biotin, Chloride, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Manganese, Molybdenum, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Gnarly Nutrition Hydrate - NSF Certified for Sport Orange Pineapple -- 14.1 ozGnarly NutritionActive Lifestyle & FitnessChloride, Folic Acid, Niacin, Vitamin B6, Riboflavin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Gnarly Nutrition Performance Greens - NSF Certified for Sport Blueberry Acai -- 12.8 ozGnarly NutritionVitamins & SupplementsVitamin C, Biotin, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Manganese, Niacin, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Gnarly Nutrition Vegan Protein - NSF Certified for Sport Chocolate -- 36.8 ozGnarly NutritionActive Lifestyle & FitnessVitamin C, Biotin, Chromium, Vitamin E, Folic Acid, Vitamin E, Iodine, Manganese, Molybdenum, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Gnarly Nutrition Vegan Protein - NSF Certified for Sport Vanilla -- 36.8 ozGnarly NutritionActive Lifestyle & FitnessVitamin C, Biotin, Chromium, Vitamin E, Folic Acid, Vitamin E, Iodine, Manganese, Molybdenum, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Go Raw Organic Sprouted Sunflower Seeds Sea Salt -- 14 ozGo RawFood & BeveragesVitamin C, Folate, Manganese, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B62024-11-29 10:47:42
Go Raw Organic Sprouted Sunflower Seeds Sea Salt -- 4 ozGo RawFood & BeveragesVitamin E, Folate, Vitamin E, Manganese, Phosphorus, Vitamin B6, Selenium, Vitamin B62024-11-29 10:47:42
Go Raw Organic Sprouted Super Simple Seeds -- 14 ozGo RawFood & BeveragesVitamin C, Folate, Manganese, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B62024-11-29 10:47:42
Goli Nutrition Apple Cider Vinegar Gummies -- 60 GummiesGoli NutritionVitamins & SupplementsFolate, Vitamin B122024-11-29 10:47:42
Goli Nutrition Kids Complete MultiVitamin Vegan -- 80 GummiesGoli NutritionVitamins & SupplementsVitamin C, Biotin, Chromium, Vitamin E, Folate, Vitamin E, Manganese, Niacin, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B6, Vitamin D2, Vitamin K12024-11-29 10:47:42
Goli Nutrition Supergreens Gummies -- 60 GummiesGoli NutritionVitamins & SupplementsFolate, Niacin, Pantothenic Acid, Vitamin B6, Vitamin A, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Good Day Chocolate Adults Energy Supplement -- 50 Candy Coated PiecesGood Day ChocolateVitamins & SupplementsBiotin, Caffeine, Folate, Niacin, Pantothenic Acid, Vitamin B6, Riboflavin, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Good Day Chocolate Kids Multivitamin -- 70 Chocolate PiecesGood Day ChocolateVitamins & SupplementsVitamin C, Biotin, Vitamin D3, Choline, Vitamin E, Folate, Vitamin E, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Good Health Inc. Veggie Straws Sea Salt -- 6.75 ozGood Health Inc.Food & BeveragesVitamin C, Vitamin B7, Vitamin E, Folate, Vitamin E, Vitamin B6, Vitamin A, Vitamin B1, Vitamin B6, Vitamin K2024-11-29 10:47:42
Green Foods Dr Hagiwara Green Magma Barley Grass Juice Powder -- 5.3 ozGreen FoodsHerbs, Botanicals & HomeopathyVitamin C, Chlorophyll, Folic Acid, Vitamin A, Vitamin K2024-11-29 10:47:42
Green Foods Dr Hagiwara Green Magma Barley Grass Juice Tablets -- 500 mg - 250 TabletsGreen FoodsHerbs, Botanicals & HomeopathyVitamin C, Chlorophyll, Folic Acid, Vitamin A2024-11-29 10:47:42
Green Foods Green Magma® Organic Barley Grass Juice Powder -- 10.6 ozGreen FoodsHerbs, Botanicals & HomeopathyVitamin C, Chlorophyll, Folic Acid, Vitamin A, Vitamin K2024-11-29 10:47:42
Green Foods Organic and Raw Wheat Grass Shots -- 10.6 ozGreen FoodsHerbs, Botanicals & HomeopathyVitamin C, Chlorophyll, Folic Acid, Iodine, Manganese, Niacin, Vitamin B6, Vitamin A, Riboflavin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Green Foods Organic and Raw Wheat Grass Shots -- 5.3 ozGreen FoodsHerbs, Botanicals & HomeopathyVitamin C, Chlorophyll, Folic Acid, Iodine, Manganese, Niacin, Vitamin B6, Vitamin A, Riboflavin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Green Foods True Vitality Plant Protein Shake with DHA Vanilla -- 25.2 ozGreen FoodsActive Lifestyle & FitnessVitamin C, Biotin, Boron, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Manganese, Molybdenum, Nickel, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, Selenium, Silicon, Thiamin, Vanadium, Vitamin B12, Vitamin B62024-11-29 10:47:42
Greens First Boost Dutch Chocolate -- 10.5 ozGreens FirstVitamins & SupplementsVitamin C, Biotin, Chromium, Vitamin E, Folic Acid, Vitamin E, Iodine, Magnesium Phosphate, Manganese, Molybdenum, Niacin, Vitamin B5, Phosphorus, Potassium Phosphate, Vitamin B6, Vitamin A, Vitamin B2, Selenium, Vitamin B1, Vitamin B12, Vitamin B6, Vitamin D22024-11-29 10:47:42
Greens First Boost French Vanilla -- 10.5 ozGreens FirstVitamins & SupplementsVitamin C, Biotin, Chromium, Vitamin E, Folic Acid, Vitamin E, Iodine, Magnesium Phosphate, Manganese, Molybdenum, Niacin, Vitamin B5, Phosphorus, Potassium Phosphate, Vitamin B6, Vitamin A, Vitamin B2, Selenium, Vitamin B1, Vitamin B12, Vitamin B6, Vitamin D22024-11-29 10:47:42
Greens First Female - ConceEVE -- 180 CapsulesGreens FirstVitamins & SupplementsCellulose, Folate, microcrystalline cellulose, D-Chiro-Inositol2024-11-29 10:47:42
Greens First Female - Prenatal with Vegan DHA Plus Probiotics -- 90 Vegetable CapsulesGreens FirstVitamins & SupplementsVitamin C, dextrin, Choline, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Vitamin B3, potassium bicarbonate, Vitamin B6, rebaudioside A, Vitamin A, Vitamin B1, Vitamin B12, Vitamin B62024-11-29 10:47:42
Greens Plus Meal Replacement PlusShake™ Raw Chocolate -- 1.5 lbsGreens PlusActive Lifestyle & FitnessVitamin C, Biotin, Chloride, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Manganese, Molybdenum, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Greens Plus Organics Superfood Amazon Chocolate -- 8.46 ozGreens PlusVitamins & SupplementsVitamin C, Vitamin B7, Vitamin B9, Vitamin B3, Vitamin B5, Vitamin B6, Vitamin A, Vitamin B2, Vitamin B1, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Greens Plus Original Superfood -- 240 Veggie CapsulesGreens PlusVitamins & SupplementsVitamin C, Vitamin E, Folate, Vitamin E, Manganese, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Halo Holistic Dry Cat Food Wild-Caught Salmon & Whitefish Recipe -- 3 lbsHaloPet Suppliesbiotin, D-calcium pantothenate, dicalcium phosphate, calcium sulfate, folic acid, potassium chloride, pyridoxine hydrochloride, sodium selenite, taurine2024-11-29 10:47:42
Halo Holistic Dry Cat Food Wild-Caught Salmon & Whitefish Recipe -- 6 lbsHaloPet Suppliesbiotin, d-calcium pantothenate, dicalcium phosphate, calcium sulfate, folic acid, Max, potassium chloride, pyridoxine hydrochloride, sodium selenite, taurine2024-11-29 10:47:42
Halo Holistic Dry Cat Food Sensitive Stomach Support Wild-Caught Whitefish Recipe -- 6 lbHaloPet Suppliesd-calcium pantothenate, dicalcium phosphate, choline chloride, folic acid, calcium carbonate, Max, potassium chloride, pyridoxine hydrochloride, sodium selenite, taurine2024-11-29 10:47:42
Halo Holistic Dry Cat Food Healthy Weight Support Cage-Free Chicken Recipe -- 3 lbsHaloPet Suppliesbiotin, d-calcium pantothenate, dicalcium phosphate, calcium sulfate, folic acid, L-carnitine, potassium chloride, pyridoxine hydrochloride, sodium selenite, taurine2024-11-29 10:47:42
Halo Holistic Dry Cat Food Healthy Weight Support Cage-Free Chicken Recipe -- 6 lbsHaloPet Suppliesbiotin, d-calcium pantothenate, dicalcium phosphate, calcium sulfate, folic acid, Max, potassium chloride, pyridoxine hydrochloride, sodium selenite, taurine2024-11-29 10:47:42
Halo Holistic Dry Dog Food Cage-Free Chicken & Brown Rice -- 3.5 lbsHaloPet Suppliesd-calcium pantothenate, dicalcium phosphate, folic acid, potassium chloride, pyridoxine hydrochloride, sodium selenite, taurine2024-11-29 10:47:42
Halo Holistic Dry Dog Food Vegan Superfoods Plant-Based Recipe -- 3.5 lbsHaloPet Suppliesbiotin, d-calcium pantothenate, dicalcium phosphate, copper sulfate, iron sulfate, folic acid, calcium carbonate, potassium chloride, pyridoxine hydrochloride, vitamin A acetate, taurine, ergocalciferol, zinc sulfate2024-11-29 10:47:42
Halo Holistic Dry Puppy Food Cage-Free Chicken & Brown Rice -- 3.5 lbsHaloPet Suppliesd-calcium pantothenate, dicalcium phosphate, folic acid, pyridoxine hydrochloride, sodium selenite, taurine2024-11-29 10:47:42
Halo Holistic Senior Dog Dry Food Cage-Free Chicken and Sweet Potato Recipe -- 3.5 lbsHaloPet Suppliesd-calcium pantothenate, choline chloride, folic acid, potassium chloride, pyridoxine hydrochloride, sodium selenite, taurine2024-11-29 10:47:42
Halo Senior Dog Wet Food Grain-Free Chicken Recipe -- 13.2 oz Each / Pack of 6HaloPet Suppliesbiotin, D-calcium pantothenate, choline chloride, Docosahexaenoic Acid, folic acid, potassium chloride, potassium iodide, pyridoxine hydrochloride, sodium carbonate, sodium selenite2024-11-29 10:47:42
Halo Wet Cat Food Grain-Free Chicken Shrimp & Crab Stew -- 5.5 oz Each / Pack of 12HaloPet Suppliesbiotin, calcium citrate, d-calcium pantothenate, dicalcium phosphate, choline chloride, folic acid, magnesium sulfate, potassium chloride, potassium iodide, pyridoxine hydrochloride, sodium selenite, taurine2024-11-29 10:47:42
Halo Wet Cat Food Grain-Free Salmon Stew -- 5.5 oz Each / Pack of 12HaloPet Suppliesbiotin, D-calcium pantothenate, choline chloride, folic acid, potassium chloride, potassium iodide, pyridoxine hydrochloride, sodium selenite, taurine, tricalcium phosphate2024-11-29 10:47:42
Halo Wet Cat Food Pate Turkey Recipe -- 5.5 oz Each / Pack of 12HaloPet Suppliesbiotin, D-calcium pantothenate, choline chloride, folic acid, calcium carbonate, magnesium sulfate, potassium chloride, potassium iodide, pyridoxine hydrochloride, sodium selenite, taurine, tricalcium phosphate2024-11-29 10:47:42
Halo Wet Cat Food Pate Grain-Free Chicken Recipe -- 5.5 oz Each / Pack of 12HaloPet Suppliesbiotin, D-calcium pantothenate, choline chloride, folic acid, potassium chloride, potassium iodide, pyridoxine hydrochloride, sodium selenite, taurine2024-11-29 10:47:42
Halo Wet Cat Food Pate Grain-Free Salmon Recipe -- 5.5 oz Each / Pack of 12HaloPet Suppliesbiotin, D-calcium pantothenate, choline chloride, folic acid, calcium carbonate, potassium chloride, potassium iodide, pyridoxine hydrochloride, sodium selenite, taurine, tricalcium phosphate2024-11-29 10:47:42
Halo Wet Cat Food Pate Grain-Free Turkey & Duck Recipe -- 5.5 oz Each / Pack of 12HaloPet Suppliesbiotin, d-calcium pantothenate, choline chloride, folic acid, calcium carbonate, magnesium sulfate, potassium chloride, potassium iodide, pyridoxine hydrochloride, sodium selenite, taurine, tricalcium phosphate2024-11-29 10:47:42
Halo Wet Cat Food Pate Grain-Free Turkey Recipe -- 5.5 oz Each / Pack of 12HaloPet Suppliesbiotin, D-calcium pantothenate, choline chloride, folic acid, calcium carbonate, potassium chloride, potassium iodide, pyridoxine hydrochloride, sodium selenite, taurine, tricalcium phosphate2024-11-29 10:47:42
Halo Wet Cat Food Pate Grain-Free Whitefish Recipe -- 5.5 oz Each / Pack of 12HaloPet Suppliesbiotin, D-calcium pantothenate, choline chloride, folic acid, potassium chloride, potassium iodide, pyridoxine hydrochloride, sodium selenite2024-11-29 10:47:42
Halo Wet Dog Food Grain-Free Beef Recipe in Broth -- 13.2 oz Each / Pack of 6HaloPet Suppliesbiotin, D-calcium pantothenate, choline chloride, folic acid, potassium chloride, potassium iodide, pyridoxine hydrochloride, sodium selenite2024-11-29 10:47:42
Halo Wet Dog Food Grain-Free Beef Stew -- 5.5 oz Each / Pack of 12HaloPet Suppliesbiotin, D-calcium pantothenate, choline chloride, folic acid, potassium chloride, potassium iodide, pyridoxine hydrochloride, sodium selenite2024-11-29 10:47:42
Halo Wet Dog Food Grain-Free Chicken Stew -- 5.5 oz Each / Pack of 12HaloPet Suppliesbiotin, calcium citrate, D-calcium pantothenate, choline chloride, folic acid, potassium chloride, potassium iodide, pyridoxine hydrochloride, sodium selenite, tricalcium phosphate2024-11-29 10:47:42
Halo Wet Dog Food Grain-Free Holistic Chicken Recipe -- 13.2 oz Each / Pack of 6HaloPet Suppliesbiotin, calcium citrate, D-calcium pantothenate, choline chloride, folic acid, potassium chloride, potassium iodide, pyridoxine hydrochloride, sodium selenite, tricalcium phosphate2024-11-29 10:47:42
Halo Wet Dog Food Grain-Free Holistic Lamb Recipe -- 13.2 oz Each / Pack of 6HaloPet Suppliesbiotin, calcium citrate, D-calcium pantothenate, choline chloride, folic acid, potassium chloride, potassium iodide, pyridoxine hydrochloride, sodium selenite, tricalcium phosphate2024-11-29 10:47:42
Halo Wet Dog Food Grain-Free Holistic Turkey & Salmon Recipe -- 13.2 oz Each / Pack of 6HaloPet Suppliesbiotin, calcium citrate, D-calcium pantothenate, choline chloride, folic acid, potassium chloride, potassium iodide, pyridoxine hydrochloride, sodium selenite, tricalcium phosphate2024-11-29 10:47:42
Halo Wet Dog Food Grain-Free Turkey & Salmon Stew -- 5.5 oz Each / Pack of 12HaloPet Suppliesbiotin, calcium citrate, D-calcium pantothenate, choline chloride, folic acid, potassium chloride, potassium iodide, pyridoxine hydrochloride, sodium selenite, tricalcium phosphate2024-11-29 10:47:42
Halo Wet Dog Food Grain-Free Small Breed Chicken & Salmon Recipe -- 5.5 oz Each / Pack of 12HaloPet Suppliesbiotin, D-calcium pantothenate, choline chloride, folic acid, potassium chloride, potassium iodide, pyridoxine hydrochloride, sodium carbonate, sodium selenite2024-11-29 10:47:42
Halo Wet Dog Food Grain-Free Small Breed Turkey & Duck Recipe -- 5.5 oz Each / Pack of 12HaloPet Suppliesbiotin, D-calcium pantothenate, choline chloride, folic acid, potassium chloride, potassium iodide, pyridoxine hydrochloride, sodium carbonate, sodium selenite, tricalcium phosphate2024-11-29 10:47:42
Happy Baby Organic Baby Food 4+ Months Mango -- 3.5 ozHappy BabyBaby & Kids ProductsVitamin C, Folate, Vitamin A2024-11-29 10:47:42
Happy Baby Organic Baby Food 6+ Months Apples Guavas & Beets -- 4 ozHappy BabyBaby & Kids ProductsVitamin C, Folate, Phosphorus, Vitamin A2024-11-29 10:47:42
Happy Baby Organic Baby Food 6+ Months Apples Pumpkin & Carrots -- 4 ozHappy BabyBaby & Kids ProductsVitamin C, Folate, Vitamin A2024-11-29 10:47:42
Happy Baby Organic Baby Food 6+ Months Green Beans Spinach & Pears -- 4 ozHappy BabyBaby & Kids ProductsVitamin C, Folate, Phosphorus, Vitamin A2024-11-29 10:47:42
Happy Baby Organic Baby Food 6+ Months Pears Kale & Spinach -- 4 ozHappy BabyBaby & Kids ProductsVitamin C, Folate, Phosphorus, Vitamin A2024-11-29 10:47:42
Happy Baby Organic Baby Food 6+ Months Pears Squash & Blackberries -- 4 ozHappy BabyBaby & Kids ProductsVitamin C, Folate, Phosphorus, Vitamin A2024-11-29 10:47:42
Happy Baby Organic Baby Food 6+ Months Pears Zucchini & Peas -- 4 ozHappy BabyBaby & Kids ProductsVitamin C, Folate, Phosphorus, Vitamin A2024-11-29 10:47:42
Happy Baby Organic Infant Formula A2 Milk Powder 0-12 Months Stage 1 -- 22.9 ozHappy BabyBaby & Kids Productsascorbyl palmitate, Vitamin C, beta-carotene, Biotin, calcium pantothenate, Chloride, cholecalciferol, Choline, cupric sulfate, Vitamin E, ferrous sulfate, folic acid, vitamin e, Inositol, Iodine, Linoleic Acid, Manganese, Niacin, niacinamide, Fat, Pantothenic Acid, Phosphorus, potassium chloride, vitamin A palmitate, Vitamin A, Riboflavin, Selenium, sodium citrate, Vitamin B1, calcium phosphate, Vitamin B12, phytonadione, Vitamin K, zinc sulfate2024-11-29 10:47:42
Happy Baby Organic Infant Formula Powder 0-12 Months Stage 1 -- 21 ozHappy BabyBaby & Kids Productsascorbyl palmitate, dl-alpha tocopheryl acetate, Vitamin C, betacarotene, Biotin, calcium pantothenate, Chloride, cholecalciferol, Choline, cupric sulfate, Vitamin E, ferrous sulfate, folic acid, vitamin E, Inositol, Iodine, Linoleic Acid, Manganese, Niacin, niacinamide, Fat, Pantothenic Acid, Phosphorus, potassium bicarbonate, potassium chloride, potassium iodide, pyridoxine hydrochloride, Vitamin B6, vitamin A palmitate, Vitamin A, Riboflavin, Selenium, sodium citrate, sodium selenite, thiamine hydrochloride, Thiamine, calcium phosphate, Vitamin B12, Vitamin B6, phytonadione, Vitamin K, zinc sulfate2024-11-29 10:47:42
Happy Baby Organic Infant Formula Powder 6-12 Months Stage 2 -- 21 ozHappy BabyBaby & Kids Productsascorbyl palmitate, dl-alpha tocopheryl acetate, Vitamin C, betacarotene, Biotin, calcium pantothenate, Chloride, cholecalciferol, Choline, cupric sulfate, Vitamin E, ferrous sulfate, folic acid, vitamin E, Inositol, Iodine, Linoleic Acid, Manganese, Niacin, niacinamide, Fat, Pantothenic Acid, Phosphorus, potassium bicarbonate, potassium chloride, potassium iodide, pyridoxine hydrochloride, Vitamin B6, vitamin A palmitate, Vitamin A, Riboflavin, Selenium, sodium citrate, sodium selenite, thiamine hydrochloride, Thiamine, calcium phosphate, Vitamin B12, Vitamin B6, phytonadione, Vitamin K, zinc sulfate2024-11-29 10:47:42
Happy Baby Organic Meal Bowl 9+ Months Sweet Potato & Coconut Curry -- 4 ozHappy BabyBaby & Kids ProductsFolate, Vitamin K2, Vitamin K2, Vitamin A2024-11-29 10:47:42
Happy Baby Organic Superfood Puffs Crawling Baby Snack Kale & Spinach -- 2.1 ozHappy BabyBaby & Kids ProductsDL-alpha-tocopherol acetate, Vitamin C, cholecalciferol, choline, Vitamin E, ferric pyrophosphate, Folate, vitamin E, calcium carbonate, Niacin, niacinamide, vitamin B5, Phosphorus, potassium chloride, pyridoxine hydrochloride, Vitamin B6, vitamin A acetate, Vitamin A, vitamin B2, Thiamin, vitamin B1, tricalcium phosphate, cyanocobalamin, vitamin B6, zinc oxide2024-11-29 10:47:42
Happy Tot Organic Fiber & Protein Puree 2+ Years Pear Kiwi & Kale -- 4 ozHappy TotBaby & Kids ProductsVitamin C, Folate, Vitamin A2024-11-29 10:47:42
Happy Tot Organic Superfoods Chia 2+ Years Banana Peach Mango -- 4.22 ozHappy TotBaby & Kids ProductsVitamin C, Folate, Phosphorus, Vitamin A2024-11-29 10:47:42
Happy Tot Organic Superfoods Chia 2+ Years Pears Mangos & Spinach -- 4 PouchesHappy TotBaby & Kids ProductsVitamin C, Folate, Vitamin A2024-11-29 10:47:42
Happy Tot Super Bellies Fruit & Veggie Blend 2+ Years -- 8 PouchesHappy TotBaby & Kids ProductsVitamin C, Folate, fructooligosaccharide, Vitamin A2024-11-29 10:47:42
Havasu Nutrition Premium Multivitamin Gummies Natural Fruit -- 60 GummiesHavasu NutritionVitamins & Supplementscitric acid, Vitamin C, Biotin, citric acid, Vitamin E, Folate, Vitamin E, Iodine, Pantothenic Acid, Vitamin B6, Vitamin A, sugar, Vitamin B12, Vitamin B62024-11-29 10:47:42
HealFast Complete Recovery - Pre & Post Surgery Nutrition -- 2 PackHealFastProfessional SupplementsVitamin C, Vitamin D3, Vitamin B9, L-Glutamine, Vitamin B3, Vitamin B5, Vitamin B6, Vitamin A, Vitamin B2, Selenium, Vitamin B1, Vitamin B12, Vitamin B62024-11-29 10:47:42
HealFast Post-Surgery Nutrition -- 100 CapsulesHealFastProfessional SupplementsVitamin C, Vitamin D3, Vitamin B9, L-Glutamine, Vitamin B3, Vitamin B5, Vitamin B6, Quercetin, Vitamin A, Vitamin B2, Selenium, Vitamin B1, Vitamin B12, Vitamin B62024-11-29 10:47:42
HealFast Pre-Surgery Nutrition -- 40 CapsulesHealFastProfessional SupplementsVitamin C, Vitamin D3, Vitamin B9, L-Glutamine, Vitamin B3, Vitamin B5, Vitamin B6, Vitamin A, Vitamin B2, Selenium, Vitamin B1, Vitamin B12, Vitamin B62024-11-29 10:47:42
Healright Daily Micronutrient Bar Caramel Apple Fig -- 2.19 ozHealrightProfessional SupplementsVitamin C, Biotin, Chromium, Vitamin E, Folate, Vitamin E, L-glutamine, glycerin, maltitol, Manganese, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Healright Daily Micronutrient Bar Chocolate Cherry Pomegranate -- 14 BarsHealrightProfessional SupplementsVitamin C, Biotin, Chromium, Vitamin E, Folate, Vitamin E, L-glutamine, glycerin, Maltitol, Manganese, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Healright Daily Micronutrient Bar Chocolate Cherry Pomegranate -- 2.19 ozHealrightProfessional SupplementsVitamin C, Biotin, Chromium, Vitamin E, Folate, Vitamin E, L-glutamine, glycerin, Maltitol, Manganese, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Healright Daily Micronutrient Bar Lemon Blueberry -- 2.19 ozHealrightProfessional SupplementsVitamin C, Biotin, Chromium, Vitamin E, Folate, Vitamin E, L-glutamine, glycerin, Maltitol, Manganese, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Healright Daily Micronutrient Bar Peanut Butter Banana -- 2.19 ozHealrightProfessional SupplementsVitamin C, Biotin, Chromium, Vitamin E, Folate, Vitamin E, L-glutamine, glycerin, Maltitol, Manganese, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Health Plus Blood Cleanse™ -- 753 mg - 90 CapsulesHealth PlusVitamins & SupplementsAstaxanthin, Folic Acid, Phosphorus, Vitamin A, Vitamin B122024-11-29 10:47:42
Healths Harmony Kids Vitamin Gummies Organic Strawberry Orange Lemon -- 60 GummiesHealths HarmonyVitamins & SupplementsVitamin C, Biotin, Vitamin E, Folate, Vitamin E, Iodine, Pantothenic Acid, Vitamin B6, Vitamin A, sodium citrate, Vitamin B12, Vitamin B62024-11-29 10:47:42
Healthy Pup Multi Max for Dogs -- 120 Soft ChewsHealthy PupPet Suppliescitric acid, alpha-Linolenic Acid, Biotin, Calcium Ascorbate, dicalcium phosphate, Vitamin D3, Choline, citric acid, Cobalt, copper carbonate, Vitamin E, ferrous sulfate, folic acid, Vitamin E, glycerin, Iodine, Linoleic Acid, maltodextrin, Manganese, Niacin, Oleic Acid, d-Pantothenic Acid, Phosphorus, potassium iodide, pyridoxine hydrochloride, Pyridoxine, vitamin A palmitate, Vitamin A, Riboflavin, sorbic acid, Thiamine, Vitamin B12, Menadione, zinc sulfate2024-11-29 10:47:42
Heaven Sent Bio Available B-12 -- 60 TabletsHeaven SentVitamins & Supplementscitric acid, Vitamin C, Biotin, citric acid, fructose, Folic Acid, Vitamin B6, sodium bicarbonate, Sorbitol, Vitamin B62024-11-29 10:47:42
Heaven Sent Wellgenix Balanced Essentials + Plus Liquid Vitamins Berry -- 32 fl ozHeaven SentVitamins & Supplementscitric acid, Antimony, Arginine, Vitamin C, Aspartic Acid, Kelp, Barium, Beryllium, Biotin, Bismuth, Boron, Bromide, Omega 3, Cerium, Cesium, Chromium, citric acid, Cobalt, Cystine, Vitamin E, fructose, Dysprosium, Erbium, Europium, Fluoride, Folate, Gadolinium, Gallium, Vitamin E, Glycine, Gold, Hafnium, Histidine, Holmium, Inositol, Iodine, Iodine, Isoleucine, Lanthanum, Leucine, Calcium Carbonate, Lithium, Lutetium, Lysine, Manganese, Methionine, Molybdenum, Neodymium, Niacin, Nickel, Niobium, Pantothenic Acid, Phenylalanine, Phosphorus, Praseodymium, Proline, Vitamin B6, Vitamin A, Rhenium, Riboflavin, Rubidium, Samarium, Scandium, Selenium, Serine, Silicon, Silver, Strontium, Tantalum, Tellurium, Terbium, Thallium, Thiamin, Thorium, Threonine, Thulium, Tin, Titanium, Tryptophan, Tungsten, Tyrosine, Valine, Vanadium, Vitamin B12, Vitamin B6, Vitamin K, Ytterbium, Yttrium, Zirconium2024-11-29 10:47:42
Human Beanz Multivitamin Jelly Beans Essential Vitamins Plus Zinc Berry Blast -- 120 Jelly BeansHuman BeanzVitamins & Supplementscitric acid, Vitamin C, Biotin, Chromium, citric acid, Vitamin E, Folate, Vitamin E, Iodine, maltodextrin, Niacin, Pantothenic Acid, Vitamin B6, Vitamin A, sodium citrate, Sugar, Vitamin B12, Vitamin B6, Vitamin D22024-11-29 10:47:42
I and Love and You Baked & Saucy Dry Dog Food Beef + Sweet Potato -- 10.25 lbsI and Love and YouPet Suppliescitric acid, D-calcium pantothenate, citric acid, copper sulfate, ferrous sulfate, folic acid, potassium chloride, pyridoxine hydrochloride, sodium selenite, Taurine, zinc oxide2024-11-29 10:47:42
I and Love and You Baked & Saucy Dry Dog Food Beef + Sweet Potato -- 4 lbsI and Love and YouPet Suppliescitric acid, D-calcium pantothenate, citric acid, copper sulfate, ferrous sulfate, folic acid, potassium chloride, pyridoxine hydrochloride, sodium selenite, Taurine, zinc oxide2024-11-29 10:47:42
I and Love and You Baked & Saucy Dry Dog Food Chicken + Sweet Potato -- 10.25 lbsI and Love and YouPet Suppliescitric acid, D-calcium pantothenate, dicalcium phosphate, citric acid, copper sulfate, ferrous sulfate, folic acid, potassium chloride, pyridoxine hydrochloride, sodium selenite, Taurine, zinc oxide2024-11-29 10:47:42
I and Love and You Baked & Saucy Dry Dog Food Chicken + Sweet Potato -- 4 lbsI and Love and YouPet Suppliescitric acid, D-calcium pantothenate, dicalcium phosphate, citric acid, copper sulfate, ferrous sulfate, folic acid, potassium chloride, pyridoxine hydrochloride, sodium selenite, Taurine, zinc oxide2024-11-29 10:47:42
I and Love and You Chicken Me Out Pate Wet Cat Food Chicken Recipe -- 3 oz Can / Pack of 24I and Love and YouPet Suppliesbiotin, d-calcium pantothenate, choline chloride, folic acid, potassium,chloride, potassium iodide, sodium selenite, Taurine2024-11-29 10:47:42
I and Love and You Farm to Sea Feast Pate Wet Cat Food Variety Pack Beef Salmon Turkey -- 3 oz Can / Pack of 12I and Love and YouPet Suppliesbiotin, D-calcium pantothenate, chloride, choline, folic acid, calcium carbonate, magnesium sulfate, potassium chloride, potassium iodide, pyridoxine hydrochloride, sodium selenite, Taurine, tricalcium phosphate2024-11-29 10:47:42
I and Love and You Feed Meow Shreds Wet Cat Food Variety Pack Chicken Salmon Tuna -- 12 PouchesI and Love and YouPet Suppliesbiotin, d-calcium pantothenate, choline chloride, folic acid, fructooligosaccharide, magnesium sulfate, potassium iodide, pyridoxine hydrochloride, sodium selenite, Taurine, tricalcium phosphate, zinc oxide2024-11-29 10:47:42
I and Love and You Naked Essentials Dry Cat Food Chicken + Duck -- 11 lbsI and Love and YouPet Suppliescitric acid, biotin, d-calcium pantothenate, choline chloride, citric acid, copper sulfate, ferrous sulfate, folic acid, Linoleic Acid, potassium chloride, pyridoxine hydrochloride, sodium selenite, Taurine, zinc oxide2024-11-29 10:47:42
I and Love and You Naked Essentials Dry Cat Food Salmon + Trout -- 11 lbsI and Love and YouPet Suppliescitric acid, biotin, d-calcium pantothenate, choline chloride, citric acid, copper sulfate, ferrous sulfate, folic acid, Linoleic Acid, potassium chloride, pyridoxine hydrochloride, sodium selenite, Taurine, zinc oxide2024-11-29 10:47:42
I and Love and You Naked Essentials Dry Cat Food Salmon + Trout -- 3.4 lbsI and Love and YouPet SuppliesBiotin, Calcium Pantothenate, Dicalcium Phosphate, Choline Chloride, Copper Sulfate, Vitamin E, Ferrous Sulfate, Folic Acid, Vitamin E, Calcium Carbonate, Pyridoxine Hydrochloride, Sodium Selenite, Taurine, Zinc Sulfate2024-11-29 10:47:42
I and Love and You Naked Essentials Dry Cat Food Hairball Care Salmon + Whitefish -- 3.4 lbsI and Love and YouPet Suppliescitric acid, biotin, D-calcium pantothenate, choline chloride, citric acid, copper sulfate, ferrous sulfate, folic acid, powdered cellulose, potassium chloride, pyridoxine hydrochloride, sodium selenite, Taurine, zinc oxide2024-11-29 10:47:42
I and Love and You Naked Essentials Dry Dog Food Chicken + Duck -- 4 lbsI and Love and YouPet Suppliescitric acid, d-calcium pantothenate, choline chloride, citric acid, copper sulfate, Vitamin E, ferrous sulfate, folic acid, Vitamin E, potassium chloride, pyridoxine hydrochloride, sodium selenite, Taurine, zinc oxide2024-11-29 10:47:42
I and Love and You Naked Essentials Dry Dog Food Duck & Chicken -- 11 lbsI and Love and YouPet SuppliesBiotin, Calcium Pantothenate, Choline Chloride, Copper Sulfate, Vitamin E, Ferrous Sulfate, Folic Acid, Vitamin E, Calcium Carbonate, Potassium Chloride, Pyridoxine Hydrochloride, Sodium Selenite, Zinc Sulfate2024-11-29 10:47:42
I and Love and You Naked Essentials Dry Dog Food Lamb + Bison -- 11 lbsI and Love and YouPet Suppliesd-calcium pantothenate, choline chloride, copper sulfate, Vitamin E, folic acid, Vitamin E, calcium carbonate, potassium chloride, pyridoxine hydrochloride, sodium selenite2024-11-29 10:47:42
I and Love and You Naked Essentials Dry Dog Food Lamb + Bison -- 4 lbsI and Love and YouPet Suppliescitric acid, d-calcium pantothenate, choline chloride, citric acid, copper sulfate, Vitamin E, ferrous sulfate, folic acid, Vitamin E, potassium chloride, pyridoxine hydrochloride, sodium selenite, Taurine, zinc oxide2024-11-29 10:47:42
I and Love and You Naked Essentials Puppy Dry Dog Food Chicken + Lentils -- 4 lbsI and Love and YouPet Suppliesd-calcium pantothenate, choline chloride, copper sulfate, Vitamin E, Docosahexaenoic Acid, iron sulfate, folic acid, Vitamin E, niacin, Phosphorus, pyridoxine hydrochloride, Vitamin A, sodium selenite, Taurine, zinc sulfate2024-11-29 10:47:42
I and Love and You Ninja Cat Jiu Jit Stew Wet Cat Food Variety Pack Chicken Salmon Tuna -- 3 oz Can / Pack of 12I and Love and YouPet Suppliesbiotin, D-calcium pantothenate, choline chloride, folic acid, calcium carbonate, sodium phosphate, potassium chloride, potassium iodide, pyridoxine hydrochloride, sodium selenite, Taurine, tricalcium phosphate2024-11-29 10:47:42
I and Love and You Nude Super Food Dry Cat Food Poultry a Plenty -- 5 lbI and Love and YouPet Suppliesbiotin, calcium pantothenate, choline chloride, copper sulfate, Vitamin E, ferrous sulfate, folic acid, Vitamin E, calcium carbonate, pyridoxine hydrochloride, sodium selenite, Taurine, zinc sulfate2024-11-29 10:47:42
I and Love and You Nude Super Food Dry Dog Food Poultry Palooza -- 5 lbsI and Love and YouPet Suppliescitric acid, d-calcium pantothenate, citric acid, copper sulfate, Docosahexaenoic Acid, ferrous sulfate, folic acid, pyridoxine hydrochloride, sodium selenite, Taurine, zinc oxide2024-11-29 10:47:42
I and Love and You Nude Super Food Dry Dog Food Simply Sea -- 5 lbsI and Love and YouPet Suppliescitric acid, d-calcium pantothenate, choline chloride, citric acid, copper sulfate, ferrous sulfate, folic acid, potassium chloride, pyridoxine hydrochloride, sodium selenite, Taurine, zinc oxide2024-11-29 10:47:42
I and Love and You Oh My Cod! Pate Wet Cat Food Cod -- 3 oz Can / Pack of 24I and Love and YouPet Suppliesbiotin, d-calcium pantothenate, choline chloride, folic acid, potassium chloride, potassium iodide, pyridoxine hydrochloride, sodium selenite, Taurine2024-11-29 10:47:42
I and Love and You Pate All Day Wet Cat Food Variety Pack Chicken Cod Turkey -- 3 oz Can / Pack of 12I and Love and YouPet Suppliesbiotin, D-calcium pantothenate, chloride, choline chloride, folic acid, potassium iodide, sodium selenite, Taurine2024-11-29 10:47:42
I and Love and You XOXOs Mix Pâté Wet Cat Food Variety Pack Chicken and Beef -- 12 CansI and Love and YouPet Suppliesbiotin, d-calcium pantothenate, choline chloride, folic acid, magnesium sulfate, potassium chloride, potassium iodide, pyridoxine hydrochloride, sodium selenite, Taurine, tricalcium phosphate, zinc oxide2024-11-29 10:47:42
I and Love and You XOXOs Mix Pâté Wet Cat Food Variety Pack Salmon and Whitefish -- 12 CansI and Love and YouPet Suppliesbiotin, D-calcium pantothenate, choline chloride, folic acid, magnesium sulfate, potassium iodide, pyridoxine hydrochloride, sodium selenite, Taurine, tricalcium phosphate, zinc oxide2024-11-29 10:47:42
I and Love and You XOXOs Mix Wet Cat Food Variety Pack Chicken & Tuna Stew -- 12 CansI and Love and YouPet Suppliesbiotin, d-calcium pantothenate, folic acid, magnesium sulfate, potassium chloride, potassium iodide, pyridoxine hydrochloride, sodium selenite, Taurine, tricalcium phosphate, zinc oxide2024-11-29 10:47:42
Igennus Super B-Complex – Methylated with Methylfolate & Vit C - Slow Release & Potent -- 60 TabletsIgennusVitamins & SupplementsVitamin C, Biotin, Folate, Niacin, Pantothenic Acid, Vitamin B6, Riboflavin, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Innate Formulas One Daily Iron Free Multivitamin -- 90 TabletsInnateProfessional SupplementsVitamin C, Biotin, Boron, Vitamin D3, Vitamin E, Folate, Vitamin E, microcrystalline cellulose, Iodine, Manganese, Molybdenum, Niacin, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, Selenium, stearic acid, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Innate Response Formulas B Complex -- 180 TabletsInnateProfessional SupplementsBiotin, Folate, Microcrystalline cellulose, Niacin, Pantothenic Acid, Vitamin B6, Riboflavin, stearic acid, Thiamine, Vitamin B12, Vitamin B62024-11-29 10:47:42
Innate Response Formulas B Complex -- 90 TabletsInnateProfessional SupplementsBiotin, Folate, Microcrystalline cellulose, Niacin, Pantothenic Acid, Vitamin B6, Riboflavin, stearic acid, Thiamine, Vitamin B12, Vitamin B62024-11-29 10:47:42
Innate Response Formulas Baby & Me Multivitamin -- 120 TabletsInnateProfessional SupplementsVitamin C, Biotin, Vitamin D3, Vitamin E, Folate, Vitamin E, Microcrystalline cellulose, Iodine, Manganese, Vitamin K2, Vitamin K2, Molybdenum, Niacin, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, Selenium, stearic acid, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Innate Response Formulas Baby & Me Multivitamin -- 60 TabletsInnateProfessional SupplementsVitamin C, Biotin, Vitamin D3, Vitamin E, Folate, Vitamin E, Microcrystalline cellulose, Iodine, Manganese, Vitamin K2, Vitamin K2, Molybdenum, Niacin, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, Selenium, stearic acid, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Innate Response Formulas Iron Response -- 90 TabletsInnateProfessional SupplementsVitamin C, Folate, stearic acid, Vitamin B122024-11-29 10:47:42
Innate Response Formulas Men Over 40 One Daily Iron Free -- 60 TabletsInnateProfessional SupplementsVitamin C, Biotin, Boron, Vitamin D3, Vitamin E, Folate, Vitamin E, Iodine, Manganese, Molybdenum, Niacin, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, Selenium, stearic acid, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Innate Response Formulas One Daily -- 90 TabletsInnateProfessional SupplementsVitamin C, Biotin, Boron, Vitamin D3, Vitamin E, Folate, Vitamin E, Microcrystalline cellulose, Iodine, Manganese, Molybdenum, Niacin, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, Selenium, stearic acid, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Innate Response Formulas Women Over 40 One Daily -- 60 TabletsInnateProfessional SupplementsVitamin C, Biotin, Boron, Vitamin D3, Vitamin E, Folate, Vitamin E, microcrystalline cellulose, Iodine, Manganese, Molybdenum, Niacin, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, Selenium, stearic acid, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Integrative Therapeutics Active B-Complex -- 60 CapsulesIntegrative TherapeuticsProfessional Supplementsascorbyl palmitate, Biotin, cellulose, Choline, Folate, Inositol, Niacin, Pantothenic Acid, Vitamin B6, Riboflavin, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Irwin Naturals Living Green Liquid-Gel Multi For Men Economy Size -- 120 SoftgelsIrwin NaturalsVitamins & Supplements L-5-Hydroxytryptophan, Vitamin C, Biotin, Chromium, Vitamin E, Folic Acid, Vitamin E, glycerin, L-Isoleucine, Manganese, Molybdenum, Niacin, Pantothenic Acid, L-Phenylalanine, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, L-Valine, Vitamin B12, Vitamin B62024-11-29 10:47:42
Irwin Naturals Living Green Liquid-Gel Multi For Women -- 120 Liquid SoftgelsIrwin NaturalsVitamins & SupplementsVitamin C, Biotin, Chromium, Vitamin E, Folic Acid, Vitamin E, glycerin, Manganese, Molybdenum, Niacin, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, titanium dioxide, Vitamin B12, Vitamin B62024-11-29 10:47:42
Irwin Naturals Living Green Liquid-Gel Multi™ For Men -- 90 Liquid SoftgelsIrwin NaturalsVitamins & Supplements L-5-Hydroxytryptophan, Vitamin C, Biotin, dicalcium phosphate, Chromium, Vitamin E, Folate, Vitamin E, L-Isoleucine, Manganese, Molybdenum, Niacin, Pantothenic Acid, L-Phenylalanine, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, titanium dioxide, L-Valine, Vitamin B12, Vitamin B62024-11-29 10:47:42
Irwin Naturals Triple-Tea Fat Burner -- 75 Liquid SoftgelsIrwin NaturalsWeight ManagementVitamin C, Vitamin E, Folic Acid, Vitamin E, Niacin, Vitamin B6, Vitamin B12, Vitamin B62024-11-29 10:47:42
Jarrow Formulas Brain Health Methyl Folate -- 400 mcg - 60 Veggie CapsJarrow FormulasVitamins & Supplements Cellulose, Folate2024-11-29 10:47:42
Jigsaw Health Activated B with SRT® -- 120 TabletsJigsaw HealthVitamins & SupplementsPABA, Biotin, Choline, Folate, Microcrystalline cellulose, Inositol, Niacin, PABA, Pantothenic Acid, Vitamin B6, Riboflavin, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Jigsaw Health Magnesium with SRT® -- 240 TabletsJigsaw HealthVitamins & SupplementsFolate, Microcrystalline cellulose, Malic Acid, Vitamin B6, Vitamin B12, Vitamin B62024-11-29 10:47:42
Jigsaw Health MagSRT® Magnesium Supplement -- 120 TabletsJigsaw HealthVitamins & SupplementsFolate, Microcrystalline cellulose, Malic Acid, Vitamin B6, Vitamin B12, Vitamin B62024-11-29 10:47:42
Jyoti Delhi Saag Spinach and Mustard Greens with Ginger and Peppers -- 15 ozJyotiFood & BeveragesVitamin C, Folate, Vitamin A2024-11-29 10:47:42
Jyoti Matar-Paneer Peas and Cheese -- 15 ozJyotiFood & BeveragesVitamin C, Folate, Vitamin A2024-11-29 10:47:42
Kabrita Goat Milk Toddler Formula 12-24 Months -- 14 ozKabritaBaby & Kids Productsvitamin E acetate, Vitamin C, Biotin, tri calcium citrate, calcium pantothenate, dicalcium phosphate, vitamin D3, choline chloride, copper sulfate, Vitamin E, ferrous sulfate, folic acid, Vitamin E, inositol, Iodine, Lactose, L-carnitine, calcium carbonate, Niacin, niacinamide, Pantothenic Acid, Phosphorus, vitamin B6 hydrochloride, Vitamin B6, retinyl acetate, Vitamin A, Riboflavin, sodium selenite, taurine, thiamine hydrochloride, Thiamin, tri calcium phosphate, Vitamin B12, Vitamin B6, vitamin K1, zinc sulfate2024-11-29 10:47:42
Kaged Plant Based Whole Food Multivitamin -- 60 Veggie CapsKagedActive Lifestyle & FitnessVitamin C, kelp, Biotin, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Manganese, Molybdenum, Niacin, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
KAL B-6 B-12 Folic Acid Dropins™ Natural Mixed Berry -- 2 fl ozKALVitamins & SupplementsFolate, Vitamin B6, stevia, Vitamin B12, Vitamin B6, xylitol2024-11-29 10:47:42
KAL B-6 B-12 Methyl Folate ActivMelt™ Mixed Berry -- 60 MicroTabletsKALVitamins & Supplementscitric acid, cellulose, citric acid, Folate, Vitamin B6, stevia, sodium bicarbonate, sorbitol, Vitamin B12, Vitamin B62024-11-29 10:47:42
Kal GABA L-Thenine Stress B Lozenge Natural Mango Tangerine -- 100 LozengesKALVitamins & SupplementsVitamin C, cellulose, fructose, Folate, GABA, Inositol, Niacin, Pantothenic Acid, Vitamin B6, stearic acid, Thiamine, Cyanocobalamin, Vitamin B6, Xylitol2024-11-29 10:47:42
KAL Nutritional Yeast Flakes -- 12 ozKALFood & BeveragesAlanine, Arginine, Aspartic Acid, Biotin, Cystine, Folate, Glutamic Acid, Glycine, Histidine, Isoleucine, Leucine, Lysine, Manganese, Methionine, Molybdenum, niacin, Pantothenic Acid, Phenylalanine, Phosphorus, Proline, pyridoxine HCI, Vitamin B6, Riboflavin, Selenium, Serine, Thiamin, Threonine, Tryptophan, Tyrosine, Valine, Vitamin B12, Vitamin B62024-11-29 10:47:42
KAL Stress B-Complex -- 100 TabletsKALVitamins & SupplementsPABA, Vitamin C, Biotin, Cellulose, Choline, Folate, Inositol, Niacin, PABA, Pantothenic Acid, Vitamin B6, Riboflavin, stearic acid, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Keto Wise Meal Replacement Shake Gold Chocolate Fudge Brownie -- 16.1 ozKeto WiseWeight ManagementVitamin C, Biotin, calcium pantothenate, cholecalciferol, Chromium, copper gluconate, Erythritol, Folate, calcium carbonate, Manganese, Niacin, niacinamide, Pantothenic Acid, pyridoxine HCL, Vitamin B6, vitamin A palmitate, Vitamin A, Riboflavin, Selenium, selenium methionine, thiamine HCL, Thiamin, cyanocobalamin, Vitamin B62024-11-29 10:47:42
Keto Wise Meal Replacement Shake Gold Creamy Peanut Butter -- 16.1 ozKeto WiseWeight ManagementVitamin C, Biotin, calcium pantothenate, cholecalciferol, Chromium, copper gluconate, Erythritol, Folate, calcium carbonate, Manganese, Niacin, niacinamide, Pantothenic Acid, pyridoxine HCL, Vitamin B6, vitamin A palmitate, Vitamin A, Riboflavin, Selenium, selenium methionine, thiamine HCL, Thiamin, cyanocobalamin, Vitamin B62024-11-29 10:47:42
Keto Wise Meal Replacement Shake Gold French Vanilla -- 16.1 ozKeto WiseWeight ManagementVitamin C, Biotin, calcium pantothenate, cholecalciferol, Chromium, copper gluconate, Erythritol, Folate, calcium carbonate, Manganese, Niacin, niacinamide, Pantothenic Acid, pyridoxine HCL, Vitamin B6, vitamin A palmitate, Vitamin A, Riboflavin, Selenium, selenium methionine, thiamine HCL, Thiamin, cyanocobalamin, Vitamin B62024-11-29 10:47:42
King Arthur Baking Company Unbleached All Purpose Flour -- 5 lbsKing Arthur Baking CompanyFood & BeveragesVitamin C, Folate, Niacin, Vitamin A, vitamin B2, Thiamin, vitamin B12024-11-29 10:47:42
King Arthur Baking Company Unbleached Cake Flour Blend -- 32 ozKing Arthur Baking CompanyFood & BeveragesVitamin C, Folic Acid, mik, Niacin, Vitamin A, Riboflavin, Thiamin2024-11-29 10:47:42
Klean Athlete B-Complex - NSF Certified for Sport -- 60 Vegetarian CapsulesKlean AthleteProfessional SupplementsBiotin, Choline, Folate, microcrystalline cellulose, Inositol, Niacin, Pantothenic Acid, Vitamin B6, Riboflavin, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Klean Athlete Gummy Multivitamin - NSF Certified for Sport Raspberry Lemonade -- 100 GummiesKlean AthleteProfessional Supplementscitric acid, Vitamin C, Biotin, Vitamin D3, Choline, Chromium, citric acid, Vitamin E, Folate, Vitamin E, Iodine, Niacin, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, sodium citrate, cane sugar, Thiamin, Vitamin B12, Vitamin B6, Vitamin K12024-11-29 10:47:42
Klean Athlete Klean Multivitamin - NSF Certified for Sport -- 60 TabletsKlean AthleteProfessional SupplementsL-methylfolate, Vitamin C, Astaxanthin, Biotin, Cellulose, Vitamin D3, Choline, Chromium, leaf, Vitamin E, Folate, Vitamin E, glycerin, Inositol, Iodine, Lutein, Lycopene, Molybdenum, Pantothenic Acid, Pterostilbene, Vitamin B6, Vitamin A, Riboflavin, Selenium, stearic acid, Thiamine, titanium dioxide, Vitamin B12, Vitamin B6, Zeaxanthin2024-11-29 10:47:42
KOS Kiss Your Blues Away - Blue Spirulina Calming Powder Blend -- 8.78 ozKOSHerbs, Botanicals & HomeopathyBiotin, Folate, malic acid2024-11-29 10:47:42
KOS Organic Plant Protein Powder Chocolate -- 20.6 ozKOSWeight Managementlipase, cellulase, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Manganese, Molybdenum, Niacin, Riboflavin, Selenium, Vitamin B12, Vitamin K2024-11-29 10:47:42
KOS Organic Plant Protein Powder Chocolate Peanut Butter -- 20.56 ozKOSWeight Managementlipase, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Manganese, Molybdenum, Niacin, Riboflavin, Selenium, Vitamin B12, Vitamin K2024-11-29 10:47:42
KOS Organic Plant Protein Powder Vanilla -- 19.6 ozKOSWeight Managementlipase, cellulase, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Manganese, Molybdenum, Niacin, Riboflavin, Selenium, Vitamin B12, Vitamin K2024-11-29 10:47:42
KOS Organic Plant Protein with Blue Spirulina & Immunity Blueberry Muffin -- 20.6 ozKOSWeight Managementlipase, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Manganese, Molybdenum, Niacin, Riboflavin, Selenium, Vitamin B12, Vitamin K2024-11-29 10:47:42
KOS Organic Superfood Plant Protein Powder Chocolate -- 28 ServingsKOSWeight Managementcellulase, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Manganese, Molybdenum, Niacin, niacinamide, potassium iodide, Riboflavin, Selenium, DL-alpha tocopherol, cyanocobalamin, zinc oxide2024-11-29 10:47:42
KOS Organic Superfood Plant Protein Powder Vanilla -- 28 ServingsKOSWeight Managementcellulase, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Manganese, Molybdenum, Niacin, niacinamide, potassium iodide, Riboflavin, Selenium, DL-alpha tocopherol, cyanocobalamin, zinc oxide2024-11-29 10:47:42
KOS Organic Superfood Plant Protein Powder - 15 Servings Strawberries & Cream -- 20.1 ozKOSWeight Managementcellulase, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Manganese, Molybdenum, Niacin, niacinamide, potassium iodide, Riboflavin, Selenium, DL-alpha tocopherol, cyanocobalamin, zinc oxide2024-11-29 10:47:42
KOS Organic Superfood Plant Protein Powder - 28 Servings Chocolate Peanut Butter -- 38.5 ozKOSWeight Managementcellulase, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Manganese, Molybdenum, Niacin, niacinamide, potassium iodide, Riboflavin, Selenium, DL-alpha tocopherol, cyanocobalamin, zinc oxide2024-11-29 10:47:42
KOS Organic Superfood Plant Protein Powder - 28 Servings Salted Caramel Coffee -- 36.54 ozKOSWeight Managementlipase, cellulase, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Manganese, Molybdenum, Niacin, niacinamide, potassium iodide, Riboflavin, Selenium, DL-alpha tocopherol, Vitamin B12, phylloquinone, zinc oxide2024-11-29 10:47:42
KOS Organic Superfood Plant Protein Powder - 28 Servings Strawberries & Cream -- 37.5 ozKOSWeight Managementcellulase, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Manganese, Molybdenum, Niacin, niacinamide, potassium iodide, Riboflavin, Selenium, DL-alpha tocopherol, cyanocobalamin, zinc oxide2024-11-29 10:47:42
KOS Organic Superfood Plant Protein Powder - 28 Servings Unflavored -- 33.6 ozKOSWeight Managementcellulase, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Manganese, Molybdenum, Niacin, niacinamide, potassium iodide, Riboflavin, Selenium, DL-alpha tocopherol, cyanocobalamin, zinc oxide2024-11-29 10:47:42
Kyolic Aged Garlic Extract™ Total Heart Health Formula 108 -- 100 CapsulesKyolicHerbs, Botanicals & Homeopathycellulose, Folate, Vitamin B6, Vitamin B12, Vitamin B62024-11-29 10:47:42
La Panzanella All Natural Artisan Crackers Mini Croccantini® Original -- 6 ozLa PanzanellaFood & BeveragesVitamin C, folic acid, niacin, Vitamin A, riboflavin2024-11-29 10:47:42
Lakewood Juice Not From Concentrate Organic Non-GMO Beet Ginger Turmeric -- 32 fl ozLakewoodFood & BeveragesVitamin C, Folate, Manganese2024-11-29 10:47:42
Lakewood Juice Not From Concentrate Organic Non-GMO Carrot Ginger Turmeric -- 32 fl ozLakewoodFood & BeveragesVitamin C, Folate, Vitamin A, Thiamin2024-11-29 10:47:42
Lakewood Juice Not From Concentrate Organic Non-GMO Mango -- 32 fl ozLakewoodFood & BeveragesVitamin C, Folate, Vitamin A2024-11-29 10:47:42
Lakewood Juice Not From Concentrate Organic Non-GMO Orange Mango -- 32 fl ozLakewoodFood & BeveragesVitamin C, Folate, Pantothenic Acid, Thiamin2024-11-29 10:47:42
Lakewood Juice Not From Concentrate Organic Non-GMO Pineapple Ginger -- 32 fl ozLakewoodFood & BeveragesVitamin C, Folate, Manganese2024-11-29 10:47:42
Lakewood Juice Not From Concentrate Organic Non-GMO Pure Pineapple -- 32 fl ozLakewoodFood & BeveragesVitamin C, Folate, Manganese2024-11-29 10:47:42
Lakewood Juice Not From Concentrate Organic Non-GMO Pure Pink Grapefruit -- 32 fl ozLakewoodFood & BeveragesVitamin C, Folate, Pantothenic Acid, Thiamin2024-11-29 10:47:42
Lakewood Juice Not From Concentrate Organic Non-GMO Pure Tart Cherry -- 32 fl ozLakewoodFood & BeveragesVitamin C, Folate, Manganese, Vitamin B6, Vitamin B62024-11-29 10:47:42
Lakewood Organic 100% Juice Blend Fresh Pressed Orange & Carrot -- 32 fl ozLakewoodFood & BeveragesVitamin C, Folate, Vitamin A, Thiamin2024-11-29 10:47:42
Lakewood Organic Fresh Pressed Juice Papaya Blend -- 32 fl ozLakewoodFood & BeveragesVitamin C, Folate, Vitamin A, Riboflavin2024-11-29 10:47:42
Lakewood Organic Fresh Pressed Juice Blend Orange & Mango -- 12.5 fl ozLakewoodFood & BeveragesVitamin C, Folate, Pantothenic Acid, Thiamin2024-11-29 10:47:42
Lakewood Organic Juice Concentrate Tart Cherry -- 12.5 fl ozLakewoodFood & BeveragesVitamin C, Folate, Manganese, Niacin, Phosphorus, Vitamin B6, Riboflavin, Thiamin, Vitamin B62024-11-29 10:47:42
Lakewood Organic Pure Juice Fresh Pressed Beet -- 32 fl ozLakewoodFood & BeveragesVitamin C, Folate, Manganese2024-11-29 10:47:42
Lakewood Organic Pure Juice Fresh Pressed Orange -- 12.5 fl ozLakewoodFood & BeveragesVitamin C, Folate, Manganese, Thiamin2024-11-29 10:47:42
Lakewood Organic Pure Juice Fresh Pressed Pomegranate -- 32 fl ozLakewoodFood & BeveragesVitamin C, Folate, Manganese, Pantothenic Acid2024-11-29 10:47:42
Lakewood Organic Pure Orange Juice -- 32 fl ozLakewoodFood & BeveragesVitamin C, Folate, Thiamin2024-11-29 10:47:42
Larabar Gluten Free No Sugar Added Fruit & Nut Bar Peanut Butter & Jelly -- 16 BarsLarabarFood & BeveragesVitamin C, Folic Acid, Niacin, Phosphorus, Vitamin A2024-11-29 10:47:42
Lean1 Nutrition 53 Fat Burning Meal Replacement Chocolate -- 2 lbsLean1Weight ManagementD-alpha-tocopherol acetate, Vitamin C, Biotin, D-calcium pantothenate, Chloride, vitamin D3, Chromium, copper gluconate, Vitamin E, beta glucans, ferrous fumarate, Folate, Vitamin E, L-glutamine, Iodine, Manganese, Molybdenum, Niacin, niacinamide, Pantothenic Acid, Phosphorus, phytosterols, potassium chloride, potassium iodide, pyridoxine hydrochloride, Vitamin B6, vitamin A palmitate, Vitamin A, Riboflavin, Selenium, sodium molybdate, sodium selenate, taurine, thiamine hydrochloride, Thiamin, alpha lipoic acid, calcium phosphate, cyanocobalamin, Vitamin B6, phytonadione, Vitamin K, zinc oxide2024-11-29 10:47:42
Lean1 Nutrition 53 Fat Burning Meal Replacement Vanilla -- 1.72 lbsLean1Weight ManagementLipase, Vitamin C, Biotin, Chloride, Chromium, Vitamin E, Folate, Vitamin E, L-Glutamine, Iodine, Maltodextrin, Manganese, Molybdenum, Niacin, Pantothenic Acid, Phosphorus, Potassium Chloride, Vitamin B6, Vitamin A, Riboflavin, Selenium, Taurine, Thiamin, Sucralose, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Lean1 Nutrition 53 Original Fat Burning Protein Shake Chocolate Peanut Butter -- 2 lbsLean1Weight Managementlipase, DL-alpha tocopheryl acetate, Vitamin C, Biotin, D-calcium pantothenate, dicalcium phosphate, cholecalciferol, Chromium, copper gluconate, Vitamin E, ferrous fumarate, Folate, Vitamin E, glutamine, Iodine, calcium carbonate, maltodextrin, Manganese, Molybdenum, Niacin, Pantothenic Acid, potassium chloride, potassium iodide, pyridoxine hydrochloride, Vitamin B6, vitamin A palmitate, Vitamin A, Riboflavin, Selenium, sodium molybdate, sodium selenate, cane sugar, taurine, Thiamin, sucralose, cyanocobalamin, Vitamin B6, phytonadione, Vitamin K, zinc oxide2024-11-29 10:47:42
Lean1 Nutrition 53 Plant-Based Fat Burning Protein Shake Vanilla -- 1.7 lbsLean1Weight ManagementBiotin, d-calcium pantothenate, dicalcium phosphate, Chromium, copper gluconate, ferrous fumarate, Folate, Iodine, maltodextrin, Manganese, Molybdenum, Niacin, niacinamide, Pantothenic Acid, potassium chloride, potassium iodide, pyridoxine hydrochloride, Vitamin B6, vitamin A palmitate, Vitamin A, Riboflavin, Selenium, sodium bicarbonate, sodium molybdate, sodium selenate, cane sugar, thiamine hydrochloride, Thiamin, titanium dioxide, sucralose, cyanocobalamin, Vitamin B6, zinc oxide2024-11-29 10:47:42
Lean1 Plant-Based Fat Burning Protein Shake Powder Chocolate -- 31.7 ozLean1Weight ManagementBiotin, d-calcium pantothenate, dicalcium phosphate, Chromium, copper gluconate, ferrous fumarate, Folate, Iodine, maltodextrin, Manganese, Molybdenum, Niacin, niacinamide, Pantothenic Acid, potassium chloride, potassium iodide, pyridoxine hydrochloride, Vitamin B6, vitamin A palmitate, Vitamin A, Riboflavin, Selenium, sodium bicarbonate, sodium molybdate, sodium selenate, cane sugar, taurine, thiamine hydrochloride, Thiamin, titanium dioxide, sucralose, cyanocobalamin, Vitamin B6, zinc oxide2024-11-29 10:47:42
Legal Sea Foods Fish Fry Gourmet -- 14.5 ozLegal Sea FoodsFood & Beveragesmonocalcium phosphate, folic acid, maltodextrin, niacin, riboflavin, baking soda2024-11-29 10:47:42
Life Extension BioActive Complete B-Complex -- 60 Vegetarian CapsulesLife ExtensionVitamins & SupplementsPABA, Biotin, D-calcium pantothenate, dicalcium phosphate, calcium sulfate, Folate, Inositol, Niacin, PABA, Pantothenic Acid, Vitamin B6, Riboflavin, stearic acid, Thiamine, Vitamin B12, Vitamin B62024-11-29 10:47:42
Life Extension Folate & Vitamin B12 -- 90 Vegetarian CapsulesLife ExtensionVitamins & Supplementsdicalcium phosphate, Folate, Microcrystalline cellulose, Vitamin B122024-11-29 10:47:42
Life Extension Two-Per-Day Capsules -- 120 CapsulesLife ExtensionVitamins & SupplementsD-alpha tocopheryl succinate, Apigenin, Vitamin C, Biotin, Boron, dicalcium phosphate, Vitamin D3, Vitamin E, riboflavin 5'-phosphate, Folate, Vitamin E, gluconate, Inositol, Iodine, maltodextrin, Manganese, Molybdenum, Niacin, niacinamide, Pantothenic Acid, pyridoxal 5'-phosphate, pyridoxine HCl, Vitamin B6, Vitamin A, Riboflavin, Thiamine, Alpha-Lipoic Acid, beta, Vitamin B12, Vitamin B62024-11-29 10:47:42
Life Extension Two-Per-Day Tablets -- 120 TabletsLife ExtensionVitamins & SupplementsD-alpha tocopheryl succinate, Apigenin, Vitamin C, Biotin, Boron, dicalcium phosphate, Vitamin D3, Vitamin E, riboflavin 5'-phosphate, Folate, Vitamin E, gluconate, glycerin, Microcrystalline cellulose, Inositol, Iodine, maltodextrin, Manganese, Molybdenum, Niacin, niacinamide, Pantothenic Acid, pyridoxal 5'-phosphate, pyridoxine HCI, Vitamin B6, Vitamin A, Riboflavin, stearic acid, Thiamine, Alpha-Lipoic Acid, beta, Vitamin B12, Vitamin B62024-11-29 10:47:42
Lifetime All One Rice Base Multiple Vitamin & Mineral Powder Unflavored -- 2.2 lbsLifetimeVitamins & SupplementsPara Aminobenzoic Acid, Vitamin C, Kelp, Beta Carotene, Betaine HCl, Biotin, Calcium Pantothenate, Dicalcium Phosphate, Choline, Chromium, Vitamin E, Folate, Vitamin E, Inositol, Iodine, Calcium Carbonate, Manganese, Molybdenum, Niacin, Pantothenic Acid, Phosphorus, Potassium Iodide, Vitamin B6, Retinol Acetate, Vitamin A, Riboflavin, Selenium, Thiamine, Vitamin B12, Vitamin B6, Vitamin D2, Vitamin K2024-11-29 10:47:42
Lifetime Multiple Vitamin & Mineral Powder Unflavored -- 2.2 lbsLifetimeVitamins & SupplementsPara Aminobenzoic Acid, Vitamin C, Kelp, Biotin, Calcium Pantothenate, Dicalcium Phosphate, Choline, Chromium, Vitamin E, Folate, Vitamin E, Inositol, Iodine, Calcium Carbonate, Manganese, Molybdenum, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Selenium, Vitamin B1, Vitamin B12, Vitamin B6, Vitamin D2, Vitamin K2024-11-29 10:47:42
Lifetime Supreme Vital Hair -- 120 CapsulesLifetimeVitamins & SupplementsVitamin C, Biotin, L-Cysteine, Folic Acid, Inositol, Vitamin B3, Vitamin B5, Vitamin B6, Vitamin A, Vitamin B2, Vitamin B1, Vitamin B62024-11-29 10:47:42
Lily of the Desert Drink Mix EcoSport Hydration Blueberry Acai -- 24 Stick PacksLily of the DesertActive Lifestyle & Fitness Citric acid, Vitamin C, Biotin, Boron, Chromium, Citric acid, Vitamin E, Folic Acid, Vitamin E, Lutein, Lycopene, Manganese, Molybdenum, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamine, Vitamin B12, Vitamin B6, Vitamin K, Zeaxanthin2024-11-29 10:47:42
Lily of the Desert Drink Mix EcoSport Hydration Lemon Lime -- 24 Stick PacksLily of the DesertActive Lifestyle & Fitness Citric acid, Vitamin C, Biotin, Boron, Chromium, Citric acid, Vitamin E, Folic Acid, Vitamin E, Lutein, Lycopene, Manganese, Molybdenum, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamine, Vitamin B12, Vitamin B6, Vitamin K, Zeaxanthin2024-11-29 10:47:42
Lily of the Desert Drink Mix EcoSport Hydration Watermelon -- 24 Stick PacksLily of the DesertActive Lifestyle & Fitness Citric acid, Vitamin C, Biotin, Boron, Chromium, Citric acid, Vitamin E, Folic Acid, Vitamin E, Lutein, Lycopene, Manganese, Molybdenum, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamine, Vitamin B12, Vitamin B6, Vitamin K, Zeaxanthin2024-11-29 10:47:42
Lily of the Desert EcoDrink Nutrient Support Caffeine Free Blueberry Pomegranate -- 24 Stick PacksLily of the DesertActive Lifestyle & Fitness Citric acid, Vitamin C, Biotin, Boron, Chromium, Citric acid, Vitamin E, Folic Acid, Vitamin E, Lutein, Lycopene, Manganese, Molybdenum, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamine, Vitamin B12, Vitamin B6, Vitamin K, Zeaxanthin2024-11-29 10:47:42
Lily of the Desert EcoDrink Nutrient Support Caffeine Free Fruit Punch -- 24 Stick PacksLily of the DesertActive Lifestyle & Fitness Citric acid, Vitamin C, Biotin, Boron, Chromium, Citric acid, Vitamin E, Folic Acid, Vitamin E, Lutein, Lycopene, Manganese, Molybdenum, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamine, Vitamin B12, Vitamin B6, Vitamin K, Zeaxanthin2024-11-29 10:47:42
Lily of the Desert EcoDrink Nutrient Support Caffeine Free Peach Mango -- 24 Stick PacksLily of the DesertActive Lifestyle & Fitness Citric acid, Vitamin C, Biotin, Boron, Chromium, Citric acid, Vitamin E, Folic Acid, Vitamin E, Lutein, Lycopene, Manganese, Molybdenum, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamine, Vitamin B12, Vitamin B6, Vitamin K, Zeaxanthin2024-11-29 10:47:42
Lily of the Desert EcoDrink Nutrient Support Caffeine Free Strawberry Lemomade -- 24 Stick PacksLily of the DesertActive Lifestyle & Fitness Citric acid, Vitamin C, Biotin, Boron, Chromium, Citric acid, Vitamin E, Folic Acid, Vitamin E, Lutein, Lycopene, Manganese, Molybdenum, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamine, Vitamin B12, Vitamin B6, Vitamin K, Zeaxanthin2024-11-29 10:47:42
Liquid Health B-Complex Mega Energy Passion Orange -- 32 fl ozLiquid HealthVitamins & Supplementscitric acid, Biotin, Choline, citric acid, Folate, Vitamin B3, Vitamin B5, pyridoxal-5 phosphate, pyridoxine hydrochloride, Vitamin B6, Vitamin B2, Vitamin B1, Vitamin B12, Vitamin B62024-11-29 10:47:42
Liquid Health Complete Multiple Natural Berry -- 32 fl ozLiquid HealthVitamins & Supplementscitric acid, Vitamin C, Biotin, Boron, d-calcium pantothenate, Choline, Chromium, citric acid, Vitamin E, erythritol, Riboflavin 5 phosphate, Folate, Vitamin E, malic acid, Manganese, Molybdenum, Niacin Vitamin B3, Pantothenic Acid, allulose, pyridoxal 5 phosphate, Vitamin B6, Vitamin A, Vitamin B12, Vitamin B62024-11-29 10:47:42
Little DaVinci Kids Focus Brain Health Tasty Orange -- 90 Chewable TabletsLittle DaVinciProfessional SupplementsBetaine Anhydrous, N,N-Dimethylglycine, Folate, microcrystalline cellulose, Vitamin B6, Sorbitol, stearic acid, Vitamin B12, Vitamin B62024-11-29 10:47:42
Little DaVinci Kids Mightiest Vite Multivitamin Powder Fruit Punch -- 30 ServingsLittle DaVinciProfessional Supplementscitric acid, Vitamin C, Vitamin D3, citric acid, Vitamin E, Folate, Vitamin E, Niacinamide, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
LivOn Laboratories Lypo-Spheric™ B-Complex plus -- 30 PacketsLivOn LaboratoriesVitamins & SupplementsBenfotiamine, Biotin, Boron, Chromium, Folate, Niacin, Pantothenic Acid, Vitamin B6, Riboflavin, Selenium, Vanadium, Vitamin B12, Vitamin B62024-11-29 10:47:42
Luna Gluten Free Whole Nutrition Bars Blueberry Bliss -- 15 BarsLunaFood & BeveragesVitamin C, Vitamin E, Folate, Vitamin E, Niacin, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Luna Gluten Free Whole Nutrition Bars Chocolate Cupcake -- 15 BarsLunaFood & BeveragesVitamin C, Vitamin E, Folate, Vitamin E, Niacin, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Luna Gluten Free Whole Nutrition Bars Chocolate Peppermint Stick -- 15 BarsLunaFood & BeveragesVitamin C, Vitamin E, Folate, Vitamin E, Niacin, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Luna Gluten Free Whole Nutrition Bars LemonZest -- 15 BarsLunaFood & BeveragesVitamin C, Vitamin E, Folate, Vitamin E, Niacin, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Manitoba Harvest Hemp Hearts Shelled Hemp Seeds Natural -- 2 ozManitoba HarvestFood & BeveragesVitamin C, Folate, Manganese, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Thiamin, Vitamin B62024-11-29 10:47:42
Manitoba Harvest Hemp Hearts Shelled Hemp Seeds -- 1 lbManitoba HarvestFood & BeveragesFolate, Manganese, Phosphorus, Vitamin B6, Riboflavin, Thiamin, Vitamin B62024-11-29 10:47:42
Manitoba Harvest Hemp Hearts Shelled Hemp Seeds -- 5 lbManitoba HarvestFood & BeveragesFolate, Manganese, Phosphorus, Vitamin B6, Riboflavin, Thiamin, Vitamin B62024-11-29 10:47:42
Manitoba Harvest Hemp Hearts Shelled Hemp Seeds -- 8 ozManitoba HarvestFood & BeveragesFolate, Manganese, Phosphorus, Vitamin B6, Riboflavin, Thiamin, Vitamin B62024-11-29 10:47:42
Manitoba Harvest Instant Superseed Oatmeal Apple & Cinnamon -- 9 ozManitoba HarvestFood & BeveragesVitamin E, Folate, Vitamin E, Manganese, Niacin, Phosphorus, Vitamin B6, Riboflavin, Selenium, Thiamin, Vitamin B62024-11-29 10:47:42
Manitoba Harvest Instant Superseed Oatmeal Maple & Brown Sugar -- 9 ozManitoba HarvestFood & BeveragesVitamin E, Folate, Vitamin E, Manganese, Niacin, Phosphorus, Vitamin B6, Riboflavin, Selenium, Thiamin, Vitamin B62024-11-29 10:47:42
Manitoba Harvest Organic Ground Hemp Seed -- 7 ozManitoba HarvestVitamins & SupplementsFolate, Manganese, Niacin, Phosphorus, Vitamin B6, Riboflavin, Thiamin, Vitamin B62024-11-29 10:47:42
Manitoba Harvest Organic Hemp + Chia & Flax -- 7 ozManitoba HarvestVitamins & SupplementsVitamin E, Folate, Vitamin E, Manganese, Niacin, Phosphorus, Vitamin B6, Riboflavin, Selenium, Thiamin, Vitamin B62024-11-29 10:47:42
Manitoba Harvest Organic Hemp Hearts Shelled Hemp Seeds -- 5 lbManitoba HarvestFood & BeveragesVitamin C, Folate, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Thiamin, Vitamin B62024-11-29 10:47:42
Manitoba Harvest Organic Hemp Hearts Shelled Hemp Seeds -- 7 ozManitoba HarvestFood & BeveragesFolate, Manganese, Phosphorus, Vitamin B6, Riboflavin, Thiamin, Vitamin B62024-11-29 10:47:42
Manitoba Harvest Organic Hemp+ Matcha Powder -- 5.5 ozManitoba HarvestVitamins & SupplementsVitamin C, Folate, Manganese, Phosphorus, Thiamin2024-11-29 10:47:42
Manitoba Harvest Organic Hemp+ Supergreens Powder -- 7.5 ozManitoba HarvestVitamins & SupplementsVitamin C, Folate, Manganese, Phosphorus, Vitamin B6, Vitamin A, Thiamin, Vitamin B62024-11-29 10:47:42
Mason Natural Daily Multiple Vitamins With Iron -- 365 TabletsMason NaturalVitamins & SupplementsPABA, Vitamin C, Vitamin E, Folate, Vitamin E, Microcrystalline cellulose, Vitamin B3, PABA, Pantothenic Acid, Vitamin B6, Vitamin A, Vitamin B2, stearic acid, Vitamin B1, titanium dioxide, Vitamin B12, Vitamin B6, Vitamin D22024-11-29 10:47:42
Mason Natural Folic Acid -- 800 mcg - 100 TabletsMason NaturalVitamins & SupplementsFolate, microcrystalline cellulose, stearic acid2024-11-29 10:47:42
Mason Natural Folic Acid B-6 & B-12 -- 90 TabletsMason NaturalVitamins & SupplementsFolate, Microcrystalline cellulose, calcium carbonate, Vitamin B6, stearic acid, Vitamin B12, Vitamin B62024-11-29 10:47:42
Mason Natural Prenatal Multivitamin with DHA & Zinc Banana Orange -- 60 GummiesMason NaturalVitamins & Supplementscitrus pectin, citric acid, Vitamin C, beta carotene, Vitamin D3, citric acid, Vitamin E, Folate, Vitamin E, Niacin, Vitamin B6, Vitamin A, sodium citrate, Vitamin B12, Vitamin B62024-11-29 10:47:42
Mason Natural Stress B-Complex with Antioxidants + Zinc -- 60 TabletsMason NaturalVitamins & SupplementsVitamin C, Biotin, Vitamin E, Folate, Vitamin E, Microcrystalline cellulose, Niacin, Pantothenic Acid, Vitamin B6, Vitamin B2, stearic acid, Vitamin B1, titanium dioxide, glyceryl triacetate, Vitamin B12, Vitamin B62024-11-29 10:47:42
MegaFood Baby & Me 2 Prenatal Multivitamin with Folate and Choline -- 120 TabletsMegaFoodVitamins & SupplementsVitamin C, Biotin, Vitamin D3, Choline, Vitamin E, Folate, Vitamin E, Microcrystalline cellulose, Iodine, Manganese, Vitamin K2, Vitamin K2, Molybdenum, Niacin, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, Selenium, stearic acid, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
MegaFood Balanced B Complex with Vitamin B12, Vitamin B6 and Folate -- 60 TabletsMegaFoodVitamins & SupplementsBiotin, Folate, Microcrystalline cellulose, Niacin, Pantothenic Acid, Vitamin B6, Riboflavin, stearic acid, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
MegaFood Balanced B Complex with Vitamin B12, Vitamin B6 and Folate -- 90 TabletsMegaFoodVitamins & SupplementsBiotin, Folate, Microcrystalline cellulose, Niacin, Pantothenic Acid, Vitamin B6, Riboflavin, stearic acid, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
MegaFood Blood Builder Iron Supplement Minis with Vitamin C -- 60 TabletsMegaFoodVitamins & SupplementsVitamin C, Folate, stearic acid, Vitamin B122024-11-29 10:47:42
MegaFood Blood Builder Iron Supplement with Vitamin C -- 180 TabletsMegaFoodVitamins & SupplementsVitamin C, Folate, stearic acid, Vitamin B122024-11-29 10:47:42
MegaFood Blood Builder Iron Supplement with Vitamin C -- 30 TabletsMegaFoodVitamins & SupplementsVitamin C, Folate, stearic acid, Vitamin B122024-11-29 10:47:42
MegaFood Blood Builder Iron Supplement with Vitamin C -- 60 TabletsMegaFoodVitamins & SupplementsVitamin C, Folate, stearic acid, Vitamin B122024-11-29 10:47:42
MegaFood Kids B Complex Vitamins -- 30 Mini TabletsMegaFoodVitamins & SupplementsBiotin, Folate, microcrystalline cellulose, Inositol, Niacin, Pantothenic Acid, Vitamin B6, Riboflavin, stearic acid, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
MegaFood Kids Multivitamin Brain & Immune Support Berrylicious -- 60 GummiesMegaFoodVitamins & Supplementscitric acid, Vitamin C, Biotin, Vitamin D3, Choline, Chromium, citric acid, Vitamin E, Folate, Vitamin E, Iodine, Molybdenum, Niacin, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, Selenium, sodium citrate, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
MegaFood Kids One Daily Multivitamin Grape -- 30 Soft ChewsMegaFoodVitamins & Supplementscitric acid, Vitamin C, Biotin, Vitamin D3, Chromium, citric acid, Vitamin E, Folate, Vitamin E, glycerin, malic acid, Molybdenum, Niacin, Pantothenic Acid, Vitamin B6, Vitamin A, Vitamin B12, Vitamin B62024-11-29 10:47:42
MegaFood Kids One Daily Multivitamin Bone Health Immune Support -- 60 Mini TabletsMegaFoodVitamins & SupplementsVitamin C, Biotin, Boron, Vitamin D3, Vitamin E, Folate, Vitamin E, microcrystalline cellulose, Iodine, Manganese, Molybdenum, Niacin, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, Selenium, Stearic acid, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
MegaFood Methyl B12 Vitamins -- 90 TabletsMegaFoodVitamins & SupplementsFolate, Microcrystalline cellulose, Vitamin B6, stearic acid, Vitamin B12, Vitamin B62024-11-29 10:47:42
MegaFood Multivitamin for Men - Gummy Vitamins Wild Blueberry -- 60 GummiesMegaFoodVitamins & Supplementscitric acid, Vitamin C, Biotin, Vitamin D3, Chromium, citric acid, Vitamin E, Folate, Vitamin E, Iodine, Lycopene, Molybdenum, Niacin, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
MegaFood Multivitamin for Women - Gummy Vitamins Tangerine -- 60 GummiesMegaFoodVitamins & Supplementscitric acid, Vitamin C, Biotin, Boron, Vitamin D3, Choline, Chromium, citric acid, Vitamin E, Folate, Vitamin E, Iodine, Molybdenum, Niacin, Vitamin B6, Vitamin A, Vitamin B2, Selenium, sodium citrate, Vitamin B1, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
MegaFood Vegan B12 with Vitamin B6 and Folate as Folic Acid -- 30 TabletsMegaFoodVitamins & SupplementsFolate, microcrystalline cellulose, Vitamin B6, stearic acid, Vitamin B12, Vitamin B62024-11-29 10:47:42
MegaFood Women Over 55+ One Daily Multivitamin -- 120 TabletsMegaFoodVitamins & SupplementsVitamin C, Biotin, Vitamin D3, Vitamin E, Folate, Vitamin E, Microcrystalline cellulose, Iodine, Manganese, Molybdenum, Niacin, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, Selenium, stearic acid, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
MegaFood Women Over 55+ One Daily Multivitamin -- 60 TabletsMegaFoodVitamins & SupplementsVitamin C, Biotin, Vitamin D3, Vitamin E, Folate, Vitamin E, Microcrystalline cellulose, Iodine, Manganese, Molybdenum, Niacin, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, Selenium, stearic acid, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
MegaFood Women Over 55+ One Daily Multivitamin -- 90 TabletsMegaFoodVitamins & SupplementsVitamin C, Biotin, Vitamin D3, Vitamin E, Folate, Vitamin E, Microcrystalline cellulose, Iodine, Manganese, Molybdenum, Niacin, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, Selenium, stearic acid, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
MenoLabs MenoFit® Menopause Probiotic for Healthy Weight -- 60 CapsulesMenoLabsVitamins & SupplementsL-5-methyltetrahydrofolate, Vitamin C, Benfotiamine, Vitamin D3, Folate, Vitamin K2, Vitamin K2, Vitamin B6, Riboflavin, Vitamin B12, Vitamin B62024-11-29 10:47:42
MenoLabs Menoglow Menopause Probiotic for Signs of Aging -- 60 CapsulesMenoLabsVitamins & SupplementsVitamin C, Benfotiamine, Vitamin D3, Folate, Vitamin K2, Vitamin K2, Vitamin B6, Riboflavin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Mi-Del Simply Mi-Delicious Ginger Snaps -- 10 ozMi-DelFood & BeveragesVitamin C, folic acid, niacin, Vitamin A, riboflavin, baking soda, thiamine2024-11-29 10:47:42
Mi-Del Swedish Style Cookies Lemon Snaps -- 10 ozMi-DelFood & BeveragesVitamin C, folic acid, niacin, Vitamin A, riboflavin, baking soda2024-11-29 10:47:42
Mill Creek Botanicals Biotin Therapy Formula Shampoo -- 14 fl ozMill CreekBeauty & Personal Carecitric acid, biotin, calendula, citric acid, cocamidopropyl betaine, goldenseal, panthenol, provitamin B5, vitamin B9, glycerin, niacin, sodium benzoate2024-11-29 10:47:42
Mill Creek Jojoba Balancing Formula Conditioner -- 14 fl ozMill CreekBeauty & Personal Carecitric acid, allantoin, biotin, calendula, cetearyl alcohol, citric acid, goldenseal, panthenol, provitamin B5, vitamin B9, glycerin, niacin, retinyl palmitate, vitamin A, sodium benzoate2024-11-29 10:47:42
Mill Creek Jojoba Balancing Formula Shampoo -- 14 fl ozMill CreekBeauty & Personal Carecitric acid, allantoin, biotin, citric acid, golden seal, panthenol, provitamin B5, vitamin B9, glycerin, niacin, sodium benzoate2024-11-29 10:47:42
Momentous Brain Drive - NSF Certified for Sport - Informed Sport Certified - 30 Servings -- 60 CapsulesMomentousProfessional SupplementsFolate, Niacin, Vitamin B6, Vitamin B12, Vitamin B62024-11-29 10:47:42
Momentous Essential Multivitamin - NSF Certified for Sport - 30 Servings -- 120 Vegetarian CapsulesMomentousProfessional SupplementsVitamin C, Benfotiamine, Biotin, Boron, Chromium, Folate, microcrystalline cellulose, Lycopene, Manganese, MK-7, MK-9, Molybdenum, Niacin, Pantethine, Pantothenic Acid, Vitamin B6, Quercetin, Trans-Resveratrol, Vitamin A, Riboflavin, Selenium, Thiamin, Vanadium, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
MRM B-12 Methylcobalamin -- 2000 mcg - 60 LozengesMRMVitamins & SupplementsFolic Acid, orange flavor, maltodextrin, sorbitol, Sucrose, Vitamin B122024-11-29 10:47:42
MRM Veggie Meal Replacement Vanilla Bean -- 3 lbsMRMActive Lifestyle & FitnessAlanine, Arginine, Vitamin C, Aspartic Acid, Biotin, Cysteine, Vitamin E, Folate, Vitamin E, Glutamic Acid, Glycine, Histidine, Iodine, Isoleucine, Leucine, Lysine, Methionine, Niacin, Pantothenic Acid, Phenylalanine, Phosphorus, Proline, Vitamin B6, Vitamin A, Riboflavin, Serine, Thiamin, Threonine, trehalose, Tryptophan, Tyrosine, Valine, Vitamin B6, Vitamin D22024-11-29 10:47:42
My Cookie Dealer Protein Cookies Double Chocolate Chip -- 12 CookiesMy Cookie DealerActive Lifestyle & Fitnessfolic acid, niacin, riboflavin, baking soda, sugar2024-11-29 10:47:42
My Cookie Dealer Protein Cookies Milk & Cookies -- 12 CookiesMy Cookie DealerActive Lifestyle & Fitnessfolic acid, invert sugar, niacin, phosphoric acid, vitamin B2, baking soda, sugar2024-11-29 10:47:42
Natrol Complete Balance® for Menopause AM - PM -- 60 CapsulesNatrolVitamins & SupplementsFolic Acid, maltodextrin, Vitamin B6, Riboflavin, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Natrol JuiceFestiv® Daily Fruit and Daily Veggie -- 60 Capsule BottlesNatrolVitamins & SupplementsVitamin C, dibasic calcium phosphate, Folate, maltodextrin, Vitamin B6, Vitamin A, Vitamin B12, Vitamin B62024-11-29 10:47:42
Natrol L-Arginine -- 5000 mg - 90 TabletsNatrolVitamins & SupplementsFolate, glycerin, methylcellulose, Vitamin B6, stearic acid, Vitamin B12, Vitamin B62024-11-29 10:47:42
Natrol Memory Complex -- 60 TabletsNatrolVitamins & Supplementsdicalcium phosphate, Folate, glycerin, Huperzine A, Microcrystalline cellulose, maltodextrin, methylcellulose, Vitamin B3, Phosphorus, Vitamin B6, stearic acid, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Naturade Total Soy® Meal Replacement Strawberry Creme -- 17.88 ozNaturadeWeight Managementd-alpha tocopheryl succinate, Vitamin C, beta carotene, Biotin, calcium pantothenate, Vitamin D3, Chromium, Vitamin E, Fructose, ferrous sulfate, Folate, Vitamin E, Iodine, maltodextrin, Manganese, Niacin, niacinamide, Pantothenic Acid, Phosphorus, potassium chloride, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, cyanocobalamin, Vitamin B62024-11-29 10:47:42
Naturade VeganSmart Protein & Greens Vanilla Crème -- 22.8 ozNaturadeWeight ManagementVitamin C, Biotin, Chromium, Folate, GI, Iodine, Manganese, Molybdenum, Niacin, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, Selenium, Sugar, Thiamin, Vitamin B12, Vitamin B6, Vitamin D2, Vitamin K2024-11-29 10:47:42
Naturade VeganSmart™ All-In-One Nutritional Shake Chai -- 15 ServingsNaturadeWeight ManagementVitamin C, Biotin, Chromium, Folate, Iodine, Manganese, Molybdenum, Niacin, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B6, Vitamin D2, Vitamin K2024-11-29 10:47:42
Naturade VeganSmart™ All-In-One Nutritional Shake Chocolate -- 15 ServingsNaturadeWeight ManagementVitamin C, Biotin, Chromium, Folate, Iodine, Manganese, Molybdenum, Niacin, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B6, Vitamin D2, Vitamin K2024-11-29 10:47:42
Naturade VeganSmart™ All-In-One Nutritional Shake Vanilla -- 15 ServingsNaturadeWeight ManagementVitamin C, Biotin, Chromium, Folate, Iodine, Manganese, Molybdenum, Niacin, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B6, Vitamin D2, Vitamin K2024-11-29 10:47:42
Natural Balance Happy Camper Stress Chill -- 120 VegCapsNatural BalanceVitamins & SupplementsChamomile, Folate, Lithium, maltodextrin, Vitamin B6, Selenium, Vitamin B12, Vitamin B62024-11-29 10:47:42
Natural Balance Maximum Strength Liquid Biotin Dietary Supplement Citrus -- 5000 mcg - 2 fl ozNatural BalanceVitamins & SupplementsBiotin, Folic Acid, Malic acid, Sodium Benzoate, Xylitol2024-11-29 10:47:42
Natural Dog Company Multivitamin Supplements For Dogs -- 90 Soft ChewsNatural Dog CompanyPet Suppliesascorbic acid, beta carotene, vitamin B7, Choline, Vitamin E, ferrous gluconate, Folic Acid, vitamin E, inositol, Iodine, Manganese, Niacin, Pantothenic Acid, potassium iodate, pyridoxine hydrochloride, vitamin B6, vitamin A acetate, Vitamin A, vitamin B2, Selenium, vitamin B1, Vitamin B12, vitamin B6, vitamin K2024-11-29 10:47:42
Natural Stacks Brain Food Stacks -- 60 Vegetarian CapsulesNatural StacksVitamins & Supplementsascorbyl palmitate, Vitamin C, Trimethylglycine, Trimethylglycine, cellulose, Folate, L-Phenylalanine, Vitamin B6, Vitamin B12, Vitamin B62024-11-29 10:47:42
Natural Stacks Dopamine Brain Food Capsules -- 45 Vegetarian CapsulesNatural StacksVitamins & Supplementsascorbyl palmitate, Vitamin C, Trimethylglycine, Trimethylglycine, cellulose, Folate, L-Phenylalanine, Vitamin B6, Vitamin B12, Vitamin B62024-11-29 10:47:42
Natural Stacks Focus Stack - NeuroFuel & Dopamine -- 60 Vegetarian CapsulesNatural StacksVitamins & Supplementsascorbyl palmitate, Vitamin C, Trimethylglycine, Trimethylglycine, Folate, L-Phenylalanine, Vitamin B6, Vitamin B12, Vitamin B62024-11-29 10:47:42
Nature Made Folic Acid -- 400 mcg - 250 TabletsNature MadeVitamins & SupplementsFolate, maltodextrin2024-11-29 10:47:42
Nature Made Multi For Her -- 90 TabletsNature MadeVitamins & SupplementsVitamin C, Biotin, Vitamin D 3, Chromium, Vitamin E, Folic Acid, Vitamin E, Iodine, maltodextrin, Manganese, Molybdenum, Niacin, Pantothenic Acid, Vitamin B6, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Nature Made Multi For Her 50+ -- 90 TabletsNature MadeVitamins & SupplementsVitamin C, Biotin, Vitamin D3, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Manganese, Molybdenum, Niacin, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Nature Made Stress B-Complex -- 75 TabletsNature MadeVitamins & Supplementsdl-alpha tocopheryl acetate, Vitamin C, Biotin, d-calcium pantothenate, Vitamin E, folic acid, Vitamin E, Niacin, niacinamide, Pantothenic Acid, pyridoxine hydrochloride, Vitamin B6, Riboflavin, stearic acid, Thiamin, Vitamin B12, Vitamin B6, zinc sulfate2024-11-29 10:47:42
Nature Made Super B Energy Complex -- 60 SoftgelsNature MadeVitamins & SupplementsBiotin, dibasic calcium phosphate, Folate, glycerin, Niacin, Pantothenic Acid, Vitamin B6, Riboflavin, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
NuGo Nutrition Original Protein Bar Churro -- 1.76 oz Each / Pack of 15NuGo NutritionWeight ManagementVitamin C, Vitamin E, Folate, Vitamin E, Niacin, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, cane sugar, Thiamin, vanilla, Vitamin B12, Vitamin B62024-11-29 10:47:42
NuGo Nutrition Protein Bars Orange Smoothie -- 15 BarsNuGo NutritionWeight ManagementVitamin C, Vitamin E, Folate, vitamin E, calcium carbonate, Niacin, niacinamide, palmitate, Phosphorus, Vitamin B6, Vitamin A, vitamin B2, cane sugar, Thiamin, vitamin B1, cyanocobalamin, vitamin B62024-11-29 10:47:42
NuGo Nutrition To Go Bars Chocolate -- 15 BarsNuGo NutritionWeight Managementd-alpha tocopheryl acetate, Vitamin C, dicalcium phosphate, Vitamin E, fructose, Folic Acid, vitamin E, calcium carbonate, maltodextrin, Niacin, niacinamide, pyridoxine hydrochloride, Vitamin B6, Vitamin A, Riboflavin, cane sugar, Thiamin, cyanocobalamin, vitamin B-62024-11-29 10:47:42
NuGo Nutrition To Go Bars Chocolate Banana -- 15 BarsNuGo NutritionWeight ManagementVitamin C, dicalcium phosphate, Vitamin E, fructose, vitamin B9, Vitamin E, microcrystalline cellulose, maltodextrin, Niacin, niacinamide, palmitate, pyridoxine hydrochloride, Vitamin B6, Vitamin A, vitamin B2, cane sugar, Thiamin, cyanocobalamin, vitamin B62024-11-29 10:47:42
NuGo Nutrition To Go Bars Coffee -- 15 BarsNuGo NutritionWeight ManagementD-alpha tocopheryl acetate, Vitamin C, dicalcium phosphate, Vitamin E, fructose, folic acid, vitamin E, microcrystalline cellulose, calcium carbonate, maltodextrin, Niacin, niacinamide, pyridoxine hydrochloride, Vitamin B6, Vitamin A, Riboflavin, cane sugar, Thiamin, cyanocobalamin, vitamin B-62024-11-29 10:47:42
NuGo Nutrition To Go Bars Peanut Butter Chocolate -- 15 BarsNuGo NutritionWeight Managementd-alpha tocopheryl acetate, Vitamin C, dicalcium phosphate, Vitamin E, fructose, folic acid, vitamin E, microcrystalline cellulose, calcium carbonate, Niacin, niacinamide, pyridoxine hydrochloride, Vitamin B6, Vitamin A, Riboflavin, sugar, Thiamin, cyanocobalamin, vitamin B-62024-11-29 10:47:42
NuGo Nutrition To Go Bars Vanilla Yogurt -- 15 BarsNuGo NutritionWeight Managementd-alpha tocopheryl acetate, Vitamin C, dicalcium phosphate, Vitamin E, fructose, folic acid, vitamin E, microcrystalline cellulose, maltodextrin, Niacin, niacinamide, Phosphorus, pyridoxine hydrochloride, Vitamin B6, Vitamin A, Riboflavin, beet sugar, Thiamin, Vitamin B12, vitamin B62024-11-29 10:47:42
Nutiva Organic Shelled Hemp Seeds -- 19 ozNutivaFood & BeveragesFolate, Manganese, Niacin, Phosphorus, Vitamin B6, Riboflavin, Thiamin, Vitamin B62024-11-29 10:47:42
NutraBio Extreme Mass Chocolate -- 15.6 ServingsNutraBioActive Lifestyle & FitnessVitamin C, Biotin, cholecalciferol, Chromium, Vitamin E, Folic Acid, Vitamin E, Iodine, Maltodextrin, Vitamin B3, niacinamide, Pantothenic Acid, Phosphorus, potassium iodide, pyridoxine hydrochloride, Vitamin B6, vitamin A palmitate, Riboflavin, Selenium, Thiamin, sucralose, Vitamin B12, Vitamin B6, vitamin K1, Vitamin K2024-11-29 10:47:42
NutraBio Extreme Mass Vanilla -- 15.6 ServingsNutraBioActive Lifestyle & FitnessVitamin C, Biotin, cholecalciferol, Chromium, Vitamin E, Folic Acid, Vitamin E, Iodine, Maltodextrin, Vitamin B3, niacinamide, Pantothenic Acid, Phosphorus, potassium iodide, pyridoxine hydrochloride, Vitamin B6, vitamin A palmitate, Riboflavin, Selenium, Thiamin, sucralose, Vitamin B12, Vitamin B6, vitamin K1, Vitamin K2024-11-29 10:47:42
NutraBio MultiSport for Men -- 120 CapsulesNutraBioActive Lifestyle & FitnessVitamin C, Biotin, Boron, Choline, Chromium, Vitamin E, Folate, Vitamin E, Inositol, Iodine, Manganese, Molybdenum, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Alpha-Lipoic Acid, Vanadium, Vitamin B12, Vitamin B62024-11-29 10:47:42
NutraBio MultiSport for Women -- 120 CapsulesNutraBioActive Lifestyle & FitnessVitamin C, Biotin, Boron, Choline, Chromium, Vitamin E, Folate, Vitamin E, Inositol, Iodine, Manganese, Molybdenum, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Alpha-Lipoic Acid, Vanadium, Vitamin B12, Vitamin B62024-11-29 10:47:42
NutraChamps B Complex Liquid Drops Raspberry -- 2 fl ozNutraChampsVitamins & Supplementscitric acid, D-Biotin, citric acid, Folate, Niacin, Pantothenic Acid, Pyridoxine, Riboflavin, Thiamine2024-11-29 10:47:42
NutraChamps Vitamin D3 + B12 Gummies Raspberry -- 60 GummiesNutraChampsVitamins & Supplementscitrus pectin, citric acid, Vitamin D3, citric acid, Folate, sodium citrate, Sugar, Vitamin B122024-11-29 10:47:42
Nutrex Research ISOFIT - 30 Servings Cookies & Cream -- 2.3 lbsNutrex ResearchActive Lifestyle & Fitnessfolic acid, niacin, vitamin B2, sugar, vitamin B1, sucralose2024-11-29 10:47:42
Nutrex Research LIPO-6® Black Hers -- 60 CapsulesNutrex ResearchActive Lifestyle & FitnessCaffeine Anhydrous, Folic Acid, Glycerin, Rauwolscine, Vitamin B12, Yohimbine2024-11-29 10:47:42
Nutri 5-MTHF L-Methylfolate -- 15 mg - 120 Vegan TabletsNutriVitamins & SupplementsFolate2024-11-29 10:47:42
Nutri Lutein Zeaxanthin & Meso-Zeaxantin Triple Caretenoid Vision Complex -- 20/12 mg - 60 Vegan CapsulesNutriVitamins & SupplementsVitamin C, Vitamin D3, Copper Gluconate, Vitamin E, Folate, Vitamin E, Lutein, Meso-Zeaxanthin, Vitamin A, Selenium, Zeaxanthin2024-11-29 10:47:42
Nutri Methylfolate 5-MTHF -- 1 mg - 120 Vegan TabletsNutriVitamins & Supplementsdicalcium phosphate, Folate2024-11-29 10:47:42
NutriBiotic Multi Vitamins & Minerals -- 180 CapsulesNutriBioticVitamins & SupplementsPara Aminobenzoic Acid, Vitamin C, Glucono delta lactone, Biotin, Vitamin D3, Choline, Chromium, Vitamin E, Folate, Vitamin E, Inositol, calcium carbonate, Manganese, Molybdenum, Niacin, Pantothenic Acid, Vitamin B6, Vitamin A, Vitamin B2, Selenium, montmorillonite, Thiamin, Vanadium, Vitamin B12, Vitamin B62024-11-29 10:47:42
NutriCology B12 Adenosylcobalamin Vegetarian Lozenges -- 3000 mcg - 60 LozengesNutriCologyVitamins & Supplementscellulose, Folic Acid, Sorbitol, stearic acid, Vitamin B122024-11-29 10:47:42
NutriCology Ocudyne II -- 200 CapsulesNutriCologyVitamins & SupplementsN-Acetyl L-Cysteine, Vitamin C, Boron, Vitamin D3, Chromium, Vitamin E, Folic Acid, Vitamin E, Glutamic Acid, Glycine, microcrystalline cellulose, Iodine, Lutein, Lycopene, Manganese, Molybdenum, Niacin, Pantothenic Acid, Vitamin B6, Quercetin, Vitamin A, Riboflavin, Selenium, Taurine, Thiamin, Alpha-Lipoic Acid, Vitamin B12, Vitamin B6, Zeaxanthin2024-11-29 10:47:42
NutriCology Super B Vitamins Non Yeast or Corn Derived -- 120 Vegetarian CapsulesNutriCologyVitamins & SupplementsPABA, Biotin, Folate, Inositol, Niacin, PABA, Pantothenic Acid, Vitamin B6, Riboflavin, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
NUUN Vitamins + Caffeine Hydration Single Tube Blackberry Citrus -- 10 TabletsNUUNActive Lifestyle & Fitnesscitric acid, d-alpha tocopherol acetate, Vitamin C, Chloride, citric acid, Vitamin E, folic acid, vitamin E, calcium carbonate, potassium bicarbonate, pyridoxal 5-phosphate, Vitamin B6, retinyl acetate, Vitamin A, riboflavin, sodium carbonate, vitamin B6, ergocalciferol2024-11-29 10:47:42
NUUN Vitamins + Caffeine Hydration Single Tube Ginger Lemonade -- 10 TabletsNUUNActive Lifestyle & Fitnesscitric acid, d-alpha tocopherol acetate, Vitamin C, Chloride, citric acid, Vitamin E, folic acid, vitamin E, calcium carbonate, potassium bicarbonate, pyridoxal 5-phosphate, Vitamin B6, retinyl acetate, Vitamin A, riboflavin, sodium carbonate, vitamin B6, ergocalciferol2024-11-29 10:47:42
NUUN Vitamins Hydration Single Tube Blueberry Pomegranate -- 10 TabletsNUUNActive Lifestyle & Fitnesscitric acid, Vitamin C, Chloride, citric acid, Vitamin E, Folic Acid, Vitamin E, Vitamin B6, Vitamin A, riboflavin, sodium carbonate, Sugar, Vitamin B62024-11-29 10:47:42
NUUN Vitamins Hydration Single Tube Grapefruit Orange -- 10 TabletsNUUNActive Lifestyle & Fitnesscitric acid, d-alpha tocopherol acetate, Vitamin C, Chloride, citric acid, Vitamin E, folic acid, vitamin E, calcium carbonate, potassium bicarbonate, pyridoxal 5-phosphate, Vitamin B6, retinyl acetate, Vitamin A, riboflavin, sodium carbonate, vitamin B6, ergocalciferol2024-11-29 10:47:42
NUUN Vitamins Hydration Single Tube Strawberry Melon -- 10 TabletsNUUNActive Lifestyle & Fitnesscitric acid, d-alpha tocopherol acetate, Vitamin C, Chloride, citric acid, Vitamin E, folic acid, vitamin E, calcium carbonate, potassium bicarbonate, pyridoxal 5-phosphate, Vitamin B6, retinyl acetate, Vitamin A, riboflavin, sodium carbonate, vitamin B6, ergocalciferol2024-11-29 10:47:42
NUUN Vitamins Hydration Single Tube Tangerine Lime -- 10 TabletsNUUNActive Lifestyle & Fitnesscitric acid, d-alpha tocopherol acetate, Vitamin C, Chloride, citric acid, Vitamin E, folic acid, vitamin E, calcium carbonate, potassium bicarbonate, pyridoxal 5-phosphate, Vitamin B6, retinyl acetate, Vitamin A, riboflavin, sodium carbonate, vitamin B6, ergocalciferol2024-11-29 10:47:42
Olly Adult Multi Probiotic Gummy Tropical Twist -- 70 GummiesOllyVitamins & Supplementscitric acid, Vitamin C, Biotin, Chromium, citric acid, Vitamin E, Folate, Vitamin E, Iodine, Niacin, Pantothenic Acid, Vitamin B6, Vitamin A, Selenium, Cane sugar, Vitamin B12, Vitamin B62024-11-29 10:47:42
Olly Kids Multi Gummy Worms Sour Fruity Punch -- 70 GummiesOllyVitamins & Supplementscitric acid, Vitamin C, Biotin, Choline, citric acid, Vitamin E, Folate, Vitamin E, Iodine, lactic acid, Pantothenic Acid, Vitamin B6, Vitamin A, beet sugar, Vitamin B12, Vitamin B62024-11-29 10:47:42
Olly Kids Multi Plus Probiotic Yum Berry Punch -- 100 GummiesOllyVitamins & Supplementscitric acid, Vitamin C, Biotin, Choline, citric acid, Vitamin E, Folate, Vitamin E, Iodine, lactic acid, Pantothenic Acid, Vitamin B6, Vitamin A, Cane sugar, Vitamin B12, Vitamin B62024-11-29 10:47:42
Olly Kids Multi plus Probiotic Yum Berry Punch -- 70 GummiesOllyVitamins & Supplementscitric acid, Vitamin C, Biotin, citric acid, Vitamin E, Folic Acid, Vitamin E, Iodine, lactic acid, Pantothenic Acid, Vitamin B6, Vitamin A, Cane sugar, Vitamin B12, Vitamin B62024-11-29 10:47:42
Olly Teen Girl Multi Berry Melon Besties -- 70 GummiesOllyVitamins & Supplementscitric acid, Vitamin C, Biotin, Vitamin D3, Chromium, citric acid, Vitamin E, Folate, Vitamin E, Iodine, lactic acid, Niacin, Pantothenic Acid, Vitamin B6, Vitamin A, Selenium, beet sugar, Vitamin B12, Vitamin B62024-11-29 10:47:42
Olly The Essential Prenatal Sweet Citrus -- 60 GummiesOllyVitamins & Supplementscitric acid, ascorbyl palmitate, Vitamin C, Choline, citric acid, Vitamin E, EPA, Folate, Vitamin E, lactic acid, Niacin, Vitamin B6, Vitamin A, sugar, Vitamin B12, Vitamin B62024-11-29 10:47:42
Olly Ultra Strength Hair -- 30 SoftgelsOllyVitamins & SupplementsBiotin, Folate, glycerin, Vitamin B122024-11-29 10:47:42
Olly Ultra Strength Prenatal Folic Acid + DHA Multivitamin -- 60 SoftgelsOllyVitamins & SupplementsVitamin C, Biotin, Vitamin E, EPA, Folate, Vitamin E, glycerin, Iodine, Niacin, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, Thiamin, titanium dioxide, Vitamin B12, Vitamin B62024-11-29 10:47:42
One Degree Organic Foods Gluten Free Sprouted Granola Vanilla Chia -- 11 ozOne Degree Organic FoodsFood & Beveragesvitamin E, Folate, vitamin E, Manganese, Phosphorus, Thiamin, tocopherols2024-11-29 10:47:42
One Degree Organic Foods Organic Sprouted Granola Cinnamon Flax -- 11 ozOne Degree Organic FoodsFood & Beveragesvitamin E, Folate, vitamin E, Manganese, Phosphorus, Thiamin, tocopherols2024-11-29 10:47:42
One Degree Organic Foods Organic Sprouted Oat Granola Honey Hemp -- 11 ozOne Degree Organic FoodsFood & Beveragesvitamin E, Folate, vitamin E, Manganese, Phosphorus, Thiamin, tocopherols2024-11-29 10:47:42
One Degree Organic Foods Sprouted Brown Rice Cacao Crisps Cacao -- 10 ozOne Degree Organic FoodsFood & Beveragesvitamin E, Folate, vitamin E, Manganese, Niacin, Phosphorus, Vitamin B6, Riboflavin, Selenium, Thiamin, tocopherols, Vitamin B62024-11-29 10:47:42
One Degree Organic Foods Sprouted Brown Rice Crisps Cereal -- 8 ozOne Degree Organic FoodsFood & Beveragesvitamin E, Folate, vitamin E, Manganese, Niacin, Phosphorus, Vitamin B6, Riboflavin, Selenium, Thiamin, tocopherols, Vitamin B62024-11-29 10:47:42
One-A-Day Mens 50 Plus Complete Multivitamin -- 65 TabletsOne-A-DayVitamins & Supplementsdl-alpha-tocopheryl acetate, Vitamin C, Biotin, d-calcium pantothenate, cholecalciferol, Chromium, copper sulfate, Vitamin E, Folate, Vitamin E, microcrystalline cellulose, Iodine, Calcium carbonate, Lycopene, Manganese, Molybdenum, Niacin, niacinamide, Pantothenic Acid, pyridoxine hydrochloride, Vitamin B6, Vitamin A, Riboflavin, Selenium, sodium molybdate, sodium selenite, stearic acid, Thiamin, titanium dioxide, cyanocobalamin, Vitamin B6, phylloquinone, Vitamin K, zinc oxide2024-11-29 10:47:42
One-A-Day Proactive 65+ Multivitamin for Men & Women -- 150 TabletsOne-A-DayVitamins & SupplementsVitamin C, Biotin, D-calcium pantothenate, Chromium, copper sulfate, Folate, microcrystalline cellulose, Iodine, Calcium carbonate, maltodextrin, Manganese, Niacin, niacinamide, Pantothenic Acid, potassium iodide, pyridoxine hydrochloride, Vitamin B6, vitamin A acetate, Vitamin A, Riboflavin, Selenium, sodium selenite, stearic acid, Thiamin, titanium dioxide, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
One-A-Day VitaCraves Adult Multi Gummies -- 150 GummiesOne-A-DayVitamins & Supplementscitric acid, vitamin E acetate, Vitamin C, d-biotin, d-calcium pantothenate, vitamin D3, Choline, citric acid, Vitamin E, folic acid, Vitamin E, Inositol, Iodine, Pantothenic Acid, potassium iodide, pyridoxine hydrochloride, Vitamin B6, vitamin A acetate, Vitamin A, sucrose, vitamin B12, Vitamin B62024-11-29 10:47:42
Optimum Nutrition Gold Standard Pre-Workout For Performance and Energy Blueberry Lemonade -- 30 ServingsOptimum NutritionActive Lifestyle & Fitnesscitric acid, acesulfame potassium, acesulfame potassium, Beta-Alanine, Caffeine, citric acid, L-Citrulline Malate, Folic Acid, malic acid, N-Acetyl L-Tyrosine, Niacin, Pantothenic Acid, Vitamin B6, tartaric acid, Thiamin, sucralose, Vitamin B12, Vitamin B62024-11-29 10:47:42
Optimum Nutrition Gold Standard Pre-Workout For Performance and Energy Fruit Punch -- 30 ServingsOptimum NutritionActive Lifestyle & Fitnesscitric acid, Beta-Alanine, Caffeine, citric acid, Folate, malic acid, N-Acetyl L-Tyrosine, Niacin, Pantothenic Acid, Vitamin B6, tartaric acid, Thiamin, sucralose, Vitamin B12, Vitamin B62024-11-29 10:47:42
Optimum Nutrition Gold Standard Pre-Workout For Performance and Energy Watermelon Candy -- 30 ServingsOptimum NutritionActive Lifestyle & Fitnesscitric acid, Beta-Alanine, Caffeine, citric acid, L-Citrulline Malate, Folate, malic acid, N-Acetyl L-Tyrosine, Niacin, Pantothenic Acid, Vitamin B6, tartaric acid, Thiamin, sucralose, Vitamin B12, Vitamin B62024-11-29 10:47:42
Optimum Nutrition Opti-Men Multivitamin for Men -- 150 TabletsOptimum NutritionActive Lifestyle & Fitness Lipase, PABA, Alpha-Carotene, Vitamin C, beta carotene, Biotin, Boron, Choline, Chromium, Cryptoxanthin, L-Cystine, Vitamin E, Folic Acid, Vitamin E, L-Glutamine, Microcrystalline cellulose, Inositol, Iodine, L-Isoleucine, Lutein, Lycopene, L-Lysine, Manganese, Molybdenum, Niacin, PABA, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, Selenium, stearic acid, Thiamin, Alpha-Lipoic Acid, L-Valine, Vanadium, Vitamin B12, Vitamin B6, Vitamin K, Zeaxanthin2024-11-29 10:47:42
Optimum Nutrition Opti-Men Multivitamin for Men -- 240 TabletsOptimum NutritionActive Lifestyle & Fitness Lipase, PABA, Alpha-Carotene, Vitamin C, beta carotene, Biotin, Boron, Choline, Chromium, Cryptoxanthin, L-Cystine, Vitamin E, Folate, Vitamin E, L-Glutamine, Microcrystalline cellulose, Inositol, Iodine, L-Isoleucine, Lutein, Lycopene, Manganese, Molybdenum, Niacin, PABA, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, Selenium, stearic acid, Thiamin, Alpha-Lipoic Acid, L-Valine, Vanadium, Vitamin B12, Vitamin B6, Vitamin K, Zeaxanthin2024-11-29 10:47:42
Optimum Nutrition Opti-Men Multivitamin for Men -- 90 TabletsOptimum NutritionActive Lifestyle & FitnessPABA, Alpha-Carotene, Vitamin C, beta carotene, Biotin, Boron, Chromium, Cryptoxanthin, L-Cystine, Vitamin E, Folate, Vitamin E, L-Glutamine, glycerine, Microcrystalline cellulose, Inositol, Iodine, L-Isoleucine, Lutein, Lycopene, L-Lysine, Manganese, Molybdenum, Niacin, PABA, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, Selenium, stearic acid, Thiamin, Alpha-Lipoic Acid, L-Valine, Vanadium, Vitamin B12, Vitamin B6, Vitamin K, Zeaxanthin2024-11-29 10:47:42
Optimum Nutrition Opti-Women Multivitamin for Women -- 120 CapsulesOptimum NutritionActive Lifestyle & FitnessAlpha-Carotene, Vitamin C, kelp, Biotin, Chromium, Cryptoxanthin, Vitamin E, Folate, Vitamin E, microcrystalline cellulose, Iodine, Isoflavone, calcium carbonate, Lutein, Lycopene, Manganese, Molybdenum, Niacin, Pantothenic Acid, Vitamin B6, vitamin A palmitate, Vitamin A, Riboflavin, Selenium, citrate, sodium selenate, citrate, Thiamin, Alpha-Lipoic Acid, calcium phosphate, Vitamin B12, Vitamin B6, Vitamin K, Zeaxanthin2024-11-29 10:47:42
Optimum Nutrition Opti-Women Multivitamin for Women -- 60 CapsulesOptimum NutritionActive Lifestyle & FitnessAlpha-Carotene, Vitamin C, kelp, Biotin, Chromium, Cryptoxanthin, Vitamin E, Folic Acid, Vitamin E, microcrystalline cellulose, Iodine, calcium carbonate, Lutein, Lycopene, Manganese, Molybdenum, Niacin, Pantothenic Acid, potassium iodide, Vitamin B6, Vitamin A, Riboflavin, Selenium, citrate, citrate, Thiamin, Alpha-Lipoic Acid, Vitamin B12, Vitamin B6, Vitamin K, Zeaxanthin2024-11-29 10:47:42
Optimum Nutrition Serious Mass Protein Powder Supplement Chocolate -- 16 ServingsOptimum NutritionActive Lifestyle & FitnessPABA, acesulfame potassium, acesulfame potassium, d-alpha tocopheryl succinate, Vitamin C, beta carotene, Biotin, calcium citrate, d-calcium pantothenate, di-calcium phosphate, cholecalciferol, Choline, Chromium, copper gluconate, Vitamin E, ferrous fumarate, folic acid, Vitamin E, L-Glutamine, Inositol, Iodine, Maltodextrin, Manganese, Molybdenum, Niacin, niacinamide, PABA, Pantothenic Acid, Phosphorus, potassium iodide, pyridoxine hydrochloride, Vitamin B6, Vitamin A, Riboflavin, Selenium, selenomethionine, Thiamin, cyanocobalamin, Vitamin B62024-11-29 10:47:42
Orgain Organic Kids Nutritional Shake 22 Vitamins & Minerals Chocolate -- 12 ShakesOrgainBaby & Kids ProductsVitamin C, Biotin, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Molybdenum, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Orgain Organic Kids Nutritional Shake 22 Vitamins & Minerals Strawberry -- 12 ShakesOrgainBaby & Kids ProductsVitamin C, Biotin, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Manganese, Molybdenum, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Orgain Organic Kids Nutritional Shake 22 Vitamins & Minerals Vanilla -- 12 ShakesOrgainBaby & Kids ProductsVitamin C, Biotin, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Manganese, Molybdenum, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamine, Vitamin B12, Vitamin B62024-11-29 10:47:42
Orgain Organic Nutrition Grass Fed Protein Shake Creamy Chocolate Fudge -- 12 ShakesOrgainActive Lifestyle & FitnessVitamin C, Biotin, Vitamin E, Folate, Vitamin E, Iodine, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Thiamine, Vitamin B12, Vitamin B62024-11-29 10:47:42
Orgain Organic Nutrition Shake Creamy Chocolate Fudge -- 12 ShakesOrgainActive Lifestyle & FitnessDL-alpha tocopheryl acetate, Vitamin C, Biotin, cholecalciferol, copper gluconate, Vitamin E, Folate, Vitamin E, Iodine, magnesium sulfate, Niacin, niacinamide, Pantothenic Acid, trisodium phosphate, Phosphorus, potassium chloride, tripotassium citrate, potassium iodide, tripotassium phosphate, pyridoxine hydrochloride, Vitamin B6, vitamin A palmitate, Vitamin A, Riboflavin, thiamine hydrochloride, Thiamin, tricalcium phosphate, cyanocobalamin, Vitamin B62024-11-29 10:47:42
Orgain Organic Nutrition Shake Sweet Vanilla Bean -- 12 ShakesOrgainActive Lifestyle & FitnessDL-alpha tocopheryl acetate, Vitamin C, Biotin, cholecalciferol, copper gluconate, Vitamin E, Folate, Vitamin E, Iodine, magnesium sulfate, Niacin, niacinamide, Pantothenic Acid, trisodium phosphate, Phosphorus, potassium chloride, tripotassium citrate, potassium iodide, pyridoxine hydrochloride, Vitamin B6, vitamin A palmitate, Vitamin A, Riboflavin, thiamine hydrochloride, Thiamin, tricalcium phosphate, cyanocobalamin, Vitamin B62024-11-29 10:47:42
Orgain Organic Nutrition Shake Grass Fed Protein Iced Cafe Mocha -- 12 ShakesOrgainActive Lifestyle & FitnessVitamin C, Biotin, Vitamin E, Folate, Vitamin E, Iodine, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Thiamine, Vitamin B12, Vitamin B62024-11-29 10:47:42
Orgain Organic Nutrition Shake Grass Fed Protein Strawberries & Cream -- 12 ShakesOrgainActive Lifestyle & FitnessVitamin C, Biotin, Folate, Iodine, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Thiamine, Vitamin B12, Vitamin B62024-11-29 10:47:42
Orgain Organic Nutrition Vegan Protein Shake Plant Based Smooth Chocolate -- 12 ShakesOrgainWeight ManagementVitamin C, Biotin, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Manganese, Molybdenum, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Orgain Organic Nutrition Vegan Protein Shake Plant Based Vanilla Bean -- 12 ShakesOrgainWeight ManagementVitamin C, Biotin, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Manganese, Molybdenum, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Thiamine, Vitamin B12, Vitamin B62024-11-29 10:47:42
Orgain Organic Vegan 21g Protein Powder + 50 Superfoods Plant Based Creamy Chocolate Fudge -- 2.02 lbsOrgainActive Lifestyle & FitnessVitamin C, Folate, Niacin, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Orgain Organic Vegan 21g Protein Powder + 50 Superfoods Plant Based Vanilla Bean -- 2.02 lbsOrgainActive Lifestyle & FitnessVitamin C, Erythritol, Folate, Niacin, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Orgain Organic Vegan Meal Replacement Powder 20g Plant Based Protein Chocolate -- 2.01 lbsOrgainActive Lifestyle & FitnessVitamin C, Erythritol, Folate, Niacin, Pantothenic Acid, Vitamin B6, Riboflavin, Thiamin, Vitamin B62024-11-29 10:47:42
Orgain Organic Vegan Meal Replacement Powder 20g Plant Based Protein Vanilla -- 2.01 lbOrgainActive Lifestyle & FitnessVitamin C, Erythritol, Folate, Niacin, Pantothenic Acid, Vitamin B6, Riboflavin, Thiamin, Vitamin B62024-11-29 10:47:42
Organic Collagen Australia Pure Collagen & Liver -- 120 CapsulesOrganic Collagen AustraliaVitamins & SupplementsVitamin B7, Folate, Vitamin A, Vitamin B122024-11-29 10:47:42
Organic Collagen Australia Pure Collagen & Strawberry -- 120 CapsulesOrganic Collagen AustraliaVitamins & SupplementsVitamin C, Folate2024-11-29 10:47:42
PB2 Peanut Powder with Cocoa -- 16 ozPB2Food & BeveragesFolate, Phosphorus, sugar2024-11-29 10:47:42
PB2 Powdered Almond Butter -- 6.5 ozPB2Food & BeveragesFolate, Phosphorus2024-11-29 10:47:42
pHresh Products Greens Raw Alkalizing Superfood 1 Month Supply -- 5 ozpHresh ProductsVitamins & SupplementsVitamin C, Folate, Vitamin A, Selenium, Vitamin K2024-11-29 10:47:42
pHresh Products pHresh Greens® Alkalizing Superfood -- 10 ozpHresh ProductsVitamins & SupplementsVitamin C, Folate, Vitamin A, Selenium, Vitamin K2024-11-29 10:47:42
pHresh Products Superblends Up Beet -- 1 lbpHresh ProductsVitamins & SupplementsVitamin C, Folate, Vitamin A2024-11-29 10:47:42
Pines International Barley Grass -- 500 mg - 250 TabletsPines InternationalHerbs, Botanicals & HomeopathyVitamin C, Folate, Vitamin A2024-11-29 10:47:42
Pines International Barley Grass -- 500 mg - 500 TabletsPines InternationalHerbs, Botanicals & HomeopathyVitamin C, Folate, Vitamin A2024-11-29 10:47:42
Pines International Organic Barley Grass Powder -- 10 ozPines InternationalHerbs, Botanicals & HomeopathyVitamin C, Folate, Vitamin A2024-11-29 10:47:42
Pines International Organic Barley Grass Powder -- 24 ozPines InternationalHerbs, Botanicals & HomeopathyVitamin C, Folate, Vitamin A2024-11-29 10:47:42
Pines International Organic Wheat Grass Powder -- 10 ozPines InternationalHerbs, Botanicals & HomeopathyVitamin C, Chromium, Folate, Selenium, Vitamin K2024-11-29 10:47:42
Pines International Organic Wheat Grass Powder -- 24 ozPines InternationalHerbs, Botanicals & HomeopathyVitamin C, Folate, Vitamin A2024-11-29 10:47:42
Pines International Organic Wheat Grass Powder -- 3.5 ozPines InternationalHerbs, Botanicals & HomeopathyVitamin C, Folic Acid, Vitamin A2024-11-29 10:47:42
Pines International Pines Wheat Grass -- 500 mg - 1400 TabletsPines InternationalHerbs, Botanicals & HomeopathyVitamin C, Chromium, Folate, Selenium, Vitamin K2024-11-29 10:47:42
Pines International Pines Wheat Grass -- 500 mg - 500 TabletsPines InternationalHerbs, Botanicals & HomeopathyVitamin C, Folate, Vitamin A2024-11-29 10:47:42
PlantFusion Complete Meal Shake Chocolate Caramel -- 32.1 ozPlantFusionActive Lifestyle & FitnessVitamin C, Biotin, Chromium, Vitamin E, Erythritol, Folate, Vitamin E, L-Glutamine, L-Isoleucine, Niacin, Phosphorus, Vitamin B6, Reb A, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
PlantFusion Complete Meal Shake Creamy Vanilla Bean -- 32.1 ozPlantFusionActive Lifestyle & FitnessVitamin C, Biotin, Chromium, Vitamin E, erythritol, Folate, Vitamin E, L-glutamine, L-isoleucine, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, reb A, Vitamin A, Riboflavin, Selenium, Thiamin, L-valine, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
PlantFusion Vegan Wholefood Blood Support with Iron-Methyl B12-Folate -- 60 Organic VegCapsPlantFusionVitamins & SupplementsVitamin C, Folate, Vitamin B122024-11-29 10:47:42
Plum Organics Baby Food Puree 6+ Months Apple Spinach & Avocado -- 6 PouchesPlum OrganicsBaby & Kids ProductsVitamin E, Folate, Vitamin E, Vitamin A2024-11-29 10:47:42
Plum Organics Mighty Protein & Fiber 12+ Months Banana White Bean Strawberry & Chia -- 6 PouchesPlum OrganicsBaby & Kids ProductsVitamin C, Folate, Phosphorus2024-11-29 10:47:42
Plum Organics Mighty Puffs Baby Snacks 9+ Months Beet + Strawberry -- 1.85 ozPlum OrganicsBaby & Kids ProductsDL-alpha tocopherol acetate, Choline, Vitamin E, Folate, vitamin E, Niacin, niacinamide, Vitamin B6, vitamin B2, thiamine hydrochloride, Thiamin, vitamin B1, cyanocobalamin, vitamin B6, zinc sulphate2024-11-29 10:47:42
SEDDS Biofolate -- 60 TabletsSEDDSVitamins & Supplementsdicalcium phosphate, Folate, Microcrystalline cellulose, stearic acid2024-11-29 10:47:42
Seeds of Change Organic Brown Basmati Rice Microwave Pouch -- 8.5 ozSeeds of ChangeFood & BeveragesVitamin C, Folate, Niacin, Vitamin A, Thiamin2024-11-29 10:47:42
Seeds of Change Organic Quinoa & Brown Rice with Garlic Microwave Pouch -- 8.5 ozSeeds of ChangeFood & BeveragesVitamin C, Folate, Niacin, Vitamin A, Thiamin2024-11-29 10:47:42
Serenity Kids Grain Free Puffs Carrot & Beet -- 6 PacksSerenity KidsBaby & Kids ProductsVitamin C, dicalcium phosphate, Folate, calcium carbonate, Phosphorus, Vitamin K2024-11-29 10:47:42
Serenity Kids Grain Free Puffs Baby Snack Pumpkin & Cinnamon -- 6 PacksSerenity KidsBaby & Kids ProductsVitamin C, dicalcium phosphate, Folate, calcium carbonate, Phosphorus, Vitamin K2024-11-29 10:47:42
Serenity Kids Grass Fed A2 Whole Milk Toddler Formula Powder 12-36 Months -- 21 ozSerenity KidsBaby & Kids ProductsL-methylfolate, ascorbyl palmitate, adenosine-5-monophosphate, alpha-tocopheryl acetate, Vitamin C, Biotin, calcium pantothenate, dicalcium phosphate, Chloride, vitamin D3, Choline, copper sulfate, cytidine-5-monophosphate, Vitamin E, ferrous sulfate, Folate, Vitamin E, inositol, Iodine, lacto-n-neotetraose, calcium carbonate, magnesium phosphate, Niacin, niacinamide, Pantothenic Acid, Phosphorus, potassium chloride, pyridoxine hydrochloride, Vitamin B6, vitamin A palmitate, Vitamin A, Riboflavin, Selenium, sodium selenite, Thiamin, Vitamin B12, Vitamin B6, phylloquinone, Vitamin K, zinc sulfate2024-11-29 10:47:42
SFI Health VitaSpectrum -- 180 Vegetarian CapsulesSFI HealthProfessional SupplementsVitamin C, beta-carotene, Biotin, Boron, cellulose, Vitamin D3, Choline, Chromium, Vitamin E, Folate, Vitamin E, Inositol, Iodine, Manganese, Molybdenum, Niacin, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vanadium, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Simple Truth Snack Crackers -- 8 ozSimple TruthFood & Beveragesammonium bicarbonate, monocalcium phosphate, folic acid, niacin, riboflavin, sodium bicarbonate2024-11-29 10:47:42
Simple Truth Organic Cinnamon Breakfast Cookie -- 8.8 ozSimple Truth OrganicFood & Beveragesfolic acid, niacin, riboflavin, sodium bicarbonate2024-11-29 10:47:42
Simple Truth Organic Fruit & Grain Bars Blueberry -- 6 BarsSimple Truth OrganicFood & Beveragescitric acid, Vitamin C, monocalcium phosphate, citric acid, Folate, calcium carbonate, Niacin, niacinamide, pyridoxine hydrochloride, Vitamin B6, vitamin A palmitate, Vitamin A, riboflavin, sodium bicarbonate, thiamine hydrochloride, Thiamin, Vitamin B6, zinc oxide2024-11-29 10:47:42
Simple Truth Organic Fruit & Grain Bars Strawberry -- 6 BarsSimple Truth OrganicFood & Beveragescitric acid, Vitamin C, tricalcium citrate, monocalcium phosphate, citric acid, Folate, calcium carbonate, Niacin, niacinamide, potassium carbonate, pyridoxine hydrochloride, Vitamin B6, vitamin A palmitate, Vitamin A, riboflavin, sodium bicarbonate, thiamine hydrochloride, Thiamin, Vitamin B6, zinc oxide2024-11-29 10:47:42
Simple Truth Organic Unsweetened Soymilk -- 32 fl ozSimple Truth OrganicFood & BeveragesVitamin C, Folate, calcium carbonate, vitamin A palmitate, Vitamin A, vitamin B2, Selenium, Vitamin B12, vitamin D22024-11-29 10:47:42
SmartyPants Adult Complete and Fiber -- 180 GummiesSmartyPantsVitamins & Supplementscitric acid, L-methylfolate, annatto, Vitamin C, Choline, citric acid, Vitamin E, EPA, Folate, Vitamin E, Iodine, Pantothenic Acid, Vitamin B6, Vitamin A, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
SmartyPants Adult Fomula Multivitamin -- 180 GummiesSmartyPantsVitamins & Supplementscitric acid, Vitamin C, Choline, citric acid, Vitamin E, Folate, Vitamin E, Iodine, Vitamin K2, Vitamin K2, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
SmartyPants Kids Formula Cherry Berry -- 120 GummiesSmartyPantsVitamins & Supplementscitric acid, L-methylfolate, Vitamin C, Choline, citric acid, Vitamin E, EPA, Folate, Vitamin E, Inositol, Iodine, Pantothenic Acid, Vitamin B6, Vitamin A, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
SmartyPants Kids Multi and Fiber Gummies -- 120 GummiesSmartyPantsVitamins & Supplementscitric acid, L-methylfolate, Vitamin C, Biotin, citric acid, Vitamin E, Folate, Vitamin E, Inositol, Iodine, Vitamin B6, Vitamin A, Riboflavin, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
SmartyPants Organic Prenatal Multi & Omegas Gummies -- 120 Vegetarian GummiesSmartyPantsVitamins & SupplementsL-methylfolate, Vitamin C, Biotin, Omega-3, Choline, Vitamin E, Folate, Vitamin E, Inositol, Iodine, Vitamin K2, Vitamin K2, Niacin, Vitamin B6, retinyl palmitate, Vitamin A, Riboflavin, Selenium, sodium citrate, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
SmartyPants Organics Kids Formula -- 120 Vegetarian GummiesSmartyPantsVitamins & SupplementsL-methylfolate, Vitamin C, Omega-3, Vitamin E, Folate, Vitamin E, Iodine, Vitamin K2, Vitamin K2, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, sodium citrate, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
SmartyPants Organics Toddler Formula -- 60 Vegetarian GummiesSmartyPantsVitamins & SupplementsL-methylfolate, Vitamin C, Omega-3, Choline, Vitamin E, Folate, Vitamin E, Iodine, Vitamin K2, Vitamin K2, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, sodium citrate, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
SmartyPants Prenatal Multi & Omegas Gummies -- 120 GummiesSmartyPantsVitamins & Supplementscitric acid, Vitamin C, Biotin, Choline, citric acid, Vitamin E, Folate, Vitamin E, Inositol, Iodine, Niacin, Vitamin B6, Vitamin A, Riboflavin, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
SmartyPants Sugar Free Kids Multi & Omegas -- 44 GummiesSmartyPantsVitamins & Supplementscitric acid, L-methylfolate, Vitamin C, Biotin, Omega-3, citric acid, Vitamin E, Folate, Vitamin E, Inositol, Iodine, allulose, Vitamin B6, Vitamin A, Riboflavin, sodium citrate, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
SmartyPants Teen Girl Multi & Omegas Gummies -- 120 GummiesSmartyPantsVitamins & Supplementscitric acid, L-methylfolate, Vitamin C, Biotin, Choline, Chromium, citric acid, Vitamin E, Folate, Vitamin E, Inositol, Iodine, Lutein, Manganese, Vitamin K2, Vitamin K2, Molybdenum, Niacin, Vitamin B6, retinyl palmitate, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B6, Vitamin K, Zeaxanthin2024-11-29 10:47:42
SmartyPants Teen Guy Multi & Omegas Gummies -- 120 GummiesSmartyPantsVitamins & Supplementscitric acid, L-methylfolate, Vitamin C, Biotin, Choline, Chromium, citric acid, Vitamin E, Folate, Vitamin E, Inositol, Iodine, Lutein, Manganese, Vitamin K2, Vitamin K2, Molybdenum, Niacin, Vitamin B6, retinyl palmitate, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B6, Vitamin K, Zeaxanthin2024-11-29 10:47:42
SmartyPants Toddler Multi & Omegas Gummies -- 90 GummiesSmartyPantsVitamins & Supplementscitric acid, L-methylfolate, Vitamin C, Biotin, Choline, citric acid, Vitamin E, Folate, Vitamin E, Inositol, Iodine, Vitamin K2, Vitamin K2, Pantothenic Acid, Vitamin B6, retinyl palmitate, Vitamin A, Riboflavin, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Snack Factory Non-GMO Pretzel Crisps Bites Garlic & Herb -- 12 ozSnack FactoryFood & Beveragescitric acid, citric acid, folic acid, lactic acid, niacin, riboflavin, cane sugar2024-11-29 10:47:42
Snack Factory Non-GMO Pretzel Crisps Bites Honey Mustard -- 12 ozSnack FactoryFood & Beveragescitric acid, acetic acid, citric acid, fructose, folic acid, malic acid, niacin, riboflavin, cane sugar2024-11-29 10:47:42
Snack Factory Non-GMO Pretzel Crisps Bites Sea Salt -- 12 ozSnack FactoryFood & Beveragesfolic acid, niacin, riboflavin, cane sugar2024-11-29 10:47:42
Snack Factory Non-GMO Pretzel Crisps Bites Spicy Ranch -- 12 ozSnack FactoryFood & Beveragescitric acid, vinegar, citric acid, folic acid, maltodextrin, niacin, riboflavin, cane sugar2024-11-29 10:47:42
Snack Factory Pretzel Crisps Deli Style Buffalo Wing -- 7.2 ozSnack FactoryFood & Beveragescitric acid, vinegar, citric acid, folic acid, maltodextrin, niacin, riboflavin, spice, sodium diacetate, monosodium glutamate, sugar2024-11-29 10:47:42
Snack Factory Pretzel Crisps Deli Style Cheddar Cheese -- 7.2 ozSnack FactoryFood & Beveragescitric acid, citric acid, folic acid, lactic acid, maltodextrin, niacin, riboflavin, sugar2024-11-29 10:47:42
Snack Factory Pretzel Crisps Deli Style Everything -- 14 ozSnack FactoryFood & Beveragesfolic acid, niacin, riboflavin, sugar2024-11-29 10:47:42
Snack Factory Pretzel Crisps Deli Style Garlic Parmesan -- 14 ozSnack FactoryFood & Beveragesfolic acid, niacin, riboflavin, cane sugar2024-11-29 10:47:42
Snack Factory Pretzel Crisps Deli Style Garlic Parmesan -- 7.2 ozSnack FactoryFood & Beveragesfolic acid, niacin, riboflavin, cane sugar2024-11-29 10:47:42
Snack Factory Pretzel Crisps Drizzlers Dark Chocolate -- 5.5 ozSnack FactoryFood & Beveragesfolic acid, niacin, riboflavin, sugar2024-11-29 10:47:42
Snack Factory Pretzel Crisps Drizzlers Milk Chocolate Caramel -- 5.5 ozSnack FactoryFood & Beveragesfolic acid, niacin, riboflavin, sugar2024-11-29 10:47:42
Snack Factory Pretzel Crisps® Party Size Cheddar Cheese -- 14 ozSnack FactoryFood & Beveragescitric acid, citric acid, folic acid, lactic acid, maltodextrin, niacin, riboflavin, sugar2024-11-29 10:47:42
Snack Factory Pretzel Crisps® Value Size Original -- 14 ozSnack FactoryFood & Beveragesfolic acid, niacin, riboflavin, sugar2024-11-29 10:47:42
Snap Supplements Blood Sugar -- 60 CapsulesSnap SupplementsHerbs, Botanicals & HomeopathyBiotin, Chromium, Folate, Niacin, Thiamin, Vanadium, Vitamin B122024-11-29 10:47:42
Snap Supplements Kidney Health -- 60 CapsulesSnap SupplementsVitamins & SupplementsL-5-MTHF, Vitamin C, chloride, Folate, Vitamin B3, niacinamide, Pantothenic Acid, Vitamin B2, citrate, citrate, Vitamin B1, Vitamin B122024-11-29 10:47:42
Solaray B-Complex 100 -- 100 VegCapsSolarayVitamins & SupplementsPABA, Biotin, Chlorine, Folate, Inositol, Niacin, PABA, Pantothenic Acid, Vitamin B6, Riboflavin, Thiamine, Vitamin B12, Vitamin B62024-11-29 10:47:42
Solgar B-Complex 100 -- 100 Vegetable CapsulesSolgarVitamins & SupplementsBiotin, Choline, Folic Acid, Inositol, Niacin, Pantothenic Acid, Vitamin B6, Riboflavin, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Solgar B-Complex 50 -- 100 Vegetable CapsulesSolgarVitamins & SupplementsBiotin, Choline, Folic Acid, Inositol, Niacin, niacinamide, Pantothenic Acid, Vitamin B6, Riboflavin, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Solgar B-Complex with Vitamin C Stress Formula -- 250 TabletsSolgarVitamins & SupplementsVitamin C, Biotin, Choline, Folic Acid, Microcrystalline cellulose, Inositol, Niacin, Pantothenic Acid, Vitamin B6, Riboflavin, Thiamin, titanium dioxide, Vitamin B12, Vitamin B62024-11-29 10:47:42
Solgar Formula VM-75® Iron-Free -- 180 TabletsSolgarVitamins & Supplementsalpha carotene, Vitamin C, Betaine HCl, Biotin, Boron, Choline, Chromium, cryptoxanthin, Vitamin E, Folic Acid, Vitamin E, Hesperidin, Microcrystalline cellulose, Inositol, Iodine, calcium carbonate, lutein, Manganese, Molybdenum, Niacin, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, Rutin, Selenium, Thiamin, titanium dioxide, Vitamin B12, Vitamin B6, zeaxanthin, zinc oxide2024-11-29 10:47:42
SOS Hydration Daily Hydration Electrolytes Lemon -- 31 ServingsSOS HydrationActive Lifestyle & Fitnesscitric acid, Vitamin C, Chloride, vitamin D3, citric acid, Folate, potassium chloride, pyridoxine hydrochloride, Vitamin B6, rebaudioside A, sodium citrate, Sugar, cyanocobalamin, vitamin B6, zinc sulfate2024-11-29 10:47:42
SOS Hydration Daily Hydration Electrolytes Lemon -- 8 SticksSOS HydrationActive Lifestyle & Fitnesscitric acid, Vitamin C, Chloride, vitamin D3, citric acid, Folate, potassium chloride, pyridoxine hydrochloride, Vitamin B6, rebaudioside A, sodium citrate, Sugar, cyanocobalamin, vitamin B6, zinc sulfate2024-11-29 10:47:42
SOS Hydration Daily Hydration Electrolytes Mango -- 31 ServingsSOS HydrationActive Lifestyle & Fitnesscitric acid, Vitamin C, Chloride, vitamin D3, citric acid, Folate, potassium chloride, pyridoxine hydrochloride, Vitamin B6, rebaudioside A, sodium citrate, Sugar, cyanocobalamin, vitamin B6, zinc sulfate2024-11-29 10:47:42
SOS Hydration Daily Hydration Electrolytes Mango -- 8 SticksSOS HydrationActive Lifestyle & Fitnesscitric acid, Vitamin C, Chloride, vitamin D3, citric acid, Folate, potassium chloride, pyridoxine hydrochloride, Vitamin B6, rebaudioside A, sodium citrate, Sugar, cyanocobalamin, vitamin B6, zinc sulfate2024-11-29 10:47:42
SOS Hydration Daily Hydration Electrolytes Mixed Berry -- 31 ServingsSOS HydrationActive Lifestyle & Fitnesscitric acid, Vitamin C, Chloride, vitamin D3, citric acid, Folate, magnesium citrate, potassium chloride, Vitamin B6, rebaudioside A, sodium citrate, Sugar, cyanocobalamin, vitamin B6, zinc sulfate2024-11-29 10:47:42
SOS Hydration Daily Hydration Electrolytes Mixed Berry -- 8 SticksSOS HydrationActive Lifestyle & Fitnesscitric acid, Vitamin C, Chloride, vitamin D3, citric acid, Folate, magnesium citrate, potassium chloride, Vitamin B6, rebaudioside A, sodium citrate, Sugar, cyanocobalamin, vitamin B6, zinc sulfate2024-11-29 10:47:42
SOS Hydration Daily Hydration Electrolytes Rainbow Sherbet -- 8 SticksSOS HydrationActive Lifestyle & Fitnesscitric acid, Vitamin C, Chloride, vitamin D3, citric acid, Folate, potassium chloride, pyridoxine hydrochloride, Vitamin B6, rebaudioside A, sodium citrate, Sugar, cyanocobalamin, vitamin B6, zinc sulfate2024-11-29 10:47:42
SOS Hydration Daily Hydration Electrolytes Watermelon -- 31 ServingsSOS HydrationActive Lifestyle & Fitnesscitric acid, Vitamin C, Chloride, vitamin D3, citric acid, Folate, potassium chloride, pyridoxine hydrochloride, Vitamin B6, rebaudioside A, sodium citrate, Sugar, cyanocobalamin, vitamin B6, zinc sulfate2024-11-29 10:47:42
SOS Hydration Daily Hydration Electrolytes Watermelon -- 8 SticksSOS HydrationActive Lifestyle & Fitnesscitric acid, Vitamin C, Chloride, vitamin D3, citric acid, Folate, potassium chloride, pyridoxine hydrochloride, Vitamin B6, rebaudioside A, sodium citrate, Sugar, cyanocobalamin, vitamin B6, zinc sulfate2024-11-29 10:47:42
Source Naturals Life Force™ Multiple No Iron -- 180 CapsulesSource NaturalsVitamins & SupplementsN-Acetyl L-Cysteine, Vitamin C, Astaxanthin, Biotin, Boron, Vitamin D3, Choline, Chromium, Coenzyme Q10, Vitamin E, DMAE, Folate, Vitamin E, microcrystalline cellulose, Inositol, Iodine, calcium carbonate, Lutein, Lycopene, Manganese, Molybdenum, N-Acetyl-L-Tyrosine, Niacin, Pantethine, Pantothenic Acid, Vitamin B6, Quercetin, Vitamin A, Riboflavin, Rutin, Selenium, Thiamin, Vitamin B12, Vitamin B6, Vitamin K12024-11-29 10:47:42
Sprout Organic Baby Food Smoothie 12+ Months Blueberry Banana Coconut Milk -- 6 PouchesSprout Organic Baby FoodBaby & Kids ProductsVitamin C, Folate, Vitamin A2024-11-29 10:47:42
Sprout Organic Baby Food Smoothie12+ Months Berry Grape Coconut Milk -- 6 PouchesSprout Organic Baby FoodBaby & Kids ProductsVitamin C, Folate, Vitamin A2024-11-29 10:47:42
Sprout Organic Baby Food Wafflez Blueberry Apple -- 5 PiecesSprout Organic Baby FoodBaby & Kids ProductsVitamin E, Folate, Vitamin E, Niacin, Thiamin2024-11-29 10:47:42
Sprout Organic Baby Food Wafflez Oatmeal Chocolate Chip -- 5 PiecesSprout Organic Baby FoodBaby & Kids ProductsVitamin E, Folate, Vitamin E, Niacin, Thiamin2024-11-29 10:47:42
Sprout Organic Baby Food Wafflez Pumpkin Butter & Jelly -- 5 PiecesSprout Organic Baby FoodBaby & Kids ProductsVitamin E, Folate, Vitamin E, Niacin, Thiamin2024-11-29 10:47:42
Stonewall Kitchen Farmhouse Pancake & Waffle Mix -- 33 ozStonewall KitchenFood & BeveragesVitamin C, monocalcium phosphate, folic acid, niacin, Vitamin A, riboflavin, sugar2024-11-29 10:47:42
Stonewall Kitchen Pancake & Waffle Mix Buttermilk -- 16 ozStonewall KitchenFood & BeveragesVitamin C, folic acid, niacin, Vitamin A, riboflavin, sodium bicarbonate, sugar2024-11-29 10:47:42
Sublingual Products B-Total Twin Pack -- 2 fl ozSublingual ProductsVitamins & SupplementsFolic Acid, glycerine, Vitamin B3, Vitamin B5, Vitamin B6, Vitamin B2, sorbitol, Vitamin B12, Vitamin B62024-11-29 10:47:42
SUKU Vitamins Active B Complex Perfect Peach -- 50 Pectin GummiesSUKU VitaminsVitamins & Supplementscitric acid, agar, Vitamin C, Biotin, citric acid, Folate, Niacin, Pantothenic Acid, Vitamin B6, Riboflavin, Thiamine, Vitamin B12, Vitamin B62024-11-29 10:47:42
SUKU Vitamins Appley Ever After Apple Cider Vinegar Gummies -- 50 GummiesSUKU VitaminsVitamins & Supplementsagar, Folate, sodium citrate, Vitamin B122024-11-29 10:47:42
SUKU Vitamins Luscious Hair -- 50 GummiesSUKU VitaminsVitamins & Supplementscitric acid, Vitamin C, Biotin, citric acid, Vitamin E, Folate, Vitamin E, Silicon, sodium citrate2024-11-29 10:47:42
SUKU Vitamins Teen Boy Total Multi Blueberry & Grape -- 60 Pectin GummiesSUKU VitaminsVitamins & Supplementscitric acid, L-5-Methyltetrahydrofolate, agar, Vitamin C, Biotin, Vitamin D3, Choline, citric acid, Vitamin E, Folate, Vitamin E, Inositol, Iodine, Vitamin K2, Vitamin K2, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Thiamine, Calcium phosphate, Vitamin B12, Vitamin B62024-11-29 10:47:42
SUKU Vitamins Teen Girl Total Multi Wild Cherry -- 60 Pectin GummiesSUKU VitaminsVitamins & Supplementscitric acid, L-5-Methyltetrahydrofolate, agar, Vitamin C, Biotin, Vitamin D3, Choline, citric acid, Vitamin E, Folate, Vitamin E, Inositol, Iodine, Vitamin K2, Vitamin K2, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Thiamine, Calcium phosphate, Vitamin B12, Vitamin B62024-11-29 10:47:42
SUKU Vitamins The Complete Kids Multi Gummy Vitamin Tropical Bonanza -- 60 GummiesSUKU VitaminsVitamins & Supplementscitric acid, agar, Vitamin C, beta-carotene, Biotin, Choline, citric acid, Vitamin E, Folate, Vitamin E, Inositol, Iodine, Pantothenic Acid, Vitamin B6, Vitamin A, sodium citrate, Vitamin B12, Vitamin B62024-11-29 10:47:42
SUKU Vitamins The Complete Prenatal Multi Pineapple & Peach -- 60 Pectin GummiesSUKU VitaminsVitamins & Supplementscitric acid, L-5-Methyltetrahydrofolate, agar, Vitamin C, Biotin, Vitamin D3, Choline, citric acid, Vitamin E, Folate, Vitamin E, Iodine, Manganese, Vitamin K2, Vitamin K2, Niacinamide, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamine, Calcium phosphate, Vitamin B12, Vitamin B62024-11-29 10:47:42
Sun Chlorella A Tablets -- 200 mg - 300 TabletsSun ChlorellaVitamins & SupplementsAlpha-Carotene, Chlorophyll, Folate, Lutein, Niacin, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Sun Chlorella A Tablets -- 500 mg - 600 TabletsSun ChlorellaVitamins & SupplementsAlpha-Carotene, Chlorophyll, Folate, Lutein, Niacin, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Vitamin B12, Vitamin B62024-11-29 10:47:42
SunButter Sunflower Butter On the Go Cups Creamy -- 6 CupsSunButterFood & BeveragesVitamin E, Folate, Vitamin E, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Sugar, Vitamin B62024-11-29 10:47:42
SunFood Organic Supergreens & Protein Powder -- 8 ozSunFoodVitamins & SupplementsLipase, Vitamin C, Cellulase, leaf, Folic Acid, Vitamin B3, Vitamin B6, Vitamin A, Vitamin B12, Vitamin B62024-11-29 10:47:42
SunFood Superfoods Organic Supergreens -- 8 ozSunFoodVitamins & SupplementsVitamin B9, Vitamin B2, Vitamin B122024-11-29 10:47:42
SunUp Liquid Methyl Folate - 60 Doses -- 680 mcg DFE - 2 fl ozSunUpVitamins & Supplementsascorbic acid, Folate2024-11-29 10:47:42
Sunwarrior Illumni8 Lean Meal Superfood Shake Chocolate -- 25.3 ozSunwarriorWeight Managementorange, Vitamin C, Biotin, Chromium, Vitamin E, Folate, Vitamin E, Manganese, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, vitamin B12, Vitamin B62024-11-29 10:47:42
Sunwarrior Vitamin Mineral Rush In Aloe Superjuice -- 30 fl ozSunwarriorHerbs, Botanicals & Homeopathy Orange, Vitamin C, Biotin, Vitamin E, Folate, Vitamin E, Niacin, Pantothenic Acid, Vitamin B6, stevia, Vitamin A, Riboflavin, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Swolverine ACV Gummy Apple -- 60 GummiesSwolverineVitamins & Supplementscitric acid, citric acid, Folate, Iodine, Vitamin B6, sodium citrate, sugar, Vitamin B12, Vitamin B62024-11-29 10:47:42
Swolverine B-Complex -- 30 TabletsSwolverineVitamins & SupplementsPara Aminobenzoic Acid, Biotin, Choline, Folate, Inositol, Calcium carbonate, Niacin, Pantothenic Acid, Vitamin B6, Riboflavin, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Swolverine Clean Carbs Sweet Potato Pie -- 870 g - 1.92 lbsSwolverineActive Lifestyle & FitnessVitamin C, Folate, Phosphorus, Vitamin A2024-11-29 10:47:42
Swolverine Multivitamin -- 60 CapsulesSwolverineActive Lifestyle & FitnessVitamin C, Biotin, Boron, Chloride, Vitamin D3, Chromium, Vitamin E, Folic Acid, Vitamin E, Iodine, Manganese, Molybdenum, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Vitamin B2, Selenium, Vitamin B1, Vitamin B12, Vitamin B6, Vitamin K12024-11-29 10:47:42
Swolverine Plant Protein Chocolate Cake -- 25 ServingsSwolverineWeight ManagementChromium, Folate, Phosphorus2024-11-29 10:47:42
Tartar Shield Cat Treats Wholesome Natural Dental Care Chicken Flavor -- 4.5 ozTartar ShieldPet Suppliesbiotin, d-calcium pantothenate, vitamin D3, choline chloride, copper sulfate, tocopherol, ethylenediamine dihydroiodide, iron sulfate, folic acid, tocopherol, calcium carbonate, malic acid, niacin, potassium chloride, pyridoxine hydrochloride, vitamin A acetate, riboflavin, sodium selenite, taurine, thiamine, vitamin B12, menadione, zinc oxide2024-11-29 10:47:42
Tartar Shield Dog Biscuits Daily Dental Treat Chicken -- 26 ozTartar ShieldPet Suppliescalcium pantothenate, vitamin d3, choline chloride, copper sulfate, vitamin e, ferrous sulfate, folic acid, vitamin e, calcium carbonate, malic acid, niacin, potassium chloride, pyridoxine hydrochloride, vitamin a, riboflavin, sodium selenite, vitamin b12, zinc oxide2024-11-29 10:47:42
Terry Naturally Clinical Essentials Multi-Vitamin & Minerals -- 60 TabletsTerry NaturallyVitamins & SupplementsPABA, citric acid, Vitamin C, Benfotiamine, Biotin, Boron, calcium ascorbate, calcium fructoborate, dicalcium phosphate, Vitamin D3, Choline, Chromium, citric acid, Vitamin E, Folate, Vitamin E, glycerol monostearate, glycine, Microcrystalline cellulose, Inositol, Iodine, maltodextrin, Manganese, Molybdenum, Niacin, PABA, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, Selenium, Vanadium, Vitamin B12, Vitamin B62024-11-29 10:47:42
Terry Naturally Healthy Feet & Nerves -- 60 CapsulesTerry NaturallyVitamins & SupplementsBiotin, Chromium, Folate, Niacin, Pantothenic Acid, Vitamin B6, Riboflavin, Thiamin, Alpha-Lipoic Acid, Vitamin B12, Vitamin B62024-11-29 10:47:42
Terry Naturally Healthy Feet & Nerves™ -- 120 CapsulesTerry NaturallyVitamins & SupplementsBenfotiamine, Biotin, Chromium, Folate, cellulose powder, Niacin, Pantothenic Acid, Vitamin B6, Riboflavin, Thiamin, Alpha-Lipoic Acid, Vitamin B12, Vitamin B62024-11-29 10:47:42
Terry Naturally Liver Fractions™ with Natural Heme Iron -- 90 CapsulesTerry NaturallyVitamins & SupplementsFolate, cellulose powder, Vitamin B122024-11-29 10:47:42
Terry Naturally Sucontral D Blood Sugar Balance -- 120 CapsulesTerry NaturallyVitamins & SupplementsVitamin C, Biotin, Chromium, Vitamin E, Folate, Vitamin E, Cellulose powder, Vitamin B6, Riboflavin, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Terry Naturally Sucontral D Blood Sugar Balance -- 60 CapsulesTerry NaturallyVitamins & SupplementsVitamin C, Biotin, Chromium, Vitamin E, Folate, Vitamin E, Cellulose powder, Vitamin B6, Riboflavin, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
The Honest Kitchen Butcher Block Pate Dog Food Beef Cheddar & Farm Veggies -- 10.5 ozThe Honest KitchenPet Suppliescalcium pantothenate, dicalcium phosphate, folic acid, calcium carbonate, potassium chloride, pyridoxine hydrochloride, vitamin B6, vitamin B2, sodium selenite, vitamin B1, vitamin B62024-11-29 10:47:42
The Honest Kitchen Butcher Block Pate Dog Food Chicken & Super Greens -- 10.5 ozThe Honest KitchenPet Suppliescalcium pantothenate, folic acid, calcium carbonate, potassium chloride, pyridoxine hydrochloride, vitamin B6, vitamin B2, sodium selenite, vitamin B1, tricalcium phosphate, vitamin B62024-11-29 10:47:42
The Honest Kitchen Butcher Block Pate Dog Food Turkey & Autumn Veggies -- 10.5 ozThe Honest KitchenPet Suppliescalcium pantothenate, folic acid, calcium carbonate, potassium chloride, pyridoxine hydrochloride, vitamin B6, vitamin B2, sodium selenite, vitamin B1, tricalcium phosphate, vitamin B62024-11-29 10:47:42
The Honest Kitchen Cate Grain Free Wet Cat Food Pate Variety Pack -- 8 PacksThe Honest KitchenPet Supplieskelp, vitamin B7, calcium pantothenate, choline chloride, folic acid, calcium carbonate, vitamin B5, potassium chloride, potassium iodide, pyridoxine hydrochloride, vitamin B6, vitamin B2, taurine, vitamin B1, vitamin B62024-11-29 10:47:42
The Honest Kitchen Cate Wet Cat Food Pate Grain Free Beef & Chicken -- 5.5 ozThe Honest KitchenPet Supplieskelp, vitamin B7, calcium pantothenate, choline chloride, folic acid, calcium carbonate, vitamin B5, potassium chloride, potassium iodide, pyridoxine hydrochloride, vitamin B6, vitamin B2, taurine, vitamin B1, vitamin B62024-11-29 10:47:42
The Honest Kitchen Cate Wet Cat Food Pate Grain Free Chicken -- 5.5 ozThe Honest KitchenPet Supplieskelp, vitamin B7, calcium pantothenate, choline chloride, folic acid, calcium carbonate, vitamin B5, potassium chloride, potassium iodide, pyridoxine hydrochloride, vitamin B6, vitamin B2, taurine, vitamin B1, vitamin B62024-11-29 10:47:42
The Honest Kitchen Cate Wet Cat Food Pate Grain Free Salmon & Cod -- 5.5 ozThe Honest KitchenPet Supplieskelp, vitamin B7, calcium pantothenate, choline chloride, folic acid, calcium carbonate, vitamin B5, potassium chloride, potassium iodide, pyridoxine hydrochloride, vitamin B6, vitamin B2, taurine, vitamin B1, vitamin B62024-11-29 10:47:42
The Honest Kitchen Dry Cat Food Whole Food Clusters Grain Free Chicken & Fish -- 4 lbsThe Honest KitchenPet Suppliesbiotin, calcium pantothenate, choline chloride, folic acid, L-carnitine, vitamin B5, pyridoxine hydrochloride, vitamin B6, vitamin B2, taurine, vitamin B1, tricalcium phosphate, vitamin B62024-11-29 10:47:42
The Honest Kitchen Dry Cat Food Whole Food Clusters Grain Free Turkey & Chicken -- 4 lbsThe Honest KitchenPet Suppliesbiotin, calcium pantothenate, choline chloride, folic acid, L-carnitine, vitamin B5, potassium chloride, pyridoxine hydrochloride, vitamin B6, vitamin B2, taurine, vitamin B1, tricalcium phosphate, vitamin B62024-11-29 10:47:42
The Honest Kitchen Dry Dog Food Whole Food Clusters Grain Free Beef -- 5 lbsThe Honest KitchenPet Suppliescalcium pantothenate, folic acid, vitamin B5, pyridoxine hydrochloride, vitamin B6, vitamin B2, taurine, vitamin B1, vitamin B62024-11-29 10:47:42
The Honest Kitchen Dry Dog Food Whole Food Clusters Grain Free Chicken -- 5 lbsThe Honest KitchenPet Suppliescalcium pantothenate, folic acid, vitamin B5, pyridoxine hydrochloride, vitamin B6, vitamin B2, taurine, vitamin B1, vitamin B62024-11-29 10:47:42
The Honest Kitchen One Pot Stews Roasted Beef Stew with Kale Sweet Potatoes & Carrots Beef -- 10.5 ozThe Honest KitchenPet Suppliescalcium pantothenate, folic acid, calcium carbonate, potassium chloride, pyridoxine hydrochloride, vitamin B6, vitamin B2, sodium selenite, vitamin B1, tricalcium phosphate, vitamin B62024-11-29 10:47:42
The Honest Kitchen One Pot Stews Simmered Salmon & Chicken with Brown Rice & Broccoli Seafood -- 10.5 ozThe Honest KitchenPet Suppliescalcium pantothenate, dicalcium phosphate, folic acid, calcium carbonate, pyridoxine hydrochloride, vitamin B6, vitamin B2, sodium selenite, vitamin B1, vitamin B62024-11-29 10:47:42
The Honest Kitchen One Pot Stews Slow Cooked Chicken with Sweet Potatoes Spinach & Apples Poultry -- 10.5 ozThe Honest KitchenPet Suppliescalcium pantothenate, dicalcium phosphate, folic acid, calcium carbonate, potassium chloride, pyridoxine hydrochloride, vitamin B6, vitamin B2, sodium selenite, vitamin B1, vitamin B62024-11-29 10:47:42
The Honest Kitchen Wet Cat Food Grain Free Minced Chicken in Bone Broth Gravy -- 5.5 ozThe Honest KitchenPet Suppliesvitamin B7, calcium pantothenate, choline chloride, folic acid, calcium carbonate, vitamin B5, potassium chloride, potassium iodide, pyridoxine hydrochloride, vitamin B6, vitamin B2, taurine, vitamin B1, tricalcium phosphate, vitamin B62024-11-29 10:47:42
The Honest Kitchen Wet Cat Food Grain Free Minced Salmon & Cod in Fish Broth Gravy -- 5.5 ozThe Honest KitchenPet Suppliesvitamin B7, calcium pantothenate, choline chloride, folic acid, calcium carbonate, vitamin B5, potassium chloride, potassium iodide, pyridoxine hydrochloride, vitamin B6, vitamin B2, taurine, vitamin B1, tricalcium phosphate, vitamin B62024-11-29 10:47:42
The Honest Kitchen Wet Cat Food Grain Free Minced Turkey Chicken & Duck in Bone Broth Gravy -- 5.5 ozThe Honest KitchenPet Suppliesvitamin B7, calcium pantothenate, choline chloride, folic acid, calcium carbonate, vitamin B5, potassium chloride, potassium iodide, pyridoxine hydrochloride, vitamin B6, vitamin B2, taurine, vitamin B1, tricalcium phosphate, vitamin B62024-11-29 10:47:42
Thompson All In One Multivitamin Iron Free -- 60 CapsulesThompsonVitamins & SupplementsVitamin C, Biotin, cellulose, Chromium, Vitamin E, Folic Acid, Vitamin E, Iodine, Manganese, Molybdenum, Niacin, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamine, Vitamin B12, Vitamin B6, Vitamin D2, Vitamin K2024-11-29 10:47:42
Thompson B 100 Complex Timed-Release -- 60 TabletsThompsonVitamins & SupplementsPABA, Biotin, Cellulose, Choline, Folate, Inositol, Niacin, PABA, Pantothenic Acid, Vitamin B6, Riboflavin, stearic acid, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Thompson B 50 Complex -- 60 Vegetarian CapsulesThompsonVitamins & SupplementsPABA, Biotin, Folic Acid, Inositol, Niacin, PABA, Pantothenic Acid, Vitamin B6, Riboflavin, Thiamine, Vitamin B12, Vitamin B62024-11-29 10:47:42
Thompson B Complex plus Rice Bran -- 60 TabletsThompsonVitamins & SupplementsBiotin, Cellulose, Folic Acid, Inositol, Niacin, Pantothenic Acid, Vitamin B6, Riboflavin, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Thompson B12 Lozenge Cherry -- 1000 mcg - 30 LozengesThompsonVitamins & SupplementsFolic Acid, Vitamin B122024-11-29 10:47:42
Thompson Multi Formula for Women -- 60 CapsulesThompsonVitamins & SupplementsVitamin C, Biotin, cellulose, Chromium, Vitamin E, Folic Acid, Vitamin E, Iodine, Manganese, Molybdenum, Niacin, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, calcium phosphate, Vitamin B12, Vitamin B62024-11-29 10:47:42
Thompson Multi-Vitamin with Minerals -- 120 TabletsThompsonVitamins & SupplementsVitamin C, Cellulose, Vitamin E, Folic Acid, Vitamin E, Iodine, Manganese, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, stearic acid, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Thompson Nuplex Multivitamin Multimineral with Iron -- 90 TabletsThompsonVitamins & SupplementsVitamin C, Cellulose, Vitamin E, Folic Acid, Vitamin E, Iodine, Manganese, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, stearic acid, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Thompson Nutritional Yeast Flakes -- 9.2 ozThompsonFood & BeveragesBiotin, folic acid, Niacin, pyridoxine HCl, Vitamin B6, Riboflavin, thiamine HCl, Thiamine, Vitamin B12, Vitamin B62024-11-29 10:47:42
Thorne Research 5-MTHF Methylfolate -- 1 mg - 60 CapsulesThorne ResearchProfessional SupplementsFolate, Microcrystalline cellulose, leucine2024-11-29 10:47:42
Thorne Research 5-MTHF Methylfolate -- 5 mg - 60 CapsulesThorne ResearchProfessional SupplementsFolate, Microcrystalline cellulose, leucine2024-11-29 10:47:42
Thorne Research B-Complex #12 -- 60 CapsulesThorne ResearchProfessional SupplementsBiotin, Choline, Folate, microcrystalline cellulose, Niacin, Pantothenic Acid, Vitamin B6, Riboflavin, Thiamine, Vitamin B12, Vitamin B62024-11-29 10:47:42
Thorne Research Basic B Complex -- 60 CapsulesThorne ResearchProfessional SupplementsBiotin, Choline, Folate, microcrystalline cellulose, leucine, magnesium citrate, Niacin, Pantothenic Acid, Vitamin B6, Riboflavin, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Thorne Research Basic Nutrient 2-Day -- 60 CapsulesThorne ResearchProfessional SupplementsVitamin C, Biotin, Boron, Calcium Pantothenate, dicalcium phosphate, Chromium, Vitamin E, Folate, d-Gamma Tocopherol, Vitamin E, Iodine, Lutein, Manganese, Niacin, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Thorne Research Basic Nutrients 2 Day - NSF Certified for Sport -- 60 CapsulesThorne ResearchProfessional SupplementsVitamin C, Biotin, Boron, Calcium Pantothenate, dicalcium phosphate, Chromium, Vitamin E, Folate, d-Gamma Tocopherol, Vitamin E, Iodine, Lutein, Manganese, Niacin, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Thorne Research Basic Prenatal -- 90 CapsulesThorne ResearchProfessional SupplementsVitamin C, Biotin, Boron, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Manganese, Niacin, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamine, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Thorne Research Ferrasorb -- 60 CapsulesThorne ResearchProfessional SupplementsVitamin C, Folate, microcrystalline cellulose, leucine, Vitamin B6, Vitamin B12, Vitamin B62024-11-29 10:47:42
Thorne Research Stress B-Complex -- 60 CapsulesThorne ResearchProfessional SupplementsBiotin, Choline, Folate, microcrystalline cellulose, Niacin, Pantothenic Acid, Vitamin B6, Riboflavin, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Tinkyada Brown Rice Elbow Pasta Gluten Free -- 16 ozTinkyadaFood & BeveragesFolate, Niacin, Riboflavin, Thiamin2024-11-29 10:47:42
Tinkyada Brown Rice Fusilli Pasta Gluten Free -- 16 ozTinkyadaFood & BeveragesFolate, Niacin, Riboflavin, Thiamin2024-11-29 10:47:42
Tinkyada Brown Rice Pasta Fettucini Gluten Free -- 14 ozTinkyadaFood & BeveragesVitamin C, Folic Acid, Niacin, Vitamin A, Riboflavin, Thiamin2024-11-29 10:47:42
Tinkyada Brown Rice Pasta Lasagne -- 10 ozTinkyadaFood & BeveragesFolate, Niacin, Riboflavin, Thiamin2024-11-29 10:47:42
Tinkyada Brown Rice Pasta Shells Gluten Free -- 16 ozTinkyadaFood & BeveragesVitamin C, Folic Acid, Niacin, Vitamin A, Riboflavin, Thiamine2024-11-29 10:47:42
Tinkyada Brown Rice Pasta Spaghetti Style Gluten Free -- 16 ozTinkyadaFood & BeveragesVitamin C, Folic Acid, Niacin, Vitamin A, Riboflavin, Thiamine2024-11-29 10:47:42
Tinkyada Brown Rice Pasta Spirals Gluten Free -- 16 ozTinkyadaFood & BeveragesFolate, Niacin, Riboflavin, Thiamin2024-11-29 10:47:42
Tinkyada Brown Rice Penne Pasta Gluten Free -- 16 ozTinkyadaFood & BeveragesVitamin C, Folic Acid, Niacin, Vitamin A, Riboflavin, Thiamin2024-11-29 10:47:42
Tinkyada Brown Rice Vegetable Pasta Spirals Gluten Free -- 12 ozTinkyadaFood & BeveragesVitamin C, Folic Acid, Niacin, Vitamin A, Riboflavin, Thiamine2024-11-29 10:47:42
Tinkyada Organic Brown Rice Pasta Elbows Gluten Free -- 12 ozTinkyadaFood & BeveragesVitamin C, Folic Acid, Niacin, Vitamin A, Riboflavin, Thiamine2024-11-29 10:47:42
Tinkyada Organic Brown Rice Pasta Spaghetti Style Gluten Free -- 12 ozTinkyadaFood & BeveragesVitamin C, Folic Acid, Niacin, Vitamin A, Riboflavin, Thiamin2024-11-29 10:47:42
Tinkyada Organic Brown Rice Pasta Spirals Gluten Free -- 12 ozTinkyadaFood & BeveragesVitamin C, Folic Acid, Niacin, Vitamin A, Riboflavin, Thiamin2024-11-29 10:47:42
Tinkyada Organic Brown Rice Penne Pasta Gluten Free -- 12 ozTinkyadaFood & BeveragesVitamin C, Folic Acid, Niacin, Vitamin A, Riboflavin, Thiamine2024-11-29 10:47:42
Tinkyada Pasta Joy™ Brown Rice Pasta Little Dreams -- 14 ozTinkyadaFood & BeveragesVitamin C, Folic Acid, Niacin, Vitamin A, Riboflavin, Thiamin2024-11-29 10:47:42
Trace Minerals Research Electrolyte Stamina Power Pak Acai Berry -- 30 PacketsTrace Minerals ResearchActive Lifestyle & Fitnesscitric acid, Vitamin C, Boron, Chloride, Chromium, citric acid, Folate, Manganese, Niacin, Pantothenic Acid, Potassium Citrate, Vitamin B6, Selenium, Alpha-Lipoic Acid, Vitamin B12, Vitamin B62024-11-29 10:47:42
Trace Minerals Research Electrolyte Stamina Power Pak Cherry Lime -- 30 PacketsTrace Minerals ResearchActive Lifestyle & FitnessVitamin C, Boron, Chloride, Chromium, Folate, malic acid, Manganese, Niacin, Pantothenic Acid, Potassium Citrate, Vitamin B6, Selenium, Alpha Lipoic Acid, Vitamin B12, Vitamin B62024-11-29 10:47:42
Trace Minerals Research Electrolyte Stamina Power Pak Cranberry -- 30 PacketsTrace Minerals ResearchActive Lifestyle & Fitnesscitric acid, Vitamin C, Boron, Chloride, Chromium, citric acid, Folate, malic acid, Manganese, Niacin, Pantothenic Acid, Potassium Citrate, Vitamin B6, Selenium, tartaric acid, Alpha Lipoic Acid, Vitamin B12, Vitamin B62024-11-29 10:47:42
Trace Minerals Research Electrolyte Stamina Power Pak Grape -- 30 PacketsTrace Minerals ResearchActive Lifestyle & Fitnesscitric acid, Vitamin C, Boron, Chloride, Chromium, citric acid, Folate, malic acid, Manganese, Niacin, Pantothenic Acid, Potassium Citrate, Vitamin B6, Selenium, Alpha Lipoic Acid, Vitamin B12, Vitamin B62024-11-29 10:47:42
Trace Minerals Research Electrolyte Stamina Power Pak Guava Passion Fruit -- 30 PacketsTrace Minerals ResearchActive Lifestyle & Fitnesscitric acid, Vitamin C, Boron, Chloride, Chromium, citric acid, Folate, glycosides, malic acid, Manganese, Niacin, Pantothenic Acid, Potassium Citrate, Vitamin B6, Selenium, steviol, Alpha-Lipoic Acid, Vitamin B12, Vitamin B62024-11-29 10:47:42
Trace Minerals Research Electrolyte Stamina Power Pak Lemon Lime -- 30 PacketsTrace Minerals ResearchActive Lifestyle & Fitnesscitric acid, Vitamin C, Boron, Chloride, Chromium, citric acid, Folate, malic acid, Manganese, Niacin, Pantothenic Acid, Potassium Citrate, Vitamin B6, Selenium, Thiamin, Alpha Lipoic Acid, Vitamin B12, Vitamin B62024-11-29 10:47:42
Trace Minerals Research Electrolyte Stamina Power Pak Mixed Berry -- 30 PacketsTrace Minerals ResearchActive Lifestyle & FitnessVitamin C, Boron, Chloride, Chromium, Folate, Manganese, Niacin, Pantothenic Acid, Potassium Citrate, Vitamin B6, Selenium, Alpha-Lipoic Acid, Vitamin B12, Vitamin B62024-11-29 10:47:42
Trace Minerals Research Electrolyte Stamina Power Pak Orange Blast -- 30 PacketsTrace Minerals ResearchActive Lifestyle & Fitnessorange, citric acid, Vitamin C, Boron, Chloride, Chromium, citric acid, Folate, malic acid, Manganese, Niacin, Pantothenic Acid, Potassium Citrate, Vitamin B6, Selenium, Thiamin, Alpha Lipoic Acid, Vitamin B12, Vitamin B62024-11-29 10:47:42
Trace Minerals Research Electrolyte Stamina Power Pak Pineapple Coconut -- 30 PacketsTrace Minerals ResearchActive Lifestyle & FitnessVitamin C, Boron, Chloride, Chromium, Folate, Manganese, Niacin, Pantothenic Acid, Potassium Citrate, Vitamin B6, Selenium, sugar, Alpha-Lipoic Acid, Vitamin B12, Vitamin B62024-11-29 10:47:42
Trace Minerals Research Electrolyte Stamina Power Pak Pomegranate Blueberry -- 30 PacketsTrace Minerals ResearchActive Lifestyle & Fitnesscitric acid, Vitamin C, Boron, Chloride, Chromium, citric acid, Folate, malic acid, Manganese, Niacin, Pantothenic Acid, Potassium Citrate, Vitamin B6, Selenium, Alpha-Lipoic Acid, Vitamin B12, Vitamin B62024-11-29 10:47:42
Trace Minerals Research Electrolyte Stamina Power Pak Raspberry -- 30 PacketsTrace Minerals ResearchActive Lifestyle & FitnessVitamin C, Boron, Chloride, Chromium, Folate, malic acid, Manganese, Niacin, Pantothenic Acid, Potassium Citrate, Vitamin B6, Selenium, Thiamin, Alpha-Lipoic Acid, Vitamin B12, Vitamin B62024-11-29 10:47:42
Trace Minerals Research Electrolyte Stamina Power Pak Tangerine -- 30 PacketsTrace Minerals ResearchActive Lifestyle & FitnessVitamin C, Boron, Chloride, Chromium, Folate, malic acid, Manganese, Niacin, Pantothenic Acid, Potassium Citrate, Vitamin B6, Selenium, Alpha-Lipoic Acid, Vitamin B12, Vitamin B62024-11-29 10:47:42
Trace Minerals Research Electrolyte Stamina Power Pak + Immunity Lemon Berry -- 30 PacketsTrace Minerals ResearchActive Lifestyle & FitnessVitamin C, Boron, Chloride, Vitamin D3, Chromium, Folate, malic acid, Manganese, Niacin, Pantothenic Acid, Potassium Citrate, Vitamin B6, Selenium, Alpha-Lipoic Acid, vanilla, Vitamin B12, Vitamin B62024-11-29 10:47:42
Trace Minerals Research Electrolyte Stamina Power Pak Sugar Free Citrus -- 30 PacketsTrace Minerals ResearchActive Lifestyle & Fitnesscitric acid, Vitamin C, Boron, Chloride, Chromium, citric acid, Folate, malic acid, Manganese, Niacin, Pantothenic Acid, Potassium Citrate, Vitamin B6, Selenium, Alpha-Lipoic Acid, Vitamin B12, Vitamin B6, Xylitol2024-11-29 10:47:42
Trace Minerals Research Electrolyte Stamina Power Pak Sugar Free Orange Mango -- 30 PacketsTrace Minerals ResearchActive Lifestyle & Fitnessorange, Vitamin C, Boron, Chloride, Chromium, Folate, malic acid, Manganese, Niacin, Pantothenic Acid, Potassium Citrate, Vitamin B6, Selenium, Alpha-Lipoic Acid, Vitamin B12, Vitamin B6, Xylitol2024-11-29 10:47:42
Trace Minerals Research Electrolyte Stamina PowerPak Watermelon -- 30 PacketsTrace Minerals ResearchActive Lifestyle & FitnessVitamin C, Boron, Chloride, Chromium, Folate, malic acid, Manganese, Niacin, Pantothenic Acid, Potassium Citrate, Vitamin B6, Selenium, tartaric acid, Alpha Lipoic Acid, Vitamin B12, Vitamin B62024-11-29 10:47:42
Trace Minerals Research Liquid Multi Vitamin-Mineral Tropical Mixed Berry -- 30 fl ozTrace Minerals ResearchVitamins & Supplementscitric acid, Vitamin C, Biotin, Boron, Calcium Citrate, Vitamin D3, Choline, Chromium, citric acid, Vitamin E, Folate, Vitamin E, Inositol, Iodine, Manganese, Vitamin K2, Vitamin K2, Molybdenum, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Selenium, Thiamine, Tricalcium Phosphate, Vitamin B12, Vitamin B6, xylitol2024-11-29 10:47:42
TransformHQ Boost Shot Energy Drink Mix - 28 Servings Blue Raspberry -- 4.8 ozTransformHQActive Lifestyle & FitnessFolic Acid, Vitamin B3, Vitamin B6, Vitamin B12, Vitamin B62024-11-29 10:47:42
TransformHQ Boost Shot Energy Drink Mix - 28 Servings Peach Mango -- 4.2 ozTransformHQActive Lifestyle & FitnessFolic Acid, Vitamin B3, Vitamin B6, Vitamin B12, Vitamin B62024-11-29 10:47:42
TransformHQ Boost Shot Energy Drink Mix - 28 Servings Pina Colada -- 6.2 ozTransformHQActive Lifestyle & FitnessFolic Acid, Vitamin B3, Vitamin B6, Vitamin B12, Vitamin B62024-11-29 10:47:42
TransformHQ Boost Shot Energy Drink Mix - 28 Servings Strawberry Lemonade -- 4.6 ozTransformHQActive Lifestyle & FitnessFolic Acid, Vitamin B3, Vitamin B6, Vitamin B12, Vitamin B62024-11-29 10:47:42
TransformHQ Hydration Mix - 42 Servings Blue Raspberry -- 0.4 lbsTransformHQActive Lifestyle & FitnessFolate, Niacin, Vitamin B6, Vitamin B12, Vitamin B62024-11-29 10:47:42
TransformHQ Hydration Mix - 42 Servings Cherry Limeade -- 0.32 lbsTransformHQActive Lifestyle & FitnessFolate, Niacin, Vitamin B6, Vitamin B12, Vitamin B62024-11-29 10:47:42
TransformHQ Hydration Mix - 42 Servings Peach Mango -- 0.3 lbsTransformHQActive Lifestyle & FitnessFolate, Niacin, Vitamin B6, Vitamin B12, Vitamin B62024-11-29 10:47:42
TransformHQ Hydration Mix - 42 Servings Pina Colada -- 0.3 lbsTransformHQActive Lifestyle & FitnessFolate, Niacin, Vitamin B6, Vitamin B12, Vitamin B62024-11-29 10:47:42
TransformHQ Hydration Mix - 42 Servings Strawberry Lemonade -- 0.4 lbsTransformHQActive Lifestyle & FitnessFolate, Niacin, Vitamin B6, Vitamin B12, Vitamin B62024-11-29 10:47:42
TransformHQ Meal Replacement Shake - 28 Servings Chocolate -- 2.6 lbsTransformHQActive Lifestyle & Fitnessd-alpha tocopheryl succinate, D-calcium pantothenate, vitamin D3, Vitamin E, Folate, vitamin E, Niacin, niacinamide, Pantothenic Acid, pyridoxine HCI, Vitamin B6, vitamin B2, Thiamin, vitamin B1, sucralose, vitamin B12, vitamin B62024-11-29 10:47:42
TransformHQ Meal Replacement Shake - 28 Servings Chocolate Peanut Butter -- 2.5 lbsTransformHQActive Lifestyle & Fitnessd-alpha tocopheryl succinate, D-calcium pantothenate, vitamin D3, Vitamin E, Folate, vitamin E, Niacin, niacinamide, Pantothenic Acid, Phosphorus, pyridoxine HCI, Vitamin B6, vitamin B2, Thiamin, sucralose, vitamin B12, vitamin B62024-11-29 10:47:42
TransformHQ Meal Replacement Shake - 28 Servings Cookies & Cream -- 2.7 lbsTransformHQActive Lifestyle & Fitnessd-alpha tocopheryl succinate, D-calcium pantothenate, vitamin D3, vitamin E, Folate, vitamin E, Niacin, niacinamide, Pantothenic Acid, Phosphorus, pyridoxine HCI, Vitamin B6, vitamin B2, Thiamin, sucralose, vitamin B12, vitamin B62024-11-29 10:47:42
TransformHQ Meal Replacement Shake - 28 Servings Orange Cream -- 2.5 lbsTransformHQActive Lifestyle & Fitnessd-alpha tocopheryl succinate, D-calcium pantothenate, vitamin D3, Vitamin E, Folate, vitamin E, Niacin, niacinamide, Pantothenic Acid, Phosphorus, pyridoxine HCI, Vitamin B6, vitamin B2, Thiamin, sucralose, vitamin B12, vitamin B62024-11-29 10:47:42
TransformHQ Meal Replacement Shake - 28 Servings Pineapple Whip -- 2.5 lbsTransformHQActive Lifestyle & Fitnessbeta-carotene, Vitamin E, Folate, Vitamin E, Niacin, Pantothenic Acid, Vitamin B6, Riboflavin, Thiamin, sucralose, Vitamin B12, Vitamin B62024-11-29 10:47:42
TransformHQ Meal Replacement Shake - 28 Servings Strawberries & Cream -- 2.5 lbsTransformHQActive Lifestyle & Fitnessd-alpha tocopheryl succinate, D-calcium pantothenate, vitamin D3, vitamin E, Folate, vitamin E, Niacin, niacinamide, Pantothenic Acid, Phosphorus, pyridoxine HCI, Vitamin B6, vitamin B2, Thiamin, sucralose, vitamin B12, vitamin B62024-11-29 10:47:42
TransformHQ Meal Replacement Shake - 28 Servings Vanilla -- 2.5 lbsTransformHQActive Lifestyle & Fitnessd-alpha tocopheryl succinate, D-calcium pantothenate, vitamin D3, Vitamin E, Folate, vitamin E, Niacin, niacinamide, Pantothenic Acid, pyridoxine HCI, Vitamin B6, vitamin B2, Thiamin, vitamin B1, sucralose, vitamin B12, vitamin B62024-11-29 10:47:42
TransformHQ Meal Replacement Shake - 7 Servings Chocolate -- 10.5 ozTransformHQActive Lifestyle & Fitnessd-alpha tocopheryl succinate, D-calcium pantothenate, vitamin D3, Vitamin E, Folate, vitamin E, Niacin, niacinamide, Pantothenic Acid, pyridoxine HCI, Vitamin B6, vitamin B2, Thiamin, vitamin B1, sucralose, vitamin B12, vitamin B62024-11-29 10:47:42
TransformHQ Meal Replacement Shake - 7 Servings Chocolate Peanut Butter -- 10.1 ozTransformHQActive Lifestyle & Fitnessd-alpha tocopheryl succinate, D-calcium pantothenate, vitamin D3, Vitamin E, Folate, vitamin E, Niacin, niacinamide, Pantothenic Acid, Phosphorus, pyridoxine HCI, Vitamin B6, vitamin B2, Thiamin, sucralose, vitamin B12, vitamin B62024-11-29 10:47:42
TransformHQ Meal Replacement Shake - 7 Servings Cookies & Cream -- 11.1 ozTransformHQActive Lifestyle & Fitnessd-alpha tocopheryl succinate, D-calcium pantothenate, vitamin D3, vitamin E, Folate, vitamin E, Niacin, niacinamide, Pantothenic Acid, Phosphorus, pyridoxine HCI, Vitamin B6, vitamin B2, Thiamin, sucralose, vitamin B12, vitamin B62024-11-29 10:47:42
TransformHQ Meal Replacement Shake - 7 Servings Strawberries & Cream -- 10.1 ozTransformHQActive Lifestyle & Fitnessd-alpha tocopheryl succinate, D-calcium pantothenate, vitamin D3, vitamin E, Folate, vitamin E, Niacin, niacinamide, Pantothenic Acid, Phosphorus, pyridoxine HCI, Vitamin B6, vitamin B2, Thiamin, sucralose, vitamin B12, vitamin B62024-11-29 10:47:42
TransformHQ Meal Replacement Shake - 7 Servings Vanilla -- 10 ozTransformHQActive Lifestyle & Fitnessd-alpha tocopheryl succinate, D-calcium pantothenate, vitamin D3, Vitamin E, Folate, vitamin E, Niacin, niacinamide, Pantothenic Acid, pyridoxine HCI, Vitamin B6, vitamin B2, Thiamin, vitamin B1, sucralose, vitamin B12, vitamin B62024-11-29 10:47:42
Tropical Oasis Adult Multi-Vitamin Mineral -- 16 fl ozTropical OasisVitamins & SupplementsVitamin C, Biotin, Vitamin E, Folic Acid, Vitamin E, Niacin, Pantothenic Acid, Vitamin B6, Quercetin, Vitamin A, Riboflavin, Thiamin Hydrochloride, Vitamin B12, Vitamin B6, xylitol2024-11-29 10:47:42
Tropical Oasis Liquid B-Complex -- 16 fl ozTropical OasisVitamins & Supplementscitric acid, Biotin, Choline, citric acid, Folic Acid, Inositol, Niacin, Pantothenic Acid, Vitamin B6, Riboflavin, Thiamin, Vitamin B12, Vitamin B6, xylitol2024-11-29 10:47:42
Tropical Oasis Mega Premium Multi-Vitamin -- 32 fl ozTropical OasisVitamins & SupplementsPABA, Vitamin C, Biotin, Choline, CoQ10, Vitamin E, Folate, Vitamin E, Inositol, Vitamin B3, PABA, Pantothenic Acid, Vitamin B6, Quercetin, Vitamin A, Vitamin B2, Vitamin B1, Vitamin B12, Vitamin B6, xylitol2024-11-29 10:47:42
True Grace Prenatal Multivitamin -- 120 Vegan TabletsTrue GraceVitamins & SupplementsVitamin C, Biotin, Choline, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Manganese, Vitamin K2, Vitamin K2, Molybdenum, Niacin, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
True Grace Prenatal Multivitamin -- 60 Vegan TabletsTrue GraceVitamins & SupplementsVitamin C, Biotin, Choline, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Manganese, Vitamin K2, Vitamin K2, Molybdenum, Niacin, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
TruLabs Sleep Nighttime Drink Mix Honey Lemon -- 6 PacketsTruLabsVitamins & Supplements5-HTP, health, Chloride, Folate, GABA, Melatonin, Niacin, Vitamin B6, stevia, sucralose, Vitamin B6, Ashwagandha2024-11-29 10:47:42
TruRoots Organic Sprouted Green Lentils -- 10 ozTruRootsFood & BeveragesFolate, Manganese, Selenium, Thiamin2024-11-29 10:47:42
TruRoots Quinoa Organic Non GMO Sprouted Trio -- 11 ozTruRootsFood & BeveragesFolate, Manganese2024-11-29 10:47:42
Twinlab Choline Cocktail™ -- 750 mg - 13.33 ozTwinlabVitamins & Supplementscitric acid, Vitamin C, Biotin, Choline, Chromium, citric acid, Coenzyme Q10, Vitamin E, fructose, DMAE, Folate, Vitamin E, L-Carnitine, Maltodextrin, Niacin, Pantothenic Acid, Vitamin B6, Reb A, Vitamin A, Riboflavin, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Twinlab Daily One Caps For Women -- 60 CapsulesTwinlabVitamins & Supplements Agnuside, Vitamin C, Biotin, Vitamin D3, Choline, Chromium, Vitamin E, riboflavin-5'-phosphate, Folate, Vitamin E, Inositol, Iodine, Manganese, Vitamin K2, Vitamin K2, Molybdenum, Niacin, Pantothenic Acid, pyridoxal-5'-phosphate, pyridoxine HCI, Vitamin B6, Vitamin A, Vitamin B2, Selenium, Vitamin B1, Vitamin B12, Vitamin B62024-11-29 10:47:42
Twinlab Daily One Caps without Iron -- 180 CapsulesTwinlabVitamins & SupplementsVitamin C, Biotin, Choline, Chromium, Vitamin E, Folate, Vitamin E, Inositol, Iodine, Manganese, Molybdenum, Niacin, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Twinlab Stress B-Complex Caps -- 100 CapsulesTwinlabVitamins & SupplementsPABA, Vitamin C, Biotin, Folic Acid, Inositol, Niacin, PABA, Pantothenic Acid, Vitamin B6, Vitamin B2, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Twinlab Stress B-Complex Caps -- 250 CapsulesTwinlabVitamins & SupplementsPABA, Vitamin C, Biotin, Choline, Folate, Inositol, Niacin, PABA, Pantothenic Acid, Vitamin B6, Riboflavin, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Vega Organic All-in-One Vegan Protein Powder Berry -- 18 ServingsVegaActive Lifestyle & FitnessB2, citric acid, Vitamin C, Biotin, citric acid, Folate, Manganese, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Vega Organic All-in-One Vegan Protein Powder Berry -- 9 ServingsVegaActive Lifestyle & FitnessB2, citric acid, Vitamin C, Biotin, citric acid, Folate, Manganese, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Vega Organic All-in-One Vegan Protein Powder Chocolate -- 10 PacketsVegaActive Lifestyle & FitnessB2, Vitamin C, Biotin, Folate, Manganese, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Vega Organic All-in-One Vegan Protein Powder Chocolate -- 17 ServingsVegaActive Lifestyle & FitnessB2, Vitamin C, Biotin, Folate, Manganese, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Vega Organic All-in-One Vegan Protein Powder Chocolate -- 42 ServingsVegaActive Lifestyle & FitnessVitamin C, Biotin, Choline, Folate, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Vega Organic All-in-One Vegan Protein Powder Chocolate -- 9 ServingsVegaActive Lifestyle & FitnessB2, Vitamin C, Biotin, Folate, Manganese, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Vega Organic All-in-One Vegan Protein Powder Coconut Almond -- 18 ServingsVegaActive Lifestyle & FitnessB2, Vitamin C, Biotin, Folate, Manganese, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Vega Organic All-in-One Vegan Protein Powder French Vanilla -- 10 PacketsVegaActive Lifestyle & FitnessB2, Vitamin C, Biotin, Choline, Folate, Manganese, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Vega Organic All-in-One Vegan Protein Powder French Vanilla -- 18 ServingsVegaActive Lifestyle & FitnessB2, citric acid, Vitamin C, Biotin, citric acid, Folate, Manganese, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Vega Organic All-in-One Vegan Protein Powder French Vanilla -- 43 ServingsVegaActive Lifestyle & FitnessB2, citric acid, Vitamin C, Biotin, citric acid, Folate, Manganese, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Vega Organic All-in-One Vegan Protein Powder French Vanilla -- 9 ServingsVegaActive Lifestyle & FitnessB2, citric acid, Vitamin C, Biotin, citric acid, Folate, Manganese, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Vega Organic All-in-One Vegan Protein Powder Plain -- 20 ServingsVegaActive Lifestyle & FitnessB2, citric acid, Vitamin C, Biotin, citric acid, Folate, Manganese, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Vega Sport® Recovery Apple Berry -- 20 ServingsVegaActive Lifestyle & Fitnesscitric acid, Biotin, Chloride, citric acid, Folate, malic acid, Niacin, Pantothenic Acid, potassium citrate, Vitamin A, Riboflavin, Thiamin2024-11-29 10:47:42
VegLife Vegan B-Complex -- 100 TabletsVegLifeVitamins & SupplementsPABA, Biotin, Folate, Inositol, Niacin, PABA, Pantothenic Acid, Vitamin B6, Riboflavin, stearic acid, Thiamine, Vitamin B12, Vitamin B62024-11-29 10:47:42
VegLife Vegan Iron -- 25 mg - 100 TabletsVegLifeVitamins & SupplementsVitamin C, Folate, stearic acid, Vitamin B122024-11-29 10:47:42
VegLife Vegan One Multiple with Iron -- 60 TabletsVegLifeVitamins & SupplementsPABA, Vitamin C, Biotin, calcium citrate, Choline, Chromium, Vitamin E, Folate, Vitamin E, Inositol, Iodine, Manganese, Molybdenum, Niacin, PABA, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, Selenium, stearic acid, Thiamine, calcium phosphate, Vitamin B12, Vitamin B62024-11-29 10:47:42
VegLife Vegan One™ Multiple Iron-Free -- 60 TabletsVegLifeVitamins & SupplementsPABA, Vitamin C, Biotin, calcium citrate, Choline, Chromium, Vitamin E, Folate, Vitamin E, Inositol, Iodine, Manganese, Molybdenum, Niacin, PABA, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, Selenium, montmorillonite clay, stearic acid, Thiamine, calcium phosphate, Vitamin B12, Vitamin B62024-11-29 10:47:42
VegLife Vital Teen™ Boys Multiple -- 60 Vegan CapsulesVegLifeVitamins & SupplementsPABA, Vitamin C, Biotin, Chromium, Vitamin E, Folate, Vitamin E, Iodine, L-carnitine, maltodextrin, Manganese, Niacin, PABA, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamine, Vitamin B12, Vitamin B62024-11-29 10:47:42
VegLife Vital Teen™ Girls Multiple -- 60 Vegan CapsulesVegLifeVitamins & SupplementsPABA, Vitamin C, Biotin, Chromium, Vitamin E, Folate, Vitamin E, Iodine, maltodextrin, Manganese, Niacin, PABA, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamine, Vitamin B12, Vitamin B62024-11-29 10:47:42
Vibrant Health Green Vibrance Pouch -- 23.83 ozVibrant HealthVitamins & SupplementsLipase, Vitamin C, Cellulase, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Phosphorus, Vitamin A, Vitamin B12, Vitamin K2024-11-29 10:47:42
Vibrant Health Green Vibrance Powder -- 23.37 ozVibrant HealthVitamins & SupplementsLipase, Vitamin C, Cellulase, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Phosphorus, Vitamin A, Selenium, Vitamin B12, Vitamin K2024-11-29 10:47:42
Vibrant Health Green Vibrance Powder -- 83 ServingsVibrant HealthVitamins & SupplementsLipase, Vitamin C, Cellulase, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Phosphorus, Vitamin A, Vitamin B12, Vitamin K2024-11-29 10:47:42
Vibrant Health Maximum Vibrance Chocolate -- 28.2 ozVibrant HealthVitamins & SupplementsLipase, Policosanol, Larch Arabinogalactan, Vitamin C, Astaxanthin, Biotin, Cellulase, Vitamin D3, Chromium, Vitamin E, Vitamin B9, Vitamin E, Iodine, Lycopene, L-Lysine, Manganese, Vitamin B3, Vitamin B5, Phosphorus, Vitamin B6, Vitamin A, Vitamin B2, Selenium, Silicon, Vitamin B1, L-Valine, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Vibrant Health Maximum Vibrance™ Multi-Supplement Powder Vanilla Bean -- 20.74 ozVibrant HealthVitamins & SupplementsLipase, Vitamin C, Biotin, Cellulase, Vitamin D3, Chromium, Vitamin E, Folic Acid, Vitamin E, Iodine, Manganese, Mustard, Nicotinic Acid, Pantothenic Acid, Phosphorus, Pyridoxine, Vitamin A, Riboflavin, Selenium, Silicon, Thiamin, Vitamin K2024-11-29 10:47:42
Vitacost B-50 Complex -- 100 CapsulesVitacost BrandVitamins & SupplementsBiotin, Choline, riboflavin 5'-phosphate, Folate, Inositol, Niacin, Pantothenic Acid, Vitamin B6, Riboflavin, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Vitacost-Synergy 3000 Multivitamin -- 180 CapsulesVitacost-SynergyVitamins & SupplementsVitamin C, d-beta tocopherol, Biotin, Boron, calcium citrate, cholecalciferol, Chromium, Coenzyme Q10, Vitamin E, d-delta tocopherol, Folate, Vitamin E, Iodine, Lutein, Manganese, Molybdenum, Niacin, Pantothenic Acid, Vitamin B6, Quercetin, retinyl palmitate, Vitamin A, Riboflavin, Selenium, Thiamin, Alpha Lipoic Acid, Vitamin B12, Vitamin B6, phytonadione, Vitamin K, Zeaxanthin2024-11-29 10:47:42
Vitacost-Synergy Basic® Multivitamin -- 60 CapsulesVitacost-SynergyVitamins & Supplementsd-alpha tocopheryl succinate, Vitamin C, d-beta tocopherol, Biotin, dicalcium phosphate, Chromium, Coenzyme Q10, Vitamin E, d-delta tocopherol, Folate, Vitamin E, Iodine, Lutein, Manganese, Molybdenum, Niacin, Pantothenic Acid, Vitamin B6, Quercetin, Vitamin A, Riboflavin, Selenium, Thiamin, Alpha Lipoic Acid, Vitamin B12, Vitamin B6, phytonadione, Vitamin K, Zeaxanthin2024-11-29 10:47:42
Vitacost-Synergy Bioavailable Folate Featuring Quatrefolic® -- 1240 mcg DFE - 60 CapsulesVitacost-SynergyVitamins & SupplementsFolate2024-11-29 10:47:42
Vitacost-Synergy Hair Skin & Nails Formula† -- 120 CapsulesVitacost-SynergyVitamins & SupplementsVitamin C, Biotin, Methylsulfonylmethane, Folate, Niacin, Pantothenic Acid, Vitamin B6, Vitamin A, Selenium, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Vitacost-Synergy Once Daily® Multivitamin -- 60 CapsulesVitacost-SynergyVitamins & SupplementsVitamin C, Biotin, Chromium, Coenzyme Q10, Vitamin E, Folate, Vitamin E, microcrystalline cellulose, Iodine, Lutein, Manganese, Molybdenum, Niacin, Pantothenic Acid, Vitamin B6, Quercetin, Vitamin A, Riboflavin, Selenium, Thiamin, Alpha Lipoic Acid, Vitamin B12, Vitamin B6, Vitamin K, Zeaxanthin2024-11-29 10:47:42
Vitacost-Synergy Optimized B-100 Complex Enhanced Absorption -- 60 CapsulesVitacost-SynergyVitamins & SupplementsBiotin, Choline, riboflavin 5'-phosphate, Folate, inositol hexanicotinate, Inositol, Niacin, niacinamide, Pantothenic Acid, pyridoxal 5-phosphate, Vitamin B6, Riboflavin, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Vitacost-Synergy Twice Daily Energy† Multivitamin -- 60 CapsulesVitacost-SynergyVitamins & SupplementsVitamin C, Benfotiamine, Biotin, cholecalciferol, Chromium, Coenzyme Q10, Vitamin E, Folate, Vitamin E, Iodine, Lutein, Manganese, Vitamin K2, Menaquinone-7, Vitamin K2, Molybdenum, Niacin, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Alpha Lipoic Acid, Vitamin B12, Vitamin B6, phytonadione, Vitamin K, Zeaxanthin2024-11-29 10:47:42
Vitacost-Synergy Ultra B Stress Formula† with Vitamin C -- 240 CapsulesVitacost-SynergyVitamins & SupplementsVitamin C, Biotin, Choline, Folate, microcrystalline cellulose, Niacin, Pantothenic Acid, Vitamin B6, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Vitafusion Brain Food Adult Gummy Natural Blueberry -- 50 GummiesVitafusionHerbs, Botanicals & HomeopathyFolate, fumaric acid, lactic acid, Vitamin B6, sugar, Vitamin B12, Vitamin B62024-11-29 10:47:42
Vitafusion Daily Wellness Multi Berry Fusion -- 30 Soft ChewsVitafusionVitamins & Supplementscitric acid, Vitamin C, Biotin, Vitamin D3, citric acid, Vitamin E, Folate, Vitamin E, glycerin, Niacin, Pantothenic Acid, Vitamin B6, Vitamin A, Cane sugar, Vitamin B12, Vitamin B62024-11-29 10:47:42
Vitafusion Fiber Well Fit Sugar Free -- 90 GummiesVitafusionVitamins & SupplementsBiotin, Folate, malic acid, Niacin, Pantothenic Acid, Vitamin B6, Vitamin B12, Vitamin B62024-11-29 10:47:42
Vitafusion Gorgeous Hair Skin & Nails Multivitamin Natural Raspberry -- 135 GummiesVitafusionVitamins & Supplementscitric acid, Vitamin C, Biotin, citric acid, Vitamin E, Folate, Vitamin E, Iodine, lactic acid, Pantothenic Acid, Vitamin B6, Vitamin A, sugar, Vitamin B12, Vitamin B62024-11-29 10:47:42
Vitafusion Hair Skin & Nails Multivitamin Natural Raspberry -- 100 GummiesVitafusionVitamins & Supplementscitric acid, Vitamin C, Biotin, citric acid, Vitamin E, Folate, Vitamin E, Iodine, lactic acid, Pantothenic Acid, Vitamin B6, Vitamin A, sucrose, Vitamin B12, Vitamin B62024-11-29 10:47:42
Vitafusion Multi + Energy Raspberry & Black Tea -- 90 GummiesVitafusionVitamins & Supplementscitric acid, Vitamin C, Biotin, Boron, Chromium, citric acid, Vitamin E, Folate, Vitamin E, Iodine, Molybdenum, Niacin, Pantothenic Acid, Vitamin B6, Vitamin A, sugar, Vitamin B12, Vitamin B62024-11-29 10:47:42
Vitafusion Multi Plus Immune Gummies -- 90 GummiesVitafusionVitamins & Supplementscitric acid, Vitamin C, Biotin, Boron, Chromium, citric acid, Vitamin E, Folate, Vitamin E, Iodine, malic acid, Molybdenum, Pantothenic Acid, Vitamin B6, Vitamin A, sugar, Vitamin B12, Vitamin B62024-11-29 10:47:42
Vitafusion MultiVites Adult Complete Multivitamin Gummy Assorted Fruit -- 70 GummiesVitafusionVitamins & SupplementsVitamin C, Biotin, Boron, Choline, Chromium, Vitamin E, Folic Acid, Vitamin E, Inositol, lactic acid, Lutein, Molybdenum, Niacin, Pantothenic Acid, Vitamin B6, Vitamin A, sucrose, Vitamin B12, Vitamin B62024-11-29 10:47:42
Vitafusion MultiVites™ Multivitamin Gummies Berry Peach and Orange -- 150 GummiesVitafusionVitamins & Supplementscitric acid, Vitamin C, Biotin, Boron, Chromium, citric acid, Vitamin E, Folic Acid, Vitamin E, Inositol, lactic acid, Molybdenum, Niacin, Pantothenic Acid, Vitamin B6, Vitamin A, sucrose, Vitamin B12, Vitamin B62024-11-29 10:47:42
Vitafusion PreNatal Gummy Vitamins Natural Raspberry Lemonade -- 90 GummiesVitafusionVitamins & SupplementsVitamin C, Vitamin E, Folate, fumaric acid, Vitamin E, lactic acid, Niacin, Vitamin B6, Vitamin A, sugar, Vitamin B12, Vitamin B62024-11-29 10:47:42
VitaHustle ONE Superfood Protein + Greens Powder - 20g Plant Protein Dark Cacao -- 10 ServingsVitaHustleActive Lifestyle & FitnessVitamin C, Biotin, Chloride, Vitamin E, Folate, Vitamin E, Iodine, Manganese, Niacin, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Vital Nutrients Once Daily Multivitamin Complete Daily Vegan For Overall Wellness -- 60 Vegan CapsulesVital NutrientsProfessional SupplementsVitamin C, Biotin, Cellulose, Chromium, Coenzyme Q10, Vitamin E, Folate, Vitamin E, Iodine, Lutein, Lycopene, Manganese, Vitamin K2, Vitamin K2, Molybdenum, Niacinamide, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B6, Zeaxanthin2024-11-29 10:47:42
Vital Nutrients B-Complex - Balanced High Potency B Vitamin Complex -- 120 CapsulesVital NutrientsProfessional Supplementsascorbyl palmitate, Biotin, Riboflavin-5-Phosphate, Folate, leucine, Niacinamide, Pantothenic Acid, Pyridoxal 5' Phosphate, Vitamin B6, Riboflavin, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Vital Nutrients B-Complex Balanced High Potency B Vitamin Complex -- 240 Vegan CapsulesVital NutrientsProfessional SupplementsBiotin, Folate, Niacin, Pantothenic Acid, Vitamin B6, Riboflavin, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Vital Nutrients Minimal and Essential Multivitamin -- 90 CapsulesVital NutrientsProfessional Supplementsascorbyl palmitate, Vitamin C, Biotin, Vitamin D3, Chromium, Vitamin E, Folate, Vitamin E, Manganese, Niacinamide, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Vital Nutrients Multi-Nutrients -Without Iron & Iodine- -- 180 Vegetarian CapsulesVital NutrientsProfessional SupplementsVitamin C, Biotin, Boron, cellulose, Vitamin D3, Chromium, Vitamin E, Folate, Vitamin E, Manganese, Molybdenum, Niacin, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vanadium, Vitamin B12, Vitamin B62024-11-29 10:47:42
Vital Nutrients Multi-Nutrients 3 Citrate-Malate Formula without Copper and Iron -- 180 CapsulesVital NutrientsProfessional SupplementsVitamin C, Biotin, Boron, Chromium, Vitamin E, Riboflavin 5' Phosphate, Folate, Vitamin E, Iodine, Manganese, Molybdenum, Niacinamide, Pantothenic Acid, Pyridoxal 5' Phosphate, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vanadium, Vitamin B12, Vitamin B62024-11-29 10:47:42
Vital Planet Vital Dog™ Daily Multivitamin Beef -- 30 Chewable TabletsVital PlanetPet Suppliesascorbic acid, kelp, d-calcium pantothenate, dicalcium phosphate, Vitamin D3, Choline, Vitamin E, methylsulfonylmethane, iron citrate, Folic Acid, Vitamin E, Iodine, Manganese, Niacin, Pantothenic Acid, potassium chloride, potassium iodide, Pyridoxine, Vitamin A, Riboflavin, Selenium, stearic acid, Thiamine, Vitamin B122024-11-29 10:47:42
Vital Proteins Apple Cider Vinegar Gummies Apple -- 60 GummiesVital ProteinsVitamins & Supplementscitric acid, citric acid, Folate, sugar, Vitamin B122024-11-29 10:47:42
Vitamin Friends Iron Vegan Gummies Strawberry -- 60 GummiesVitamin FriendsVitamins & Supplementscitric acid, Vitamin C, Beta Carotene, Biotin, citric acid, Folic Acid, Vitamin B3, Vitamin B5, Vitamin B6, sodium citrate, Vitamin B12, Vitamin B62024-11-29 10:47:42
Vitanica Dopamine Assist™ -- 60 Vegetarian CapsulesVitanicaVitamins & SupplementsFolate, Vitamin B6, Quercetin, Vitamin B62024-11-29 10:47:42
Vitanica Iron Extra RBC Support -- 60 Vegetarian CapsulesVitanicaVitamins & SupplementsVitamin C, calcium ascorbate, ferrous fumarate, ferrous succinate, Folate, Vitamin B122024-11-29 10:47:42
Vitanica Maternal Symmetry™ OB Multivitamin -- 180 Vegetarian CapsulesVitanicaVitamins & SupplementsVitamin C, Biotin, Boron, calcium ascorbate, Chromium, Vitamin E, ferrous fumarate, ferrous succinate, riboflavin-5-phosphate, Folate, Vitamin E, Iodine, Manganese, Vitamin B3, Pantothenic Acid, Vitamin B6, Vitamin A, vitamin B2, Selenium, Thiamin, vitamin B1, Vitamin B12, Vitamin B6, Vitamin D2, Vitamin K2024-11-29 10:47:42
Viteyes Classic Areds 2 Companion Multivitamin -- 30 CapletsViteyesVitamins & SupplementsBiotin, Boron, Chloride, Chromium, Folate, Microcrystalline cellulose, Iodine, Lycopene, Manganese, Molybdenum, Niacin, Nickel, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Selenium, Silicon, stearic acid, Thiamin, Vanadium, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Viteyes Classic AREDS 2 Companion Multivitamin Beta-Carotene Free -- 90 CapletsViteyesVitamins & SupplementsBiotin, Boron, Chloride, Chromium, Folate, Microcrystalline cellulose, Iodine, Lycopene, Molybdenum, Niacin, Nickel, Pantothenic Acid, Phosphorus, Vitamin B6, Riboflavin, Silicon, stearic acid, Thiamin, Vanadium, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Viteyes Complete Eye & Total Body Health Multivitamin -- 180 CapsulesViteyesVitamins & SupplementsN-Acetyl Cysteine, Vitamin C, Biotin, Boron, Chromium, Coenzyme Q10, Vitamin E, Folate, Vitamin E, Inositol, Iodine, Lutein, Lycopene, Manganese, Molybdenum, Niacin, Nickel, Pantothenic Acid, Phosphorus, Vitamin B6, Vitamin A, Riboflavin, Selenium, Taurine, Thiamin, Alpha-Lipoic Acid, Vitamin B12, Vitamin B6, Vitamin K, Zeaxanthin2024-11-29 10:47:42
Viteyes Optic Nerve Support -- 90 TabletsViteyesVitamins & SupplementsN-Acetyl Cysteine, Vitamin C, Dicalcium phosphate, Coenzyme Q10, Vitamin E, Folate, Vitamin E, microcrystalline cellulose, Quercetin Dihydrate, stearic acid, Taurine, Alpha-Lipoic Acid, Vitamin B122024-11-29 10:47:42
Wellements Organic Baby Multivitamin Drops 2 Months+ Cherry -- 1 fl ozWellementsBaby & Kids Productscitric acid, Vitamin C, citric acid, Vitamin E, Folate, Vitamin E, Niacin, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, Thiamin, Vitamin B62024-11-29 10:47:42
Wellness Canned Cat Food Grain Free Chicken -- 5.5 ozWellnessPet Suppliesbeta-carotene, D-calcium pantothenate, dicalcium phosphate, choline chloride, folic acid, calcium carbonate, niacin, potassium chloride, pyridoxine hydrochloride, sodium selenite, taurine2024-11-29 10:47:42
Wellness Canned Cat Food Grain Free Minced Chicken Dinner -- 3 ozWellnessPet Suppliesbiotin, D-calcium pantothenate, folic acid, niacin, sodium phosphate, potassium chloride, potassium iodide, pyridoxine hydrochloride, sodium selenite, Taurine2024-11-29 10:47:42
Wellness Canned Cat Food Grain Free Sliced Chicken -- 3 ozWellnessPet Suppliesbiotin, D-calcium pantothenate, folic acid, niacin, sodium phosphate, potassium chloride, potassium iodide, pyridoxine hydrochloride, sodium selenite, Taurine2024-11-29 10:47:42
Wellness Canned Cat Food Grain Free Sliced Turkey Salmon -- 5.5 ozWellnessPet Suppliesbiotin, D-calcium pantothenate, choline chloride, folic acid, niacin, sodium phosphate, potassium chloride, potassium iodide, pyridoxine hydrochloride, sodium selenite, Taurine2024-11-29 10:47:42
Wellness Complete Health Dry Dog Food Small Breed Deboned Turkey and Oatmeal Recipe -- 4 lbsWellnessPet SuppliesAscorbic Acid, biotin, d-calcium pantothenate, choline chloride, copper sulfate, ferrous sulfate, folic acid, calcium carbonate, niacin, potassium chloride, pyridoxine hydrochloride, riboflavin, sodium selenite, taurine, zinc sulfate2024-11-29 10:47:42
Wellness Core Canine Original Formula Dry Dog Food -- 4 lbsWellnessPet Suppliesascorbic acid, beta-carotene, biotin, d-calcium pantothenate, choline chloride, copper sulfate, ferrous sulfate, folic acid, calcium carbonate, niacin, pyridoxine hydrochloride, riboflavin, sodium selenite, taurine, zinc sulfate2024-11-29 10:47:42
Wellness CORE Healthy Food For Cats Salmon-Whitefish and Herring Recipe -- 5.5 ozWellnessPet Suppliesbiotin, D-calcium pantothenate, choline chloride, folic acid, max, niacin, potassium chloride, potassium iodide, pyridoxine hydrochloride, sodium selenite, Taurine2024-11-29 10:47:42
Wellness Core Wet Cat Food Tiny Tasters Pate Chicken -- 1.75 ozWellnessPet Suppliesbiotin, D-calcium pantothenate, choline chloride, folic acid, magnesium sulfate, niacin, potassium chloride, pyridoxine hydrochloride, sodium carbonate, sodium selenite, Taurine, thiamine hydrochloride, tricalcium phosphate2024-11-29 10:47:42
Wellness Dry Cat Food Complete Health Grain Free Indoor Recipe -- 5.5 lbsWellnessPet Suppliesascorbic acid, biotin, D-calcium pantothenate, choline chloride, copper sulfate, Vitamin E, ferrous sulfate, folic acid, Vitamin E, Glucosamine, L-carnitine, calcium carbonate, max, niacin, Phosphorus, potassium chloride, pyridoxine hydrochloride, Vitamin A, riboflavin, sodium selenite, Taurine, vitamin K, zinc sulfate2024-11-29 10:47:42
Wellness Natural Dry Dog Food Complete Health Super 5 Mix Deboned Chicken & Oatmeal Recipe -- 5 lbsWellnessPet Suppliesascorbic acid, biotin, d-calcium pantothenate, choline chloride, copper sulfate, ferrous sulfate, folic acid, calcium carbonate, niacin, potassium chloride, pyridoxine hydrochloride, riboflavin, sodium selenite, taurine, zinc sulfate2024-11-29 10:47:42
Wellness Wet Cat Food Shreds Healthy Indulgence Chicken & Turkey -- 3 oz Each / Pack of 24WellnessPet Suppliesbiotin, D-calcium pantothenate, choline chloride, folic acid, magnesium sulfate, max, niacin, potassium chloride, potassium iodide, pyridoxine hydrochloride, Taurine, thiamine hydrochloride, tricalcium phosphate2024-11-29 10:47:42
Wholesome Story Myo & D-Chiro Inositol with MTHF Folate + Vitamin D3 -- 120 Vegetarian CapsulesWholesome StoryVitamins & SupplementsVitamin D3, Folate, D-Chiro Inositol2024-11-29 10:47:42
Wild Harvest Dry Cat Food Chicken Brown Rice & Egg -- 3 lbsWild HarvestPet Suppliesbiotin, calcium pantothenate, calcium sulfate, choline chloride, copper sulfate, folic acid, pyridoxine hydrochloride, sodium selenite, taurine, zinc sulfate2024-11-29 10:47:42
Wild Harvest Dry Cat Food Chicken Recipe -- 3 lbsWild HarvestPet Suppliesbiotin, D-calcium pantothenate, choline chloride, copper sulfate, iron sulfate, folic acid, niacin, pyridoxine hydrochloride, sodium selenite, taurine, zinc sulfate2024-11-29 10:47:42
Wild Harvest Dry Cat Food Salmon & Brown Rice Recipe -- 3 lbsWild HarvestPet Suppliesbeta carotene, biotin, D-calcium pantothenate, choline chloride, Vitamin E, iron sulfate, folic acid, Vitamin E, powdered cellulose, Linoleic Acid, L-lysine, niacin, Phosphorus, pyridoxine hydrochloride, Vitamin A, sodium selenite, Taurine, zinc sulfate2024-11-29 10:47:42
Wild Harvest Dry Dog Food Chicken & Brown Rice -- 4 lbsWild HarvestPet Suppliesbiotin, calcium pantothenate, choline chloride, copper sulfate, folic acid, niacin, potassium chloride, pyridoxine hydrochloride, sodium selenite2024-11-29 10:47:42
Wild Harvest Dry Dog Food Lamb & Brown Rice & Carrot -- 4 lbsWild HarvestPet Suppliesbeta carotene, biotin, calcium pantothenate, dicalcium phosphate, choline chloride, copper sulfate, folic acid, L-carnitine, calcium carbonate, L-lysine, niacin, pyridoxine hydrochloride, sodium selenite, zinc sulfate2024-11-29 10:47:42
Wild Harvest Grain Free Salmon & Vegetable Dry Dog Food -- 3.5 lbsWild HarvestPet Suppliesbiotin, d-calcium pantothenate, choline chloride, copper sulfate, folic acid, magnesium sulfate, niacin, potassium chloride, pyridoxine hydrochloride, sodium selenite, taurine, zinc sulfate2024-11-29 10:47:42
Wild Harvest Grain Free Shredded Chicken in Gravy Recipe Wet Cat Food Chicken -- 5.5 ozWild HarvestPet Suppliesbiotin, D-calcium pantothenate, folic acid, calcium carbonate, sodium phosphate, potassium chloride, potassium iodide, pyridoxine hydrochloride, sodium selenite, Taurine2024-11-29 10:47:42
Wild Harvest Grain Free Shredded Salmon in Gravy Recipe Wet Cat Food Salmon -- 5.5 ozWild HarvestPet Suppliesbiotin, D-calcium pantothenate, folic acid, calcium carbonate, sodium phosphate, potassium chloride, potassium iodide, pyridoxine hydrochloride, sodium selenite, Taurine2024-11-29 10:47:42
Wild Harvest Grain Free Turkey & Sweet Potato Stew Recipe Wet Dog Food Turkey Stew -- 13.2 ozWild HarvestPet Suppliesbiotin, d-calcium pantothenate, choline chloride, folic acid, potassium chloride, potassium iodide, pyridoxine hydrochloride, sodium selenite, tricalcium phosphate2024-11-29 10:47:42
Wild Harvest Pate Cat Food Chicken & Whitefish Recipe -- 5.5 ozWild HarvestPet Suppliesbiotin, D-calcium pantothenate, choline chloride, folic acid, potassium chloride, potassium iodide, pyridoxine hydrochloride, sodium selenite, Taurine2024-11-29 10:47:42
Wild Harvest Pate Cat Food Grain Free Turkey & Giblets Recipe -- 5.5 ozWild HarvestPet Suppliesbiotin, D-calcium pantothenate, choline chloride, folic acid, potassium chloride, potassium iodide, pyridoxine hydrochloride, sodium selenite, Taurine2024-11-29 10:47:42
Wild Harvest Wet Dog Food Beef & Chicken Recipe -- 13.2 ozWild HarvestPet Suppliesbiotin, d-calcium pantothenate, choline chloride, folic acid, potassium chloride, potassium iodide, pyridoxine hydrochloride, sodium selenite2024-11-29 10:47:42
Woodstock Non-GMO Almond Butter Smooth Unsalted -- 16 ozWoodstockFood & BeveragesFolate2024-11-29 10:47:42
World Organic B-12 with Folic Acid -- 2 fl ozWorld OrganicVitamins & SupplementsFolate, Vitamin B122024-11-29 10:47:42
World Organic Hair-Nu Supplement -- 120 TabletsWorld OrganicVitamins & SupplementsPABA, Vitamin C, Biotin, Di-calcium phosphate, Choline, L-Cysteine, Folate, Inositol, Iodine, PABA, Pantothenic Acid, Vitamin B6, stearic acid, Vitamin B62024-11-29 10:47:42
World Organic Ultra-B Liquid -- 16 fl ozWorld OrganicVitamins & SupplementsPABA, Biotin, Choline, Folate, Inositol, Niacin, PABA, Pantothenic Acid, Vitamin B6, Riboflavin, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Zahler B-Complex Bioactive B Complex Formula -- 60 Time Release TabletsZahlerVitamins & SupplementsBenfotiamine, Biotin, Dicalcium phosphate, Choline, Folate, microcrystalline cellulose, Inositol, Niacin, Pantethine, Vitamin B6, Riboflavin, stearic acid, Vitamin B12, Vitamin B62024-11-29 10:47:42
Zahler B-Complex Bioactive B-Complex Formula -- 120 Time Release TabletsZahlerVitamins & SupplementsBenfotiamine, Biotin, Dicalcium phosphate, Choline, Folate, microcrystalline cellulose, Inositol, Niacin, Pantethine, Vitamin B6, Riboflavin, stearic acid, Vitamin B12, Vitamin B62024-11-29 10:47:42
Zahler Iron Complex Gentle & Non-Constipating Formula -- 100 CapsulesZahlerVitamins & SupplementsVitamin C, Folate, L-Histidine, Vitamin B122024-11-29 10:47:42
Zahler Methylfolate -- 60 CapsulesZahlerVitamins & SupplementsFolate, microcrystalline cellulose2024-11-29 10:47:42
Zahler Multivitamin Beauty -- 60 CapsulesZahlerVitamins & SupplementsVitamin C, Astaxanthin, Biotin, Vitamin D3, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Manganese, Vitamin K2, Vitamin K2, Molybdenum, Niacin, Pantethine, Vitamin B6, Quercetin, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Zahler Multivitamin Brainfood -- 60 CapsulesZahlerVitamins & SupplementsVitamin C, Vitamin D3, Choline, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Lutein, Manganese, Vitamin K2, Vitamin K2, Molybdenum, Niacin, Vitamin B6, Quercetin, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Zahler Multivitamin Metabolism -- 60 CapsulesZahlerVitamins & SupplementsVitamin C, Vitamin D3, Choline, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Manganese, Vitamin K2, Vitamin K2, Molybdenum, Niacin, Pantethine, Vitamin B6, Quercetin, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Zahler Multivitamin One Daily -- 60 CapsulesZahlerVitamins & SupplementsVitamin C, Vitamin D3, Chromium, Vitamin E, Folate, Vitamin E, Iodine, Manganese, Vitamin K2, Vitamin K2, Molybdenum, Niacin, Pantethine, Vitamin B6, Quercetin, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Zahler Prenatal + DHA 300 Optimal Formula -- 120 SoftgelsZahlerVitamins & Supplementsannatto, Vitamin C, Biotin, Choline, Chromium, Vitamin E, Docosahexaenoic Acid, Folate, Vitamin E, glycerin, Iodine, Manganese, Molybdenum, Niacin, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Zahler Prenatal + DHA 300 Optimal Formula -- 180 SoftgelsZahlerVitamins & SupplementsVitamin C, Biotin, Vitamin D3, Choline, Chromium, Vitamin E, Docosahexaenoic Acid, Riboflavin 5-Phosphate, Folate, Vitamin E, Iodine, Manganese, Vitamin K2, Vitamin K2, Molybdenum, Niacin, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Vitamin B12, Vitamin B6, Vitamin K12024-11-29 10:47:42
Zesty Paws 8-in-1 Multivitamin Bites Supplement for Dogs Chicken -- 250 Soft ChewsZesty PawsPet Suppliescitric acid, Vitamin C, Biotin, calcium pantothenate, citric acid, Vitamin E, Docosahexaenoic Acid, Folic Acid, vitamin E, powdered cellulose, Vitamin B3, Vitamin B5, Vitamin B6, Vitamin B2, Vitamin B1, vitamin B12, Vitamin B62024-11-29 10:47:42
Zesty Paws 8-in-1 Multivitamin Bites Supplement for Dogs Chicken -- 90 Soft ChewsZesty PawsPet Supplies Lipase, Vitamin C, Biotin, Cellulase, Vitamin D3, Coenzyme Q10, Vitamin E, Folic Acid, Vitamin E, Manganese, Niacin, Pantothenic Acid, Vitamin B6, Vitamin B2, sorbic acid, Vitamin B1, Vitamin B12, Vitamin B62024-11-29 10:47:42
Zesty Paws 8-in-1 Multivitamin Bites Supplement for Dogs Peanut Butter -- 90 Soft ChewsZesty PawsPet Suppliescitric acid, Vitamin C, Biotin, calcium pantothenate, citric acid, Vitamin E, Docosahexaenoic Acid, Folic Acid, vitamin E, powdered cellulose, manganese, Vitamin B3, Vitamin B5, Vitamin B6, Vitamin B2, Vitamin B1, vitamin B12, Vitamin B62024-11-29 10:47:42
Zesty Paws Ancient Elements 8-in-1 Bites Multi-functional Supplement Dogs Bison -- 90 Soft ChewsZesty PawsPet Supplies Lipase, Biotin, Cellulase, Vitamin D3, Coenzyme Q10, Methylsulfonylmethane, Folic Acid, Vitamin A2024-11-29 10:47:42
Zesty Paws Hemp Elements 8-in-1 Multivitamin Supplement for Dogs Chicken -- 90 Soft ChewsZesty PawsPet Supplies Lipase, citric acid, Vitamin C, Biotin, Cellulase, Vitamin D3, citric acid, Coenzyme Q10, Vitamin E, Folic Acid, Vitamin E, powdered cellulose, Manganese, Niacin, Pantothenic Acid, Vitamin B6, Vitamin A, Vitamin B2, Vitamin B1, Vitamin B-12, Vitamin B62024-11-29 10:47:42
Zesty Paws Senior Advanced 11-in-1 Multivitamin Glucosamine Supplement for Dogs Chicken -- 90 Soft ChewsZesty PawsPet Supplieslipase, Vitamin C, Biotin, cellulase, Vitamin D3, Coenzyme Q10, Vitamin E, methylsulfonylmethane, folic acid, vitamin E, powdered cellulose, Lutein, Niacin, Pantothenic Acid, Vitamin B6, Vitamin A, Vitamin B2, sorbic acid, vitamin B1, vitamin B12, vitamin B62024-11-29 10:47:42
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ZOA Zoa+ Pre-Workout Powder - Maximum Performance - NSF Certified For Sport Cherry Lime -- 25 ServingsZOAActive Lifestyle & Fitnesscitric acid, acesulfame potassium, acesulfame potassium, Beta-Alanine, Betaine Anhydrous, citric acid, Folate, malic acid, Niacin, Pantothenic Acid, Vitamin B6, sucralose, Vitamin B12, Vitamin B62024-11-29 10:47:42
ZOA Zoa+ Pre-Workout Powder - Maximum Performance - NSF Certified For Sport Fruit Punch -- 25 ServingsZOAActive Lifestyle & Fitnesscitric acid, Beta-Alanine, Betaine Anhydrous, citric acid, Folate, malic acid, Niacin, Pantothenic Acid, Vitamin B6, sucralose, Vitamin B12, Vitamin B62024-11-29 10:47:42
ZOA Zoa+ Pre-Workout Powder - Maximum Performance - NSF Certified For Sport Wild Berry -- 25 ServingsZOAActive Lifestyle & Fitnesscitric acid, acesulfame potassium, acesulfame potassium, Beta-Alanine, Betaine Anhydrous, citric acid, Folate, malic acid, Niacin, Pantothenic Acid, Vitamin B6, sucralose, Vitamin B12, Vitamin B62024-11-29 10:47:42
Zoup Chicken Bone Broth Chicken Potpie Soup -- 16 ozZoupFood & Beveragesfolic acid, niacin, riboflavin, spice2024-11-29 10:47:42
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Roles (3)

RoleDescription
human metaboliteAny mammalian metabolite produced during a metabolic reaction in humans (Homo sapiens).
nutrientA nutrient is a food component that an organism uses to survive and grow.
mouse metaboliteAny mammalian metabolite produced during a metabolic reaction in a mouse (Mus musculus).
[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 (2)

ClassDescription
folic acidsA group of heterocyclic compounds based on the pteroic acid skeleton conjugated with one or more L-glutamic acid units.
N-acyl-amino acidA carboxamide resulting from the formal condensation of a carboxylic acid with the amino group of an amino acid.
[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 (13)

PathwayProteinsCompounds
Metabolism14961108
Metabolism of vitamins and cofactors146155
Metabolism of water-soluble vitamins and cofactors102114
Metabolism of folate and pterines1629
Folate metabolism ( Folate metabolism )2039
Folic acid network070
Folate biosynthesis08
Selenium micronutrient network095
Folate metabolism156
Trans-sulfuration, one-carbon metabolism and related pathways053
One-carbon metabolism and related pathways038
Ethanol effects on histone modifications017
Disorders of folate metabolism and transport1827

Protein Targets (38)

Potency Measurements

ProteinTaxonomyMeasurementAverage (µ)Min (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Chain A, MAJOR APURINIC/APYRIMIDINIC ENDONUCLEASEHomo sapiens (human)Potency35.48130.003245.467312,589.2998AID2517
Chain A, TYROSYL-DNA PHOSPHODIESTERASEHomo sapiens (human)Potency39.81070.004023.8416100.0000AID485290
Chain A, Putative fructose-1,6-bisphosphate aldolaseGiardia intestinalisPotency39.81070.140911.194039.8107AID2451
Chain A, HADH2 proteinHomo sapiens (human)Potency18.85410.025120.237639.8107AID893
Chain B, HADH2 proteinHomo sapiens (human)Potency18.85410.025120.237639.8107AID893
Chain A, 2-oxoglutarate OxygenaseHomo sapiens (human)Potency17.55950.177814.390939.8107AID2147
Chain A, Ferritin light chainEquus caballus (horse)Potency12.58935.623417.292931.6228AID485281
acid sphingomyelinaseHomo sapiens (human)Potency25.118914.125424.061339.8107AID504937
glp-1 receptor, partialHomo sapiens (human)Potency7.07950.01846.806014.1254AID624417
USP1 protein, partialHomo sapiens (human)Potency39.81070.031637.5844354.8130AID504865
GLI family zinc finger 3Homo sapiens (human)Potency27.30600.000714.592883.7951AID1259369
AR proteinHomo sapiens (human)Potency0.00210.000221.22318,912.5098AID743042
aldehyde dehydrogenase 1 family, member A1Homo sapiens (human)Potency15.84890.011212.4002100.0000AID1030
thyroid stimulating hormone receptorHomo sapiens (human)Potency7.94330.001318.074339.8107AID926
retinoid X nuclear receptor alphaHomo sapiens (human)Potency26.03850.000817.505159.3239AID1159527; AID1159531
estrogen-related nuclear receptor alphaHomo sapiens (human)Potency68.58960.001530.607315,848.9004AID1224841; AID1224842
estrogen nuclear receptor alphaHomo sapiens (human)Potency12.33480.000229.305416,493.5996AID743075; AID743079
glucocerebrosidaseHomo sapiens (human)Potency22.38720.01268.156944.6684AID2101
vitamin D (1,25- dihydroxyvitamin D3) receptorHomo sapiens (human)Potency13.20700.023723.228263.5986AID743223; AID743241
alpha-galactosidaseHomo sapiens (human)Potency22.38724.466818.391635.4813AID1467
activating transcription factor 6Homo sapiens (human)Potency0.00060.143427.612159.8106AID1159516
lysosomal alpha-glucosidase preproproteinHomo sapiens (human)Potency50.11870.036619.637650.1187AID2100
15-hydroxyprostaglandin dehydrogenase [NAD(+)] isoform 1Homo sapiens (human)Potency35.48130.001815.663839.8107AID894
nuclear factor erythroid 2-related factor 2 isoform 2Homo sapiens (human)Potency11.58210.00419.984825.9290AID504444
DNA polymerase betaHomo sapiens (human)Potency100.00000.022421.010289.1251AID485314
Cellular tumor antigen p53Homo sapiens (human)Potency2.73060.002319.595674.0614AID651631
Alpha-synucleinHomo sapiens (human)Potency3.98110.56239.398525.1189AID652106
[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)
Bile salt export pumpHomo sapiens (human)IC50 (µMol)1,000.00000.11007.190310.0000AID1443987; AID1449628
Thymidylate synthaseHomo sapiens (human)IC50 (µMol)290.00000.00662.06379.5000AID212156
Thymidylate synthaseHomo sapiens (human)Ki40.00000.00010.34353.0000AID212457
Thymidylate synthaseMus musculus (house mouse)IC50 (µMol)590.00000.00041.322610.0000AID212636; AID213840
Aldo-keto reductase family 1 member B1Homo sapiens (human)IC50 (µMol)52.50000.00101.191310.0000AID1713572
Solute carrier organic anion transporter family member 1A3Rattus norvegicus (Norway rat)Ki14.10000.50003.30008.2000AID681604
[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)
Chain A, Dihydrofolate reductaseEscherichia coliKd9.51009.51009.51009.5100AID977611
Dihydrofolate reductaseEscherichia coli K-12Kd3.33670.00001.24596.6000AID57251; AID57256; AID57262
[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)
Multidrug resistance-associated protein 4Homo sapiens (human)Km170.00001.90004.27259.6900AID680355
Folylpolyglutamate synthase, mitochondrialMus musculus (house mouse)Km234,000,000.00008.00008.00008.0000AID71200
Folylpolyglutamate synthase, mitochondrialHomo sapiens (human)Km104.60000.40004.53447.3000AID71218
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Biological Processes (275)

Processvia Protein(s)Taxonomy
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)
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)
dTMP biosynthetic processThymidylate synthaseHomo sapiens (human)
dTTP biosynthetic processThymidylate synthaseHomo sapiens (human)
circadian rhythmThymidylate synthaseHomo sapiens (human)
response to xenobiotic stimulusThymidylate synthaseHomo sapiens (human)
response to toxic substanceThymidylate synthaseHomo sapiens (human)
negative regulation of translationThymidylate synthaseHomo sapiens (human)
uracil metabolic processThymidylate synthaseHomo sapiens (human)
methylationThymidylate synthaseHomo sapiens (human)
response to progesteroneThymidylate synthaseHomo sapiens (human)
response to vitamin AThymidylate synthaseHomo sapiens (human)
response to cytokineThymidylate synthaseHomo sapiens (human)
tetrahydrofolate interconversionThymidylate synthaseHomo sapiens (human)
response to ethanolThymidylate synthaseHomo sapiens (human)
response to organophosphorusThymidylate synthaseHomo sapiens (human)
developmental growthThymidylate synthaseHomo sapiens (human)
cartilage developmentThymidylate synthaseHomo sapiens (human)
response to glucocorticoidThymidylate synthaseHomo sapiens (human)
response to folic acidThymidylate synthaseHomo sapiens (human)
intestinal epithelial cell maturationThymidylate synthaseHomo sapiens (human)
DNA biosynthetic processThymidylate synthaseHomo sapiens (human)
liver regenerationThymidylate synthaseHomo sapiens (human)
10-formyltetrahydrofolate biosynthetic processDihydrofolate reductaseEscherichia coli K-12
response to xenobiotic stimulusDihydrofolate reductaseEscherichia coli K-12
folic acid biosynthetic processDihydrofolate reductaseEscherichia coli K-12
one-carbon metabolic processDihydrofolate reductaseEscherichia coli K-12
response to methotrexateDihydrofolate reductaseEscherichia coli K-12
tetrahydrofolate biosynthetic processDihydrofolate reductaseEscherichia coli K-12
response to antibioticDihydrofolate reductaseEscherichia coli K-12
dihydrofolate metabolic processDihydrofolate reductaseEscherichia coli K-12
folic acid metabolic processDihydrofolate reductaseEscherichia coli K-12
retinoid metabolic processAldo-keto reductase family 1 member B1Homo sapiens (human)
epithelial cell maturationAldo-keto reductase family 1 member B1Homo sapiens (human)
renal water homeostasisAldo-keto reductase family 1 member B1Homo sapiens (human)
carbohydrate metabolic processAldo-keto reductase family 1 member B1Homo sapiens (human)
prostaglandin metabolic processAldo-keto reductase family 1 member B1Homo sapiens (human)
C21-steroid hormone biosynthetic processAldo-keto reductase family 1 member B1Homo sapiens (human)
L-ascorbic acid biosynthetic processAldo-keto reductase family 1 member B1Homo sapiens (human)
regulation of urine volumeAldo-keto reductase family 1 member B1Homo sapiens (human)
retinol metabolic processAldo-keto reductase family 1 member B1Homo sapiens (human)
negative regulation of apoptotic processAldo-keto reductase family 1 member B1Homo sapiens (human)
daunorubicin metabolic processAldo-keto reductase family 1 member B1Homo sapiens (human)
doxorubicin metabolic processAldo-keto reductase family 1 member B1Homo sapiens (human)
fructose biosynthetic processAldo-keto reductase family 1 member B1Homo sapiens (human)
cellular hyperosmotic salinity responseAldo-keto reductase family 1 member B1Homo sapiens (human)
metanephric collecting duct developmentAldo-keto reductase family 1 member B1Homo sapiens (human)
calcium ion homeostasisAlpha-synucleinHomo sapiens (human)
negative regulation of transcription by RNA polymerase IIAlpha-synucleinHomo sapiens (human)
microglial cell activationAlpha-synucleinHomo sapiens (human)
positive regulation of receptor recyclingAlpha-synucleinHomo sapiens (human)
positive regulation of neurotransmitter secretionAlpha-synucleinHomo sapiens (human)
negative regulation of protein kinase activityAlpha-synucleinHomo sapiens (human)
fatty acid metabolic processAlpha-synucleinHomo sapiens (human)
neutral lipid metabolic processAlpha-synucleinHomo sapiens (human)
phospholipid metabolic processAlpha-synucleinHomo sapiens (human)
activation of cysteine-type endopeptidase activity involved in apoptotic processAlpha-synucleinHomo sapiens (human)
mitochondrial membrane organizationAlpha-synucleinHomo sapiens (human)
adult locomotory behaviorAlpha-synucleinHomo sapiens (human)
response to xenobiotic stimulusAlpha-synucleinHomo sapiens (human)
response to iron(II) ionAlpha-synucleinHomo sapiens (human)
regulation of phospholipase activityAlpha-synucleinHomo sapiens (human)
negative regulation of platelet-derived growth factor receptor signaling pathwayAlpha-synucleinHomo sapiens (human)
regulation of glutamate secretionAlpha-synucleinHomo sapiens (human)
regulation of dopamine secretionAlpha-synucleinHomo sapiens (human)
synaptic vesicle exocytosisAlpha-synucleinHomo sapiens (human)
synaptic vesicle primingAlpha-synucleinHomo sapiens (human)
regulation of transmembrane transporter activityAlpha-synucleinHomo sapiens (human)
negative regulation of microtubule polymerizationAlpha-synucleinHomo sapiens (human)
receptor internalizationAlpha-synucleinHomo sapiens (human)
protein destabilizationAlpha-synucleinHomo sapiens (human)
response to magnesium ionAlpha-synucleinHomo sapiens (human)
negative regulation of transporter activityAlpha-synucleinHomo sapiens (human)
response to lipopolysaccharideAlpha-synucleinHomo sapiens (human)
negative regulation of monooxygenase activityAlpha-synucleinHomo sapiens (human)
positive regulation of peptidyl-serine phosphorylationAlpha-synucleinHomo sapiens (human)
response to type II interferonAlpha-synucleinHomo sapiens (human)
cellular response to oxidative stressAlpha-synucleinHomo sapiens (human)
SNARE complex assemblyAlpha-synucleinHomo sapiens (human)
positive regulation of SNARE complex assemblyAlpha-synucleinHomo sapiens (human)
regulation of locomotionAlpha-synucleinHomo sapiens (human)
dopamine biosynthetic processAlpha-synucleinHomo sapiens (human)
mitochondrial ATP synthesis coupled electron transportAlpha-synucleinHomo sapiens (human)
regulation of macrophage activationAlpha-synucleinHomo sapiens (human)
positive regulation of apoptotic processAlpha-synucleinHomo sapiens (human)
negative regulation of apoptotic processAlpha-synucleinHomo sapiens (human)
negative regulation of cysteine-type endopeptidase activity involved in apoptotic processAlpha-synucleinHomo sapiens (human)
negative regulation of neuron apoptotic processAlpha-synucleinHomo sapiens (human)
positive regulation of endocytosisAlpha-synucleinHomo sapiens (human)
negative regulation of exocytosisAlpha-synucleinHomo sapiens (human)
positive regulation of exocytosisAlpha-synucleinHomo sapiens (human)
regulation of long-term neuronal synaptic plasticityAlpha-synucleinHomo sapiens (human)
synaptic vesicle endocytosisAlpha-synucleinHomo sapiens (human)
synaptic vesicle transportAlpha-synucleinHomo sapiens (human)
positive regulation of inflammatory responseAlpha-synucleinHomo sapiens (human)
regulation of acyl-CoA biosynthetic processAlpha-synucleinHomo sapiens (human)
protein tetramerizationAlpha-synucleinHomo sapiens (human)
positive regulation of release of sequestered calcium ion into cytosolAlpha-synucleinHomo sapiens (human)
neuron apoptotic processAlpha-synucleinHomo sapiens (human)
dopamine uptake involved in synaptic transmissionAlpha-synucleinHomo sapiens (human)
negative regulation of dopamine uptake involved in synaptic transmissionAlpha-synucleinHomo sapiens (human)
negative regulation of serotonin uptakeAlpha-synucleinHomo sapiens (human)
regulation of norepinephrine uptakeAlpha-synucleinHomo sapiens (human)
negative regulation of norepinephrine uptakeAlpha-synucleinHomo sapiens (human)
excitatory postsynaptic potentialAlpha-synucleinHomo sapiens (human)
long-term synaptic potentiationAlpha-synucleinHomo sapiens (human)
positive regulation of inositol phosphate biosynthetic processAlpha-synucleinHomo sapiens (human)
negative regulation of thrombin-activated receptor signaling pathwayAlpha-synucleinHomo sapiens (human)
response to interleukin-1Alpha-synucleinHomo sapiens (human)
cellular response to copper ionAlpha-synucleinHomo sapiens (human)
cellular response to epinephrine stimulusAlpha-synucleinHomo sapiens (human)
positive regulation of protein serine/threonine kinase activityAlpha-synucleinHomo sapiens (human)
supramolecular fiber organizationAlpha-synucleinHomo sapiens (human)
negative regulation of mitochondrial electron transport, NADH to ubiquinoneAlpha-synucleinHomo sapiens (human)
positive regulation of glutathione peroxidase activityAlpha-synucleinHomo sapiens (human)
positive regulation of hydrogen peroxide catabolic processAlpha-synucleinHomo sapiens (human)
regulation of synaptic vesicle recyclingAlpha-synucleinHomo sapiens (human)
regulation of reactive oxygen species biosynthetic processAlpha-synucleinHomo sapiens (human)
positive regulation of protein localization to cell peripheryAlpha-synucleinHomo sapiens (human)
negative regulation of chaperone-mediated autophagyAlpha-synucleinHomo sapiens (human)
regulation of presynapse assemblyAlpha-synucleinHomo sapiens (human)
amyloid fibril formationAlpha-synucleinHomo sapiens (human)
synapse organizationAlpha-synucleinHomo sapiens (human)
chemical synaptic transmissionAlpha-synucleinHomo sapiens (human)
liver developmentFolylpolyglutamate synthase, mitochondrialHomo sapiens (human)
nucleobase-containing compound metabolic processFolylpolyglutamate synthase, mitochondrialHomo sapiens (human)
glutamate metabolic processFolylpolyglutamate synthase, mitochondrialHomo sapiens (human)
one-carbon metabolic processFolylpolyglutamate synthase, mitochondrialHomo sapiens (human)
folic acid-containing compound metabolic processFolylpolyglutamate synthase, mitochondrialHomo sapiens (human)
animal organ regenerationFolylpolyglutamate synthase, mitochondrialHomo sapiens (human)
folic acid metabolic processFolylpolyglutamate synthase, mitochondrialHomo sapiens (human)
tetrahydrofolylpolyglutamate biosynthetic processFolylpolyglutamate synthase, mitochondrialHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Molecular Functions (96)

Processvia Protein(s)Taxonomy
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)
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)
mRNA regulatory element binding translation repressor activityThymidylate synthaseHomo sapiens (human)
thymidylate synthase activityThymidylate synthaseHomo sapiens (human)
folic acid bindingThymidylate synthaseHomo sapiens (human)
protein homodimerization activityThymidylate synthaseHomo sapiens (human)
sequence-specific mRNA bindingThymidylate synthaseHomo sapiens (human)
dihydrofolate reductase activityDihydrofolate reductaseEscherichia coli K-12
protein bindingDihydrofolate reductaseEscherichia coli K-12
folic acid bindingDihydrofolate reductaseEscherichia coli K-12
oxidoreductase activityDihydrofolate reductaseEscherichia coli K-12
NADP bindingDihydrofolate reductaseEscherichia coli K-12
methotrexate bindingDihydrofolate reductaseEscherichia coli K-12
dihydrofolic acid bindingDihydrofolate reductaseEscherichia coli K-12
NADP+ bindingDihydrofolate reductaseEscherichia coli K-12
NADPH bindingDihydrofolate reductaseEscherichia coli K-12
retinal dehydrogenase activityAldo-keto reductase family 1 member B1Homo sapiens (human)
aldose reductase (NADPH) activityAldo-keto reductase family 1 member B1Homo sapiens (human)
protein bindingAldo-keto reductase family 1 member B1Homo sapiens (human)
electron transfer activityAldo-keto reductase family 1 member B1Homo sapiens (human)
prostaglandin H2 endoperoxidase reductase activityAldo-keto reductase family 1 member B1Homo sapiens (human)
glyceraldehyde oxidoreductase activityAldo-keto reductase family 1 member B1Homo sapiens (human)
allyl-alcohol dehydrogenase activityAldo-keto reductase family 1 member B1Homo sapiens (human)
L-glucuronate reductase activityAldo-keto reductase family 1 member B1Homo sapiens (human)
glycerol dehydrogenase [NADP+] activityAldo-keto reductase family 1 member B1Homo sapiens (human)
all-trans-retinol dehydrogenase (NADP+) activityAldo-keto reductase family 1 member B1Homo sapiens (human)
fatty acid bindingAlpha-synucleinHomo sapiens (human)
phospholipase D inhibitor activityAlpha-synucleinHomo sapiens (human)
SNARE bindingAlpha-synucleinHomo sapiens (human)
magnesium ion bindingAlpha-synucleinHomo sapiens (human)
transcription cis-regulatory region bindingAlpha-synucleinHomo sapiens (human)
actin bindingAlpha-synucleinHomo sapiens (human)
protein kinase inhibitor activityAlpha-synucleinHomo sapiens (human)
copper ion bindingAlpha-synucleinHomo sapiens (human)
calcium ion bindingAlpha-synucleinHomo sapiens (human)
protein bindingAlpha-synucleinHomo sapiens (human)
phospholipid bindingAlpha-synucleinHomo sapiens (human)
ferrous iron bindingAlpha-synucleinHomo sapiens (human)
zinc ion bindingAlpha-synucleinHomo sapiens (human)
lipid bindingAlpha-synucleinHomo sapiens (human)
oxidoreductase activityAlpha-synucleinHomo sapiens (human)
kinesin bindingAlpha-synucleinHomo sapiens (human)
Hsp70 protein bindingAlpha-synucleinHomo sapiens (human)
histone bindingAlpha-synucleinHomo sapiens (human)
identical protein bindingAlpha-synucleinHomo sapiens (human)
alpha-tubulin bindingAlpha-synucleinHomo sapiens (human)
cysteine-type endopeptidase inhibitor activity involved in apoptotic processAlpha-synucleinHomo sapiens (human)
tau protein bindingAlpha-synucleinHomo sapiens (human)
phosphoprotein bindingAlpha-synucleinHomo sapiens (human)
molecular adaptor activityAlpha-synucleinHomo sapiens (human)
dynein complex bindingAlpha-synucleinHomo sapiens (human)
cuprous ion bindingAlpha-synucleinHomo sapiens (human)
tetrahydrofolylpolyglutamate synthase activityFolylpolyglutamate synthase, mitochondrialHomo sapiens (human)
ATP bindingFolylpolyglutamate synthase, mitochondrialHomo sapiens (human)
metal ion bindingFolylpolyglutamate synthase, mitochondrialHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Ceullar Components (50)

Processvia Protein(s)Taxonomy
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)
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)
nucleusThymidylate synthaseHomo sapiens (human)
cytoplasmThymidylate synthaseHomo sapiens (human)
mitochondrionThymidylate synthaseHomo sapiens (human)
mitochondrial inner membraneThymidylate synthaseHomo sapiens (human)
mitochondrial matrixThymidylate synthaseHomo sapiens (human)
cytosolThymidylate synthaseHomo sapiens (human)
mitochondrionThymidylate synthaseHomo sapiens (human)
cytosolThymidylate synthaseHomo sapiens (human)
cytosolDihydrofolate reductaseEscherichia coli K-12
cytosolDihydrofolate reductaseEscherichia coli K-12
extracellular spaceAldo-keto reductase family 1 member B1Homo sapiens (human)
nucleoplasmAldo-keto reductase family 1 member B1Homo sapiens (human)
cytosolAldo-keto reductase family 1 member B1Homo sapiens (human)
extracellular exosomeAldo-keto reductase family 1 member B1Homo sapiens (human)
cytosolAldo-keto reductase family 1 member B1Homo sapiens (human)
platelet alpha granule membraneAlpha-synucleinHomo sapiens (human)
extracellular regionAlpha-synucleinHomo sapiens (human)
extracellular spaceAlpha-synucleinHomo sapiens (human)
nucleusAlpha-synucleinHomo sapiens (human)
cytoplasmAlpha-synucleinHomo sapiens (human)
mitochondrionAlpha-synucleinHomo sapiens (human)
lysosomeAlpha-synucleinHomo sapiens (human)
cytosolAlpha-synucleinHomo sapiens (human)
plasma membraneAlpha-synucleinHomo sapiens (human)
cell cortexAlpha-synucleinHomo sapiens (human)
actin cytoskeletonAlpha-synucleinHomo sapiens (human)
membraneAlpha-synucleinHomo sapiens (human)
inclusion bodyAlpha-synucleinHomo sapiens (human)
axonAlpha-synucleinHomo sapiens (human)
growth coneAlpha-synucleinHomo sapiens (human)
synaptic vesicle membraneAlpha-synucleinHomo sapiens (human)
perinuclear region of cytoplasmAlpha-synucleinHomo sapiens (human)
postsynapseAlpha-synucleinHomo sapiens (human)
supramolecular fiberAlpha-synucleinHomo sapiens (human)
protein-containing complexAlpha-synucleinHomo sapiens (human)
cytoplasmAlpha-synucleinHomo sapiens (human)
axon terminusAlpha-synucleinHomo sapiens (human)
neuronal cell bodyAlpha-synucleinHomo sapiens (human)
mitochondrial inner membraneFolylpolyglutamate synthase, mitochondrialHomo sapiens (human)
mitochondrial matrixFolylpolyglutamate synthase, mitochondrialHomo sapiens (human)
cytosolFolylpolyglutamate synthase, mitochondrialHomo sapiens (human)
cytoplasmFolylpolyglutamate synthase, mitochondrialHomo sapiens (human)
mitochondrionFolylpolyglutamate synthase, mitochondrialHomo sapiens (human)
cytosolFolylpolyglutamate synthase, mitochondrialHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (157)

Assay IDTitleYearJournalArticle
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.
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.
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.
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.
AID1745845Primary qHTS for Inhibitors of ATXN expression
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.
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.
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.
AID651635Viability Counterscreen for Primary qHTS for Inhibitors of ATXN expression
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.
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.
AID1347161Confirmatory screen NINDS Rhodamine 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.
AID1347425Rhodamine-PBP qHTS Assay for Modulators of WT P53-Induced Phosphatase 1 (WIP1)2019The Journal of biological chemistry, 11-15, Volume: 294, Issue:46
Physiologically relevant orthogonal assays for the discovery of small-molecule modulators of WIP1 phosphatase in high-throughput screens.
AID1347108qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh41 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
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.
AID1508627Counterscreen qHTS for small molecule stabilizers of the endoplasmic reticulum resident proteome: GLuc-NoTag assay2021Cell reports, 04-27, Volume: 35, Issue:4
A target-agnostic screen identifies approved drugs to stabilize the endoplasmic reticulum-resident proteome.
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.
AID1347153Confirmatory 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.
AID1347168HepG2 cells viability 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.
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.
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.
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.
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.
AID1347167Vero cells viability 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.
AID1508628Confirmatory 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.
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.
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.
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.
AID1347149Furin counterscreen 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.
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.
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.
AID1347169Tertiary RLuc qRT-PCR qHTS assay for Zika virus inhibitors2020Proceedings of the National Academy of Sciences of the United States of America, 12-08, Volume: 117, Issue:49
Therapeutic candidates for the Zika virus identified by a high-throughput screen for Zika protease inhibitors.
AID1347105qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for MG 63 (6-TG R) cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
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.
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.
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.
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.
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.
AID1508629Cell Viability qHTS for small molecule stabilizers of the endoplasmic reticulum resident proteome2021Cell reports, 04-27, Volume: 35, Issue:4
A target-agnostic screen identifies approved drugs to stabilize the endoplasmic reticulum-resident proteome.
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.
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.
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.
AID1347152Confirmatory screen NINDS 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.
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.
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.
AID1636357Drug activation in human Hep3B cells assessed as human CYP3A4-mediated drug metabolism-induced cytotoxicity measured as decrease in cell viability at 300 uM pre-incubated with BSO for 18 hrs followed by incubation with compound for 3 hrs in presence of NA2016Bioorganic & medicinal chemistry letters, 08-15, Volume: 26, Issue:16
Development of a cell viability assay to assess drug metabolite structure-toxicity relationships.
AID679486TP_TRANSPORTER: uptake in Xenopus laevis oocytes1998FEBS letters, Nov-06, Volume: 438, Issue:3
Functional characterization of the rat multispecific organic anion transporter OAT1 mediating basolateral uptake of anionic drugs in the kidney.
AID99303Compound was tested for release of tritium from 1 uM [5-3H]-dUMP into water at a con of 0.4 mM and without addition of bovine thymidylate synthase to cell suspension in absence of CH2O1992Journal of medicinal chemistry, Apr-03, Volume: 35, Issue:7
Synthesis and biological activity of novel folic acid analogues: pteroyl-S-alkylhomocysteine sulfoximines.
AID1053335Photocytotoxicity against human KB cells overexpressing folate receptor assessed as cell viability incubated for 24 hrs followed by halogen light illumination measured after 20 mins by MTT assay2013Journal of medicinal chemistry, Nov-14, Volume: 56, Issue:21
Preparation and in vitro photodynamic activities of folate-conjugated distyryl boron dipyrromethene based photosensitizers.
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).
AID230430It is the ratio of apparent kinetic constant to that of relative maximum velocity1991Journal of medicinal chemistry, Sep, Volume: 34, Issue:9
Folate analogues. 35. Synthesis and biological evaluation of 1-deaza, 3-deaza, and bridge-elongated analogues of N10-propargyl-5,8-dideazafolic acid.
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).
AID500670Inhibition of Escherichia coli K-12 recombinant His-tagged folylpoly-gamma-glutamate synthetase expressed in Escherichia coli BL21 at 200 uM LC-MS/MS method2008Nature chemical biology, Oct, Volume: 4, Issue:10
A domino effect in antifolate drug action in Escherichia coli.
AID678798TP_TRANSPORTER: uptake (vesicle) in membrane vesicle from ABCG2-R482-expressing HEK293 cells2003Cancer research, Jul-15, Volume: 63, Issue:14
Transport of methotrexate, methotrexate polyglutamates, and 17beta-estradiol 17-(beta-D-glucuronide) by ABCG2: effects of acquired mutations at R482 on methotrexate transport.
AID71492Catalytic rate folyl-poly-glutamate synthetase1989Journal of medicinal chemistry, Jul, Volume: 32, Issue:7
Synthesis and antitumor activity of 5-deaza-5,6,7,8-tetrahydrofolic acid and its N10-substituted analogues.
AID679488TP_TRANSPORTER: inhibition of PAH uptake in Xenopus laevis oocytes1998FEBS letters, Nov-06, Volume: 438, Issue:3
Functional characterization of the rat multispecific organic anion transporter OAT1 mediating basolateral uptake of anionic drugs in the kidney.
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).
AID213840Inhibitory activity against thymidylate synthase in the intact L1210 cells1986Journal of medicinal chemistry, Jul, Volume: 29, Issue:7
Folate analogues. 25. Synthesis and biological evaluation of N10-propargylfolic acid and its reduced derivatives.
AID71218Apparent kinetic constant of substrate activity for Hog liver Folyl-polyglutamate synthase1991Journal of medicinal chemistry, Sep, Volume: 34, Issue:9
Folate analogues. 35. Synthesis and biological evaluation of 1-deaza, 3-deaza, and bridge-elongated analogues of N10-propargyl-5,8-dideazafolic acid.
AID412673Inhibition of Escherichia coli MurD assessed as residual activity at 500 uM2009Bioorganic & medicinal chemistry letters, Jan-01, Volume: 19, Issue:1
Synthesis and biological evaluation of new glutamic acid-based inhibitors of MurD ligase.
AID212457Inhibitory constant of thymidylate synthase was determined in human AML cells1987Journal of medicinal chemistry, Apr, Volume: 30, Issue:4
Folate analogues as inhibitors of thymidylate synthase.
AID681897TP_TRANSPORTER: inhibition of Taurocholate uptake in the presence of Folate at a concentration of 20uM in membrane vesicles from MRP4-expressing V79 cells2003Hepatology (Baltimore, Md.), Aug, Volume: 38, Issue:2
Cotransport of reduced glutathione with bile salts by MRP4 (ABCC4) localized to the basolateral hepatocyte membrane.
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.
AID99304Compound was tested for release of tritium from 1 uM [5-3H]-dUMP into water at a con of 0.4 mM and without addition of bovine thymidylate synthase to cell suspension in absence of serine1992Journal of medicinal chemistry, Apr-03, Volume: 35, Issue:7
Synthesis and biological activity of novel folic acid analogues: pteroyl-S-alkylhomocysteine sulfoximines.
AID105505Compound was evaluated for inhibition of MTX influx into MOLT-4 cells1991Journal of medicinal chemistry, Sep, Volume: 34, Issue:9
Folate analogues. 35. Synthesis and biological evaluation of 1-deaza, 3-deaza, and bridge-elongated analogues of N10-propargyl-5,8-dideazafolic acid.
AID230505Ratio of relative Vmax to that of Km values.1991Journal of medicinal chemistry, Jan, Volume: 34, Issue:1
Folic acid analogues lacking the 2-carbon are substrates for folylpolyglutamate synthetase and inhibit cell growth.
AID18069Apparent Km (Michaelis-Menten constant) of the compound.1991Journal of medicinal chemistry, Jan, Volume: 34, Issue:1
Folic acid analogues lacking the 2-carbon are substrates for folylpolyglutamate synthetase and inhibit cell growth.
AID1633880Cytotoxicity against human MCF7 cells in low folate medium assessed as reduction in metabolic activity at 1 to 150 uM incubated for 24 to 72 hrs by MTS assay2019Bioorganic & medicinal chemistry letters, 08-01, Volume: 29, Issue:15
Folic acid conjugates of a bleomycin mimic for selective targeting of folate receptor positive cancer cells.
AID71229Relative maximum velocity of substrate activity for Hog liver Folyl-polyglutamate synthase (relative to control of 50 uM aminopterin)1991Journal of medicinal chemistry, Sep, Volume: 34, Issue:9
Folate analogues. 35. Synthesis and biological evaluation of 1-deaza, 3-deaza, and bridge-elongated analogues of N10-propargyl-5,8-dideazafolic acid.
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).
AID57251Thermodynamic Dissociation Constant for compound-Phe31-dihydrofolate reductase (DHFR) complex at pH 71988Journal of medicinal chemistry, Jan, Volume: 31, Issue:1
Evaluation of the importance of hydrophobic interactions in drug binding to dihydrofolate reductase.
AID43856Tested for the inhibition of [14C]-DDATHF influx in CCRF-CEM cells of human leukemic lymphoblast1994Journal of medicinal chemistry, Jul-08, Volume: 37, Issue:14
Synthesis and biological activity of N omega-hemiphthaloyl-alpha,omega- diaminoalkanoic acid analogues of aminopterin and 3',5-dichloroaminopterin.
AID101080Inhibitory activity against growth of L1210 leukemia cells in culture1992Journal of medicinal chemistry, Apr-03, Volume: 35, Issue:7
Synthesis and biological activity of novel folic acid analogues: pteroyl-S-alkylhomocysteine sulfoximines.
AID71205Activity (relative Vmax) was evaluated in vitro by purified mouse liver folate polyglutamate synthetase (FPGS). 1985Journal of medicinal chemistry, Jul, Volume: 28, Issue:7
Synthesis of the antileukemic agents 5,10-dideazaaminopterin and 5,10-dideaza-5,6,7,8-tetrahydroaminopterin.
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.
AID681604TP_TRANSPORTER: inhibition of MTX uptake in OAT-K1-expressing MDCK cells2000The Journal of pharmacology and experimental therapeutics, Jun, Volume: 293, Issue:3
Trans-stimulation effects of folic acid derivatives on methotrexate transport by rat renal organic anion transporter, OAT-K1.
AID682068TP_TRANSPORTER: inhibition of MTX uptake (MTX: 0.026 uM, Folic acid: 100 uM) in OAT-K1-expressing LLC-PK1 cells1996The Journal of biological chemistry, Aug-23, Volume: 271, Issue:34
Cloning and functional characterization of a novel rat organic anion transporter mediating basolateral uptake of methotrexate in the kidney.
AID101223Inhibitory activity against growth of L1210 leukemia cells in culture1992Journal of medicinal chemistry, Apr-03, Volume: 35, Issue:7
Synthesis and biological activity of novel folic acid analogues: pteroyl-S-alkylhomocysteine sulfoximines.
AID1164841Inhibition of [3H]folic acid binding to FRalpha (unknown origin) expressed in Chinese hamster RT16 cells2014Journal of medicinal chemistry, Oct-09, Volume: 57, Issue:19
Structure-activity profiles of novel 6-substituted pyrrolo[2,3-d]pyrimidine thienoyl antifolates with modified amino acids for cellular uptake by folate receptors α and β and the proton-coupled folate transporter.
AID22613Maximal elimination rate of metabolism for hog liver folyl-poly-glutamate synthetase was evaluated1989Journal of medicinal chemistry, Jul, Volume: 32, Issue:7
Inhibition of mammalian folylpolyglutamate synthetase and human dihydrofolate reductase by 5,8-dideaza analogues of folic acid and aminopterin bearing a terminal L-ornithine.
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).
AID681603TP_TRANSPORTER: uptake in Xenopus laevis oocytes1999Molecular pharmacology, Apr, Volume: 55, Issue:4
Cloning and functional characterization of a new multispecific organic anion transporter, OAT-K2, in rat kidney.
AID681346TP_TRANSPORTER: ATP-dependent uptake in membrane vesicle from MRP8-expressing LLC-PK1 cells2005Molecular pharmacology, Feb, Volume: 67, Issue:2
Transport of bile acids, sulfated steroids, estradiol 17-beta-D-glucuronide, and leukotriene C4 by human multidrug resistance protein 8 (ABCC11).
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).
AID101225Inhibitory activity against growth of L1210 leukemia cells in culture at 0.5 mM; No significant inhibition1992Journal of medicinal chemistry, Apr-03, Volume: 35, Issue:7
Synthesis and biological activity of novel folic acid analogues: pteroyl-S-alkylhomocysteine sulfoximines.
AID681024TP_TRANSPORTER: inhibition of PAH uptake (PAH: 20 uM, Folic acid: 1000 uM) in OAT-expressing COS-7 cells1999The Journal of biological chemistry, Jan-15, Volume: 274, Issue:3
Heterologous expression and functional characterization of a mouse renal organic anion transporter in mammalian cells.
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).
AID386623Inhibition of 4-(4-(dimethylamino)styryl)-N-methylpyridinium uptake at human OCT1 expressed in HEK293 cells at 100 uM by confocal microscopy2008Journal of medicinal chemistry, Oct-09, Volume: 51, Issue:19
Structural requirements for drug inhibition of the liver specific human organic cation transport protein 1.
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.
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).
AID625278FDA Liver Toxicity Knowledge Base Benchmark Dataset (LTKB-BD) drugs of no concern for DILI2011Drug discovery today, Aug, Volume: 16, Issue:15-16
FDA-approved drug labeling for the study of drug-induced liver injury.
AID603957Octanol-water partition coefficient, log P of the compound2008European journal of medicinal chemistry, Apr, Volume: 43, Issue:4
QSPR modeling of octanol/water partition coefficient for vitamins by optimal descriptors calculated with SMILES.
AID1164842Inhibition of [3H]folic acid binding to FRbeta (unknown origin) expressed in Chinese hamster D4 cells2014Journal of medicinal chemistry, Oct-09, Volume: 57, Issue:19
Structure-activity profiles of novel 6-substituted pyrrolo[2,3-d]pyrimidine thienoyl antifolates with modified amino acids for cellular uptake by folate receptors α and β and the proton-coupled folate transporter.
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.
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.
AID1638523Binding affinity to [13C]-labeled DHFR DHFR (unknown origin) expressed in Escherichia coli BL21(DE3) using hyperpolarized compound sample at 1.6 mM by dissolution dynamic nuclear polarization and NMR spectroscopy2019Journal of medicinal chemistry, 03-14, Volume: 62, Issue:5
Determination of Ligand Binding Epitope Structures Using Polarization Transfer from Hyperpolarized Ligands.
AID1713572Inhibition of recombinant human ALR2 using D,L-glyceraldehyde and NADPH as substrate preincubated for 3 mins followed by substrate addition and measured for 3 mins by spectrophotometric analysis2016Bioorganic & medicinal chemistry letters, 10-15, Volume: 26, Issue:20
Pterin-7-carboxamides as a new class of aldose reductase inhibitors.
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.
AID71200Activity (apparent Km ) was evaluated in vitro by purified mouse liver folate polyglutamate synthetase (FPGS). 1985Journal of medicinal chemistry, Jul, Volume: 28, Issue:7
Synthesis of the antileukemic agents 5,10-dideazaaminopterin and 5,10-dideaza-5,6,7,8-tetrahydroaminopterin.
AID1636356Drug activation in human Hep3B cells assessed as human CYP2C9-mediated drug metabolism-induced cytotoxicity measured as decrease in cell viability at 300 uM pre-incubated with BSO for 18 hrs followed by incubation with compound for 3 hrs in presence of NA2016Bioorganic & medicinal chemistry letters, 08-15, Volume: 26, Issue:16
Development of a cell viability assay to assess drug metabolite structure-toxicity relationships.
AID212156Ability to inhibit thymidylate synthase derived from human leukemia K562 cells1987Journal of medicinal chemistry, Apr, Volume: 30, Issue:4
Folate analogues as inhibitors of thymidylate synthase.
AID679299TP_TRANSPORTER: uptake in membrane vesicles from MRP3-expressing HEK293 cells2001Cancer research, Oct-01, Volume: 61, Issue:19
Transport of methotrexate (MTX) and folates by multidrug resistance protein (MRP) 3 and MRP1: effect of polyglutamylation on MTX transport.
AID680355TP_TRANSPORTER: uptake in membrane vesicles from MRP4-expressing Sf9 cells2002Cancer research, Jun-01, Volume: 62, Issue:11
Analysis of methotrexate and folate transport by multidrug resistance protein 4 (ABCC4): MRP4 is a component of the methotrexate efflux system.
AID71201Activity (relative Km ) was evaluated in vitro by purified mouse liver folate polyglutamate synthetase (FPGS). 1985Journal of medicinal chemistry, Jul, Volume: 28, Issue:7
Synthesis of the antileukemic agents 5,10-dideazaaminopterin and 5,10-dideaza-5,6,7,8-tetrahydroaminopterin.
AID71385Apparent catalytic rate folyl-poly-glutamate synthetase1989Journal of medicinal chemistry, Jul, Volume: 32, Issue:7
Synthesis and antitumor activity of 5-deaza-5,6,7,8-tetrahydrofolic acid and its N10-substituted analogues.
AID1633863Induction of ROS generation in human KB cells at 30 uM incubated for 72 hrs by APF probe-based flow cytometer analysis relative to control2019Bioorganic & medicinal chemistry letters, 08-01, Volume: 29, Issue:15
Folic acid conjugates of a bleomycin mimic for selective targeting of folate receptor positive cancer cells.
AID1443995Hepatotoxicity in human assessed as drug-induced liver injury2014Hepatology (Baltimore, Md.), Sep, Volume: 60, Issue:3
Human drug-induced liver injury severity is highly associated with dual inhibition of liver mitochondrial function and bile salt export pump.
AID1633879Cytotoxicity against human KB cells in low folate medium assessed as reduction in metabolic activity at 1 to 150 uM incubated for 24 to 72 hrs by MTS assay2019Bioorganic & medicinal chemistry letters, 08-01, Volume: 29, Issue:15
Folic acid conjugates of a bleomycin mimic for selective targeting of folate receptor positive cancer cells.
AID1633874Displacement of folate-FITC from folate receptor in human KB cells at 25 to 1000 pmol incubated for 10 mins by FITC staining-based FACS analysis2019Bioorganic & medicinal chemistry letters, 08-01, Volume: 29, Issue:15
Folic acid conjugates of a bleomycin mimic for selective targeting of folate receptor positive cancer cells.
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).
AID231680Ratio between Ki values of CCRF-CEM and CEM/MTX1994Journal of medicinal chemistry, Jul-08, Volume: 37, Issue:14
Synthesis and biological activity of N omega-hemiphthaloyl-alpha,omega- diaminoalkanoic acid analogues of aminopterin and 3',5-dichloroaminopterin.
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).
AID1053445Displacement of [3H]-folic acid from human folate receptor-alpha expressed in Chinese hamster RT16 cells after 15 mins2013Journal of medicinal chemistry, Nov-14, Volume: 56, Issue:21
Tumor-targeting with novel non-benzoyl 6-substituted straight chain pyrrolo[2,3-d]pyrimidine antifolates via cellular uptake by folate receptor α and inhibition of de novo purine nucleotide biosynthesis.
AID1053444Displacement of [3H]-folic acid from human folate receptor-beta expressed in Chinese hamster D4 cells after 15 mins2013Journal of medicinal chemistry, Nov-14, Volume: 56, Issue:21
Tumor-targeting with novel non-benzoyl 6-substituted straight chain pyrrolo[2,3-d]pyrimidine antifolates via cellular uptake by folate receptor α and inhibition of de novo purine nucleotide biosynthesis.
AID57256Thermodynamic Dissociation Constant for compound-Tyr31-dihydrofolate reductase (DHFR) complex at pH 71988Journal of medicinal chemistry, Jan, Volume: 31, Issue:1
Evaluation of the importance of hydrophobic interactions in drug binding to dihydrofolate reductase.
AID1146785Induction of Streptococcus faecalis growth1977Journal of medicinal chemistry, Mar, Volume: 20, Issue:3
P-Aminobenzoic acid derivatives. Mode of action and structure-activity relationships in a cell-free system (Escherichia coli).
AID588220Literature-mined public compounds from Kruhlak et al phospholipidosis modelling dataset2008Toxicology mechanisms and methods, , Volume: 18, Issue:2-3
Development of a phospholipidosis database and predictive quantitative structure-activity relationship (QSAR) models.
AID99305Compound was tested for release of tritium from 1 uM [5-3H]-dUMP into water at a conc of 0.4 mM enzyme(bovine thymidylate synthase) was added to cell suspension in presence of CH2O1992Journal of medicinal chemistry, Apr-03, Volume: 35, Issue:7
Synthesis and biological activity of novel folic acid analogues: pteroyl-S-alkylhomocysteine sulfoximines.
AID588210Human drug-induced liver injury (DILI) modelling dataset from Ekins et al2010Drug metabolism and disposition: the biological fate of chemicals, Dec, Volume: 38, Issue:12
A predictive ligand-based Bayesian model for human drug-induced liver injury.
AID238138Dissociation constant against folic acid receptor (FAR); Value ranges from 0.1-1 nM2005Journal of medicinal chemistry, Jun-02, Volume: 48, Issue:11
Targeting and inhibition of cell growth by an engineered dendritic nanodevice.
AID18279Maximum rate of metabolism for hog liver folyl-poly-glutamate synthetase was evaluated1989Journal of medicinal chemistry, Jul, Volume: 32, Issue:7
Inhibition of mammalian folylpolyglutamate synthetase and human dihydrofolate reductase by 5,8-dideaza analogues of folic acid and aminopterin bearing a terminal L-ornithine.
AID1613376Binding affinity to folate receptor in human KB cells after 1 hr in presence of [3H]-FA by scintillation counting assay relative to control2019European journal of medicinal chemistry, Feb-01, Volume: 163Small molecule-drug conjugates: A novel strategy for cancer-targeted treatment.
AID1443987Inhibition of recombinant human BSEP expressed in baculovirus infected sf21 cell membrane vesicles assessed as reduction in ATP-dependent [3H]-taurocholate uptake in to vesicles after 5 mins by TopCount method2014Hepatology (Baltimore, Md.), Sep, Volume: 60, Issue:3
Human drug-induced liver injury severity is highly associated with dual inhibition of liver mitochondrial function and bile salt export pump.
AID71494First order catalytic rate folyl-poly-glutamate synthetase1989Journal of medicinal chemistry, Jul, Volume: 32, Issue:7
Synthesis and antitumor activity of 5-deaza-5,6,7,8-tetrahydrofolic acid and its N10-substituted analogues.
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).
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).
AID212636Inhibitory activity against the thymidylate synthase in the Permeabilized L1210 cells1986Journal of medicinal chemistry, Jul, Volume: 29, Issue:7
Folate analogues. 25. Synthesis and biological evaluation of N10-propargylfolic acid and its reduced derivatives.
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).
AID99306Compound was tested for release of tritium from 1 uM [5-3H]-dUMP into water at a conc of 0.4 mM enzyme(bovine thymidylate synthase) was added to cell suspension in presence of serine1992Journal of medicinal chemistry, Apr-03, Volume: 35, Issue:7
Synthesis and biological activity of novel folic acid analogues: pteroyl-S-alkylhomocysteine sulfoximines.
AID1443992Total Cmax in human administered as single dose2014Hepatology (Baltimore, Md.), Sep, Volume: 60, Issue:3
Human drug-induced liver injury severity is highly associated with dual inhibition of liver mitochondrial function and bile salt export pump.
AID1633881Cytotoxicity against human IGROV1 cells in low folate medium assessed as reduction in metabolic activity at 1 to 150 uM incubated for 24 to 72 hrs by MTS assay2019Bioorganic & medicinal chemistry letters, 08-01, Volume: 29, Issue:15
Folic acid conjugates of a bleomycin mimic for selective targeting of folate receptor positive cancer cells.
AID588209Literature-mined public compounds from Greene et al multi-species hepatotoxicity modelling dataset2010Chemical research in toxicology, Jul-19, Volume: 23, Issue:7
Developing structure-activity relationships for the prediction of hepatotoxicity.
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).
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.
AID23337Relative maximum volume distribution of the compound.1991Journal of medicinal chemistry, Jan, Volume: 34, Issue:1
Folic acid analogues lacking the 2-carbon are substrates for folylpolyglutamate synthetase and inhibit cell growth.
AID46774Tested for inhibition of [14C]-DDATHF influx in CEM/MTX cells of human leukemic lymphoblasts1994Journal of medicinal chemistry, Jul-08, Volume: 37, Issue:14
Synthesis and biological activity of N omega-hemiphthaloyl-alpha,omega- diaminoalkanoic acid analogues of aminopterin and 3',5-dichloroaminopterin.
AID252410Concentration required to completely block the uptake of either G5-FI-FA or G5-FI-FA-MTX dendrimer (30 nM) in FAR expressing KB cells2005Journal of medicinal chemistry, Jun-02, Volume: 48, Issue:11
Targeting and inhibition of cell growth by an engineered dendritic nanodevice.
AID1443991Induction of mitochondrial dysfunction in Sprague-Dawley rat liver mitochondria assessed as inhibition of mitochondrial respiration per mg mitochondrial protein measured for 20 mins by A65N-1 oxygen probe based fluorescence assay2014Hepatology (Baltimore, Md.), Sep, Volume: 60, Issue:3
Human drug-induced liver injury severity is highly associated with dual inhibition of liver mitochondrial function and bile salt export pump.
AID1636440Drug activation in human Hep3B cells assessed as human CYP2D6-mediated drug metabolism-induced cytotoxicity measured as decrease in cell viability at 300 uM pre-incubated with BSO for 18 hrs followed by incubation with compound for 3 hrs in presence of NA2016Bioorganic & medicinal chemistry letters, 08-15, Volume: 26, Issue:16
Development of a cell viability assay to assess drug metabolite structure-toxicity relationships.
AID57262Thermodynamic Dissociation Constant for compound-Val31-dihydrofolate reductase (DHFR) complex at pH 71988Journal of medicinal chemistry, Jan, Volume: 31, Issue:1
Evaluation of the importance of hydrophobic interactions in drug binding to dihydrofolate reductase.
AID681915TP_TRANSPORTER: inhibition of MTX uptake (MTX: 20 uM, Folic acid: 300 uM) in membrane vesicles from MRP4-expressing Sf9 cells2002Cancer research, Jun-01, Volume: 62, Issue:11
Analysis of methotrexate and folate transport by multidrug resistance protein 4 (ABCC4): MRP4 is a component of the methotrexate efflux system.
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.
AID1811Experimentally measured binding affinity data derived from PDB2006The Journal of biological chemistry, May-12, Volume: 281, Issue:19
Evolutional design of a hyperactive cysteine- and methionine-free mutant of Escherichia coli dihydrofolate reductase.
AID977611Experimentally measured binding affinity data (Kd) for protein-ligand complexes derived from PDB2006The Journal of biological chemistry, May-12, Volume: 281, Issue:19
Evolutional design of a hyperactive cysteine- and methionine-free mutant of Escherichia coli dihydrofolate reductase.
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.
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.
AID1159550Human Phosphogluconate dehydrogenase (6PGD) Inhibitor Screening2015Nature cell biology, Nov, Volume: 17, Issue:11
6-Phosphogluconate dehydrogenase links oxidative PPP, lipogenesis and tumour growth by inhibiting LKB1-AMPK signalling.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (28,545)

TimeframeStudies, This Drug (%)All Drugs %
pre-19908739 (30.61)18.7374
1990's2630 (9.21)18.2507
2000's6251 (21.90)29.6817
2010's7995 (28.01)24.3611
2020's2930 (10.26)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials1,945 (6.48%)5.53%
Reviews3,194 (10.65%)6.00%
Case Studies735 (2.45%)4.05%
Observational116 (0.39%)0.25%
Other24,011 (80.03%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (566)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Effect of Preconceptional Sildenafil Citrate Treatment in Women With Early Unexplained Recurrent Pregnancy Loss: a Randomized Controlled Trial [NCT03766594]Phase 190 participants (Actual)Interventional2018-01-01Completed
Hydroxychloroquine for Improvement of Pregnancy Outcome in Unexplained Recurrent Miscarriage [NCT04228263]156 participants (Actual)Interventional2020-01-01Completed
A Phase II/III Study of N-803 (ALT-803) Plus Pembrolizumab Versus Standard of Care in Participants With Stage IV or Recurrent Non-Small Cell Lung Cancer Previously Treated With Anti-PD-1 or Anti-PD-L1 Therapy (Lung-MAP Non-Match Sub-Study) [NCT05096663]Phase 2/Phase 382 participants (Actual)Interventional2022-03-15Active, not recruiting
Malaria Risk Prior to and During Early Pregnancy in Nulliparous Women Receiving Long-term Weekly Iron and Folic Acid Supplementation (WIFS): a Non-inferiority Randomized Controlled Trial [NCT01210040]1,959 participants (Actual)Interventional2011-04-30Completed
Prevent and Treat Double-Blind Factorial Randomized Trials of Daily Oral Vitamin D, Omega 3, and Combination Vitamins B, C and Zinc Supplementation for the Treatment and Prevention of COVID-19 [NCT04828538]0 participants (Actual)Interventional2021-01-01Withdrawn(stopped due to Recruitment failure)
Multicentre Randomised Double-blind, Placebo-controlled 2x2 Factorial Trial Investigating the Effects of Adding Mirtazapine and Folic Acid to Existing Therapy for Patients With Schizophrenia [NCT01263080]Phase 4333 participants (Actual)Interventional2010-11-30Completed
Evaluating the Efficacy of Weekly Folic Acid in Pediatric Inflammatory Bowel Disease Patients on Methotrexate [NCT03860012]Phase 4100 participants (Anticipated)Interventional2018-09-11Recruiting
Folic Acid Clinical Trial (FACT): Biomarker Subgroup Analysis [NCT03981029]51 participants (Actual)Observational2011-12-19Completed
A Randomized Phase II Study of Perioperative Atezolizumab +/- Chemotherapy in Resectable MSI-H/dMMR Gastric and Gastroesophageal Junction (GEJ) Cancer [NCT05836584]Phase 2240 participants (Anticipated)Interventional2024-06-08Recruiting
Randomized Trial of Standard Chemotherapy Alone or Combined With Atezolizumab as Adjuvant Therapy for Patients With Stage III Colon Cancer and Deficient DNA Mismatch Repair [NCT02912559]Phase 3700 participants (Anticipated)Interventional2017-10-16Active, not recruiting
Randomized Phase II Study of 2nd Line FOLFIRI Versus Modified FOLFIRI With PARP Inhibitor ABT-888 (Veliparib) (NSC-737664) in Metastatic Pancreatic Cancer [NCT02890355]Phase 2123 participants (Actual)Interventional2016-09-01Active, not recruiting
A Phase I Study of Riluzole in Combination With mFOLFOX6/Bevacizumab in Patients With Metastatic Colorectal Cancer [NCT04761614]Phase 113 participants (Actual)Interventional2021-04-02Active, not recruiting
Scaling-up High-impact Micronutrient Supplementation Interventions to Improve Adolescents' Nutrition and Health in Burkina Faso [NCT04657640]Phase 32,100 participants (Anticipated)Interventional2020-12-11Active, not recruiting
Comparison of Acetyl- L- Carnitine and Folic Acid Versus Coenzyme Q10 and Folic Acid on Semen and Hormonal Parameters and Semen Oxidative Status in Patients of Primary Infertility. A Double Blind Randomized Clinical Trial [NCT05616000]Phase 286 participants (Actual)Interventional2022-08-06Completed
Pembrolizumab Plus Bevacizumab and Chemotherapy as First-Line Treatment for Advanced or Metastatic Non-Squamous NSCLC Patients With EGFR Exon 20 Insertion Mutation: An Open-Label, Single-Arm, Phase II Trial [NCT05751187]Phase 254 participants (Anticipated)Interventional2023-06-27Recruiting
ESSAI DE PHASE III RANDOMISE EVALUANT LE FOLFOX AVEC OU SANS DOCETAXEL (TFOX) EN 1ère LIGNE DE CHIMIOTHERAPIE DES ADENOCARCINOMES OESO-GASTRIQUES LOCALEMENT AVANCES OU METASTATIQUES [NCT03006432]Phase 3507 participants (Actual)Interventional2016-12-19Active, not recruiting
Multicenter Clinical Study, Phase III, Randomized, Double-blind, of Prospectively Evaluate the Effectiveness and Tolerability of Apevitin BC Comparing to Vitamin Complex in Appetite Stimulation [NCT01283646]Phase 351 participants (Actual)Interventional2011-10-31Completed
Trial of Pre-Pregnancy Supplements [NCT01183572]802 participants (Actual)Interventional2010-08-31Completed
The Potential Effects of Inofolic Plus on Abnormal Ovarian Reserve Parameters in Subfertile Women [NCT01290432]15 participants (Actual)Interventional2011-02-28Completed
Study on the Role of a Combination of Nutraceuticals (Armolipid Prev) With an Effect on Blood Pressure and Lipids in the Control of Cardiovascular Risk [NCT01293162]150 participants (Actual)Observational2010-09-30Completed
The Effect of High Dose Folic Acid Versus Placebo on the Rate of Gestational Diabetes or Gestational Hypertension in Pregnant Women: a Randomized Controlled Trial. [NCT01302756]0 participants (Actual)Interventional2012-04-30Withdrawn
Phase II Clinical Trial to Evaluate the Efficacy of Second-line FOLFIRI + Panitumumab in Subjects With Wild Type RAS Metastatic Colorectal Cancer Who Have Received FOLFOX + Panitumumab in First-line [NCT03751176]Phase 231 participants (Actual)Interventional2018-11-08Active, not recruiting
Phase II Study of the Combination of Low-Intensity Chemotherapy and Blinatumomab in Patients With Philadelphia Chromosome Negative Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) [NCT03518112]Phase 26 participants (Actual)Interventional2018-04-18Terminated(stopped due to Due to Competing Studies)
Nutrition, Arsenic and Cognitive Function in Children [NCT03384862]239 participants (Actual)Interventional2018-01-27Completed
Effects of Intensive Antihypertensive Therapies on the Risk of Stroke in Hypertensive Adults: A Prospective Randomized Open-Label Blinded-Endpoint Trial, a Feasibility Study [NCT02817503]Phase 4100 participants (Anticipated)Interventional2015-12-31Enrolling by invitation
Role of Methotrexate in Improving Physical Function in Older Adults With Elevated Levels of Inflammation [NCT02079948]Phase 20 participants (Actual)Interventional2014-02-28Withdrawn(stopped due to Potential participants had concerns about taking the study drug (methotrexate).)
Folic Acid and B Vitamins for Secondary Prevention of Stroke : A Double-blinded Randomized Controlled Trial [NCT01317849]0 participants (Actual)Interventional2011-07-31Withdrawn(stopped due to financial assistance financial assistance financial assistance financial assistance financial assistance without financial assistance)
Phase II, Multicentric Randomized Trial, Evaluating the Efficacy of Fluoropyrimidine-based Standard Chemotherapy, Associated to Either Cetuximab or Bevacizumab, in KRAS Wild-type Metastatic Colorectal Cancer Patients With Progressive Disease After Receivi [NCT01442649]Phase 2133 participants (Actual)Interventional2010-12-31Completed
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)
A Multi-center, Single Arm, Safety and Efficacy Study of Pralatrexate With Vitamin B12 and Folic Acid Supplementation in Subjects With Relapsed or Refractory Peripheral T-cell Lymphoma [NCT03349333]Phase 385 participants (Actual)Interventional2015-09-10Completed
A Multicenter, Efficacy and Safety Study of Methotrexate to Increase Response Rates in Patients With Uncontrolled Gout Receiving KRYSTEXXA® (Pegloticase) (MIRROR Open-Label [OL]) [NCT03635957]Phase 414 participants (Actual)Interventional2018-09-26Completed
On the Impact of Therapeutic Tumor Necrosis Factor-alpha Inhibition on Anogenital Human Papillomavirus Infection [NCT02376478]222 participants (Actual)Observational2009-12-31Completed
Phase 2 Study of Hepatic Arterial Infusion With Oxaliplatin, Folinic Acid and 5 Fluorouracil Alone or in Combination With Intravenous Chemotherapy in Heavily Pre-Treated Patients With Liver-Predominant Metastasis From Colorectal Cancer [NCT02345746]Phase 20 participants (Actual)Interventional2012-12-31Withdrawn(stopped due to patient population)
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
A Phase II Trial to Evaluate the Efficacy and Safety of FOLFIRI + Panitumumab as First-line Treatment in Elderly Patients With RAS/BRAF Wild-type Unresectable Metastatic Colorectal Cancer and Good Performance Status [NCT03142516]Phase 220 participants (Actual)Interventional2017-10-31Completed
Pilot Study for the Evaluation of the Effectiveness of Natural Versus Synthetic Vitamin B Complexes in Humans. [NCT03444155]30 participants (Actual)Interventional2017-05-08Completed
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 Cluster-randomized, Non-inferiority Open-label Trial of the Impact of Supplementation Regimen on Consumption of Prenatal Calcium and Iron/Folic Acid Supplements and Adherence to Related Recommendations [NCT02238704]1,032 participants (Actual)Interventional2014-09-30Completed
Novel Strategies in Weight Loss in Women With Polycystic Ovary Syndrome: do Changes in the Gut Microbiome Play a Role? [NCT03642600]Phase 421 participants (Actual)Interventional2019-02-28Completed
A Multi-centre Randomised Double Blind Placebo Controlled Study Comparing Two Regimens of Combination Therapy in Early DMARD Naive Rheumatoid Arthritis. [NCT01308255]Phase 4112 participants (Actual)Interventional2006-09-30Completed
Sequential Use of Nab-paclitaxel Plus Gemcitabine and mFOLFIRINOX as Neoadjuvant Chemotherapy for Resectable Pancreatic Cancer: A Randomized Control Study [NCT03750669]Phase 2416 participants (Anticipated)Interventional2018-10-20Recruiting
Avelumab Added to FOLFIRI Plus Cetuximab Followed by Avelumab Maintenance in Patients With Previously Untreated RAS Wild-type Colorectal Cancer. The Phase II FIRE-6 Study [NCT05217069]Phase 257 participants (Actual)Interventional2019-09-27Active, not recruiting
A Phase 2, Single-Arm, Open-Label, Multicenter, Study of Folotyn® (Pralatrexate Injection) in Combination With Oral Leucovorin to Prevent or Reduce Mucositis in Patients With Hematological Malignancies Including PTCL and CTCL [NCT02106650]Phase 236 participants (Actual)Interventional2014-07-31Completed
A Phase 2 Study of Blinatumomab (NSC# 765986) in Combination With Nivolumab (NSC # 748726), a Checkpoint Inhibitor of PD-1, in B-ALL Patients Aged >/= 1 to < 31 Years Old With First Relapse [NCT04546399]Phase 2550 participants (Anticipated)Interventional2020-12-04Suspended(stopped due to Other - FDA Partial Clinical Hold)
Randomised, Multicentre, Phase II Pilot Study to Assess the Efficacy and Safety of Treatment With FOLFIRI-aflibercept Compared to Initial Treatment With FOLFIRI-aflibercept (for 6 Cycles) Followed by Maintenance With 5FU-aflibercept, in an Elderly Populat [NCT03279289]Phase 2170 participants (Actual)Interventional2017-10-25Completed
A Two-Cohort Randomized Phase II, Double-Blind, Parallel Group Study in Patients With Active Rheumatoid Arthritis Evaluating the Efficacy and Safety of GDC-0853 Compared With Placebo and Adalimumab in Patients With an Inadequate Response to Previous Metho [NCT02833350]Phase 2578 participants (Actual)Interventional2016-09-09Completed
Phase I Trial of FOLFIRI in Combination With Sorafenib and Bevacizumab in Patients With Advanced Gastrointestinal Malignancies [NCT01383343]Phase 117 participants (Actual)Interventional2011-08-31Completed
The Effects of a 3-months Dietary Intervention With Folate Enhanced Foods on Folate Status in Healthy Egyptian Women [NCT02373033]57 participants (Actual)Interventional2013-03-31Completed
Effects of Combined Therapy With Myo-inositol and Alpha-Lipoic Acid on Clinical, Endocrine and Metabolic Features in Women Affected by Polycystic Ovary Syndrome [NCT02651636]40 participants (Actual)Interventional2014-06-30Completed
A Phase III Clinical Trial Comparing Infusional 5-Fluorouracil (5-FU), Leucovorin, and Oxaliplatin (mFOLFOX6) Every Two Weeks With Bevacizumab to the Same Regimen Without Bevacizumab for the Treatment of Patients With Resected Stages II and III Carcinoma [NCT00096278]Phase 32,710 participants (Actual)Interventional2004-09-15Completed
Effects of Armolipid Plus on Indices of Insulin Resistance in Patients With Metabolic Syndrome [NCT01087632]66 participants (Actual)Interventional2009-09-30Completed
Relative Bioavailability of Folic Acid and L-5-Methlytetrahydrofolate [NCT01584050]150 participants (Actual)Interventional2012-05-31Completed
A Phase 1 Study of Alisertib (MLN8237) in Combination With mFOLFOX in Gastrointestinal Tumors [NCT02319018]Phase 114 participants (Actual)Interventional2015-08-27Completed
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
Randomized Phase 2 Study Comparing Second Look Laparoscopy to Standard Follow up in Patients With no Radiologic Evidence of Disease at 6 Months After Complete Resection of Colorectal Mucinous Carcinoma [NCT01628211]Phase 2140 participants (Anticipated)Interventional2012-04-30Recruiting
A Phase II, Multi-center, Randomized, Parallel Group, Double-blind, MTX Controlled Study to Assess the Clinical Efficacy, Safety and Tolerability of CH-4051 in Patients With Active RA Who Have Shown an Inadequate Response to MTX Monotherapy [NCT01116141]Phase 2250 participants (Actual)Interventional2010-09-30Completed
Effect of Polyvitaminics (Pyridoxine Hydrochloride, Folic Acid and Cyanocobalamin) in the Concentration of Homocysteine and Lipid Profile in Postmenopausal Women: a Randomized Controlled, Double-blind Clinical Trial [NCT03221816]Phase 460 participants (Actual)Interventional2008-12-31Completed
Effect of Methotrexate Carried by a Lipid Nanoemulsion on Left Ventricular Remodeling After ST-elevation Myocardial Infarction [NCT03516903]Phase 2/Phase 335 participants (Actual)Interventional2018-04-17Terminated(stopped due to Due to the COVID-19 pandemic. With a second wave just beginning, and considering that we are testing an immunosuppressant in patients with high risk for COVID-19 complications, we would not be able to re-start recruitment safely in the near future.)
Effect of Adding Folic Acid on Lipid Parameters in Population With Dyslipidemias [NCT03674333]68 participants (Anticipated)Interventional2018-09-24Not yet recruiting
A Phase II Study of Dasatinib (Sprycel®) (NSC #732517) as Primary Therapy Followed by Transplantation for Adults >/= 18 Years With Newly Diagnosed Ph+ Acute Lymphoblastic Leukemia by CALGB, ECOG and SWOG [NCT01256398]Phase 266 participants (Actual)Interventional2010-12-14Completed
Improved Effects of Myo-inositol in Association With Alpha-lactalbumin in PCOS Women [NCT03422289]37 participants (Actual)Interventional2016-11-02Completed
Folic Acid and Intensive Antihypertensive Therapy for Cerebrovascular and Cardiovascular Events Prevention Among Patients With Hypertension and Cerebral Small Vascular Diseases (FAITH)----A Multicenter, Randomized, Controlled, Open-label, 2x2 Factorial, B [NCT05169021]Phase 415,000 participants (Anticipated)Interventional2021-12-31Not yet recruiting
A Randomized Controlled Study of the Efficacy of Hepatic Arterial Perfusion Chemotherapy Concurrently Compared to Sequentially Combined With Targeted and Immunotherapy in Potentially Resectable Intermediate and Advanced HCC [NCT06041477]Phase 3540 participants (Anticipated)Interventional2023-09-30Recruiting
A Randomize Controlled Trial of Folic Acid, Calcium and Vitamin D in Preventing Colorectal Polyps and Colorectal Cancer [NCT02066688]Phase 2/Phase 32,400 participants (Anticipated)Interventional2013-01-31Recruiting
Use of Myo-inositol as Adjuvant Therapy in Patients With Polycystic Ovary Syndrome (PCOS) in Vitro Fertilization (IVF) [NCT02221154]Phase 449 participants (Actual)Interventional2014-11-30Terminated(stopped due to Difficulty recruiting)
A Comparative Study of Myo Inositol and Metformin in Improving Biochemical and Clinical Profile of Patients With Polycystic Ovarian Syndrome; a Randomized Clinical Trial [NCT04204044]Early Phase 1126 participants (Anticipated)Interventional2020-11-01Not yet recruiting
A Randomized, Open-label Phase 2 Study of EC145 Single-agent and the Combination of EC145 Plus Docetaxel Versus Docetaxel Alone in Participants With Folate-receptor Positive [FR(++)] Second Line NSCLC [NCT01577654]Phase 2203 participants (Actual)Interventional2011-03-31Completed
A Phase II Trial to Assess the Safety, Immunological Activity of TroVax® Plus Pemetrexed/Cisplatin in Patients With Malignant Pleural Mesothelioma [NCT01569919]Phase 226 participants (Anticipated)Interventional2012-12-31Recruiting
A Study on the Effectiveness of IFA Supplementation, Deworming, and Nutrition Education in Addressing Anemia Among Adolescent Girls in Two Counties in Liberia [NCT05073562]0 participants (Actual)Interventional2021-10-31Withdrawn(stopped due to Change in funding availability)
The Potential Nephro-protective Effect of Folic Acid and/or Pentoxifylline on Patients With Chronic Kidney Disease [NCT05284656]Phase 380 participants (Anticipated)Interventional2022-01-08Enrolling by invitation
Folic Acid Supplementation in Pregnant Women: Dose Response [NCT02124642]51 participants (Actual)Interventional2014-05-31Completed
A Randomized Withdrawal Double-blind Study of Etanercept Monotherapy Compared to Methotrexate Monotherapy for Maintenance of Remission in Subjects With Rheumatoid Arthritis [NCT02373813]Phase 3371 participants (Actual)Interventional2015-02-20Completed
Effect of Energy Dense Biscuits in Under Nourished Pregnant Women on Birth Weight of Their Newborns in a Low Income Peri-urban Setting of Karachi; a Community Based Randomized Interventional Study [NCT02294240]224 participants (Anticipated)Interventional2014-09-30Active, not recruiting
Optimizing Periconceptional and Prenatal Folic Acid Supplementation [NCT02300948]Phase 483 participants (Actual)Interventional2006-12-31Completed
A Phase III Multicenter Open-label Randomized Trial to Evaluate Efficacy and Safety of Folfirinox (FFX) Versus Combination of CPI-613 With Modified Folfirinox (mFFX) in Patients With Metastatic Adenocarcinoma of the Pancreas [NCT03504423]Phase 3528 participants (Actual)Interventional2018-11-09Completed
To Observe the Pathological Remission Rate and Safety of FOLFOXIRI for Neoadjuvant Treatment of High-risk Locally Advanced Colorectal Cancer With a Single-arm, Open, Prospective Phase II Exploratory Clinical Study [NCT05018182]Phase 269 participants (Anticipated)Interventional2021-08-02Recruiting
Impact of Iron/Folic Acid Versus Folic Acid Supplements During Pregnancy on Maternal and Children's Health: A Randomized Controlled Trial in China [NCT02221752]2,367 participants (Actual)Interventional2009-06-30Completed
The Effect of Orally Administered Iron-saturated Lactoferrin on Systemic Iron Homeostasis in Pregnant Women Suffering From Iron Deficiency and Iron Deficiency Anaemia [NCT03481790]Phase 2200 participants (Actual)Interventional2017-09-01Completed
A Randomized, Double-Blind, Controlled Trial on the Homocysteine-Lowering Effects of Different Doses of Folic Acid Among Patients With Hypertension According to Methylenetetrahydrofolate Reductase C677T Genotypes [NCT03472508]Phase 43,600 participants (Anticipated)Interventional2018-03-20Recruiting
Emacrit Plus in Prosthetic Hip and Knee Surgery [NCT04880499]60 participants (Actual)Interventional2021-04-21Completed
A Randomized Controlled Trial to Study the Effect of Folic Acid Supplementation in Pregnant Women Having Thalassaemia Trait [NCT04310059]270 participants (Anticipated)Interventional2024-07-01Not yet recruiting
Short-course Radiotherapy Versus Chemoradiotherapy, Followed by Consolidation Chemotherapy, and Selective Organ Preservation for MRI-defined Intermediate and High-risk Rectal Cancer Patients [NCT04246684]Phase 3702 participants (Anticipated)Interventional2020-10-15Active, not recruiting
Efficacy and Safety of Folic Acid Supplementation Lowering Arsenic in a Chronic, Low-level Exposed Arsenic Population: a Randomized, Double-blind, Placebo Controlled Clinical Trial. [NCT02235948]Phase 2450 participants (Anticipated)Interventional2014-07-31Active, not recruiting
Different Effects of Inositol Stereoisomers on Insulin Sensitivity in Women With Gestational Diabetes [NCT02097069]80 participants (Anticipated)Interventional2014-04-30Not yet recruiting
Involvement of Reticulum Endoplasmic Stress in the Physiopathology of Polycystic Ovary Syndrome: Possible Therapeutic Implications of Insulin Sensitizers. [NCT02302326]50 participants (Anticipated)Interventional2013-01-31Completed
Blood Folate and Homocysteine Levels Following Administration of Folic Acid According to Different Daily Dosing Schedules:a Simulation of Food Fortification [NCT00207558]1,100 participants InterventionalCompleted
Effect of Metformin With or Without Folate Addiction on Uterine Blood Flow and Trophoblastic Invasion in Pregnant Patients With Polycystic Ovary Syndrome [NCT01115140]Phase 450 participants (Actual)Interventional2010-03-31Completed
Effects of Vitamin Supplementation and Strength Training in Parkinson's Disease [NCT01238926]40 participants (Anticipated)Interventional2008-05-31Active, not recruiting
A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of MEGF0444A Dosed to Progression in Combination With Bevacizumab and FOLFOX in Patients With Previously Untreated Metastatic Colorectal Cancer [NCT01399684]Phase 2127 participants (Actual)Interventional2011-11-30Completed
Open, Randomized, Controlled, Multicenter Phase III Study Comparing 5FU/ FA Plus Irinotecan Plus Cetuximab Versus 5FU/FA Plus Irinotecan as First-line Treatment for Epidermal Growth Factor Receptor-expressing Metastatic Colorectal Cancer [NCT00154102]Phase 31,221 participants (Actual)Interventional2004-05-31Completed
Effect of Mild Increase in Folic Acid Intake on the Distribution of Folate Forms in Relation to a Common Polymorphism in One Folate Catabolising Enzyme [NCT01105351]75 participants (Actual)Interventional2010-06-30Completed
A Phase 3, Randomized, Double-blind, Placebo-controlled Study Evaluating Combination of TST001, Nivolumab and Chemotherapy as First-Line Treatment in Subjects With Claudin18.2 Positive Locally Advanced or Metastatic Gastric or Gastroesophageal Junction (G [NCT06093425]Phase 3950 participants (Anticipated)Interventional2023-10-31Not yet recruiting
A Phase III Randomized Trial Investigating Bortezomib (NSC# 681239) on a Modified Augmented BFM (ABFM) Backbone in Newly Diagnosed T-Lymphoblastic Leukemia (T-ALL) and T-Lymphoblastic Lymphoma (T-LLy) [NCT02112916]Phase 3847 participants (Actual)Interventional2014-10-04Active, not recruiting
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
A Phase 2 Study of Inotuzumab Ozogamicin (NSC# 772518) in Children and Young Adults With Relapsed or Refractory CD22+ B-Acute Lymphoblastic Leukemia (B-ALL) [NCT02981628]Phase 280 participants (Anticipated)Interventional2017-06-19Active, not recruiting
Risk-Stratified Randomized Phase III Testing of Blinatumomab (NSC#765986) in First Relapse of Childhood B-Lymphoblastic Leukemia (B-ALL) [NCT02101853]Phase 3669 participants (Actual)Interventional2014-12-17Active, not recruiting
Intensified Methotrexate, Nelarabine (Compound 506U78) and Augmented BFM Therapy for Children and Young Adults With Newly Diagnosed T-cell Acute Lymphoblastic Leukemia (ALL) or T-cell Lymphoblastic Lymphoma [NCT00408005]Phase 31,895 participants (Actual)Interventional2007-01-22Active, not recruiting
Effects Intravenous Iron and Oral Iron Therapy on Erythropoietin Dose in Maintenance Hemodialysis Patients: An Open-label, Randomized, Controlled Study [NCT04464850]Phase 3124 participants (Anticipated)Interventional2020-07-29Recruiting
Efficacy Study of Folic Acid Supplementation on Homocysteine Levels in Adolescent Epileptics Taking Antiepileptic Drugs: A Single Blind Randomized Controlled Clinical Trial [NCT02318446]Phase 336 participants (Anticipated)Interventional2015-03-31Not yet recruiting
Randomized Clinical Trial to Evaluate the Efficacy of High Dose of Folic Acid to Prevent the Occurrence of Congenital Malformations [NCT01244347]Phase 35,000 participants (Anticipated)Interventional2009-07-31Active, not recruiting
Effect of Preoperative Vitamin B12 on Post Operative Cognitive Dysfunction in Elderly Patients Undergoing Non-cardiac Surgery: A Multi-Center, Prospective, Randomized, Double-blinded, Controlled Clinical Trial [NCT03485404]40 participants (Actual)Interventional2019-01-10Terminated(stopped due to Due to slow recruiment. Only 40 patients were recruited in four years.)
High Risk B-Precursor Acute Lymphoblastic Leukemia (ALL) [NCT00075725]Phase 33,154 participants (Actual)Interventional2003-12-29Completed
[NCT01160419]Phase 249 participants (Anticipated)Interventional2009-12-31Active, not recruiting
Dietary Supply of Docosahexaenoic Acid (DHA) and 5-methyl-tetrahydro-folate (MTHF) During the Second Half of Pregnancy and Early Infancy [NCT01180933]315 participants (Actual)Interventional2001-11-30Completed
An Evaluation of Folic Acid to Improve Endothelial Sensitivity to Shear Stress in Post-menopausal Women. [NCT04016090]40 participants (Anticipated)Interventional2019-05-16Recruiting
Mitochondrial Cofactors for the Treatment of Hyperbilirubinemia Due to PEG-Asparaginase and or Inotuzumab Ozogamicin in Patients With Acute Lymphoblastic Leukemia (ALL) [NCT03564678]Phase 278 participants (Anticipated)Interventional2018-05-17Recruiting
A Phase 1, Open-label, Dose-finding Study of Pralatrexate Plus Systemic Bexarotene in Patients With Relapsed or Refractory Cutaneous T Cell Lymphoma [NCT01134341]Phase 134 participants (Actual)Interventional2010-03-31Completed
South African Paediatric Surgical Outcomes Study-2 (SAPSOS-2). A South African Multi-centre Pilot Trial to Assess the Feasibility and Clinical Efficacy of Preoperative Oral Iron to Treat Preoperative Iron-deficiency Anaemia in Children Undergoing Elective [NCT05681871]Phase 2/Phase 3420 participants (Anticipated)Interventional2023-01-16Not yet recruiting
Pretreatment With Myo-inositol in Hyperandrogenic PCOS Patients Undergoing ART: a Randomized Controlled Trial [NCT03767569]Phase 3134 participants (Anticipated)Interventional2018-09-01Recruiting
Myoinositol Supplementation, Insulin Resistance and Fetal Sonographic Parameters in Gestational Diabetes, Diet Treated: a Prospective, Randomized, Placebo-controlled Study [NCT03763669]120 participants (Actual)Interventional2018-11-14Completed
Managing Endothelial Dysfunction in COVID-19 : A Randomized Controlled Trial at the Lebanese American University Medical Center- Rizk Hospital [NCT04631536]Phase 342 participants (Actual)Interventional2021-01-10Active, not recruiting
Effect of Moringa Oleifera Leaf Capsul on Hemoglobin Levels in Anemia: A Pilot Study [NCT05737862]Phase 360 participants (Actual)Interventional2022-04-01Completed
The Effect of Encapsulation Material and Encapsulated Micronutrients on Iron Absorption in Iron Depleted Women Consuming Iron Fortified Bread. [NCT03332602]24 participants (Actual)Interventional2018-04-04Completed
[NCT01560065]Phase 40 participants InterventionalCompleted
A Phase 1b/2 Study to Evaluate the Safety, Pharmacokinetics, and Clinical Activity of Oleclumab (MEDI9447) With or Without Durvalumab in Combination With Chemotherapy in Subjects With Metastatic Pancreatic Ductal Adenocarcinoma [NCT03611556]Phase 1/Phase 2213 participants (Actual)Interventional2018-06-21Completed
Effect of Folic Acid on Motor Aspects of Daily Living and Oxidative Stress in Levodopa Treated Parkinson's Disease Patients: A Randomized, Double-Blind, Placebo Controlled Trial [NCT05959044]Phase 260 participants (Anticipated)Interventional2023-04-16Recruiting
Phase 2 Study of Pemetrexed in Combination With Cisplatin and Cetuximab in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck [NCT01057589]Phase 266 participants (Actual)Interventional2010-02-28Completed
Pilot Study of FOLFOX6 Plus Sir-Spheres® Microspheres (Chemo-radiotherapy) in Combination With Bevacizumab (Avastin) as a First Line Treatment in Patients With Nonresectable Liver Metastases From Primary Colorectal Carcinoma [NCT00735241]Phase 2/Phase 30 participants (Actual)Interventional2008-07-31Withdrawn(stopped due to Withdrawn by the study sponsor.)
A Dose-Escalation Study to Evaluate the Safety and Tolerability of SCH 717454 in Combination With Different Treatment Regimens in Subjects With Advanced Solid Tumors (Phase 1B/2; Protocol No. P04722) [NCT00954512]Phase 1/Phase 215 participants (Actual)Interventional2009-09-25Terminated(stopped due to This study was terminated for business reasons.)
A Multi Center Phase II Study of 5-Fluorouracil/ Folinic Acid Plus Gemcitabine in Patients With Advanced Pancreatic Cancer. [NCT00919282]Phase 278 participants (Actual)Interventional1997-09-30Completed
Phase II Study of Oxaliplatin in Combination With 5-fluorouracil (5-FU) and Folinic Acid (FA) in Patients Who Have Failed First-line Treatment for Locally Advanced or Metastatic Cervical Cancer. [NCT00782041]Phase 211 participants (Actual)Interventional2003-01-31Terminated(stopped due to protocol violation)
Determination of the Suitability of Urinary Total P-aminobenzoylglutamate (p-ABG)and Formiminoglutamate (FIGLU) as a Markers for Folate Status [NCT00689949]53 participants (Actual)Interventional2008-06-30Completed
Effect of Folate on Colonic and Blood Cells [NCT00611000]Phase 120 participants (Anticipated)Interventional2003-06-30Completed
"PsyCARE Trial - Efficiency of a Composite Personalised Care on Functional Outcome in Early Psychosis : A Prospective Randomised Controlled Trial " [NCT05796401]Phase 3500 participants (Anticipated)Interventional2023-06-15Not yet recruiting
SIMBA-Study Investigating Mental Acuity Effects of B-vitamins in Children [NCT00811291]250 participants (Actual)Interventional2008-09-30Completed
Influence of Preoperative Vitamin B12 and Folate Administration on Homocysteine Concentrations After Nitrous Oxide Anesthesia [NCT00901394]63 participants (Actual)Interventional2009-03-31Completed
An Exploratory, Randomized, Blinded, Placebo-Controlled Trial of Folic Acid and L-methylfolate in Parkinson's Disease [NCT00853879]150 participants (Actual)Interventional2006-12-31Terminated
A Non-randomized Phase 2 Study of Alvocidib (Flavopiridol) Plus Oxaliplatin With or Without 5-FU and Leucovorin for Relapsed or Refractory Germ-Cell Tumors [NCT00957905]Phase 236 participants (Actual)Interventional2009-06-30Completed
A Phase Ib Adaptive Study Dasatinib for the Prevention of Oxaliplatin-Induced Neuropathy in Patients With Metastatic Gastrointestinal Cancer Receiving FOLFOX Chemotherapy With or Without Bevacizumab [NCT04164069]Phase 19 participants (Anticipated)Interventional2020-09-02Active, not recruiting
A Pilot Study to Assess the Efficacy and Safety of Folic Acid and/or Vitamin B Complex on Hepatitis C Infected Patients Treated With Pegylated Interferon and Ribavirin. [NCT02150291]Phase 4120 participants (Anticipated)Interventional2014-05-31Recruiting
A Phase IIa Open Label, Randomized Clinical Trial to Study the Safety and Efficacy of Vintafolide and the Combination of Vintafolide and Paclitaxel Compared to Paclitaxel in Subjects With Advanced Triple Negative Breast Cancer Using Etarfolatide (EC20) Su [NCT01953536]Phase 20 participants (Actual)Interventional2014-04-30Withdrawn
A Phase 2 Randomized, Multicenter, Double-Blind Study of the Glutaminase Inhibitor Telaglenastat With Pembrolizumab and Chemotherapy Versus Placebo With Pembrolizumab and Chemotherapy in First-Line, Metastatic KEAP1/NRF2-Mutated, Nonsquamous, Non-Small Ce [NCT04265534]Phase 240 participants (Actual)Interventional2020-07-24Terminated(stopped due to Lack of Clinical Benefit)
A Phase II Study of EC17 (Folate-hapten Conjugate) in Patients With Progressive Metastatic Renal Cell Carcinoma [NCT00485563]Phase 212 participants (Actual)Interventional2007-06-30Terminated(stopped due to Changes in treatment paradigm resulted in a lower than expected rate of accrual.)
A Pilot and Feasibility Study of PD-1 Blockade With Nivolumab in Combination With Chemotherapy in Patients With Borderline Resectable Pancreatic Adenocarcinoma [NCT03970252]Early Phase 136 participants (Anticipated)Interventional2019-07-24Recruiting
Phase 1b/2 Clinical Trial of Neoadjuvant Pembrolizumab Plus Concurrent Chemoradiotherapy With Weekly Carboplatin and Paclitaxel in Adult Patients With Resectable, Locally Advanced Adenocarcinoma of the Gastroesophageal Junction or Gastric Cardia [NCT02730546]Phase 1/Phase 231 participants (Actual)Interventional2016-06-24Active, not recruiting
Randomized Phase III Trial of 5-FU Based Maintenance Therapy With or Without Panitumumab in Patients With RAS Wild Type Metastatic Colorectal Cancer After Induction With FOLFOX + Panitumumab [NCT03300609]Phase 34 participants (Actual)Interventional2018-02-27Terminated(stopped due to Insufficient Accrual)
Phase I/II Clinical Trial of Intrathecal Pemetrexed as First Line Intrathecal Chemotherapy in Patients With Leptomeningeal Metastasis [NCT05289908]Phase 1/Phase 234 participants (Actual)Interventional2022-02-21Active, not recruiting
Randomised Study to Investigate FOLFOXIRI Plus Cetuximab vs. FOLFOXIRI Plus Bevacizumab as First-line Treatment of BRAF-mutated Metastatic Colorectal Cancer [NCT04034459]Phase 2109 participants (Actual)Interventional2016-11-25Active, not recruiting
Randomized Controlled Trial of the Impact of Treating Moderately Malnourished Women in Pregnancy [NCT02120599]1,867 participants (Actual)Interventional2014-03-31Completed
Comparison of Bioavailability of Dexketoprofen-Vit B vs Dexketoprofen (Stadium®), Dose 25 mg in Healthy Subjects, of Both Genders, Under Fasting Conditions [NCT05027126]Phase 136 participants (Actual)Interventional2019-02-28Completed
Role of Folinic Acid in Improving the Adaptive Skills and Language Impairment in Children With Autism Spectrum Disorder [NCT05013164]Phase 244 participants (Actual)Interventional2020-10-01Completed
Single-arm Phase II Study of Maintenance Therapy With Aflibercept After First-line Treatment With FOLFIRI Plus Aflibercept in Metastatic Colorectal Cancer Patients [NCT02129257]Phase 273 participants (Actual)Interventional2014-05-26Completed
The Purpose of This Study is to Evaluate the Effectiveness of MB-6 as Adjuvant Therapy in Reducing Neutropenia When Given Oxaliplatin-based Chemotherapy in Patients With Stage 3 Colorectal Cancer Previously Treated With Surgery. [NCT02135887]184 participants (Anticipated)Observational2013-11-04Recruiting
Effect of Folic Acid Supplementation in Pregnancy on Preeclampsia-Folic Acid Clinical Trial (FACT) [NCT01355159]Phase 32,464 participants (Actual)Interventional2011-04-30Completed
Periprocedural Administration of Folic Acid for Prevention of Contrast Induced Nephropathy in Patients Undergoing Coronary CTA/Angiography/Angioplasty [NCT02444013]Phase 4400 participants (Anticipated)Interventional2015-05-31Recruiting
Neurovascular Regulation During Exercise in Humans With Chronic Kidney Disease [NCT02947750]Phase 2150 participants (Anticipated)Interventional2016-10-31Recruiting
Leucovorin for the Treatment of Language Impairment in Children With Autism Spectrum Disorder [NCT02839915]Phase 2134 participants (Anticipated)Interventional2020-08-13Recruiting
Folic Acid Handling by the Human Gut: Implications for Food Fortification and Supplementation [NCT02135393]6 participants (Actual)Interventional2009-04-30Completed
Standard Risk B-precursor Acute Lymphoblastic Leukemia (ALL) [NCT00103285]Phase 35,377 participants (Actual)Interventional2005-04-11Completed
An Open-Label, Randomized Phase 2 Study of ABT-869 in Combination With mFOLFOX6 (Oxaliplatin, 5-Fluorouracil, and Folinic Acid) Versus Bevacizumab in Combination With mFOLFOX6 as Second-line Treatment of Subjects With Advanced Colorectal Cancer [NCT00707889]Phase 2159 participants (Actual)Interventional2008-10-31Completed
The Effect of Oral Folinic Acid Rescue Therapy on Pemetrexed Induced Neutropenia: A Randomized Open-label Trial [NCT06010277]Phase 450 participants (Anticipated)Interventional2023-02-06Recruiting
Folic Acid Supplementation in Children With Sickle-Cell Disease: A Randomized Double-Blind Cross-Over Trial [NCT04011345]31 participants (Actual)Interventional2020-11-23Completed
Impact of Preoperative Treatment of Anemia and Iron Deficiency in Cardiac Surgery on Outcome. [NCT02031289]Phase 41,003 participants (Actual)Interventional2013-12-31Completed
A Phase I/II Clinical Trial of FOLFOX Bevacizumab Plus Botensilimab and Balstilimab (3B-FOLFOX) in Patients With MSS Metastatic Colorectal Cancer [NCT05627635]Phase 1/Phase 286 participants (Anticipated)Interventional2023-05-03Recruiting
A Phase III Study of Consolidative Radiotherapy in Patients With Oligometastatic HER2 Negative Esophageal and Gastric Adenocarcinoma (EGA) [NCT04248452]Phase 3314 participants (Anticipated)Interventional2020-05-26Recruiting
Evaluation of the Effect of Folic Acid Supplementation on the Presentation of Nuclear Abnormalities Associated With Cytogenotoxic Damage Induced by Chronic Drug Use. [NCT05712044]45 participants (Anticipated)Interventional2023-02-01Not yet recruiting
An Investigator-Initiated, Assessor Blinded, Randomized Study Comparing the Mechanism of Action of Adalimumab to Methotrexate in Subjects With Moderate to Severe Chronic Plaque Psoriasis. [NCT00932113]Phase 433 participants (Actual)Interventional2009-06-30Completed
Randomized Trial of 10 mg Versus 30 mg Per Week of Folic Acid in Combination With Methotrexate in Rheumatoid Arthritis [NCT01583959]Phase 4100 participants (Actual)Interventional2012-04-30Completed
Enalapril Maleate and Folic Acid Tablets for Primary Prevention of Stroke in Patients With Hypertension: a Post-marketing, Double-blind, Randomized Controlled Trial. [NCT00794885]Phase 420,702 participants (Actual)Interventional2008-05-31Completed
Myo-inositol May Prevent Gestational Diabetes in Obese Women [NCT01047982]220 participants (Actual)Interventional2010-03-31Completed
Folic Acid and Creatine as Therapeutic Approaches for Lowering Blood Arsenic [NCT01050556]Phase 4600 participants (Actual)Interventional2010-09-30Completed
Multi-Centre Phase III Open Label Randomized Trial Comparing CPT-11 In Combination With A 5-FU/FA Infusional Regimen To The Same 5-FU/FA Infusional Regimen Alone, As Adjuvant Treatment After Resection Of Liver Metastases For Colorectal Cancer. [NCT00143403]Phase 3321 participants (Actual)Interventional2001-12-31Completed
"International Multi-center Comparative Double-blind Randomized Clinical Trial of Efficacy and Safety of BCD-055 (JSC BIOCAD, Russia) and Remicade® in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis" [NCT02762838]Phase 3426 participants (Actual)Interventional2016-01-31Completed
Open Comparative Study With a Cross-over According to Patients'Preference Receiving Xeloda or UFT With Folinic Acid in Advanced or Metastatic Colo-rectal Cancer [NCT00905047]Phase 389 participants (Actual)Interventional2005-09-30Completed
FIRE-5 -Study: Optimal Anti-EGFR Treatment of mCRC Patients With Low-Frequency RAS Mutation [NCT04034173]Phase 2120 participants (Anticipated)Interventional2019-08-01Not yet recruiting
Enalapril Maleate and Folic Acid Tablets for Prevention of Chronic Kidney Diseases in Patients With Hypertension: a Double-blind Randomized Controlled Trial [NCT01871740]Phase 40 participants (Actual)Interventional2008-05-31Withdrawn(stopped due to The sponsor and the PIs both agreed that the CSPPT-CKD should be a sub-study of the CSPPT insted of an independent randomized trial.)
A Phase II Trial of Pemetrexed (Alimta [Registered Trademark]) Combined With Sirolimus (Rapamycin, Rapamune [Registered Trademark]) in Subjects With Relapsed or Refractory NSCLC [NCT00923273]Phase 1/Phase 242 participants (Actual)Interventional2008-02-29Terminated(stopped due to Premature closure - investigator left the National Institutes of Health.)
Low Dose Prednisone Therapy in Women With Recurrent Pregnancy Loss [NCT04558268]Phase 2/Phase 3242 participants (Anticipated)Interventional2020-12-31Not yet recruiting
A Randomized, Double-blind, Multi-center Phase Ⅲ Comparative Study to Evaluate the Efficacy and Safety of Recombinant Human-mouse Chimeric Anti-TNF-alpha Monoclonal Antibody for Injection. [NCT04178850]Phase 3568 participants (Anticipated)Interventional2017-10-13Recruiting
Metformin for Prevention of Gestational Diabetes in Pregnant Women With Polycystic Ovarian Syndrome: Randomized Controlled Trial (RCT ) [NCT02802215]Phase 2/Phase 380 participants (Anticipated)Interventional2016-01-31Recruiting
Open-label, Multicenter, Randomized, Parallel Study to Investigate pk, pd, Efficacy and Safety of Tocilizumab (TCZ, RO4877533) Following Subcutaneous Administration of TCZ 162 mg Weekly or Every Other Week in Combination With Methotrexate in Patients With [NCT00965653]Phase 129 participants (Actual)Interventional2009-08-31Completed
FLOX + Cetuximab (Erbitux®): First Line Treatment for Patients With Metastatic Colorectal Cancer and Wild Type K-RAS Tumor, A Phase II Study [NCT00660582]Phase 2152 participants (Actual)Interventional2008-04-30Completed
Randomized Three Arm Phase III Trial on Induction Treatment With a Fluoropyrimidine-, Oxaliplatin- and Bevacizumab-based Chemotherapy for 24 Weeks Followed by Maintenance Treatment With a Fluoropyrimidine and Bevacizumab vs. Bevacizumab Alone vs. no Maint [NCT00973609]Phase 3853 participants (Actual)Interventional2009-08-31Completed
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
Folate Rechallenge: A Pilot Study [NCT00672360]Phase 213 participants (Actual)Interventional2007-05-31Completed
Routine Administration of Folic Acid and Vitamin B12 to Prevent Childhood Infections in Young Indian Children [NCT00717730]Phase 21,000 participants (Actual)Interventional2010-01-31Completed
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
A Phase II, Double-blind, Placebo Controlled, Randomized Study to Assess the Efficacy and Safety of 2 Doses of ZD6474 (Vandetanib) in Combination With FOLFOX vs FOLFOX Alone for the Treatment of Colorectal Cancer in Patients Who Have Failed Therapy With a [NCT00500292]Phase 2109 participants (Actual)Interventional2007-03-31Completed
A Retrospective Analysis of Neevo® and Neevo®DHA Compared to a Standard Prenatal Vitamin in Anemia During Pregnancy (N-001) [NCT01062958]100 participants (Actual)Observational2009-12-31Completed
A Phase II Trial of Preoperative FOLFIRINOX Followed by Gemcitabine Based Chemoradiotherapy in Patients With Borderline Resectable Pancreatic Adenocarcinoma [NCT01897454]Phase 223 participants (Actual)Interventional2012-01-27Terminated(stopped due to Study was terminated due to slower than anticipated accrual)
Prevention of Intrauterine Growth Retardation in Hounde District, Burkina Faso: the Malaria Component [NCT00680732]Phase 41,370 participants (Actual)Interventional2003-06-30Completed
A Randomized, Double Blind, Placebo-Controlled, Phase II Study to Evaluate Efficacy, Safety, and Pharmacokinetics of SC12267 (35 mg) in Combination With Methotrexate Compared to Methotrexate Alone in Patients With Rheumatoid Arthritis [NCT01010581]Phase 2266 participants (Actual)Interventional2009-11-30Completed
A Randomized Trial of Quadruple Fortified Salt for Anemia and Birth Defects Prevention in Southern India [NCT03853304]1,000 participants (Anticipated)Interventional2023-10-01Active, not recruiting
Nutritional Anemia: Prevention and Treatment in Early Childhood [NCT00701246]196 participants (Actual)Interventional2005-04-30Completed
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
Acceptability and Feasibility of Micronutrient Powders Versus Iron Syrup for Anemia Prevention in Young Children [NCT02610881]110 participants (Actual)Interventional2015-12-31Completed
Effect of Folic Acid Supplementation in Patient's Calcific Aortic Valve Disease With Mild Aortic Valve Stenosis [NCT05861648]Phase 2100 participants (Anticipated)Interventional2023-07-01Not yet recruiting
A Randomized, Double-Blind, Phase III Study of Platinum+Pemetrexed Chemotherapy With or Without Pembrolizumab (MK-3475) in First Line Metastatic Non-squamous Non-small Cell Lung Cancer Subjects (KEYNOTE-189) [NCT03950674]Phase 340 participants (Actual)Interventional2016-02-22Completed
A Randomized, Double-Blind, Phase III Study of Platinum+Pemetrexed Chemotherapy With or Without Pembrolizumab (MK-3475) in First Line Metastatic Non-squamous Non-small Cell Lung Cancer Subjects (KEYNOTE-189) [NCT02578680]Phase 3616 participants (Actual)Interventional2016-01-15Completed
Multicenter, Randomized, Double-blind, Phase III Trial to Investigate the Efficacy and Safety of Oral BIBF 1120 Plus Standard Pemetrexed Therapy Compared to Placebo Plus Standard Pemetrexed Therapy in Patients With Stage IIIB/IV or Recurrent Non Small Cel [NCT00806819]Phase 3718 participants (Actual)Interventional2008-12-31Completed
An Open Labeled Phase 2 Study of Gemcitabine in Combination With Cisplatin, 5-FU (24h CI) and Folinic Acid in Patients With Inoperable Esophageal Cancer [NCT00759226]Phase 292 participants (Actual)Interventional2002-07-31Completed
An Open-label Pharmacokinetic Drug Interaction Study of Folic Acid and 250 Mcg NGM/35 Mcg E E (ORTHO-CYCLEN) in Healthy Women. [NCT00709332]Phase 147 participants (Actual)Interventional2005-01-31Completed
Randomized, Multinational, Study Of Aflibercept And Modified FOLFOX6 As First-Line Treatment In Patients With Metastatic Colorectal Cancer [NCT00851084]Phase 2268 participants (Actual)Interventional2009-02-28Completed
HPV Clearance by Folic Acid Supplementation (FACT for HPV) [NCT00703196]Phase 2368 participants (Actual)Interventional2007-03-31Completed
A Phase I Study Evaluating the Safety and Efficacy of TGR 1202 Alone and in Combination With Either Nab-paclitaxel + Gemcitabine or With FOLFOX in Patients With Select Relapsed or Refractory Solid Tumors [NCT02574663]Phase 166 participants (Actual)Interventional2015-09-11Completed
Safety and Efficacy of Optimal Methotrexate With Folic Acid in Patients With Rheumatoid Arthritis in Meizhou, Guangdong: a Randomized Case-control Study [NCT04066803]Phase 4160 participants (Anticipated)Interventional2018-08-01Recruiting
A Multicenter, Randomised Phase II Trial on the Therapy of Advanced Gastric Cancer or Adenocarcinoma of the Esophagogastric Junction in Patients Older Than 65 Years With Specific Regard of Quality of Life and Pharmacogenetic Risk Profile [NCT00737373]Phase 2143 participants (Actual)Interventional2007-08-31Completed
Folate Pharmacogenomics and Risk of Atypical Antipsychotic Metabolic Side Effects [NCT00815854]88 participants (Actual)Interventional2008-10-31Completed
Evaluation of the Clinical Efficacy and Safety of Dapoxetine, Combined Dapoxetine With Folic Acid and Combined Dapoxetine With Vitamin B12 in Treatment of Patients With Premature Ejaculation: A Randomized Placebo-controlled Clinical Trial [NCT04085354]Phase 3120 participants (Actual)Interventional2019-02-10Completed
A Prospective, Randomized Trial Of Simultaneous Pancreatic Cancer Treatment With Enoxaparin and ChemoTherapy (PROSPECT) [NCT00785421]Phase 2/Phase 3312 participants (Actual)Interventional2004-04-30Completed
An Open-label Pharmacokinetic Drug Interaction Study of Folic Acid and 250 Mcg NGM/35 Mcg EE (ORTHO-CYCLEN) in Healthy Women.. [NCT00709982]Phase 147 participants (Actual)Interventional2005-05-31Completed
seconD-line Folfiri/aflIbercept in proSpecTIvely Stratified, Anti-EGFR resistaNt, Metastatic coloreCTal Cancer patIents With RAS Validated Wild typE Status [NCT04252456]150 participants (Anticipated)Interventional2018-04-23Recruiting
A Pivotal Bioequivalence Study of 250 Mcg NGM/25 Mcg EE With or Without Folic Acid in Healthy Female Subjects [NCT00709644]Phase 154 participants (Actual)Interventional2005-04-30Completed
Randomized Phase 3 Study on the Optimization of Bevacizumab With mFOLFOX/mOXXEL in the Treatment of Patients With Metastatic Colorectal Cancer [NCT01718873]Phase 3230 participants (Actual)Interventional2012-05-31Completed
Department of Geriatrics [NCT02575092]Phase 2/Phase 34,000 participants (Actual)Interventional2015-11-01Completed
Phase II-III Study Comparing Radiochemotherapy With the FOLFOX Regimen Versus Radiochemotherapy With 5FU-cisplatin (Herskovic Regimen) in First Line Treatment of Patients With Inoperable Oesophageal Cancer. [NCT00861094]Phase 2/Phase 3266 participants (Actual)Interventional2008-03-31Completed
Phase III Study of the Effects of Folic Acid Supplementation on Serum Folate and Plasma Homocysteine in Older Adults: A Dose-Response Trial [NCT00807807]Phase 3133 participants (Actual)Interventional1996-06-30Completed
Examining the Commonness of the C677T Mutation in the MTHFR Gene in Subjects With B12 Deficiency and the Influence of the B12 Deficiency Combined With the C677T Mutation on the MTHFR Gene on Endothelial Function. [NCT00730574]100 participants (Actual)Interventional2008-07-31Terminated(stopped due to completed patient rectuitment)
Preoperative Hypofractionated Radiotherapy With FOLFOX for Esophageal/Gastroesophageal Junction Adenocarcinoma (PHOX) [NCT06078709]Phase 299 participants (Anticipated)Interventional2023-11-20Recruiting
Effect of Ultra-short-term Treatment of Patients With Iron Deficiency or Anemia Undergoing Adolescent Scoliosis Correction [NCT04343170]44 participants (Anticipated)Interventional2023-11-01Active, not recruiting
Folic Acid Administration Reduces the Progression of Microalbuminuria [NCT00737126]40 participants (Actual)Interventional2004-01-31Completed
The Nurses' Health Study (NHS) and Health Professionals Follow-Up Study (HPFS) Folic Acid Prevention Trial [NCT00512850]672 participants (Actual)Interventional1996-05-31Completed
A Placebo-Controlled Trial of Folate With B12 in Schizophrenia Patients With Residual Symptoms [NCT00611806]Phase 4140 participants (Actual)Interventional2007-12-31Completed
A Randomized, Phase 2b, Multi-center Study of Pralatrexate Versus Erlotinib in Patients With Stage IIIB/IV Non-small Cell Lung Cancer After Failure of at Least 1 Prior Platinum-based Treatment [NCT00606502]Phase 2201 participants (Actual)Interventional2008-01-31Completed
Effect of Homocysteine-Lowering Therapy With Folic Acid, Vitamin B12, and Vitamin B6 on Endothelium-Dependent Vasodilatation of Forearm Resistance Vessels in Patients With Coronary Heart Disease [NCT00693589]Phase 236 participants (Actual)Interventional2005-01-31Completed
Comparison of the Effects of Dietary Folate and Phytate on the Absorption of Zinc From Either Zinc-amino Acids (ZnAA) or Zinc-chloride (ZnCl2) [NCT05273710]10 participants (Actual)Interventional2022-03-28Completed
Efficacy and Safety of Two Neoadjuvant Strategies With Bevacizumab in Locally Advanced Resectable Rectal Cancer: A Randomized, Non-Comparative Phase II Study [NCT00865189]Phase 291 participants (Actual)Interventional2007-10-23Completed
A Randomized, Double-blind, Placebo-controlled, Multicenter, Two-part, Dose Ranging and Confirmatory Study With an Operationally Seamless Design, Evaluating Efficacy and Safety of SAR153191 on Top of Methotrexate (MTX) in Patients With Active Rheumatoid A [NCT01061736]Phase 2/Phase 31,675 participants (Actual)Interventional2010-03-31Completed
A Phase I, Single Center, Randomized, Open-Label, Study Investigating the Effect of Food, Rabeprazole, Methotrexate and Formulation on the Pharmacokinetics of GDC-0853 and the Effect of GDC-0853 on the Pharmacokinetics of Methotrexate in Healthy Subjects [NCT02699710]Phase 150 participants (Actual)Interventional2015-09-03Completed
A Phase I Study of EC0489 Administered Weeks 1 and 3 of a 4-Week Cycle [NCT00852189]Phase 165 participants (Actual)Interventional2009-04-30Completed
A Prospective Multicenter Study With 5-FU, Leucovorin, Oxaliplatin and Docetaxel (FLOT) in Patients With Locally Advanced, Limited Metastatic or Extensive Metastatic Adenocarcinoma of the Stomach or Esophagogastric Junction [NCT00849615]Phase 2252 participants (Actual)Interventional2009-02-28Completed
Periconceptional Iron Supplementation on Iron and Folate Indicators Among Pregnant and Non-pregnant Women in Rural Bangladesh. [NCT00953134]Early Phase 1273 participants (Actual)Interventional2007-02-28Completed
An Exploratory Phase 2 Study of Pemetrexed/Cisplatin as Pre-operative Chemotherapy in the Treatment of Stage IIIAN2 Nonsquamous Non-Small Cell Lung Cancer [NCT01165021]Phase 219 participants (Actual)Interventional2010-11-30Completed
[NCT01384994]Phase 2111 participants (Anticipated)Interventional2011-08-31Recruiting
A Study of the Effect of Folic Acid Supplementation on the Anti-malarial Action of Sulfadoxine-pyrimethamine When Used for Intermittent Preventive Treatment in Gambian Primigravidae. [NCT00120822]Phase 31,000 participants Interventional2002-07-31Completed
Protocol EC-FV-01: A Phase 1 Study of EC145 Administered in Weeks 1 and 3 of a 4-Week Cycle [NCT00308269]Phase 132 participants (Actual)Interventional2006-03-31Completed
Impact of Folates in the Care of the Male Infertility [NCT01407432]Phase 3162 participants (Actual)Interventional2011-11-30Completed
Observational Study of Effectiveness and Safety of Add-on Milgamma® and Milgamma® Compositum Step-Therapy in Routine Practice of Management of Adult Patients With Acute Non-Specific Low Back Pain Receiving Modern NSAIDs [NCT03892707]500 participants (Actual)Observational2018-12-15Completed
A Phase I Study of EC90 With GPI-0100 Adjuvant Followed by EC17 With Cytokines (Interleukin-2 [IL-2] and Interferon-alpha [IFN-alpha]) in Patients With Refractory or Metastatic Cancer [NCT00329368]Phase 113 participants (Actual)Interventional2005-09-30Completed
Phase 3 Study of Adjuvant Chemoradiotherapy of Advanced Resectable Rectal Cancer Comparing Modulation of 5-FU With Folinic Acid or With Interferon-alpha [NCT01060501]Phase 3796 participants (Actual)Interventional1992-07-31Completed
Pemetrexed With Simplified Folate and Dexamethasone Supplementation Versus Pemetrexed With Standard Supplementation as Second-line Chemotherapy for Patients With Non-squamous Non-small Cell Lung Cancer [NCT00609518]Phase 2111 participants (Actual)Interventional2008-02-29Completed
Profile Of Methylation and Gene Expression Of Gene ADRB3 And Effects Of Ingestion Of Folate, Hazelnuts And Diets Oil Capsule Antioxidants In Case Inflammatory [NCT02846025]Phase 230 participants (Actual)Interventional2015-10-31Completed
Antenatal Multiple Micronutrient Supplementation to Improve Infant Survival and Health in Bangladesh [NCT00860470]Phase 344,567 participants (Actual)Interventional2008-01-31Completed
Bioavailability of Folic Acid and L-5-methyltetrahydrofolic Acid in Fortified Bread: a Randomized Placebo-controlled Trial [NCT01570088]Phase 245 participants (Actual)Interventional2012-04-30Completed
Effect of Folic Acid and Vitamin B12 Supplementation on Biochemical Parameters in Subjects With Type-2 Diabetes [NCT02786823]Phase 2/Phase 380 participants (Actual)Interventional2017-05-01Completed
Pharmacogenetics of Adverse Outcomes After Nitrous Oxide Anesthesia [NCT00655980]687 participants (Actual)Interventional2008-02-29Completed
Effect of Adjunctive Use of Vitamin B3 and B9 on Myeloperoxidase Level in the GCF of Patients With Stage I and II Periodontitis, a Randomized, Parallel Group, Double Blinded, Placebo Controlled Study [NCT05435378]Early Phase 130 participants (Anticipated)Interventional2022-07-01Not yet recruiting
A Multicenter, Randomized, Open-label, 3-Arm Phase 3 Study of Encorafenib + Cetuximab Plus or Minus Binimetinib vs. Irinotecan/Cetuximab or Infusional 5-Fluorouracil (5-FU)/Folinic Acid (FA)/Irinotecan (FOLFIRI)/Cetuximab With a Safety Lead-in of Encorafe [NCT02928224]Phase 3702 participants (Actual)Interventional2016-10-13Completed
Phase II Study of Preoperative Radiation With Concurrent Capecitabine, Oxaliplatin and Bevacizumab Followed by Surgery and Postoperative 5-FU, Leucovorin, Oxaliplatin (FOLFOX) and Bevacizumab in Patients With Locally Advanced Rectal Cancer [NCT00321685]Phase 257 participants (Actual)Interventional2006-07-25Completed
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
Comparative Effectiveness of the Different Treatment Modalities for Management of Vaso-occlusive Painful Crisis in Pediatric Sickle Cell Disease [NCT04301336]Phase 2/Phase 3350 participants (Actual)Interventional2019-11-01Completed
Effect of 1 Year Vitamin D or D Plus B-vitamins on Bone Markers in Elderly People [NCT02586181]93 participants (Actual)Interventional2009-08-31Completed
A Randomized Phase II Study of Gemcitabine and Nab-Paclitaxel Compared With 5-Fluorouracil, Leucovorin, and Liposomal Irinotecan in Older Patients With Treatment Naïve Metastatic Pancreatic Cancer (GIANT) [NCT04233866]Phase 2176 participants (Actual)Interventional2020-08-26Active, not recruiting
HLA-DRB1 and HLA-DQB1 Genotyping for Autoantibody-positive and -Negative Patients With Atrophic Glossitis or Burning Mouth Syndrome [NCT01931293]750 participants (Anticipated)Interventional2013-04-30Recruiting
Individually Randomized Trial of Higher-dose Iron (60 mg, 45 mg) Compared to Low-dose Iron (30 mg) in Multiple Micronutrient Supplements in Pregnancy on Moderate and Severe Maternal Anemia- MMS Versus IFA Crossover Trial [NCT06069856]Phase 3130 participants (Anticipated)Interventional2025-09-30Not yet recruiting
Hypofractionated Radiotherapy Combined With Chemotherapy and Toripalimab for Locally Recurrent Rectal Cancer: a Single-arm, Two-cohort, Phase II Trial (TORCH-R) [NCT05628038]Phase 293 participants (Anticipated)Interventional2022-08-18Recruiting
A Randomised, Cross-over Phase II Study to Investigate the Efficacy and Safety of Glucarpidase for Routine Use After High Dose Methotrexate in Patients With Bone Sarcoma [NCT02022358]Phase 234 participants (Actual)Interventional2007-07-31Terminated(stopped due to Recruitment almost complete, has been slow and challenging)
Effect of Low Dose Oral Folic Acid Supplementation on Phenytoin Induced Gingival Overgrowth: A Randomized Double Blind Controlled Trial. [NCT00781196]Phase 3120 participants (Anticipated)Interventional2008-05-31Completed
Relationships of One-carbon Cycle Pathway With Psychopathology and Metabolic Abnormalities in Patients With Schizophrenia and Potential Intervention Strategy With Folic Acid and Vitamin B12 [NCT02916121]88 participants (Anticipated)Interventional2016-10-31Not yet recruiting
Intravenous Ferric Carboxymaltose Compared With Oral Iron in the Treatment of Iron Deficiency Anemia at Delivery in Tanzania [NCT02541708]Phase 3230 participants (Actual)Interventional2015-09-30Active, not recruiting
Open, Randomized, Multicenter, Randomized Phase II Trial Comparing the Combination of Cetuximab With Oxaliplatin/5-FU/FA Versus the Combination of Cetuximab With Irinotecan/5-FU/FA as Neoadjuvant Treatment in Patients With Non-Resectable Colorectal Liver [NCT00153998]Phase 2135 participants (Actual)Interventional2004-11-30Completed
A Phase II Study of Twice Weekly Paclitaxel, Cisplatin and Weekly 24-Hour Infusion of High-Dose 5-Fluorouracil and Folinic Acid in the Treatment of Recurrent or Metastatic Esophageal Cancer [NCT00154700]Phase 240 participants Interventional2001-01-31Completed
Effect of Omega 3 Fats on Sperm Quality and Sexual Function in Infertile Men Age 35-55 [NCT00406874]Phase 26 participants (Actual)Interventional2007-01-31Terminated(stopped due to reports indicating that increased folic acid intake may increase colin cancer)
Interventions for Tobacco Dependent Adolescents [NCT00158171]Phase 2128 participants (Actual)Interventional2002-04-30Completed
Evaluation of the Efficacy of Different Strategies to Treat Anemia in Mexican Children: A Randomized Clinical Trial [NCT00822380]680 participants (Actual)Interventional2003-03-31Completed
A Phase II Trial of Preoperative Chemotherapy and Chemoradiotherapy for Potentially Resectable Adenocarcinoma of the Stomach and Gastroesophageal Junction [NCT00525785]Phase 258 participants (Actual)Interventional2004-01-31Completed
SEARCH: Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine [NCT00124072]Phase 312,064 participants (Actual)Interventional1998-07-31Completed
A Phase 1/2a Open-label Study of Pralatrexate and Gemcitabine With Vitamin B12 and Folic Acid Supplementation in Patients With Relapsed or Refractory Lymphoproliferative Malignancies [NCT00481871]Phase 1/Phase 2119 participants (Actual)Interventional2007-05-31Completed
The Effects of Aspirin in Gestation and Reproduction: A Multi-center, Controlled, Double-blind Randomized Trial. [NCT00467363]1,228 participants (Actual)Interventional2007-06-30Completed
An Open-Label, Single-Arm, Maintenance Study to Demonstrate Long-Term Efficacy and Safety of CT-P10 in Patients With Rheumatoid Arthritis Who Were Treated With Rituximab (MabThera or CT-P10) in Study CT-P10 1.1 [NCT01873443]Phase 187 participants (Actual)Interventional2013-05-31Completed
The Effect of Jobelyn ( Extract of Sorghum Bicolor) on the Haematological Parameters of Patients With Sickle Cell Anaemia Disease. [NCT01703104]Phase 1/Phase 2150 participants (Actual)Interventional2012-01-31Completed
Effect of Home-fortification With Micronutrient Powder Sprinkles in Hematologic and Nutritional Status in Preschool Children in Medellín: a Randomized Clinical Trial. [NCT01917032]Phase 3100 participants (Anticipated)Interventional2013-09-30Not yet recruiting
Effect of Lowering of Plasma Homocysteine Concentrations After an Oral Methionine Load on Vascular Function in Healthy Volunteers [NCT00126347]40 participants Interventional2002-08-31Completed
VIP (Vitamins In Psychosis) Study. A Randomized Double Blind Placebo Controlled Trial of the Effects of Vitamin B12, B6 and Folic Acid Augmentation on Cognition and Symptoms in Early Psychosis. [NCT00202280]Phase 2/Phase 3120 participants (Actual)Interventional2004-09-30Completed
Iron Supplementation Among Adolescent Girls in India [NCT00198848]2,800 participants (Anticipated)Interventional2005-09-30Completed
A Phase IB Study of Pembrolizumab in Combination With Pemetrexed and Oxaliplatin in Patients With Chemo-Refractory Metastatic Colorectal Cancer [NCT03626922]Phase 133 participants (Anticipated)Interventional2019-05-15Active, not recruiting
Homocysteine Lowering and Atherosclerosis Reduction Trial (HART) [NCT00217178]Phase 4900 participants Interventional2000-01-31Active, not recruiting
A Randomised Placebo-Controlled Trial to Evaluate Interactions Between Riboflavin and Folate Intake and Genotype in Reducing Risk of Cervical Cancer [NCT00220532]Phase 1/Phase 2180 participants Interventional2005-07-31Terminated
Does Small Scale Cereal-based Fortification Hold the Key to Improved Micronutrient Status in Ethiopia? The Case of Folic Acid and Vitamin B12 in Teenage Girls in Arba Minch, Ethiopia [NCT06100146]474 participants (Anticipated)Interventional2023-09-06Recruiting
An Interventional, Prospective Open-Label Study of Immunosuppressive Therapies to Mitigate Immune-Mediated Loss of Therapeutic Response to Asfotase Alfa (STRENSIQ®) for Hypophosphatasia (RESTORE) [NCT06015750]Phase 48 participants (Anticipated)Interventional2024-02-20Not yet recruiting
Comparison of the Effect of Folic Acid and 5-methyltetrahydrofolate (5MTHF) on Serum Folate and Homocysteine Levels, and Abortion Rates in Women Suffering From Recurrent Abortion [NCT01976676]Phase 2/Phase 3220 participants (Actual)Interventional2011-04-30Completed
The Efficacy of Methotrexate for the Prevention of Postmolar Gestational Trophoblastic Disease Among Patients With High-Risk Hydatidiform Mole [NCT01984099]Phase 399 participants (Actual)Interventional2011-12-31Completed
Study of Effects of Preoperative Oral Domperidone on Gastric Residual Volume After Clear Fluid Ingestion in Patients Scheduled for Elective Surgeries: Prospective , Randomized ,Double Blinded Controlled Study [NCT05570292]Phase 340 participants (Actual)Interventional2022-10-10Completed
A Phase I A/B Study of the Folic Acid-Tubulysin Conjugate EC1456 In Patients With Advanced Solid Tumors [NCT01999738]Phase 193 participants (Actual)Interventional2013-10-31Completed
Clinical Trial of Effectiveness of Folic Acid Therapy on Homocysteine Level and Carotid Intima-Media Thickness After Kidney Transplantation [NCT00570856]Phase 460 participants (Actual)Interventional2005-06-30Terminated
Feasibility, Acceptability and Directional Signal Effect on Blood Folate Levels of Iodized Salt Fortified With Folic Acid: Clinical Study [NCT05935631]32 participants (Actual)Interventional2023-01-24Completed
A Multi-Institution Phase II Study of Pralatrexate With Vitamin B12 and Folic Acid Supplementation for Previously Treated Recurrent or Metastatic Head and Neck Squamous Cell Cancer (HNSCC) [NCT01183065]Phase 213 participants (Actual)Interventional2010-08-31Completed
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Efficacy and Safety Study of Methotrexate to Increase Response Rates in Patients With Uncontrolled Gout Receiving KRYSTEXXA® (Pegloticase) (MIRROR Randomized Controlled Trial [RCT]) [NCT03994731]Phase 4152 participants (Actual)Interventional2019-06-13Completed
VITATOPS - A Study of VITAmins TO Prevent Stroke [NCT00097669]8,164 participants (Actual)Interventional1998-11-30Completed
Phase I/II Clinical Study of Pralatrexate in Japanese Patients With Relapsed or Refractory Peripheral T-cell Lymphoma [NCT02013362]Phase 1/Phase 225 participants (Actual)Interventional2014-03-31Completed
An Open-label, Randomized, Controlled, Multicenter Phase III Trial to Compare Cetuximab in Combination With FOLFOX-4 Versus FOLFOX-4 Alone in the First Line Treatment of Metastatic Colorectal Cancer in Chinese Subjects With RAS Wild-type Status [NCT01228734]Phase 3553 participants (Actual)Interventional2010-09-09Completed
Phase Ib Trial of Two Folate Binding Protein (FBP) Peptide Vaccines (E39 and J65) in Breast and Ovarian Cancer Patients [NCT02019524]Phase 139 participants (Actual)Interventional2013-09-30Completed
Vitamin B12 and Folinic Acid Supplementation in Mitochondrial DNA Deletion Syndromes [NCT06186154]Phase 125 participants (Anticipated)Interventional2024-01-31Not yet recruiting
A Multicenter, Randomized Phase II Trial of Avastin Plus Gemcitabine Plus 5FU/Folinic Acid (A + FFG) vs. Avastin Plus Oxaliplatin Plus 5FU/Folinic Acid (A + FOLFOX 4) as Therapy for Patients With Metastatic Colorectal Cancer [NCT00192075]Phase 284 participants (Actual)Interventional2003-06-30Completed
5-methyltetrahydrofolate Survival and Inflammation in ESRD Patients [NCT00626223]341 participants (Actual)Interventional1998-01-31Completed
Primary Prevention of Multi-micronutrient Supplementation During Peri-conception Against Congenital Heart Disease: A Community-based Randomised Controlled Trial in China [NCT02537392]7,315 participants (Actual)Interventional2015-09-30Completed
Treatment of Patients With Newly Diagnosed Standard Risk B-Lymphoblastic Leukemia (B-ALL) or Localized B-Lineage Lymphoblastic Lymphoma (B-LLy) [NCT01190930]Phase 39,350 participants (Actual)Interventional2010-08-09Active, not recruiting
The Efficacy of Pantoprazole Treatment in Patients With Functional Dyspepsia: Randomised, Double-blind, Placebo-controlled Trial. [NCT01608750]Phase 4200 participants (Anticipated)Interventional2012-06-30Not yet recruiting
Low Molecular Weight Heparin for Treatment of Recurrent Miscarriage With Negative Antiphospholipid Antibodies: a Randomized Controlled Trial [NCT01608347]Phase 4228 participants (Actual)Interventional2010-01-31Completed
Phase IB Study to Evaluate the Safety of Selinexor (KPT-330) in Combination With Multiple Standard Chemotherapy or Immunotherapy Agents in Patients With Advanced Malignancies [NCT02419495]Phase 1221 participants (Actual)Interventional2015-06-26Active, not recruiting
Prospective, Single-centre, Double-Blind, Randomised, Placebo-controlled Study Evaluating Efficacy of Adalimumab + Methotrextate Compared With Placebo + Methotrexate in Patients With Early Oligoarthritis (ADEOS) [NCT04154852]Phase 222 participants (Actual)Interventional2011-06-30Completed
A Pilot Study of D-Chiro-Inositol Plus Folic Acid in Overweight Patients With Type 1 Diabetes [NCT02730949]Phase 326 participants (Actual)Interventional2014-03-31Completed
Timing, Duration and Severity of Infant Iron Deficiency: Developmental Impacts [NCT00613717]2,371 participants (Actual)Interventional2009-11-30Completed
Randomized, Placebo-controlled, Cross-over, Double-blind Study of a Metabolic Support Therapy With Q10 Ubiquinol and a Multivitamin B and E Complex in Two Cohorts of Patients With Idiopathic and Syndromic Autism (Phelan-McDermid Syndrome) [NCT04312152]200 participants (Anticipated)Interventional2019-03-09Enrolling by invitation
Effect of Natural Compounds on the Severity of HPV-induced Cervical Lesions [NCT05625308]40 participants (Actual)Interventional2022-07-01Completed
Effect of Preoperative Folic Acid Intervention on Postoperative Recovery Period in Children With Head and Neck and Maxillofacial Surgery [NCT04135885]300 participants (Anticipated)Interventional2019-12-30Not yet recruiting
The Role of Sub-clinical Inflammation on the Iron Status of Myanmar Anaemic Adolescent Schoolgirls During Iron and Vitamin A Supplementation [NCT01198574]Phase 3402 participants (Actual)Interventional2010-07-31Completed
Evaluation and Comparison of the Efficacy of a New Standard Pre-operative Chemotherapy for Stage II and III Colorectal Cancer According to the FOLFOX4 Regimen With Routine Chemoradiation Therapy [NCT05378919]Phase 2250 participants (Anticipated)Interventional2015-06-01Recruiting
A Phase 2, Single-arm, Open-label, Multi-center Study of Pralatrexate in Patients With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma [NCT00998946]Phase 229 participants (Actual)Interventional2009-09-30Completed
A Phase Ib Study to Evaluate the Safety and Tolerability of Durvalumab and Tremelimumab in Combination With First-Line Chemotherapy in Patients With Advanced Solid Tumors. [NCT02658214]Phase 132 participants (Actual)Interventional2016-04-28Completed
A Pivotal Bioequivalence Study of 250 Mcg NGM/35 Mcg EE With or Without Folic Acid in Healthy Female Subjects. [NCT00709189]Phase 153 participants (Actual)Interventional2005-05-31Completed
A Randomized, Open Label Absolute Bioavailability Study of Folic Acid. [NCT00709267]Phase 112 participants (Actual)Interventional2004-10-31Completed
Primary Surgery Plus Single Course Methotrexate Versus Primary Methotrexate for Treatment of Gestational Trophoblastic Neoplasms in Low Risk Cases Above 40y: a Randomized Controled Trial [NCT02606539]Phase 2/Phase 320 participants (Anticipated)Interventional2015-09-30Recruiting
Effect of Folic Acid on Homocysteine Levels and Flow-mediated Dilation in HIV and HIV-HCV Coinfected Patients: a Randomized Controlled Trial [NCT02810275]Phase 369 participants (Actual)Interventional2012-10-31Completed
A Randomized, Double-blind, Multicenter Phase 3 Study of Irinotecan, Folinic Acid, and 5-Fluorouracil (FOLFIRI) Plus Ramucirumab or Placebo in Patients With Metastatic Colorectal Carcinoma Progressive During or Following First-Line Combination Therapy Wit [NCT01183780]Phase 31,072 participants (Actual)Interventional2010-12-02Completed
Phase 2, Rand, Placebo-Controlled, Double-Blind, Dose Ranging Study to Evaluating Safety/Efficacy of Gerilimzumab in Patients With Moderately to Severely Active Rheumatoid Arthritis Inadequately Treated With Methotrexate or TNFα Antagonist [NCT02795299]Phase 20 participants (Actual)Interventional2018-01-31Withdrawn(stopped due to Study not started due to Sponsor decision to not move forward with compound.)
[NCT01426490]Phase 2/Phase 3300 participants (Anticipated)Interventional2011-08-31Recruiting
[NCT01514942]Phase 40 participants InterventionalCompleted
The Ondansetron Premedication Trial in Juvenile Idiopathic Arthritis [NCT04169828]176 participants (Anticipated)Interventional2019-08-02Recruiting
A Phase 1, Open-label Study of Pralatrexate With Vitamin B12 and Folic Acid Supplementation in Patients With Relapsed or Refractory Cutaneous T-cell Lymphoma [NCT00554827]Phase 155 participants (Actual)Interventional2007-08-31Completed
Phase III Study Analyzing the Effectiveness of Dalteparin Therapy as Intervention in Recurrent Pregnancy Loss [NCT00400387]Phase 3449 participants (Actual)Interventional2006-11-30Completed
Vitamin B12 and Folic Acid Supplementation for Preventing Fractures in Elderly People [NCT00696514]Phase 13,000 participants (Anticipated)Interventional2008-09-30Active, not recruiting
A ComboMATCH Treatment Trial: FOLFOX in Combination With Binimetinib as 2nd Line Therapy for Patients With Advanced Biliary Tract Cancers With MAPK Pathway Alterations [NCT05564403]Phase 266 participants (Anticipated)Interventional2024-05-07Recruiting
Phase I Study of Irinotecan Liposome (Nal-IRI), Fluorouracil and Rucaparib in the Treatment of Select Gastrointestinal Metastatic Malignancies Followed by a Phase Ib of First and Second Line Treatment of Both Unselected and Selected (for BRCA 1/2 and PALB [NCT03337087]Phase 1/Phase 218 participants (Anticipated)Interventional2018-11-02Active, not recruiting
A Randomized Crossover Trial Comparing Oral Capecitabine and Intravenous Fluorouracil + Folinic Acid (Nordic FU/FA Regimen) for Patient Preference in Colorectal Cancer [NCT00212589]Phase 360 participants Interventional2002-12-31Completed
Impact of Pre-Pregnancy Micronutrient Supplementation on Maternal and Child Outcomes [NCT01665378]5,011 participants (Actual)Interventional2011-10-31Completed
A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of the Safety and Tolerability of Subcutaneously Administered Sarilumab in Japanese Patients With Rheumatoid Arthritis Receiving Concomitant Methotrexate [NCT01850680]Phase 161 participants (Actual)Interventional2013-04-30Completed
[NCT01851941]Phase 252 participants (Actual)Interventional2004-10-31Completed
AZD8931, an Inhibitor of EGFR, ERBB2 and ERBB3 Signalling, in Combination With FOLFIRI: a Phase I/II Study to Determine the Importance of Schedule and Activity in Colorectal Cancer [NCT01862003]Phase 224 participants (Actual)Interventional2014-05-31Completed
Randomized Controlled Clinical Study of Folic Acid Treatment of Radiation Esophagitis After Chemoradiation in Lung Cancer [NCT05296369]90 participants (Anticipated)Interventional2022-03-01Recruiting
Air Pollution, Epigenetics and Cardiovascular Health: A Human Intervention Trial [NCT01864824]Phase 110 participants (Actual)Interventional2013-06-30Completed
Potentially Resectable Metastatic Colorectal Cancer With Wild-type KRAS and BRAF: Alternating Chemotherapy Plus Cetuximab - A Randomised Phase II Trial [NCT01867697]Phase 2173 participants (Actual)Interventional2012-05-31Completed
Perioperative Immunotherapy vs. Chemo-immunotherapy Stratified by Early Response Evaluation in Patients With Advanced Gastric Cancer (GC) and Adenocarcinoma of the Esophago-gastric Junction (AEG) [NCT04062656]Phase 221 participants (Actual)Interventional2019-09-26Active, not recruiting
Open Label, Multicenter, Phase II Study Evaluating the Efficacy and Safety of IMC-11F8 in Combination With 5-FU/FA and Oxaliplatin (mFOLFOX-6) in Patients With Treatment-naïve, Locally-advanced or Metastatic Colorectal Cancer [NCT00835185]Phase 244 participants (Actual)Interventional2007-08-31Completed
A Phase 1/2a, Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Anti-tumor Activity of PEN-866 in Patients With Advanced Solid Malignancies [NCT03221400]Phase 1/Phase 2340 participants (Anticipated)Interventional2017-08-29Recruiting
Effects of Propofol and Sevoflurane on Blood Folic Acid and Homocysteine Concentrations in Children With Cochlear Implant Surgery [NCT03595163]80 participants (Anticipated)Interventional2018-01-01Enrolling by invitation
Vitamin D, Vitamin B12, and Folic Acid Among Patients With Lifelong Premature Ejaculation and Non-responding to Dapoxetine Treatment. [NCT04355949]60 participants (Actual)Interventional2020-02-28Completed
Phase II Study of the Hyper-CVAD Regimen in Sequential Combination With Inotuzumab Ozogamicin as Frontline Therapy for Adults With B-Cell Lineage Acute Lymphocytic Leukemia [NCT03488225]Phase 24 participants (Actual)Interventional2018-03-28Terminated(stopped due to the study was closed early due to competing trials)
Vitamin Intervention for Stroke Prevention [NCT00004734]Phase 30 participants Interventional1996-09-30Completed
[NCT01921192]Phase 4160 participants (Anticipated)Interventional2012-09-30Recruiting
Impact of Vitamin B12 Supplementation With Iron and Folic Acid on Adolescent Girls [NCT01490944]Phase 2360 participants (Anticipated)Interventional2012-01-31Recruiting
Folic Acid Supplementation for Improving Homocysteine Levels, Cognitive and Depressive Status in Eating Disorders [NCT01493674]Phase 424 participants (Actual)Interventional2008-01-31Completed
Prevention of Neural Tube Defects by Inositol in Conjunction With Folic Acid (PONTI Study) [NCT00452829]Phase 1100 participants (Actual)Interventional2009-09-30Completed
Prevention of Mood Disorders by Folic Acid Supplementation [NCT00459264]112 participants (Actual)Interventional2005-12-31Completed
Randomized Double-blind Controlled Clinical Trial to Assess the Impact of Folic Acid and Omega-3 Fatty Acids Supplementation on the Severity of Depressive Symptoms in Older Adults With Identified Depression [NCT00480207]Phase 2/Phase 315 participants (Actual)Interventional2007-05-31Completed
Effect of Folic Acid on Endothelial and Baroreceptor Function in Patients With Heart Failure [NCT00491907]Phase 40 participants Interventional2004-10-31Terminated(stopped due to recruitment is finished)
A Canadian Multicenter, Randomized, Double-Blind Placebo-Controlled Study of Methotrexate and Folic Acid in Systemic Lupus Erythematosus: A Phase III Trial. [NCT00470522]Phase 386 participants (Actual)Interventional1995-06-30Completed
Blood Pressure Lowering Effect of B-vitamins in Adults With a Genetic Pre-disposition to Elevated Blood Pressure. [NCT04278378]2,564 participants (Actual)Interventional2011-06-28Completed
Phase II/III Study of Circulating Tumor DNA as a Predictive Biomarker in Adjuvant Chemotherapy in Patients With Stage IIA Colon Cancer (COBRA) [NCT04068103]Phase 2/Phase 31,408 participants (Anticipated)Interventional2019-12-16Recruiting
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
Preventing Fetal Body and Brain Size Reduction in Low-income Smoking Mothers: A Randomized Clinical Trial [NCT01248260]495 participants (Actual)Interventional2011-02-28Completed
Folate Augmentation of Treatment - Evaluation for Depression: a Randomised Controlled Trial [NCT00514410]Phase 4730 participants (Anticipated)Interventional2007-07-31Completed
The Role of Neurovascular Dysfunction and Oxidative Stress in the Exercise Intolerance of Renal Failure [NCT01356966]Phase 274 participants (Actual)Interventional2011-05-31Completed
Efficacy of Antihypertensive and Plasma Total Homocysteine Lowering Combined Therapy With Enalapril and Folic Acid in Hypertensive Patients:A Multicenter Double Blind Randomized Clinical Trial [NCT00520247]Phase 2443 participants (Actual)Interventional2005-09-30Completed
Phase II Randomized Study Comparing FOLFIRINOX + Panitumumab Versus mFOLFOX6 + Panitumumab in Metastatic Colorectal Cancer Patients Selected by RAS and B-RAF Status From Circulating DNA Analysis [NCT02980510]Phase 2219 participants (Actual)Interventional2016-12-31Active, not recruiting
A Phase III Study of Risk Directed Therapy for Infants With Acute Lymphoblastic Leukemia (ALL): Randomization of Highest Risk Infants to Intensive Chemotherapy +/- FLT3 Inhibition (CEP-701, Lestaurtinib; NSC#617807) [NCT00557193]Phase 3218 participants (Actual)Interventional2008-01-15Active, not recruiting
An Uncontrolled, Open-label, Phase II Study in Subjects With Metastatic Adenocarcinoma of the Colon or Rectum Who Are Receiving First Line Chemotherapy With mFOLFOX6 (Oxaliplatin/ Folinic Acid/5-fluorouracil [5-FU]) in Combination With Regorafenib [NCT01289821]Phase 254 participants (Actual)Interventional2011-02-28Completed
A Randomized, Double-blind, Double-dummy, 2-parallel Arms Clinical Trial to Assess the Pharmacodynamic Effect on Plasma Folate and Red Blood Cell Folate and to Compare the Profile of Circulating Folate Metabolites During 24 Weeks of Treatment With an Oral [NCT01258660]Phase 1172 participants (Actual)Interventional2006-12-31Completed
A Phase 3, Global, Multi-Center, Double-Blind, Randomized, Efficacy Study of Zolbetuximab (IMAB362) Plus mFOLFOX6 Compared With Placebo Plus mFOLFOX6 as First-line Treatment of Subjects With Claudin (CLDN)18.2-Positive, HER2-Negative, Locally Advanced Unr [NCT03504397]Phase 3566 participants (Actual)Interventional2018-06-21Active, not recruiting
Randomized, Open Label Trial of Iron and Folic Acid on Change of Fungal Pattern [NCT02908581]Phase 242 participants (Actual)Interventional2016-06-30Completed
Effects of Myo-inositol, Alpha-Lactalbumin and Folic Acid Treatment in PCOS Women of Mexico and Italy [NCT04645745]36 participants (Actual)Interventional2019-06-15Completed
Randomized Phase II Trial Of Neoadjuvant Combined Modality Therapy For Locally Advanced Rectal Cancer [NCT00081289]Phase 2146 participants (Actual)Interventional2004-03-31Completed
A Randomized Phase III Trial Comparing Chemotherapy With Folfirinox to Gemcitabine in Locally Advanced Pancreatic Carcinoma [NCT02539537]Phase 3171 participants (Actual)Interventional2015-10-23Active, not recruiting
A Randomized, Double-Blind, Two-Part, Parallel-Group, Comparative Study to Evaluate Blood Folate Levels in Women Taking an Oral Contraceptive With and Without Folic Acid [NCT00301587]Phase 30 participants (Actual)InterventionalWithdrawn(stopped due to Company decision to not fund further development of women's health new drug development programs.)
[NCT00378456]0 participants InterventionalCompleted
Folate Supplementation in Schizophrenia [NCT00249288]Phase 446 participants (Actual)Interventional2003-12-31Completed
Phase I Clinical Study of Folate [NCT00096330]Phase 120 participants (Actual)Interventional2004-09-30Completed
Oral Cleft Prevention Trial in Brazil [NCT00098319]Phase 32,200 participants (Anticipated)Interventional2004-01-31Completed
Effect of Lowering of Fasting Plasma Homocysteine Concentrations Through Supplementation With Betaine or Folic Acid on Vascular Function in Healthy Volunteers [NCT00102843]40 participants Interventional2002-10-31Completed
Impact of Zinc Supplementation on Mortality and Hospitalizations in Children Aged 1 Months to 23 Months [NCT00269542]94,359 participants (Actual)Interventional2002-02-28Completed
Zinc Supplementation Impact on Child Mortality--Nepal [NCT00109551]Phase 358,000 participants Interventional2001-10-31Completed
The Folic Acid and Carotid Intima-Media Thickness (FACIT) Study: A Randomized Controlled Trial [NCT00110604]835 participants Interventional2000-09-30Completed
The Effect of Oral Vitamin B12 Supplementation on Cognitive Performance in Elderly People: the Brain12 Study [NCT00111267]165 participants Interventional2003-05-31Completed
Effect of Folic Acid Treatment in Coronary Artery Disease [NCT00300352]Phase 260 participants (Anticipated)Interventional2004-05-31Recruiting
A Randomized Pilot Study of the Activation of the Hemostatic Pathway by FOLFIRI + Bevacizumab With or Without Dalteparin in First Line Treatment of Advanced Colorectal Cancer [NCT00323011]Phase 25 participants (Actual)Interventional2006-05-31Terminated(stopped due to drug not available)
Systemic Oxaliplatin or Intra-arterial Chemotherapy Combined With LV5FU2 +/- Irinotecan and an Target Therapy in First Line Treatment of Metastatic Colorectal Cancer Restricted to the Liver [NCT02885753]Phase 3348 participants (Anticipated)Interventional2016-12-31Recruiting
A Randomized, Double-blind, Multicenter Study With a Placebo-controlled Period Assessing the Efficacy and Safety of Sarilumab Added to Methotrexate (MTX) in Japanese Patients With Moderately to Severely Active Rheumatoid Arthritis Who Are Inadequate Respo [NCT02293902]Phase 3243 participants (Actual)Interventional2014-11-30Completed
Multicenter Randomized Trial Evaluating FOLFIRI Plus Cetuximab Versus FOLFIRI Plus Bevacizumab in First Line Treatment of Metastatic Colorectal Cancer. [NCT00433927]Phase 3568 participants (Anticipated)Interventional2007-01-31Active, not recruiting
Role of NO Activity for the Development of Diabetic Nephropathy [NCT00136188]Phase 2/Phase 3100 participants (Actual)Interventional2009-08-31Completed
HOPE-2 Study (Heart Outcomes Prevention Evaluation-2 Study) [NCT00106886]Phase 45,000 participants Interventional1999-12-31Active, not recruiting
Evaluation of Anthelminthics and Multivitamins for Treatment of Severe Anemia in Pregnant Women and Children 6-24 Months of Age in Pakistan [NCT00116493]Phase 31,009 participants (Actual)Interventional2004-04-30Completed
5-Fluorouracil/Folinate/Oxaliplatin (Eloxatin) (FLOX Regimen), Given Continuously or Intermittently, in Combination With Cetuximab (Erbitux), in First-line Treatment of Metastatic Colorectal Cancer. A Phase III Multicenter Trial. [NCT00145314]Phase 3571 participants (Actual)Interventional2005-05-31Completed
Polymorphism C677T MTHFR and Diet With Folate in Oxidative Stress, Lipid Profile and Homocysteine [NCT02953522]48 participants (Actual)Interventional2015-11-30Completed
Evaluation Concerning the Influence of Myo-inositol Therapy on the Dynamics of Embryo Development in Patients Suffering From PCOS Undergoing ICSI Treatment [NCT02385396]Phase 2217 participants (Actual)InterventionalCompleted
Phase I/Ib Trial of ATR Inhibitor BAY 1895344 in Combination With FOLFIRI in GI Malignancies With a Focus on Metastatic Colorectal and Gastric/Gastroesophageal Cancers [NCT04535401]Phase 190 participants (Anticipated)Interventional2021-08-13Active, not recruiting
A Phase 2 Study of Zolbetuximab (IMAB362) as Monotherapy and in Combination With Chemotherapy and/or Immunotherapy in Subjects With Metastatic or Locally Advanced Unresectable Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma and Locoregional Gast [NCT03505320]Phase 2143 participants (Anticipated)Interventional2018-06-29Recruiting
A Randomized, Placebo Controlled, Multicenter Clinical Study Investigating Efficacy of Rituximab in the Inhibition of Joint Structural Damage Assessed by Magnetic Resonance Imaging in Patients With Rheumatoid Arthritis and Inadequate Response to Methotrex [NCT00578305]Phase 3185 participants (Actual)Interventional2007-11-30Completed
Comparative Efficacy of Amlodipine Folic Acid vs. Amlodipine on the Risk of First Ischemic Stroke Among Patients With H-type Hypertension and MTHFR 677 CC/CT Genotype: A Multi-center, Randomized, Controlled Clinical Trial [NCT04974138]Phase 425,000 participants (Anticipated)Interventional2022-04-01Not yet recruiting
Phase I/II Study of Carboplatin and Pralatrexate in Patients With Recurrent Platinum-Sensitive Ovarian, Fallopian or Primary Peritoneal Cancer [NCT01188876]Phase 1/Phase 250 participants (Actual)Interventional2010-08-31Completed
Treatment of Atypical Teratoid/Rhabdoid Tumors (AT/RT) of the Central Nervous System With Surgery, Intensive Chemotherapy, and 3-D Conformal Radiation [NCT00653068]Phase 370 participants (Actual)Interventional2008-12-08Active, not recruiting
Trial of Vitamins Among Children of HIV-infected Women [NCT00197730]Phase 32,387 participants (Actual)Interventional2004-06-30Completed
A Randomized, Double-blind, Parallel-group, Placebo- and Active Calibrator-controlled Study Assessing the Clinical Benefit of SAR153191 Subcutaneous (SC) on Top of MTX in Patients With Active RA Who Have Failed Previous TNF-α Antagonists [NCT01217814]Phase 216 participants (Actual)Interventional2010-11-30Terminated(stopped due to Due to delay in the study and the impact on the development timelines, not due to any identified safety concerns)
Protocol EC-0225-01: A Phase 1 Study of EC0225 Administered Weeks 1 and 3 of a 4-Week Cycle [NCT00441870]Phase 177 participants (Actual)Interventional2007-02-28Completed
Induction Chemotherapy Before or After Preoperative Chemoradiotherapy and Surgery for Locally Advanced Rectal Cancer: A Randomized Phase II Trial of the German Rectal Cancer Study Group [NCT02363374]Phase 2311 participants (Actual)Interventional2015-03-25Completed
[NCT01511835]Phase 40 participants InterventionalRecruiting
A Phase III Randomized Trial for the Treatment of Newly Diagnosed Supratentorial PNET and High Risk Medulloblastoma in Children < 36 Months Old With Intensive Induction Chemotherapy With Methotrexate Followed by Consolidation With Stem Cell Rescue vs. [NCT00336024]Phase 391 participants (Actual)Interventional2007-08-06Active, not recruiting
Observational Study of the Impact of Circulating T Regulatory Cells (Tregs) on Clinical Outcome of Metastatic Colorectal Cancer (MCRC) Patients Treated With Standard Fluorouracil/Irinotecan/Bevacizumab First Line Therapy [NCT01533740]31 participants (Actual)Observational2012-03-31Completed
Combination Therapy With Myo-inositol and Folic Acid Versus Myo-inositol Alone: Effects of Six Months Treatment on Clinical, Endocrine and Metabolic Features in Obese Women With Polycystic Ovary Syndrome [NCT01555190]50 participants (Actual)Interventional2012-01-31Completed
B-Vitamin Atherosclerosis Intervention Trial (BVAIT) [NCT00114400]Phase 2/Phase 3506 participants Interventional2000-11-30Completed
A Phase I Trial of Lometrexol Sodium and Paclitaxel Adminsitered Intravenously Every 21 Days in Conjunction With Oral Folic Acid in Patients With Solid Tumors [NCT00024310]Phase 10 participants Interventional2001-09-30Active, not recruiting
Mechanisms of Antifolate Efficacy in Arthritis [NCT00000395]Phase 240 participants (Actual)Interventional1996-09-30Completed
UKCAP Trial: A Multi-Center Double Blind Randomised Controlled Trial Of Aspirin And/Or Folate Supplementation For the Prevention Of Recurrent Colorectal Adenomas [NCT00033319]0 participants Interventional1997-05-31Active, not recruiting
Evaluation of a Package of Nutrition Interventions to School-based Nutrition and Health Intervention for Adolescents in Bangladesh [NCT05455073]3,018 participants (Actual)Interventional2019-07-31Completed
[NCT01540747]Phase 40 participants InterventionalCompleted
A Multi-centre, Randomised, Parallel Group, Open-label, Phase II, Single-stage Selection Trial of Liposomal Irinotecan (Nal-IRI) and 5-fluorouracil (5-FU)/Folinic Acid or Docetaxel as Second-line Therapy in Patients With Progressive Poorly Differentiated [NCT03837977]Phase 2102 participants (Anticipated)Interventional2018-11-13Active, not recruiting
Factors Affecting Colonic Folate Absorption and Metabolism in Humans [NCT03421483]24 participants (Anticipated)Interventional2018-12-17Active, not recruiting
The Effect of Folic Acid Supplementation on Efficacy of Sulfadoxine-pyrimethamine in Pregnant Women in Western Kenya [NCT00130065]Phase 4600 participants Interventional2003-11-30Completed
3389 Colorectal Adenoma: Chemoprevention With Folic Acid [NCT00018551]Phase 20 participants Interventional1998-10-31Completed
Oral Cleft Prevention Program [NCT00397917]Phase 34,000 participants (Actual)Interventional2006-11-30Completed
A Phase II Multicenter Study Of Lometrexol Sodium And Folic Acid In Subjects With Previously Treated Stage IIIB or IV Non-Small Cell Lung Cancer [NCT00033722]Phase 20 participants Interventional2002-02-28Active, not recruiting
A Phase 1 Trial of ALIMTA (Pemetrexed) in Patients With Locally Advanced or Metastatic Cancer [NCT00034463]Phase 10 participants InterventionalCompleted
Dosage Effects of Folic Acid on Blood Folates of Honduran Women [NCT00207532]100 participants Interventional2005-03-31Completed
The Relative Bioavailability of Folate From a Mixed Diet Compared to Synthetic Folic Acid Using a Stable Isotope Method [NCT00130585]75 participants Interventional2005-05-31Completed
Impact of Iron/Folic Acid Versus Multimicronutrient Versus Folic Acid Supplements During Pregnancy on Mortality, Morbidity, and Complications During Pregnancy, Labor, and Delivery: A Randomized Controlled Trial in China [NCT00133744]Phase 318,962 participants (Actual)Interventional2006-05-31Completed
The Effect of Folic Acid Concentration and Folic Acid Supplementation on Warfarin Pharmacokinetic and Warfarin Dose Requirement at Steady State. [NCT00162409]400 participants (Anticipated)Interventional2001-08-31Recruiting
A Dose-finding Randomized Trial of Vitamin B12 Supplementation: Biomarker Responses and Implications for Dietary Recommendations. [NCT04731948]200 participants (Actual)Interventional2004-10-01Completed
Nutrition, Immunology, and Epidemiology of Tuberculosis [NCT00170404]Phase 3887 participants Interventional2000-06-30Completed
A Trial of Micronutrients and Adverse Pregnancy Outcomes [NCT00197548]Phase 38,468 participants (Actual)Interventional2001-08-31Completed
Single-Arm, Multicenter, Prospective, Phase 2 Study for the Evaluation of Biomarkers in Patients With Advanced &/or Metastatic Colorectal Cancer With Wild Type KRAS Treated Biweekly With Chemotherapy and Cetuximab as First-Line Treatment [NCT01276379]Phase 2221 participants (Actual)Interventional2011-01-31Completed
Early Blocking Strategy for Metachronous Liver Metastasis of Colorectal Cancer Based on Pre-hepatic CTC Detection [NCT05720559]Phase 2100 participants (Anticipated)Interventional2023-03-01Not yet recruiting
Phase I Study to Determine the Safety of Quercetin in COPD Patients [NCT01708278]Phase 19 participants (Actual)Interventional2014-02-28Completed
Dilapan-S With Adjunctive Misoprostol for Same-day Second Trimester Dilation and Evacuation: A Randomized Trial [NCT01818414]29 participants (Actual)Interventional2013-10-31Terminated(stopped due to Concerns for safety)
Mitigation Efforts in Arsenic Exposure With Folic Acid Supplementation: Reducing Toxicity and Exploring the Impact on Lung Health [NCT05656664]100 participants (Anticipated)Interventional2023-09-14Enrolling by invitation
Effectiveness of Comprehensive Tertiary Interventions on Incidence and Clinical Outcomes of Birth Defects : a Cluster Randomisation Intervention Trial [NCT03725878]2,200 participants (Anticipated)Interventional2018-10-31Recruiting
Comparative Efficacy of Amlodipine Folic Acid vs. Amlodipine on the Risk of First Ischemic Stroke Among Patients With Hypertension and MTHFR 677 TT Genotype: A Multi-center, Randomized, Controlled Clinical Trial [NCT04974151]Phase 424,000 participants (Anticipated)Interventional2022-04-01Not yet recruiting
Effects of Treatment With Resveratrol on Oocyte and Embryo Quality in Patients Undergoing Assisted Reproductive Techniques( ART) [NCT04386499]100 participants (Actual)Interventional2019-01-10Completed
Calcium Aspirin Multiple Micronutrients (CAMMS) or Iron-folic Acid (IFA) to Reduce Preterm Birth [NCT05612984]Phase 310,000 participants (Anticipated)Interventional2024-04-01Not yet recruiting
Randomized Trial of Homocysteine-lowering With B Vitamins for Secondary Prevention of Cardiovascular Disease After Acute Myocardial Infarction. The Norwegian Vitamin Trial (NORVIT) [NCT00266487]3,750 participants Interventional1998-12-31Completed
Essai De Phase III De Chimiotherapie Par FOLFOX 4 Ou Par Une Succession FOLFOX 7 - FOLFIRI Chez Des Patients Ayant Des Metastases Resecables D'Origine Colorectale - MIROX [NCT00268398]Phase 3284 participants (Actual)Interventional2002-07-31Completed
A Study of Serum Folate Levels in Patients Treated With Olaparib [NCT04024254]Phase 2/Phase 310 participants (Actual)Interventional2020-07-21Completed
A Multicenter Randomized, Open-label Study to Compare the Efficacy of Subcutaneous Infliximab Monotherapy With Subcutaneous Infliximab and Concomitant Immunosuppression in the Treatment of Moderate to Severe Crohn's Disease [NCT06059989]Phase 3158 participants (Anticipated)Interventional2021-11-25Recruiting
Preoperative FOLFOX Versus Postoperative Risk-adapted Chemotherapy in Patients With Locally Advanced Rectal Cancer and Low Risk for Local Failure: A Randomized Phase III Trial of the German Rectal Cancer Study Group [NCT04495088]Phase 3818 participants (Anticipated)Interventional2020-09-30Recruiting
Open, Multi-center Phase I/II Trial With Mitomycin C in Combination With 5-Fluorouracil and Folinic Acid in Pretreated Patients With Metastatic Gastrointestinal Cancer [NCT00289445]Phase 1/Phase 20 participants Interventional1999-09-30Completed
Phase I/II Study of CT-2106 in Combination With Infusional 5-fluorouracil/Folinic Acid (5-FU/FA)(de Gramont Schedule) as Second Line in Patients With Metastatic Colorectal Cancer Failing an Oxaliplatin Plus 5-FU/FA Regimen [NCT00291785]Phase 1/Phase 248 participants (Actual)Interventional2004-01-31Completed
One-year Double-blind Placebo-controlled Phase 2-3 Study to Evaluate the Effect of Oral Folinic Acid Treatment (1mg/kg/d) on the Psychomotor Development of Young Down Syndrome Patients [NCT00294593]Phase 2/Phase 3120 participants Interventional2000-10-31Completed
Effect of Add-on Anti-Toxoplasmosis Treatment on Parameters Defining Toxoplasma Gondii Infection and on Psychopathology in Patients With Schizophrenia or Major Depression Serologically Positive for Toxoplasma Gondii - Phase 3 Study [NCT00300404]Phase 340 participants Interventional2002-01-31Completed
Micronutrient Supplementation for Women With PCO-syndrome - Influence of Nutrition and Physiology on the Development of PCOS-typical Parameters [NCT03306745]60 participants (Actual)Interventional2017-06-02Completed
PHASE II DOUBLE-BLIND CHEMOPREVENTION TRIAL OF HIGH DOSE FOLIC ACID VERSUS PLACEBO IN PATIENTS WITH RESECTED COLORECTAL POLYPS [NCT00002650]Phase 280 participants (Anticipated)Interventional1995-06-12Completed
Homocysteine Lowering by B Vitamins and the Secondary Prevention of Deep-Vein Thrombosis and Pulmonary Embolism. A Randomized, Placebo-Controlled, Double Blind Trial. [NCT00314990]620 participants Interventional1996-01-31Completed
An Observational Study of Avastin® (Bevacizumab) in Combination With Chemotherapy for Treatment of First-line Metastatic Colorectal Adenocarcinoma [NCT01506167]719 participants (Actual)Observational2012-07-06Completed
[NCT01626443]Phase 446 participants (Actual)Interventional2014-01-31Completed
Effect of Methyl-donor Nutrient Supplementation on Methylation Profile of Inflammatory-related Genes in Lupus Patients With Obesity: a Clinical Trial [NCT05097365]48 participants (Anticipated)Interventional2022-01-01Not yet recruiting
A Randomized, Phase III, Multicenter, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Onartuzumab (MetMAb) in Combination With 5-Fluorouracil, Folinic Acid, and Oxaliplatin (mFOLFOX6) in Patients With Metastatic HER2-Negative, [NCT01662869]Phase 3564 participants (Actual)Interventional2012-11-30Completed
Introduction of Multiple Micronutrient Supplementation to Antenatal Care in Bamako, Mali [NCT05312242]486 participants (Actual)Interventional2022-02-10Completed
Dietary Allowance of Methyl Donor Nutrients to Minimize Risks of Non-alcoholic Fatty Liver Progression: Novel Diagnostic and Therapeutic Markers in Metabolomics of Gut Microbiome/Host Methyl Nutrition and the Working Mechanisms [NCT05291104]60 participants (Anticipated)Interventional2022-04-01Enrolling by invitation
Main Objective While Treating the Ulcers is to Reduce the Discomfort and Accelerate Healing. Thus the Purpose of the Study is to Find Out Therapeutic Role of Topical Folic Acid on Oral Ulcerations [NCT04989049]Early Phase 175 participants (Anticipated)Interventional2022-09-30Not yet recruiting
Effect of a Fortified Balanced Energy-Protein Supplement on Birth Outcome and Child Growth in Houndé District, Burkina Faso. [NCT03533712]Phase 41,788 participants (Actual)Interventional2019-10-30Completed
Antioxidant Effect of the Extract of Jobelyn (Sorghum Bicolor) on the Quality of Life of Patients With Sickle Cell Disease [NCT01704794]Phase 1/Phase 296 participants (Anticipated)Interventional2013-04-30Recruiting
Feasibility of an Immediate Preoperative Chemotherapy Before Resection of Colorectal Cancer and Research of Gene Expressions Changes Induced in the Tumor, Predictive of Chemotherapy Efficiency [NCT01715363]Phase 23 participants (Actual)Interventional2012-07-31Terminated(stopped due to Recruitment difficulties)
The Effect of Folic Acid Supplementation and Pregnancy on the Folate Forms in Red Blood Cells [NCT01741077]32 participants (Actual)Observational2008-05-31Completed
Folic Acid-fortified Iodized Salt and Serum Folate Concentration in Reproductive-aged Women of Rural India [NCT06174883]80 participants (Actual)Observational2022-06-01Completed
Prospective International Multicenter Observational Cohort Study Evaluating Progress and Outcomes of Pregnancy in Women Using Various Vitamin Support Regimens Before and During Pregnancy (UNONA Study) [NCT05062044]1,500 participants (Anticipated)Observational2021-12-02Recruiting
Buccal Misoprostol During Cesarean Section for Preventing Postpartum Hemorrhage in Women With Risk Factors for Uterine Atony [NCT01733329]Phase 4123 participants (Actual)Interventional2008-02-29Completed
Phase 2 Study of Pralatrexate in Female Patients With Previously-treated Advanced or Metastatic Breast Cancer [NCT01118624]Phase 222 participants (Actual)Interventional2010-03-31Completed
A Randomized Phase III Study Comparing 5-FU, Leucovorin and Oxaliplatin Versus 5-FU, Leucovorin, Oxaliplatin and Bevacizumab in Patients With Stage II Colon Cancer at High Risk for Recurrence to Determine Prospectively the Prognostic Value of Molecular Ma [NCT00217737]Phase 33,610 participants (Anticipated)Interventional2005-09-06Active, not recruiting
Efficacy for Acute Pain Alleviation of 50 mg Diclofenac 1 Hour Prior to Endometrial Sampling in Cases of Abnormal Uterine Bleeding [NCT01762306]90 participants (Anticipated)Interventional2012-11-30Recruiting
Short-term Folinic Acid Supplementation Improves Vascular Reactivity in HIV-infected Individuals: a Randomized Trial [NCT01768182]30 participants (Actual)Interventional2009-08-31Completed
Open, Randomized, Multicenter Phase II Trial With Cetuximab /5-FU/FA/Irinotecan or Cetuximab/5-FU/FA /Irinotecan/Oxaliplatin in K-ras/B-raf Wild Type Patients or With Irinotecan/Oxaliplatin/5-FU/FA With or Without Bevacizumab in K-ras Mutant Patients as N [NCT01802645]Phase 291 participants (Actual)Interventional2013-03-31Active, not recruiting
Effect of Myoinositol on Serum Asprosin Levels in Pregnant Women [NCT05943158]40 participants (Actual)Interventional2021-06-01Completed
A Phase II/I Open-Label Clinical Trial of CPI-613 in Combination With Modified FOLFIRINOX in Patients With Locally Advanced Pancreatic Cancer and Good Performance Status [NCT03699319]Phase 1/Phase 249 participants (Actual)Interventional2018-12-07Active, not recruiting
Effect of Obesity and Folic Acid Supplementation on Gene-specific DNA Methylation in Women of Reproductive Age [NCT01841658]50 participants (Actual)Interventional2013-04-30Completed
An Investigator Initiated Phase 1 Trial To Evaluate mFOLFOX6 With Selinexor (KPT-330), An Oral Selective Inhibitor Of Nuclear Export (SINE), In Patients With Metastatic Colorectal Cancer [NCT02384850]Phase 110 participants (Actual)Interventional2015-03-31Terminated
Phase Ib/II Treatment of Advanced Pancreatic Cancer With Anti-CD3 x Anti-EGFR-Bispecific Antibody Armed Activated T-Cells (BATs) in Combination With Low Dose IL-2 and GM-CSF [NCT02620865]Phase 1/Phase 22 participants (Actual)Interventional2015-12-31Completed
Intermittent or Continuous Panitumumab Plus FOLFIRI for First-line Treatment of Patients With RAS/B-RAF Wild-type Metastatic Colorectal Cancer: a Randomized Phase 2 Trial [NCT04425239]Phase 2151 participants (Actual)Interventional2018-05-21Completed
Open, Randomized, Controlled, Multicenter Phase III Study Comparing CMAB009 Plus FOLFIRI Versus FOLFIRI Alone as First-line Treatment for Epidermal Growth Factor Receptor-expressing, RAS/BRAF Wild-type, Metastatic Colorectal Cancer [NCT03206151]Phase 3520 participants (Actual)Interventional2017-12-12Active, not recruiting
Effects Of A Mixed Diet Intervention Versus Folic Acid Supplementation And Metafolin® Supplementation On Folate Status And Cardiovascular Disease Risk Factors In Healthy Adults [NCT00372645]180 participants (Actual)Interventional2005-05-31Completed
A Phase 1/2, Double-Blind, Placebo-Controlled Study of the Pharmacokinetics, Safety and Tolerability of GSK3196165 in Combination With Methotrexate Therapy, in Japanese Subjects With Active Moderate-Severe Rheumatoid Arthritis Despite Treatment With Metho [NCT03028467]Phase 1/Phase 215 participants (Actual)Interventional2017-01-24Completed
A Randomized, Open-Label, Phase 3 Study of Cosibelimab (CK-301) in Combination With Platinum+Pemetrexed Chemotherapy in Subjects With First-Line Metastatic Non-squamous Non-Small Cell Lung Cancer [NCT04786964]Phase 325 participants (Actual)Interventional2021-12-08Terminated(stopped due to Regional political conflict)
A Phase 2, Randomized Study to Evaluate Safety, Efficacy, and Optimal Dose of ABBV-400 in Combination With Fluorouracil, Folinic Acid, and Bevacizumab in Previously Treated Subjects With Unresectable Metastatic Colorectal Cancer [NCT06107413]Phase 2206 participants (Anticipated)Interventional2023-11-12Recruiting
An Open-Label Multicenter Phase 1b Study of E7046 in Combination With Radiotherapy/Chemoradiotherapy (RT/CRT) in Preoperative Treatment of Subjects With Rectum Cancer [NCT03152370]Phase 129 participants (Actual)Interventional2017-05-17Completed
The Role of Vitamin B Complex as an Adjuvant Therapy for Diabetic Nephropathy in Pediatric Patients With Type 1 Diabetes [NCT03594240]Phase 380 participants (Actual)Interventional2017-03-01Completed
Effect of Reducing Inflammation With Low Dose Methotrexate on Inflammatory Markers and Endothelial Function in Treated and Suppressed HIV Infection [NCT01949116]Phase 2176 participants (Actual)Interventional2014-01-31Completed
Phase II Multicentric Randomized Trial, Evaluating the Best Protocol of Chemotherapy, Associated With Targeted Therapy According to the Tumor KRAS Status, in Metastatic Colorectal Cancer (CCRM) Patients With Initially Non-resectable Hepatic Metastases [NCT01442935]Phase 2256 participants (Actual)Interventional2011-02-28Completed
MEGA (Met or EGFR Inhibition in Gastroesophageal Adenocarcinoma): FOLFOX Alone or in Combination With AMG 102 or Panitumumab as First-line Treatment in Patients With Advanced Gastroesophageal Adenocarcinoma FNCLCC-FFCD-AGEO PRODIGE 17-ACCORD 20 Randomized [NCT01443065]Phase 2162 participants (Actual)Interventional2011-01-31Completed
Efficacy of Lipid-based Nutrient Supplements (LNS) for Pregnant and Lactating Women and Their Infants [NCT00970866]3,499 participants (Actual)Interventional2009-11-30Completed
A Phase III, Randomised, Multicentre Open-label Study of Active Symptom Control (ASC) Alone or ASC With Oxaliplatin/ 5F-U Chemotherapy for Patients With Locally Advanced/ Metastatic Biliary Tract Cancers Previously Treated With Cisplatin/ Gemcitabine Chem [NCT01926236]Phase 3162 participants (Actual)Interventional2014-02-28Completed
Management of Preoperative Anaemia in Surgical Oncology as a Tool to Reduce Blood Transfusion Need [NCT05505006]Phase 4500 participants (Anticipated)Interventional2021-03-02Recruiting
Nutri-CAP: Nutrition for Children, Adolescent Girls, and Pregnant Women in Slums of Dhaka City [NCT05311436]3,260 participants (Anticipated)Interventional2022-07-01Recruiting
A Folinic Acid Intervention for ASD: Links to Folate Receptor-alpha Autoimmunity & Redox Metabolism [NCT01602016]Phase 299 participants (Actual)Interventional2012-05-31Terminated(stopped due to Non-compliance)
A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients With Moderately to Severely Active Rheumatoid Arthritis Who Have Had Limited or No Treatment With Disease-Modifying Ant [NCT01711359]Phase 3588 participants (Actual)Interventional2012-11-30Completed
A Prospective, Single-arm, Single-center, Phase II Clinical Trial to Evaluate the Efficacy of Quintuple Method for the Treatment of Multiple Refractory Colorectal Liver Metastases [NCT05774964]Phase 2100 participants (Anticipated)Interventional2023-03-15Not yet recruiting
A Phase III Trial of Irinotecan / 5-FU / Leucovorin or Oxaliplatin / 5-FU/ Leucovorin With Bevacizumab, or Cetuximab (C225), or With the Combination of Bevacizumab and Cetuximab for Patients With Untreated Metastatic Adenocarcinoma of the Colon or Rectum [NCT00265850]Phase 32,334 participants (Actual)Interventional2005-11-30Completed
An Open Labelled Phase III Adjuvant Trial of Disease-free Survival in Patients With Resected Pancreatic Ductal Adenocarcinoma Randomized to Allocation of Oxaliplatin- or Gemcitabine-based Chemotherapy by Standard Clinical Criteria or by a Transcriptomic T [NCT05314998]Phase 3394 participants (Anticipated)Interventional2023-07-01Not yet recruiting
A Phase 2,Open-label Study of First Line Pemetrexed Plus Cisplatin Versus Gemcitabine Plus Cisplatin for Advanced and Metastatic Non Small Cell Lung Cancer and Biomarker Study [NCT01194453]Phase 2288 participants (Actual)Interventional2009-11-30Completed
Randomized Phase II Study for Evaluation of Efficacy and Safety of Maintenance Treatment With 5-FU/FA Plus Panitumumab vs. 5-FU/FA Alone After Prior Induction Treatment With mFOLFOX6 Plus Panitumumab and Re-induction With mFOLFOX6 Plus Panitumumab in Case [NCT01991873]Phase 2387 participants (Actual)Interventional2014-04-30Completed
An Open-label 2:1 Randomized Phase II Study of Panitumumab Plus FOLFOXIRI or FOLFOXIRI Alone as First-line Treatment of Patients With Non-resectable Metastatic Colorectal Cancer and RAS Wild Type [NCT01328171]Phase 293 participants (Actual)Interventional2011-04-30Completed
The Methotrexate in ERosive INflammatory Osteoarthritis (MERINO) Trial: A Randomized Placebo-controlled Trial to Investigate Clinical Efficacy and Safety of Methotrexate in Erosive Inflammatory Hand Osteoarthritis. [NCT04579848]Phase 4153 participants (Anticipated)Interventional2021-08-12Recruiting
"Phase-2 Study Evaluating Overall Response Rate (Efficacy) and Autonomy Daily Living Preservation (Tolerance) of FOLFIRINOX Pharmacogenetic Dose Adjusted, in Elderly Patients (70 yo. or Older) With a Metastatic Pancreatic Adenocarcinoma." [NCT02143219]Phase 272 participants (Actual)Interventional2014-07-31Completed
A Phase I, Open-Label Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Ascending Doses of AZD0156 Monotherapy or in Combination With Either Cytotoxic Chemotherapies or Novel Anti-Cancer Agents in Patients With Advance [NCT02588105]Phase 184 participants (Actual)Interventional2015-11-10Completed
Efficacy of Novel Agents for Treatment of SARS-CoV-2 Infection Among High-Risk Outpatient Adults: An Adaptive Randomized Platform Trial [NCT04354428]Phase 2/Phase 3289 participants (Actual)Interventional2020-04-16Terminated(stopped due to Low number of events contributing to primary outcome)
Effect of Treatment With Myo-inositol on Human Semen Parameters in Patients Undergoing IVF Cycles [NCT01828710]62 participants (Actual)Interventional2012-08-31Completed
Hydroxychloroquine is an Immunomodulator for Improvement of Pregnancy Outcomes in Preeclampsia [NCT04755322]50 participants (Actual)Interventional2021-03-01Completed
A Single-Center, Open-Label Study to Assess the Effects of the Addition of Modulators of Homocysteine to Adalimumab Therapy in the Treatment of Moderate to Severe Plaque Psoriasis Evaluated With the PASI, PGA and DLQI [NCT01704599]Phase 1/Phase 28 participants (Actual)Interventional2009-01-31Terminated(stopped due to side effect and poor clinical outcome)
A Phase II Study of Pemetrexed (Alimta) as Second-Line Therapy for Hormone Refractory Prostate Cancer: Hoosier Oncology Group GU03-67 [NCT00216099]Phase 249 participants (Actual)Interventional2005-02-28Completed
Phase II Trial of Bevacizumab in Combination With Pemetrexed as Second Line Therapy in Patients With Stable Brain Metastases From Non-small Cell Lung Cancer (NSCLC) (Excluding Squamous Cell Carcinoma) [NCT00227019]Phase 216 participants (Actual)Interventional2006-03-31Completed
Open-label, Single Arm Phase II Trial Investigating the Efficacy, Safety and Quality of Life of Neoadjuvant Chemotherapy With Liposomal Irinotecan Combined With Oxaliplatin and 5-Fluorouracil/Folinic Acid Followed by Curative Surgical Resection in Patient [NCT04617457]Phase 2150 participants (Anticipated)Interventional2021-10-10Recruiting
MYPP-trial: Myo-inositol Supplementation to Prevent Pregnancy Complications in Women With Polycystic Ovary Syndrome: a Multicentre Double-blind Randomised Controlled Trial [NCT05524259]464 participants (Anticipated)Interventional2019-06-21Recruiting
Folic Acid Supplementation as an Appetizer in Primary Malnourished Egyptian Infants and Children [NCT03040219]Phase 4100 participants (Anticipated)Interventional2017-04-01Not yet recruiting
Managing Endothelial Dysfunction in Critically Ill COVID-19 Patients at the Lebanese American University Medical Center- Rizk Hospital [NCT04813471]Phase 370 participants (Anticipated)Interventional2021-01-20Recruiting
Phase II Study to Evaluatate the Efficacy of Gemcitabine Plus Erlotinib for RASH-positive Patients With Metastatic Pancreatic Cancer and Friendly Risk Circumstances [NCT01729481]Phase 2150 participants (Actual)Interventional2012-07-31Active, not recruiting
Therapeutic Mechanism of Jianpi Huoxue Recipe in Treating Gastric Premalignant Lesion:A Multi-center, Randomized and Controlled Experiment [NCT03823248]Phase 1/Phase 2480 participants (Anticipated)Interventional2019-03-01Recruiting
A Phase II Study of Neoadjuvant Chemotherapy With and Without Immunotherapy to CA125 (Oregovomab) Followed by Hypofractionated Stereotactic Radiotherapy & Concurrent HIV Protease Inhibitor Nelfinavir in Locally Advanced Pancreatic Cancer [NCT01959672]Phase 211 participants (Actual)Interventional2013-09-06Completed
The Study of the Influence of Intestinal and Cellular Iron and Foliate Transporters on Bioavailability of These Micronutrients in the Organism [NCT03438942]200 participants (Actual)Interventional2018-09-30Completed
A Randomized, Double Blind, Placebo-controlled Pilot-study to Evaluate Efficacy and Safety of Low-dose hrIL-2 in the Treatment of Methotrexate (MTX)-Naive Patients With Rheumatoid Arthritis [NCT02467504]Phase 247 participants (Actual)Interventional2015-07-01Completed
A Randomised Double Blind Study of the Effects of Homocysteine Lowering Therapy on Mortality and Cardiac Events in Patients Undergoing Coronary Angiography [NCT00354081]Phase 33,096 participants (Actual)Interventional1999-04-30Completed
A Novel Phase I/IIa Open Label Study of IMM 101 in Combination With Selected Standard of Care (SOC) Regimens in Patients With Metastatic Cancer or Unresectable Cancer at Study Entry [NCT03009058]Phase 1/Phase 22 participants (Actual)Interventional2017-05-24Terminated(stopped due to Commercial reasons)
Effect of Preoperative Buccal Misoprostol on Blood Loss in Second-trimester [NCT01436266]Phase 33 participants (Actual)Interventional2011-07-31Terminated(stopped due to Slow enrollment)
Steam (Sequencing Triplet With Avastin and Maintenance): FOLFOXIRI/Bevacizumab Regimens (Concurrent and Sequential) vs. FOLFOX/Bevacizumab in First-Line Metastatic Colorectal Cancer [NCT01765582]Phase 2280 participants (Actual)Interventional2013-01-23Terminated
A Phase II Study of Pemetrexed/Carboplatin/Radiotherapy and Bevacizumab in Patients With Unresectable Stage III Non-Small-Cell Lung Cancer [NCT00402883]Phase 25 participants (Actual)Interventional2006-11-30Terminated(stopped due to Terminated due to bevacizumab and chemoradiotherapy toxicity)
Women's Antioxidant and Folic Acid Cardiovascular Study (WAFACS) [NCT00000541]Phase 20 participants Interventional1993-05-31Completed
A 24-Week Randomized, Double-Blind, Placebo-Controlled, Phase 2 Dose Finding Study to Evaluate the Efficacy and Safety of 3 Doses of Namilumab (20 mg, 80 mg and 150 mg) in Combination With Methotrexate (MTX) in Subjects With Moderate to Severe Rheumatoid [NCT02379091]Phase 2108 participants (Actual)Interventional2014-12-17Completed
A Study to Determine the Ability of Folate Conjugates to Target Folate Receptors in Ovarian Cancer Tumors [NCT00003763]35 participants (Actual)Interventional1997-12-08Completed
[NCT00004495]84 participants (Anticipated)Interventional1999-06-30Completed
Folic Acid and Zinc Supplementation Trial: A Multi-center, Double-blind, Block-randomized, Placebo-controlled Trial [NCT01857310]2,370 participants (Actual)Interventional2013-06-30Completed
COordinated Nivolumab and IntraperiToneal IL-2 for Gastric CanceR With PeritOneaL Metastasis (CONTROL) Phase 1b Pilot Study [NCT05802056]Phase 115 participants (Anticipated)Interventional2023-11-29Recruiting
Is Natural Folate as Effective as Synthetic Folic Acid in Increasing Serum and Red Blood Cell Folate Concentrations During Pregnancy? A Proof-of-concept Pilot Study [NCT04022135]60 participants (Actual)Interventional2019-09-16Completed
A Prospective Study of FOLFIRI Plus Panitumumab in Extended RAS Wild Type and BRAF Wild Type Metastatic Colorectal Cancer With Acquired Resistance to Prior Cetuximab (or Panitumumab) Plus Irinotecan-Based Therapy and Who Failed at Least One Subsequent Non [NCT02508077]Phase 21 participants (Actual)Interventional2016-02-16Terminated(stopped due to Poor Accrual)
A Pilot Study of Zimberelimab and Quemliclustat Combination With Chemotherapy in Patients With Borderline Resectable and Locally Advanced Pancreatic Adenocarcinoma [NCT05688215]Phase 1/Phase 256 participants (Anticipated)Interventional2023-03-07Recruiting
Patient Blood Management In CARdiac sUrgical patientS: the ICARUS Study [NCT04744181]479 participants (Actual)Observational2021-01-18Completed
A 24-week Randomized, Open-Label, Parallel-Group, Active-Controlled, Exploratory, Proof-of-Mechanism Imaging Study Investigating the Efficacy of 150 mg of Namilumab Administered Subcutaneously vs Adalimumab in Patients With Moderate to Severe Early Rheuma [NCT02393378]Phase 27 participants (Actual)Interventional2015-04-08Terminated(stopped due to Strategic decision - to understand data from psoriasis study - NCT02129777 and wait for results of formal proof of concept study - NCT02379091.)
Metabolic Consequences of High-Dose Folic Acid Supplementation on Kinetics of 1-Carbon Metabolism [NCT01687127]25 participants (Anticipated)Interventional2024-01-01Not yet recruiting
Phase II Double-Blinded, Placebo-Controlled Randomized Study Examining the Safety and Efficacy of Natrunix Versus Methotrexate (+Folate) for the Treatment of Rheumatoid Arthritis [NCT05363917]Phase 2150 participants (Anticipated)Interventional2022-06-15Not yet recruiting
An Examination of Changes in Urinary Metabolites With Use of Folinic Acid in Children With Autism Spectrum Disorder (ASD) [NCT03771560]Phase 2/Phase 318 participants (Actual)Interventional2018-02-15Completed
A Phase II Clinical Trial Evaluating Overall Survival With Therasphere® In Conjunction With 2nd-Line FOLFOX In Patients With Gemcitabine-Refractory Pancreatic Carcinoma With Liver Metastases [NCT01581307]Phase 29 participants (Actual)Interventional2012-04-30Completed
A Phase III Randomized Trial of Pulse Actinomycin-D Versus Multi-day Methotrexate for the Treatment of Low-Risk Gestational Trophoblastic Neoplasia [NCT01535053]Phase 357 participants (Actual)Interventional2012-06-18Completed
The Use of Intravenous Vitamin B Complex Improves Renal Recovery in Patients With Acute Kidney Injury [NCT04893733]Phase 4180 participants (Anticipated)Interventional2020-09-01Recruiting
Efficacy Assessment of Systematic Treatment With Folinic Acid and Thyroid Hormone on Psychomotor Development of Down Syndrome Young Children [NCT01576705]Phase 3175 participants (Actual)Interventional2012-04-02Completed
A Phase II Study of Neo-adjuvant Therapy With Oxaliplatin, Leucovorin, 5-Fluorouracil, Panitumumab (Vectibix) and Radiation in Patients With Locally Advanced Adenocarcinoma of the Esophagus or Gastroesophageal Junction [NCT01307956]Phase 211 participants (Actual)Interventional2011-02-28Terminated(stopped due to Drug manufacturer - Amgen requested study stop, per DSMB observation in POWER trial)
Randomized Controlled Blind End Point Study of Enalapril Folic Acid Tablets Combined With Calcium Antagonist or Diuretic to Prevent Stroke in Patients With Type H Hypertension [NCT04952051]Phase 31,000 participants (Actual)Interventional2014-07-01Completed
The Clinical and Biochemical Effects of Folic Acid on Sudanese Women With Polycystic Ovary Syndrome (PCOS) [NCT03268733]Phase 1/Phase 290 participants (Anticipated)Interventional2017-09-01Recruiting
Biodistribution, Tumor Detection, and Radiation Dosimentry of [18F]-AZAFOL as POSITRON EMISSION TOMOGRAPHY (PET) Tracer in Folate Receptor Positive Cancer Imaging [NCT03242993]Phase 115 participants (Actual)Interventional2017-04-01Completed
Suitability of an Infant Formula With L-5-Methyltetrahydrofolate for the Particular Nutritional Use in Infants [NCT02437721]360 participants (Actual)Interventional2015-05-31Completed
An Open-label Study of the Efficacy and Safety of Re-treatments With Rituximab (MabThera®/Rituxan®) in Patients With Active Rheumatoid Arthritis [NCT02093026]Phase 2465 participants (Actual)Interventional2002-08-31Completed
Intrathecal Pemetrexed for Recurrent Leptomeningeal Metastasis From Non-small Cell Lung Cancer: A Prospective Pilot Clinical Trial [NCT03101579]Phase 113 participants (Actual)Interventional2017-03-01Completed
Randomized Phase II Selection Study of Ramucirumab and Paclitaxel Versus FOLFIRI in Refractory Small Bowel Adenocarcinoma [NCT04205968]Phase 294 participants (Anticipated)Interventional2020-06-01Recruiting
School-Based Assessment of Micronutrient Interventions in Adolescents (SAMIA) in Zanzibar [NCT05104554]2,940 participants (Anticipated)Interventional2022-03-10Recruiting
Phase I Study of Escalated Pharmacologic Dose, of Oral Folinic Acid in Combination With Temozolomide, According to Stupp R. Regimen, in Patients With Operated Grade-IV Astocytoma and a Non-methylated Gene Status of MGMT. [NCT01700569]Phase 124 participants (Actual)Interventional2013-01-31Terminated(stopped due to changing the standard of care)
Study of Endostar Combined With mFOLFOX6 for First-line Treatment of Metastatic Colorectal Cancer and Efficacy Prediction [NCT01832948]Phase 230 participants (Anticipated)Interventional2013-01-31Recruiting
A Phase IIb, Double-Blind, Placebo-Controlled, Dose-Adaptive, Study of the Efficacy and Safety of GSK3196165 in Combination With Methotrexate Therapy, in Subjects With Active Moderate-Severe Rheumatoid Arthritis Despite Treatment With Methotrexate [NCT02504671]Phase 2222 participants (Actual)Interventional2015-07-23Completed
MTHFR Gene Mutation C6777T and Concentration of Vitamin B12, Folic Acid, Homocysteine and High Sensitive CRP in the Blood of Pregnant Women With Gestational Diabetes Mellitus. [NCT04952324]100 participants (Actual)Observational [Patient Registry]2020-09-01Completed
NeoOPTIMIZE: An Open-Label, Phase II Trial to Assess the Efficacy of Adaptive Switching of FOLFIRINOX or Gemcitabine/Nab-Paclitaxel as a Neoadjuvant Strategy for Patients With Resectable and Borderline Resectable/Locally Advanced Unresectable Pancreatic C [NCT04539808]Phase 260 participants (Anticipated)Interventional2021-05-27Recruiting
A Randomised Study to Assess the Efficacy of Cetuximab Rechallenge in Patients With Metastatic Colorectal Cancer (RAS Wild-type) Responding to First-line Treatment With FOLFIRI Plus Cetuximab [NCT02934529]Phase 3673 participants (Actual)Interventional2015-03-31Active, not recruiting
A Phase I, Randomised, Open-Label, Single-Dose, Two-Treatment, Two-Way Crossover, Two-Stage Study to Evaluate the Bioequivalence of Onivyde (Irinotecan Liposome Injection) Manufactured at Two Different Sites Administered in Combination With Anti-Cancer Ag [NCT05383352]Phase 1122 participants (Anticipated)Interventional2022-05-30Recruiting
A Phase III Randomized Trial for Newly Diagnosed High Risk B-Lymphoblastic Leukemia (B-ALL) Including a Stratum Evaluating Dasatinib (NSC#732517) in Patients With Ph-like Tyrosine Kinase Inhibitor (TKI) Sensitive Mutations [NCT02883049]Phase 35,937 participants (Actual)Interventional2012-02-29Active, not recruiting
A Phase II Study Of Neo-Adjuvant Chemotherapy And Radiation In Patients With Locally Advanced Pancreatic Cancer [NCT00089024]Phase 229 participants (Actual)Interventional2004-02-25Completed
A Prospective Phase II/III Randomized, Blinded Study to Demonstrate the Safety and Effectiveness of Jobelyn ( a Herbal Preparation ) in Pre-operative Management of Anaemia in Gynaecological Patients [NCT01670955]Phase 273 participants (Actual)Interventional2012-12-31Completed
Effects of Inositol Alone or Associated With Alpha-lipoic Acid in Polycystic Ovary Syndrome Treatment [NCT04881851]90 participants (Anticipated)Interventional2015-05-07Recruiting
A Prospective, Randomised, Controlled, Open-label, Multicentre Study to Evaluate Efficacy, Safety and Patient-Reported Outcomes of Peptide Receptor Radionuclide Therapy (PRRT) With 177Lu-Edotreotide Compared to Best Standard of Care in Patients With Well- [NCT04919226]Phase 3202 participants (Anticipated)Interventional2021-12-21Recruiting
Development of a Novel Folic Acid Wound Dressing to Enhance Nitric Oxide Bioactivity Required for Diabetic Foot Ulcer Wound Healing [NCT04723134]Phase 230 participants (Anticipated)Interventional2021-12-01Recruiting
Understanding Effects of Folic Acid on the Methylosome and Transcriptome of Women With Spina Bifida Affected Pregnancies [NCT05500690]50 participants (Anticipated)Interventional2023-10-08Recruiting
Effects of Oral Inositol Supplementation on Spontaneous Reproductive Outcomes in Infertile Polycystic Ovarian Syndrome Women. [NCT03598374]80 participants (Anticipated)Interventional2022-01-01Not yet recruiting
An Open Label, Multicenter, Phase 2 Study Evaluating the Safety and Efficacy of IMC-1121B in Combination With 5-FU/FA and Oxaliplatin (Modified FOLFOX-6) as First-line Therapy in Patients With Metastatic Colorectal Cancer [NCT00862784]Phase 248 participants (Actual)Interventional2009-04-30Completed
A Prospective, Multi-centric, Phase Ⅲ, Randomized, Controlled Study to Evaluate the Efficacy and Safety of Second-Line Adjuvant Therapy With Nab-Paclitaxel Plus Gemcitabine (AG) Versus Oxaliplatin Plus Folinic Acid and Fluorouracil (OFF) for Gemcitabine-R [NCT02506842]Phase 3300 participants (Anticipated)Interventional2015-06-30Recruiting
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
Mature B-Cell Lymphoma And Leukemia Study III [NCT01046825]Phase 2/Phase 3128 participants (Actual)Interventional2010-09-09Active, not recruiting
Effect of Preoperative Intervention With Folic Acid and Vitamin B12 on Postoperative Neurobehavioral Changes in Children [NCT04456985]360 participants (Anticipated)Interventional2020-06-01Recruiting
Changes in Hematologic Profile, Vitamin B12 and Folic Acid Level in Cirrhotic Patients Received Sofosbuvir and Daclatasvir With or Without Ribavirin [NCT03283176]50 participants (Actual)Observational2018-03-01Completed
Phase I / II Dose Escalation of Oxaliplatin Via a Laparoscopic Approach of Aerosol Pressurized Intraperitoneal Chemotherapy for Nonresectable Peritoneal Metastases of Digestive Cancers (Stomach, Hail and Colorectal) [NCT03294252]Phase 1/Phase 234 participants (Actual)Interventional2017-05-24Terminated(stopped due to The 34 patients included had all completed their treatment period under the protocol and the data could be collected to assess the main objective and the secondary objectives before the last theoretical follow-up.)
Open Label Randomized Bioequivalence Study to Evaluate the Pharmacokinetic and Safety Profile of Bevacizumab Biosimilar (BEVZ92) vs Bevacizumab (AVASTIN®), Both With FOLFOX or FOLFIRI, in First-line Treatment for mCRC Patients [NCT02069704]Phase 1142 participants (Actual)Interventional2014-10-29Completed
Effect of Folic Acid Supplementation on Plasma Homocysteine Level in Obese Children: a Randomized Double Blinded Placebo Controlled Trial [NCT01766310]Phase 450 participants (Actual)Interventional2012-12-31Completed
Effects of Oral Inositol Supplementation on Obstetrics Outcomes in Polycystic Ovary Syndrome Women After Spontaneous Conception [NCT03585738]80 participants (Anticipated)Interventional2022-01-01Not yet recruiting
A Randomized, Phase II, Multicenter, Double-Blind, Placebo-Controlled Study Evaluating The Efficacy And Safety Of Onartuzumab (MetMAb) In Combination With 5-Fluorouracil, Folinic Acid, And Oxaliplatin (mFOLFOX6) In Patients With Metastatic HER2-Negative G [NCT01590719]Phase 2123 participants (Actual)Interventional2012-07-31Completed
A Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects With Rheumatoid Arthritis and an Inadequate Response to Methotrexate [NCT00950989]Phase 2252 participants (Actual)Interventional2009-12-30Completed
B-Complex: A Nutraceutical SANS Countermeasure [NCT05366933]Phase 116 participants (Anticipated)Interventional2022-08-01Recruiting
A Phase 2, Single-Arm Study of Pralatrexate in Patients With Advanced or Metastatic Relapsed Transitional Cell Carcinoma of the Urinary Bladder [NCT00722553]Phase 230 participants (Actual)Interventional2008-07-31Completed
FASTERCC: Folic Acid Supplement Versus Placebo for Treating Mucositis Adverse Events in Metastatic Renal Cell Carcinoma Patients Receiving Targeted Therapy. A Randomized, Double-blind Trial From the Danish Renal Cancer Group (DARENCA Study-4) [NCT03581773]Phase 2100 participants (Anticipated)Interventional2017-12-20Recruiting
Effectiveness of Quadruple Fortified Salt in Improving Hemoglobin Levels Among Anemic Women of Reproductive Age (18-49 Years) in Rural Low Resource Setting [NCT04404751]174 participants (Actual)Interventional2019-08-23Completed
A Randomized, Double-Masked and Placebo-Controlled Study to Evaluate the Efficacy and Safety of Sarilumab Administered Subcutaneously Every 2 Weeks in Patients With Non-Infectious, Intermediate, Posterior or Pan-Uveitis (NIU) [NCT01900431]Phase 258 participants (Actual)Interventional2013-10-31Completed
Randomized Phase II Trial of Single Agent MEK Inhibitor Trametinib (GSK1120212) Vs 5-Fluorouracil or Capecitabine in Refractory Advanced Biliary Cancer [NCT02042443]Phase 253 participants (Actual)Interventional2014-02-28Completed
The Effect of Folinic Acid Rescue Following Methotrexate (MTX) Graft-versus-host Disease (GVHD) Prophylaxis on Regimen Related Toxicity and Transplantation Outcome: a Double Blind Randomized Controlled Study [NCT02506231]Phase 2/Phase 3160 participants (Anticipated)Interventional2015-10-31Not yet recruiting
The Effects of Zinc Supplementation in Children With Sickle Cell Disease in Western Kenya: a Pilot Study [NCT03293641]40 participants (Actual)Interventional2016-05-20Completed
Trial Evaluating Folic Acid Supplementation by Concomitant Administration of Ethinyl Estradiol + Levonorgestrel (Ethinyl Estradiol + Levonorgestrel + Folic Acid - Coated Tablet - 0.02 mg + 0.10 mg + 0.4 mg; Biolab Sanus Farmaceutica Ltda) in Female Volunt [NCT03359057]Phase 336 participants (Actual)Interventional2013-02-26Completed
Imaging Companion Study To ACTG A5314: Effect of Reducing Inflammation With Low Dose Methotrexate on Inflammatory Markers and Endothelial Function in Treated and Suppressed HIV Infection [NCT02312219]35 participants (Actual)Observational2014-11-30Completed
A Prospective Randomized Phase III Trial of Maintenance Pemetrexed Versus Observation in Patients With Recurrent or Metastatic Urothelial Carcinoma Who Completed First Line Platinum-based Chemotherapy Without Disease Progression [NCT03193788]Phase 374 participants (Anticipated)Interventional2017-01-31Recruiting
A Phase II, Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of RO5520985 (Vanucizumab) Plus FOLFOX Versus Bevacizumab Plus FOLFOX in Patients With Previously Untreated Metastatic Colorectal Cancer [NCT02141295]Phase 2197 participants (Actual)Interventional2014-06-30Terminated
A Study to Evaluate the Potential of Concomitant Ramucirumab to Affect the Pharmacokinetics of Irinotecan and Its Metabolite SN-38 When Coadministered With Folinic Acid and 5 Fluorouracil in Patients With Advanced Malignant Solid Tumors [NCT01634555]Phase 229 participants (Actual)Interventional2012-10-31Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00075725 (7) [back to overview]Correlation of Early Marrow Response Status With MRD Negative.
NCT00075725 (7) [back to overview]Correlation of Minimal Residual Disease (MRD) Positive With Overall Survival (OS)
NCT00075725 (7) [back to overview]Correlation of Minimal Residual Disease (MRD) Positive With Event Free Survival (EFS)
NCT00075725 (7) [back to overview]Correlation of Minimal Residual Disease (MRD) Negative With Overall Survival (OS).
NCT00075725 (7) [back to overview]Correlation of Minimal Residual Disease (MRD) Negative With Event Free Survival (EFS).
NCT00075725 (7) [back to overview]Correlation of Early Marrow Response Status With MRD Positive.
NCT00075725 (7) [back to overview]Comparison of the Increase in Cure Rate of High Risk ALL Without Causing More Serious Side Effects Between Interventions
NCT00081289 (18) [back to overview]Number of Participants With Grade 3+ Treatment-related Adverse Events Preoperatively
NCT00081289 (18) [back to overview]Change From Baseline in EORTC QLQ-CR38 Defecation Symptom Score at Post-operative Chemotherapy
NCT00081289 (18) [back to overview]Change From Baseline in EORTC QLQ-CR38 Defecation Symptom Score at Completion of Chemoradiation
NCT00081289 (18) [back to overview]Change From Baseline in QLQ-C30 Global Health Status Score at Completion of Chemoradiation
NCT00081289 (18) [back to overview]Number of Participants With Grade 3+ Treatment-related Adverse Events Postoperatively
NCT00081289 (18) [back to overview]Distant Failure Rate at 4 Years
NCT00081289 (18) [back to overview]Disease-free Survival Rate at 4 Years
NCT00081289 (18) [back to overview]Change From Baseline in QLQ-C30 Global Health Status Score at Two Years
NCT00081289 (18) [back to overview]Change From Baseline in QLQ-C30 Global Health Status Score at Completion of Post-operative Chemotherapy
NCT00081289 (18) [back to overview]Change From Baseline in EORTC QLQ-CR38 Gastro-intestinal Symptom Score at Two Years
NCT00081289 (18) [back to overview]Local-regional Failure Rate at 4 Years
NCT00081289 (18) [back to overview]Change From Baseline in EORTC QLQ-CR38 Gastro-intestinal Symptom Score at Completion of Post-operative Chemotherapy
NCT00081289 (18) [back to overview]Change From Baseline in EORTC QLQ-CR38 Gastro-intestinal Symptom Score at Completion of Chemoradiation
NCT00081289 (18) [back to overview]Change From Baseline in EORTC QLQ-CR38 Defecation Symptom Score at Two Years
NCT00081289 (18) [back to overview]Pathologic Complete Response Rate
NCT00081289 (18) [back to overview]Second Primary Rate at 4 Years
NCT00081289 (18) [back to overview]Survival Rate at 4 Years
NCT00081289 (18) [back to overview]Number of Participants With Grade 3+ Treatment-related Adverse Events
NCT00089024 (2) [back to overview]Number of Participants Experiencing Grade 3-4 Toxicity While Receiving the Study Treatment
NCT00089024 (2) [back to overview]Surgical Exploration
NCT00096278 (2) [back to overview]Survival
NCT00096278 (2) [back to overview]Disease-free Survival
NCT00097669 (1) [back to overview]Non-fatal Stroke, Non-fatal Myocardial Infarction or Death Due to Vascular Causes
NCT00103285 (10) [back to overview]Event-free Survival (EFS) for SR-Low Patients
NCT00103285 (10) [back to overview]Event-Free Survival Probability According to MRD Status End Induction (Day 29)
NCT00103285 (10) [back to overview]Event-free Survival (EFS) for SR-High Patients.
NCT00103285 (10) [back to overview]Overall Survival Probability (OS) According to Induction Day 29 MRD Status
NCT00103285 (10) [back to overview]Event-free Survival (EFS) for SR-Average ALL Patients
NCT00103285 (10) [back to overview]Event-Free Survival (EFS) for Low MRD (Negative) Subjects by Genetic Subset (TEL/Trisomy Positive vs Negative)
NCT00103285 (10) [back to overview]Event-free Survival (EFS) for SR-Average ALL Patients
NCT00103285 (10) [back to overview]Health-related Quality of Life Relative to Physical, Social and Emotional Impairment
NCT00103285 (10) [back to overview]Optimal Time Point for Advance Health Related Quality of Life Intervention
NCT00103285 (10) [back to overview]Early Marrow Status (EMS) by MRD Status End Induction (Day 29)
NCT00124072 (1) [back to overview]Major Vascular Events (MVE)
NCT00143403 (2) [back to overview]Disease Free Survival (DFS)
NCT00143403 (2) [back to overview]Overall Survival Rates
NCT00154102 (15) [back to overview]Overall Survival Time (OS)
NCT00154102 (15) [back to overview]Participants With No Residual Tumor After Metastatic Surgery
NCT00154102 (15) [back to overview]Progression-free Survival Time (Chinese V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Wild-Type Population) - Independent Review Committee (IRC) Assessments
NCT00154102 (15) [back to overview]Progression-free Survival Time (KRAS Mutant Population) - Independent Review Committee (IRC) Assessments
NCT00154102 (15) [back to overview]Safety - Number of Patients Experiencing Any Adverse Event
NCT00154102 (15) [back to overview]Quality of Life (QOL) Assessment European Organisation for the Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status
NCT00154102 (15) [back to overview]Quality of Life Assessment (EORTC QLQ-C30) Social Functioning
NCT00154102 (15) [back to overview]Disease Control Rate - Independent Review Committee (IRC) Assessments
NCT00154102 (15) [back to overview]Progression-free Survival (PFS) Time - Independent Review Committee (IRC) Assessments
NCT00154102 (15) [back to overview]Best Overall Response Rate - Independent Review Committee (IRC) Assessments
NCT00154102 (15) [back to overview]Best Overall Response Rate (KRAS Mutant Population) - Independent Review Committee (IRC) Assessments
NCT00154102 (15) [back to overview]Best Overall Response Rate (KRAS Wild-Type Population) - Independent Review Committee (IRC) Assessments
NCT00154102 (15) [back to overview]Duration of Response - Independent Review Committee (IRC) Assessments
NCT00154102 (15) [back to overview]Overall Survival Time (KRAS Mutant Population)
NCT00154102 (15) [back to overview]Overall Survival Time (KRAS Wild-Type Population)
NCT00192075 (11) [back to overview]Time to Progressive Disease - Avastin Subgroup
NCT00192075 (11) [back to overview]Survival at 12 Months and 24 Months - Avastin Subgroup
NCT00192075 (11) [back to overview]Toxicity - Avastin Subgroup
NCT00192075 (11) [back to overview]Tumor Response - Avastin Subgroup
NCT00192075 (11) [back to overview]Tumor Response by Response Evaluation Criteria In Solid Tumors (RECIST)
NCT00192075 (11) [back to overview]Duration of Response - A+FOLFOX4 - Avastin Subgroup
NCT00192075 (11) [back to overview]Progression-Free Survival - Avastin Subgroup
NCT00192075 (11) [back to overview]Progression-Free Survival
NCT00192075 (11) [back to overview]Overall Survival
NCT00192075 (11) [back to overview]Duration of Response
NCT00192075 (11) [back to overview]Time to Progressive Disease
NCT00216099 (8) [back to overview]Time to Progression
NCT00216099 (8) [back to overview]Time to Prostate-Specific Antigen (PSA)/Serological Progression
NCT00216099 (8) [back to overview]Best Overall PSA Response
NCT00216099 (8) [back to overview]RFC1 G80A Genotype
NCT00216099 (8) [back to overview]OBJECTIVE Overall Response Rate
NCT00216099 (8) [back to overview]Safety and Tolerability
NCT00216099 (8) [back to overview]Overall Survival
NCT00216099 (8) [back to overview]Rate of Clinical Benefit
NCT00227019 (3) [back to overview]Incidence of Central Nervous System (CNS) Hemorrhagic Events
NCT00227019 (3) [back to overview]Overall Survival (OS)
NCT00227019 (3) [back to overview]Progression-free Survival (PFS)
NCT00249288 (14) [back to overview]Correlation Between Baseline Blood Folate Levels and Dietary Intake
NCT00249288 (14) [back to overview]Correlations Between Baseline Blood Homocysteine Levels and Clinical Ratings of Negative Symptoms by Comparing Lab Levels in Deficit Syndrome Versus Non-deficit Syndrome Patients
NCT00249288 (14) [back to overview]Correlation Between Baseline Homocysteine Levels and Smoking Status
NCT00249288 (14) [back to overview]Correlation Between Baseline Blood Homocysteine Levels and Dietary Intake
NCT00249288 (14) [back to overview]Correlation Between Baseline Blood B12 Levels and MTHFR Genotype
NCT00249288 (14) [back to overview]Correlation Between Baseline Blood Folate or B12 Levels and Dietary Intake
NCT00249288 (14) [back to overview]Correlation Between Baseline Serum B12 Levels and Dietary Intake
NCT00249288 (14) [back to overview]Correlation Between Baseline Serum B12 Levels and Smoking Status
NCT00249288 (14) [back to overview]Correlations Between Baseline Blood B12 Levels and Clinical Ratings of Negative Symptoms by Comparing Lab Levels in Deficit Syndrome Versus Non-deficit Syndrome Patients
NCT00249288 (14) [back to overview]Correlation Between Baseline Blood Homocysteine Levels and MTHFR Genotype
NCT00249288 (14) [back to overview]Correlation Between Baseline Blood Folate and Smoking Status
NCT00249288 (14) [back to overview]Correlation Between Baseline Blood Folate and MTHFR Genotype
NCT00249288 (14) [back to overview]Efficacy of Folate Supplementation for Reducing Negative Symptoms as Measured by the SANS Modified Total
NCT00249288 (14) [back to overview]Correlations Between Baseline Blood Folate and Clinical Ratings of Negative Symptoms by Comparing Lab Levels in Deficit Syndrome Versus Non-deficit Syndrome Patients
NCT00265850 (2) [back to overview]Overall Survival
NCT00265850 (2) [back to overview]Progression-free Survival (PFS)
NCT00321685 (5) [back to overview]5-year Recurrence-free Survival Rate
NCT00321685 (5) [back to overview]5-year Overall Survival Rate
NCT00321685 (5) [back to overview]Resection Rate for T3 Rectal Cancers
NCT00321685 (5) [back to overview]Resection Rate for T4 Rectal Cancers
NCT00321685 (5) [back to overview]Pathologic Complete Response Rate
NCT00336024 (10) [back to overview]Number of Participants With Chronic Primary Hypothyroidism/Subclinical Compensatory HypothyroidismHypothyroidism/Subclinical Compensatory Hypothyroidism
NCT00336024 (10) [back to overview]Number of Participants With Chronic Low Somatomedin C
NCT00336024 (10) [back to overview]Number of Participants With Chronic Diabetes Insipidus
NCT00336024 (10) [back to overview]Number of Participants With Chronic Central Hypothyroidism
NCT00336024 (10) [back to overview]Rates of Nutritional Toxicities
NCT00336024 (10) [back to overview]Rates of Gastrointestinal Toxicities
NCT00336024 (10) [back to overview]Median/Range of Patients for Total Quality of Life (QOL) Score, Intelligence Quotient (IQ) and Processing Speed Index (PSI).
NCT00336024 (10) [back to overview]Percentage of Participants With Event Free Survival (EFS)
NCT00336024 (10) [back to overview]Percentage of Participants With Any Acute Adverse Events
NCT00336024 (10) [back to overview]Number of Participants With Secondary Malignancies
NCT00408005 (8) [back to overview]Disease-free Survival (DFS) for Randomized Methotrexate T-ALL Cohort (Arm I + Arm II vs. Arm III + Arm IV)
NCT00408005 (8) [back to overview]Disease-free Survival (DFS) for T-cell Lymphoblastic Lymphoma (T-LLy) Cohort
NCT00408005 (8) [back to overview]Disease-free Survival (DFS) for Randomized Nelarabine T-ALL Cohort (Arm I vs. Arm II vs. Arm III vs. Arm IV)
NCT00408005 (8) [back to overview]Cumulative Incidence of CNS Relapse for T-ALL by Risk Group
NCT00408005 (8) [back to overview]Disease-free Survival (DFS) for Randomized Nelarabine T-ALL Cohort (Arm I + Arm III vs. Arm II + Arm IV)
NCT00408005 (8) [back to overview]Disease-free Survival (DFS) for Randomized Methotrexate T-ALL Cohort (Arm I vs. Arm II vs. Arm III vs. Arm IV)
NCT00408005 (8) [back to overview]Cumulative Incidence of CNS Relapse for T-ALL by Risk Group
NCT00408005 (8) [back to overview]Disease-free Survival (DFS) for T-cell Lymphoblastic Lymphoma (T-LLy) Cohort
NCT00467363 (13) [back to overview]Molar Pregnancy
NCT00467363 (13) [back to overview]Live Birth
NCT00467363 (13) [back to overview]hCG Recognized Pregnancy
NCT00467363 (13) [back to overview]Fetal Pregnancy Loss
NCT00467363 (13) [back to overview]Ectopic Pregnancy
NCT00467363 (13) [back to overview]Early Pregnancy Loss (EPL)
NCT00467363 (13) [back to overview]Clinically Recognized Pregnancy
NCT00467363 (13) [back to overview]Stillbirth
NCT00467363 (13) [back to overview]Preeclampsia
NCT00467363 (13) [back to overview]Small for Gestational Age Infant
NCT00467363 (13) [back to overview]Abruption
NCT00467363 (13) [back to overview]Preterm Birth
NCT00467363 (13) [back to overview]Pregnancy Losses Occurring Less Than 10 Weeks
NCT00481871 (3) [back to overview]Progression-free Survival (PFS) Time
NCT00481871 (3) [back to overview]Objective Responses Assessed by International Workshop Criteria (IWC)
NCT00481871 (3) [back to overview]Duration of Response
NCT00500292 (1) [back to overview]Number of Patients With an Objective Disease Progression Event
NCT00525785 (1) [back to overview]Complete Pathologic Response Rate
NCT00557193 (10) [back to overview]Describe in Vitro Sensitivity as a Molecular Mechanism of Primary Resistance to Lestaurtinib in Leukemic Blasts
NCT00557193 (10) [back to overview]Number of Patients Who Experienced Lestaurtinib-related Dose Limiting Toxicity (DLT)
NCT00557193 (10) [back to overview]Percent Probability for Event-free Survival (EFS) for Patients on Arm A
NCT00557193 (10) [back to overview]Percent Probability for Event-free Survival (EFS) for Patients on Arm C at Dose Level 2 (DL2)
NCT00557193 (10) [back to overview]Percent Probability of Event Free Survival (EFS) by MRD Status and Treatment Arm
NCT00557193 (10) [back to overview]Pharmacodynamics PIA Levels in Infants Given Lestaurtinib at DL2 in Combination With Chemotherapy
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]Describe FLT3 Protein Expression as a Molecular Mechanism of Acquired Resistance to Lestaurtinib in Leukemic Blasts
NCT00557193 (10) [back to overview]Describe FLT3 Protein Expression as a Molecular Mechanism of Primary Resistance to Lestaurtinib in Leukemic Blasts
NCT00557193 (10) [back to overview]Describe in Vitro Sensitivity as a Molecular Mechanism of Acquired Resistance to Lestaurtinib in Leukemic Blasts
NCT00578305 (16) [back to overview]Percentage of Participants With Improvement in Synovitis at Weeks 24 and 52
NCT00578305 (16) [back to overview]Percentage of Participants With Improvement in Osteitis at Weeks 24 and 52
NCT00578305 (16) [back to overview]Percentage of Participants With European League Against Rheumatism (EULAR) Good, Moderate, or no Response at Weeks 24 and 52
NCT00578305 (16) [back to overview]Percentage of Participants With an Improvement of at Least 20%, 50%, or 70% in the American College of Rheumatology (ACR) Score (ACR20/50/70) From Baseline at Weeks 24 and 52
NCT00578305 (16) [back to overview]Percentage of Participants in Remission Response (Disease Activity Score 28 [DAS28] < 2.6) at Weeks 24 and 52
NCT00578305 (16) [back to overview]Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 24 and 52
NCT00578305 (16) [back to overview]Change in Magnetic Resonance Imaging (MRI) Synovitis Score From Baseline to Weeks 12, 24, and Week 52
NCT00578305 (16) [back to overview]Change in Magnetic Resonance Imaging (MRI) Osteitis Score From Baseline to Weeks 12, 24, and Week 52
NCT00578305 (16) [back to overview]Change in Magnetic Resonance Imaging (MRI) Erosion Score From Baseline to Week 24
NCT00578305 (16) [back to overview]Change in Magnetic Resonance Imaging (MRI) Erosion Score From Baseline to Weeks 12 and 52
NCT00578305 (16) [back to overview]Change From Baseline in the Disease Activity Score 28 (DAS28) at Weeks 24 and 52
NCT00578305 (16) [back to overview]Percentage of Participants Achieving a Major Clinical Response at Week 52
NCT00578305 (16) [back to overview]Correlation of Magnetic Resonance Imaging Assessments and Clinical Outcome Measures
NCT00578305 (16) [back to overview]Percentage of Participants With no Progression/no Worsening in Bone Erosion at Weeks 24 and 52
NCT00578305 (16) [back to overview]Percentage of Participants With no Newly Eroded Joints at Weeks 24 and 52
NCT00578305 (16) [back to overview]Percentage of Participants With Low Disease Activity (Disease Activity Score 28 [DAS28] ≤ 3.2) at Weeks 24 and 52
NCT00606502 (4) [back to overview]Adverse Events of Patients Receiving Pralatrexate vs. Erlotinib
NCT00606502 (4) [back to overview]Progression-free Survival (PFS) of Patients Receiving Pralatrexate vs. Erlotinib
NCT00606502 (4) [back to overview]Overall Survival (OS) of Patients Receiving Pralatrexate vs. Erlotinib
NCT00606502 (4) [back to overview]Response Rate (RR) to Treatment of Patients Receiving Pralatrexate vs. Erlotinib
NCT00609518 (4) [back to overview]Proportion of Participants With Best Overall Tumor Response (Response Rate)
NCT00609518 (4) [back to overview]Safety: Number of Participants With Drug-Related Grade 3 or 4 Toxicity
NCT00609518 (4) [back to overview]Progression-free Survival (PFS)
NCT00609518 (4) [back to overview]Overall Survival
NCT00611806 (4) [back to overview]Scale for Assessment of Negative Symptoms (SANS)
NCT00611806 (4) [back to overview]Positive Sub Scale of the Positive and Negative Syndrome Scale (PANSS)
NCT00611806 (4) [back to overview]Positive and Negative Syndrome Scale (PANSS) and FOLH1, MTHRF, MTR, and COMT Genotype
NCT00611806 (4) [back to overview]Positive and Negative Syndrome Scale (PANSS)
NCT00653068 (4) [back to overview]Overall Survival (OS)
NCT00653068 (4) [back to overview]Non-hematological Toxicity Associated With Chemotherapy: Grade 3 or Higher During Protocol Therapy
NCT00653068 (4) [back to overview]Event-free Survival
NCT00653068 (4) [back to overview]Toxic Death
NCT00655980 (1) [back to overview]Non-fatal MI
NCT00720109 (5) [back to overview]Percent of Patients MRD Positive (MRD > 0.01%) at End of Consolidation
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]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]Event-Free Survival (EFS) of Patients With Standard-risk Disease Treated With Dasatinib in Combination With Intensified Chemotherapy
NCT00720109 (5) [back to overview]Contribution of Dasatinib on Minimal Residual Disease (MRD) After Induction Therapy
NCT00722553 (5) [back to overview]Overall Survival (OS)
NCT00722553 (5) [back to overview]Progression Free Survival (PFS)
NCT00722553 (5) [back to overview]Clinical Benefit Rate (CBR)
NCT00722553 (5) [back to overview]Duration of Response (DOR)
NCT00722553 (5) [back to overview]Objective Response Rate (ORR)
NCT00792948 (3) [back to overview]Overall Survival (OS)
NCT00792948 (3) [back to overview]Relapse-free Survival (RFS) After Allogeneic Stem Cell Transplantation
NCT00792948 (3) [back to overview]Continuous Complete Remission (CCR) Rate
NCT00806819 (14) [back to overview]Follow-up Analysis of Progression Free Survival (PFS) as Assessed by Investigator
NCT00806819 (14) [back to overview]Quality of Life (QoL)
NCT00806819 (14) [back to overview]Objective Tumor Response
NCT00806819 (14) [back to overview]Incidence and Intensity of Adverse Events
NCT00806819 (14) [back to overview]Clinical Improvement.
NCT00806819 (14) [back to overview]Time to Confirmed Objective Tumour Response
NCT00806819 (14) [back to overview]Duration of Confirmed Objective Tumour Response
NCT00806819 (14) [back to overview]Overall Survival (Key Secondary Endpoint)
NCT00806819 (14) [back to overview]Progression Free Survival (PFS) as Assessed by Central Independent Review
NCT00806819 (14) [back to overview]Change From Baseline in Tumour Size
NCT00806819 (14) [back to overview]Disease Control
NCT00806819 (14) [back to overview]Dose Normalised Predose Plasma Concentration at Steady State (Cpre,ss,Norm) of Nintedanib and of Its Metabolites BIBF 1202 and BIBF 1202 Glucuronide
NCT00806819 (14) [back to overview]Follow-up Analysis of Progression Free Survival (PFS) as Assessed by Central Independent Review
NCT00806819 (14) [back to overview]Duration of Disease Control
NCT00835185 (12) [back to overview]Duration of Response
NCT00835185 (12) [back to overview]Area Under the Concentration-Time Curve From Time 0 to Infinity [AUC(0-∞)] of IMC-11F8 at Study Day 1 of Cycle 1
NCT00835185 (12) [back to overview]Clearance (CL) of IMC-11F8 at Study Day 1 of Cycle 1
NCT00835185 (12) [back to overview]Half-Life (t1/2) of IMC-11F8 at Study Day 1 of Cycle 1
NCT00835185 (12) [back to overview]Maximum Concentration (Cmax) of IMC-11F8 at Study Day 1 of Cycle 1
NCT00835185 (12) [back to overview]Overall Survival (OS)
NCT00835185 (12) [back to overview]Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response )
NCT00835185 (12) [back to overview]Progression-Free Survival (PFS)
NCT00835185 (12) [back to overview]Serum Anti-IMC-11F8 Antibody Assessment (Immunogenicity)
NCT00835185 (12) [back to overview]Kirsten Rat Sarcoma (KRAS) Mutation Status
NCT00835185 (12) [back to overview]Volume of Distribution (Vss) of IMC-11F8 at Study Day 1 of Cycle 1
NCT00835185 (12) [back to overview]Number of Participants With Adverse Events (AEs), Serious AEs (SAEs) or Death
NCT00851084 (6) [back to overview]Progression Free Survival (PFS)
NCT00851084 (6) [back to overview]Progression Free Survival (PFS) Rate at 12 Months
NCT00851084 (6) [back to overview]Number of Participants With Treatment-emergent Adverse Events (TEAE)
NCT00851084 (6) [back to overview]Overall Objective Response Rate (ORR)
NCT00851084 (6) [back to overview]Immunogenicity of Intravenous (IV) Aflibercept
NCT00851084 (6) [back to overview]Overall Survival (OS)
NCT00860470 (10) [back to overview]Infant Mortality Through 6 mo of Age
NCT00860470 (10) [back to overview]Moderate to Late Preterm
NCT00860470 (10) [back to overview]Neonatal Mortality
NCT00860470 (10) [back to overview]Post-neonatal Mortality
NCT00860470 (10) [back to overview]Preterm Birth
NCT00860470 (10) [back to overview]Still Birth Rates
NCT00860470 (10) [back to overview]Extremely Pre-term
NCT00860470 (10) [back to overview]Small for Gestation Age
NCT00860470 (10) [back to overview]Very Pre-term
NCT00860470 (10) [back to overview]Low Birth Weight
NCT00862784 (7) [back to overview]Duration of Response
NCT00862784 (7) [back to overview]Number of Participants With IMC-1121B (Ramucirumab)-Related Severe Adverse Events (SAEs)
NCT00862784 (7) [back to overview]Percentage of Participants With Complete Response or Partial Response [Objective Response Rate (ORR)]
NCT00862784 (7) [back to overview]Progression-Free Survival (PFS)
NCT00862784 (7) [back to overview]Number of Participants With IMC-1121B (Ramucirumab)-Related Adverse Events (AEs)
NCT00862784 (7) [back to overview]Serum Anti-IMC-1121B (Immunogenicity) at Day 1
NCT00862784 (7) [back to overview]Overall Survival (OS)
NCT00865189 (11) [back to overview]Percentage of Participants With Surgery
NCT00865189 (11) [back to overview]Disease-Free Survival (DFS)
NCT00865189 (11) [back to overview]Number of Cycles of Chemotherapy
NCT00865189 (11) [back to overview]Percentage of Participants Who Died
NCT00865189 (11) [back to overview]Number of Cycles of Radiotherapy
NCT00865189 (11) [back to overview]Overall Survival
NCT00865189 (11) [back to overview]Percentage of Participants With Tumor Sterilization Defined by ypT0-N0
NCT00865189 (11) [back to overview]Percentage of Participants With Local and Distant Recurrences
NCT00865189 (11) [back to overview]Number of Cycles of Induction Chemotherapy
NCT00865189 (11) [back to overview]Percentage of Participants With Tumor Down-Staging (ypT0-pT2)
NCT00865189 (11) [back to overview]Percentage of Participants With Second Cancer, Local or Regional Recurrence, Distant Metastasis, or Death
NCT00901394 (1) [back to overview]Change in Plasma Total Homocysteine Concentration (tHcy)
NCT00923273 (4) [back to overview]Phase I: Maximum Tolerated Dose (MTD) of Pemetrexed
NCT00923273 (4) [back to overview]Phase I: Maximum Tolerated Dose (MTD) of Sirolimus
NCT00923273 (4) [back to overview]Phase II: Clinical Response Rate
NCT00923273 (4) [back to overview]Number of Participants With Serious and Non-Serious Adverse Events
NCT00932113 (6) [back to overview]Clinical Endpoints for Psoriasis: Target Lesion Score
NCT00932113 (6) [back to overview]Clinical Endpoints for Psoriasis: Photography Completed
NCT00932113 (6) [back to overview]Biologic Activity Endpoints
NCT00932113 (6) [back to overview]Clinical Endpoints for Psoriasis: % Body Surface Area
NCT00932113 (6) [back to overview]Clinical Endpoints for Psoriasis: PASI 75
NCT00932113 (6) [back to overview]Clinical Endpoints for Psoriasis: Physician's Global Assessment (PGA) Clear or Almost Clear (PGA 0-1)
NCT00950989 (8) [back to overview]Number of Participants With Treatment Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation
NCT00950989 (8) [back to overview]PK of Brodalumab: Area Under the Curve During the Dosing Interval (AUCtau)
NCT00950989 (8) [back to overview]Pharmacokinetics (PK) of Brodalumab: Maximum Observed Concentration (Cmax)
NCT00950989 (8) [back to overview]PK of Brodalumab: Time to Maximum Observed Concentration (Tmax)
NCT00950989 (8) [back to overview]Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 12
NCT00950989 (8) [back to overview]Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12
NCT00950989 (8) [back to overview]Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12
NCT00950989 (8) [back to overview]Disease Activity Score 28 (DAS28) at Week 12
NCT00954512 (2) [back to overview]Part 2: Number of Participants With Each Type of Response Evaluation Criteria in Solid Tumors (RECIST)-Determined Overall Best Response
NCT00954512 (2) [back to overview]Part 1: Number of Participants Who Experienced One or More Adverse Events (AEs)
NCT00957905 (1) [back to overview]Objective Response Rate
NCT00998946 (4) [back to overview]Progression Free Survival (PFS)
NCT00998946 (4) [back to overview]Overall Survival (OS)
NCT00998946 (4) [back to overview]Objective Response Rate (ORR)
NCT00998946 (4) [back to overview]Duration of Response (DOR)
NCT01057589 (6) [back to overview]Percent of Participants With a Partial Response (PR) or a Complete Response (CR)
NCT01057589 (6) [back to overview]Change From Baseline in Participant Reported European-Quality of Life 5 Dimension Instrument (EQ-5D) Visual Analog Scale (VAS) at End of Triplet Combination Therapy and End of Maintenance Therapy
NCT01057589 (6) [back to overview]Change From Baseline in Performance Status Scale for Head and Neck Cancer Patients (PSS-HNC)
NCT01057589 (6) [back to overview]Progression Free Survival (PFS)
NCT01057589 (6) [back to overview]Overall Survival (OS)
NCT01057589 (6) [back to overview]Change From Baseline in Participant Reported EQ-5D Utility Score at End of Triplet Combination Therapy and End of Maintenance Therapy
NCT01061736 (5) [back to overview]Part A: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12
NCT01061736 (5) [back to overview]Part B: Percentage of Participants Achieving a Major Clinical Response at Week 52
NCT01061736 (5) [back to overview]Part B: Percentage of Participants Achieving ACR20 Response at Week 24
NCT01061736 (5) [back to overview]Part B: Change From Baseline in Health Assessment Question Disability Index (HAQ-DI) at Week 16
NCT01061736 (5) [back to overview]Part B: Change From Baseline in Van Der Heijde Modified Total Sharp Score (mTSS) at Week 52
NCT01118624 (4) [back to overview]Overall Survival (OS)
NCT01118624 (4) [back to overview]Objective Response Rate (ORR)
NCT01118624 (4) [back to overview]Incidence of Adverse Events (AEs) and Laboratory Abnormalities
NCT01118624 (4) [back to overview]Duration of Response (DOR)
NCT01165021 (5) [back to overview]Percentage of Participants With No Viable Tumor Cells in Resected Lung Tissue [Pathological Complete Remission (pCR)]
NCT01165021 (5) [back to overview]Percentage of Participants Who Exhibit a Downward Shift in Tumor Extent From Stage IIIAN2 to Stages IIIA, II, I, or Stage 0
NCT01165021 (5) [back to overview]Progression-Free Survival (PFS)
NCT01165021 (5) [back to overview]Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)]
NCT01165021 (5) [back to overview]Overall Survival (OS)
NCT01183065 (1) [back to overview]To Determine the Overall Response Rate (CR+PR)
NCT01183780 (7) [back to overview]Change From Baseline in EuroQol- 5D (EQ-5D)
NCT01183780 (7) [back to overview]Change From Baseline in European Organisation for Research and Treatment of Cancer [EORTC] QLQ-C30 Global Health Status
NCT01183780 (7) [back to overview]Percentage of Participants With Treatment-Emergent Anti-Ramucirumab Antibodies
NCT01183780 (7) [back to overview]Progression-free Survival (PFS) Time
NCT01183780 (7) [back to overview]Observed Maximum Concentration (Cmax) and Observed Minimum Concentration (Cmin) of Ramucirumab
NCT01183780 (7) [back to overview]Percentage of Participants Achieving an Objective Response (Objective Response Rate)
NCT01183780 (7) [back to overview]Overall Survival (OS)
NCT01188876 (6) [back to overview]Maximum Concentration of Drug in Plasma (Cmax)
NCT01188876 (6) [back to overview]Overall Survival
NCT01188876 (6) [back to overview]Progression Free Survival
NCT01188876 (6) [back to overview]Treatment Related Adverse Events
NCT01188876 (6) [back to overview]Area Under the Plasma Drug Concentration-Time Curve (AUC)
NCT01188876 (6) [back to overview]Maximum Tolerated Dose (MTD)
NCT01190930 (41) [back to overview]Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL at End of Maintenance Cycle 1: Left
NCT01190930 (41) [back to overview]Burden of Therapy in Boy AR Patients Overall at End of Therapy: Emotional
NCT01190930 (41) [back to overview]Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Emotional
NCT01190930 (41) [back to overview]Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Physical
NCT01190930 (41) [back to overview]Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Social Functioning
NCT01190930 (41) [back to overview]Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 4: Emotional
NCT01190930 (41) [back to overview]Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 4: Physical
NCT01190930 (41) [back to overview]Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 4: Social Functioning
NCT01190930 (41) [back to overview]Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Physical
NCT01190930 (41) [back to overview]Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Social Functioning
NCT01190930 (41) [back to overview]Burden of Therapy in AR Patients Overall at End of Consolidation Therapy: Emotional
NCT01190930 (41) [back to overview]Burden of Therapy in AR Patients Overall at End of Consolidation Therapy: Physical
NCT01190930 (41) [back to overview]Burden of Therapy in AR Patients Overall at End of Consolidation Therapy: Social Functioning
NCT01190930 (41) [back to overview]Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 1: Emotional
NCT01190930 (41) [back to overview]Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 1: Physical
NCT01190930 (41) [back to overview]Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 1: Social Functioning
NCT01190930 (41) [back to overview]Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 4: Emotional
NCT01190930 (41) [back to overview]Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 4: Physical
NCT01190930 (41) [back to overview]Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 4: Social Functioning
NCT01190930 (41) [back to overview]Burden of Therapy in Boy AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Therapy: Emotional
NCT01190930 (41) [back to overview]Burden of Therapy in Boy AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Therapy: Physical
NCT01190930 (41) [back to overview]Burden of Therapy in Boy AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Therapy: Social Functioning
NCT01190930 (41) [back to overview]Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Emotional
NCT01190930 (41) [back to overview]Sample Collection of Central Path Review Slides in B-LLy Patients
NCT01190930 (41) [back to overview]Overall Survival (OS) for B-LLy Patients
NCT01190930 (41) [back to overview]Event Free Survival (EFS) for B-LLy Patients
NCT01190930 (41) [back to overview]Disease Free Survival (DFS) in Average Risk (AR) Patients Based on the Methotrexate Dose Randomization
NCT01190930 (41) [back to overview]DFS in Low Risk (LR) Patients Based on Randomization to 1 of 2 Low-intensity Regimens
NCT01190930 (41) [back to overview]Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL at End of Consolidation Therapy-Right
NCT01190930 (41) [back to overview]Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL at End of Consolidation Therapy-Left
NCT01190930 (41) [back to overview]Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL 12 Months Post Therapy: Right
NCT01190930 (41) [back to overview]Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL 12 Months Post Therapy: Left
NCT01190930 (41) [back to overview]Burden of Therapy in Boy AR Patients Overall at End of Therapy: Social Functioning
NCT01190930 (41) [back to overview]Burden of Therapy in Boy AR Patients Overall at End of Therapy: Physical
NCT01190930 (41) [back to overview]DFS in Average Risk (AR) Patients Based on the Pulse Frequency Randomization
NCT01190930 (41) [back to overview]DFS for SR Down Syndrome Patients With Standardized Treatment and Enhanced Supportive Care
NCT01190930 (41) [back to overview]Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Right
NCT01190930 (41) [back to overview]Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Left
NCT01190930 (41) [back to overview]Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Right
NCT01190930 (41) [back to overview]Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Left
NCT01190930 (41) [back to overview]Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL at End of Maintenance Cycle 1: Right
NCT01194453 (2) [back to overview]Response Rate
NCT01194453 (2) [back to overview]Progression Free Survival (PFS)
NCT01198574 (3) [back to overview]Haemoglobin Level
NCT01198574 (3) [back to overview]Status of Tissue Iron Store
NCT01198574 (3) [back to overview]Status of Cellular Iron Deficiency
NCT01217814 (1) [back to overview]Pharmacokinetic (PK) Parameter: Serum Concentration of Functional and Bound Sarilumab
NCT01228734 (5) [back to overview]Overall Survival (OS) Time
NCT01228734 (5) [back to overview]Progression Free Survival (PFS) Time
NCT01228734 (5) [back to overview]Best Overall Response Rate (ORR)
NCT01228734 (5) [back to overview]Time to Treatment Failure (TTF)
NCT01228734 (5) [back to overview]Number of Subjects With Curative Surgery of Liver Metastases
NCT01256398 (6) [back to overview]Probability of Being BCR-ABL Negative in the Bone Marrow and Peripheral Blood at the Completion of the CNS Prophylaxis Course (Restricted to Those Patients Achieving a CR)
NCT01256398 (6) [back to overview]Response
NCT01256398 (6) [back to overview]Overall Survival (OS)
NCT01256398 (6) [back to overview]Disease Free Survival (DFS)
NCT01256398 (6) [back to overview]Disease Free Survival Defined From the Date of First Induction Complete Response (CR) to Relapse or Death Due to Any Cause
NCT01256398 (6) [back to overview]Feasibility of Maintenance Therapy in This Patient Population (Restricted to Those Patients Achieving a CR). Feasibility Will be Defined as the Number of Deaths Ocuring.
NCT01258660 (8) [back to overview]Proportion of Participants With RBC Folate Below 906 Nmol/L in the Yasmin + Metafolin Group in the Folate Elimination Phase (Week 24 to 44)
NCT01258660 (8) [back to overview]Homocysteine Concentrations in Plasma at Baseline and at the End of Treatment (Week 24) With Metafolin
NCT01258660 (8) [back to overview]Homocysteine Concentrations in Plasma at Baseline and at the End of Treatment (Week 24) With Folic Acid
NCT01258660 (8) [back to overview]Folate Metabolite Pattern in Plasma at Cycle 6
NCT01258660 (8) [back to overview]Folate Metabolite Pattern in Plasma at Cycle 3
NCT01258660 (8) [back to overview]Folate Metabolite Pattern in Plasma at Baseline
NCT01258660 (8) [back to overview]Area Under the Curve From Time 0 to 24 Weeks [AUC(0-24weeks)] for Plasma Folate and RBC (Red Blood Cell) Folate (Baseline Corrected)
NCT01258660 (8) [back to overview]Area Under the Curve (AUC) From Time 0 to 24 Weeks [AUC(0-24weeks)] for Plasma Folate and RBC (Red Blood Cell) Folate (Baseline Uncorrected)
NCT01276379 (5) [back to overview]Progression Free Survival
NCT01276379 (5) [back to overview]Response Duration
NCT01276379 (5) [back to overview]Secondary Biomarkers Analysis
NCT01276379 (5) [back to overview]Frequency of Adverse Events
NCT01276379 (5) [back to overview]Overall Survival
NCT01289821 (6) [back to overview]Duration of Response (DOR)
NCT01289821 (6) [back to overview]Disease Control (DC)
NCT01289821 (6) [back to overview]Duration of Stable Disease (DOSD)
NCT01289821 (6) [back to overview]Progression-free Survival (PFS)
NCT01289821 (6) [back to overview]Overall Survival (OS)
NCT01289821 (6) [back to overview]Objective Response (OR)
NCT01307956 (4) [back to overview]Progression-free Survival
NCT01307956 (4) [back to overview]Complete Pathological Response (pCR) Rate
NCT01307956 (4) [back to overview]Overall Survival
NCT01307956 (4) [back to overview]Number of Patients Who Can Undergo Resection
NCT01355159 (25) [back to overview]Periventricular Leukomalacia
NCT01355159 (25) [back to overview]Perinatal Mortality
NCT01355159 (25) [back to overview]Intrauterine Growth Restriction (<10th Percentile)
NCT01355159 (25) [back to overview]Composite Severe Adverse Fetal/Neonatal Outcome
NCT01355159 (25) [back to overview]Early Onset Sepsis
NCT01355159 (25) [back to overview]HELLP (Hemolysis, Elevated Liver Enzyme Levels & Low Platelet Count)
NCT01355159 (25) [back to overview]Neonatal Intensive Care Unit (NICU) Admission
NCT01355159 (25) [back to overview]Neonatal Death
NCT01355159 (25) [back to overview]Neonatal Death
NCT01355159 (25) [back to overview]Need for Oxygen at 28 Days
NCT01355159 (25) [back to overview]Necrotising Enterocolitis
NCT01355159 (25) [back to overview]Length of Stay in 'High Level' Neonatal Care Unit
NCT01355159 (25) [back to overview]Intraventricular Hemorrhage (IVH)
NCT01355159 (25) [back to overview]Intrauterine Growth Restriction (<3rd Percentile)
NCT01355159 (25) [back to overview]Maternal Death
NCT01355159 (25) [back to overview]Antenatal Inpatient Length of Stay
NCT01355159 (25) [back to overview]Ventilation
NCT01355159 (25) [back to overview]Stillbirth
NCT01355159 (25) [back to overview]Spontaneous Abortion
NCT01355159 (25) [back to overview]Severe Preeclampsia
NCT01355159 (25) [back to overview]Retinopathy of Prematurity
NCT01355159 (25) [back to overview]Preterm Birth
NCT01355159 (25) [back to overview]Premature Rupture of Membranes
NCT01355159 (25) [back to overview]Preeclampsia
NCT01355159 (25) [back to overview]Placenta Abruption
NCT01356966 (3) [back to overview]Change in Resting Muscle Sympathetic Nerve Activity (MSNA)
NCT01356966 (3) [back to overview]Change in Mean Central Augmentation Index (AIx)
NCT01356966 (3) [back to overview]Change in Heart-rate-corrected Augmentation Index (AIx)
NCT01436266 (1) [back to overview]Blood Loss
NCT01535053 (6) [back to overview]Patient-reported Quality of Life (QOL) After Baseline Visit.
NCT01535053 (6) [back to overview]Percentage of Participants With Complete Response
NCT01535053 (6) [back to overview]Patient-reported Quality of Life (QOL) at Baseline
NCT01535053 (6) [back to overview]The Number of Participants With Post Protocol Multi-agent Chemotherapy Treatment for Each Arm.
NCT01535053 (6) [back to overview]The Number of Participants With Post Protocol Surgical Treatment for Each Arm.
NCT01535053 (6) [back to overview]Number of Participants With CTCAE v4 Graded Adverse Events With Low-risk Gestational Trophoblastic Neoplasia by Arm
NCT01576705 (2) [back to overview]GMDS (Griffiths Mental Development Scale)
NCT01576705 (2) [back to overview]BL (Brunet Lezine Revised Scale)
NCT01581307 (3) [back to overview]Median Overall Survival (OS)
NCT01581307 (3) [back to overview]Rate of Progression Free Survival (PFS)
NCT01581307 (3) [back to overview]Overall Response Rate (ORR)
NCT01634555 (6) [back to overview]Pharmacokinetics: Dose-Normalized AUC(0-∞) of Irinotecan and Its Metabolite SN-38 in Cycle 2
NCT01634555 (6) [back to overview]Pharmacokinetics: Dose-Normalized Cmax of Irinotecan and Its Metabolite SN-38 in Cycle 2
NCT01634555 (6) [back to overview]Pharmacokinetics: Dose-Normalized Maximum Observed Drug Concentration (Cmax) of Irinotecan and Its Metabolite SN-38 in Cycle 1
NCT01634555 (6) [back to overview]Number of Participants With Treatment Emergent Anti-Drug Antibodies (TE-ADA)
NCT01634555 (6) [back to overview]Pharmacokinetics: Cmax of Ramucirumab (IMC-1121B)
NCT01634555 (6) [back to overview]Pharmacokinetics: Dose-Normalized Area Under the Concentration Versus Time Curve of Irinotecan and Its Metabolite SN-38 From Time Zero to Infinity [AUC(0-∞)] in Cycle 1
NCT01704599 (24) [back to overview]Number of Participants Within the Categories of Increasing and Decreasing Serum Magnesium
NCT01704599 (24) [back to overview]PASI Change Related to Baseline Body Mass Index Above, Below and Equal to 27.3
NCT01704599 (24) [back to overview]Number of Participants With Category Change in Vitamin B12 Blood Level
NCT01704599 (24) [back to overview]Number of Participants Who Fulfilled the Category of Having Height Measured
NCT01704599 (24) [back to overview]Number of Participants With a Categorical Change in Static Physician Global Assessment (sPGA):
NCT01704599 (24) [back to overview]Number of Participants With a Categorical DLQI (Dermatology Life Quality Index) Change
NCT01704599 (24) [back to overview]Number of Participants With Category Change in Serum Folic Acid Level.
NCT01704599 (24) [back to overview]Number of Participants With Category Change in Serum VEGF (Vascular Endothelial Growth Factorl)
NCT01704599 (24) [back to overview]Number of Participants Within Categories of Body Temperature Change
NCT01704599 (24) [back to overview]PASI Change in Participants With Baseline VEGF Above 140 pg/ml and in Participants With Normal Baseline VEGF
NCT01704599 (24) [back to overview]Number of Participants in the Categories of Normalizing, Unchanging and Newly Abnormal Electrocardiograms (EKGs)
NCT01704599 (24) [back to overview]Number of Particpants With a Categorical PASI (Psoriasis Area and Severity Index) Change
NCT01704599 (24) [back to overview]Number of Participants Within the Categories of Positive Urine Pregnancy Test (Urine Hcg)
NCT01704599 (24) [back to overview]Number of Participants Within the Categories of Elevated and Normal Helicobacter Pylori Antibody
NCT01704599 (24) [back to overview]Number of Participants Within the Categories of Increasing and Decreasing Serum Vitamin B6 Level
NCT01704599 (24) [back to overview]Number of Participants Within the Categories of Increasing and Decreasing Serum Phosphorus
NCT01704599 (24) [back to overview]EKG Categoryy Changes Related to Homocysteine Changes
NCT01704599 (24) [back to overview]Number of Participants in Categories or Increasing and Decreasing Changes Within the CBC (Complete Blood Count)
NCT01704599 (24) [back to overview]Psoriasis Change in Participants With High H. Pylori Titers and With Normal Titers.
NCT01704599 (24) [back to overview]Number of Participants in the Categories of Having and of Not Having a Serious Adverse Event (SAE)
NCT01704599 (24) [back to overview]Number of Participants Within the Categories of Increasign and Decreasing Body Weight
NCT01704599 (24) [back to overview]Number of Participants Within the Categories of Increasing and Decreasing Blood Pressure and Pulse Measures:
NCT01704599 (24) [back to overview]Number of Participants Within the Categories of Increasing and Decreasing Serum Homocysteine
NCT01704599 (24) [back to overview]Number of Participants in the Categories of Having and Not Having an Adverse Event
NCT01708278 (1) [back to overview]Participants Who Experienced Safety Concerns, Where Safety Concerns of Quercetin Supplementation is Indicated by Significant Change From Baseline Measures of Tests Indicated Below in Outcome Measure Description
NCT01711359 (22) [back to overview]Change From Baseline in Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR)
NCT01711359 (22) [back to overview]Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores (Self-Perceived Health)
NCT01711359 (22) [back to overview]Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scores
NCT01711359 (22) [back to overview]Change From Baseline in Joint Space Narrowing and Bone Erosion Scores
NCT01711359 (22) [back to overview]Change From Baseline in Mental Component Score (MCS) and Physical Component Score (PCS) of the Medical Outcomes Study 36-Item Short Form Health Survey Version 2 Acute (SF-36v2 Acute)
NCT01711359 (22) [back to overview]Change From Baseline in the Modified Total Sharp Score (mTSS)
NCT01711359 (22) [back to overview]Change From Baseline in Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Scores
NCT01711359 (22) [back to overview]Change From Baseline in Worst Joint Pain Numeric Rating Scale (NRS)
NCT01711359 (22) [back to overview]Change From Baseline in Worst Tiredness Numeric Rating Scale (NRS)
NCT01711359 (22) [back to overview]Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response
NCT01711359 (22) [back to overview]Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response
NCT01711359 (22) [back to overview]Percentage of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Remission
NCT01711359 (22) [back to overview]Percentage of Participants Achieving American College of Rheumatology 20% Improvement (ACR20)
NCT01711359 (22) [back to overview]Percentage of Participants Achieving American College of Rheumatology 20% Improvement (ACR20)
NCT01711359 (22) [back to overview]Percentage of Participants Who Achieved a Simplified Disease Activity Index (SDAI) Score ≤3.3
NCT01711359 (22) [back to overview]Population Pharmacokinetics (PK): Peak Concentration at Steady State (Cmax,ss) of Baricitinib
NCT01711359 (22) [back to overview]Population PK: Area Under the Concentration Versus Time Curve at a Dosing Interval at Steady State (AUCtau,ss) of Baricitinib
NCT01711359 (22) [back to overview]Change From Baseline in Clinical Disease Activity Index (CDAI) Score
NCT01711359 (22) [back to overview]Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores
NCT01711359 (22) [back to overview]Change From Baseline in Duration of Morning Joint Stiffness
NCT01711359 (22) [back to overview]Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
NCT01711359 (22) [back to overview]Change From Baseline in the Disease Activity Score Based on a 28-Joint Count and High-sensitivity C-reactive Protein (DAS28-hsCRP)
NCT01718873 (5) [back to overview]Objective Response Rate
NCT01718873 (5) [back to overview]Disease Control Rate
NCT01718873 (5) [back to overview]Toxic Effects
NCT01718873 (5) [back to overview]Progression-free Survival (PFS)
NCT01718873 (5) [back to overview]Overall Survival
NCT01733329 (4) [back to overview]Postpartum Hemorrhage
NCT01733329 (4) [back to overview]Blood Loss
NCT01733329 (4) [back to overview]Need for Additional Uterotonic Medications
NCT01733329 (4) [back to overview]Uterine Atony
NCT01765582 (7) [back to overview]Proportion of Participants Who Underwent Liver Metastases Resections
NCT01765582 (7) [back to overview]Proportion of Participants Considered by the Investigator to be Unresectable on Study Enrollment Who Subsequently Underwent Attempted Curative Resections of Metastases
NCT01765582 (7) [back to overview]Progression-Free Survival During First-Line Therapy (PFS1)
NCT01765582 (7) [back to overview]Percentage of Participants With Overall Response During First-Line Therapy (ORR1)
NCT01765582 (7) [back to overview]Percentage of Participants With Adverse Events
NCT01765582 (7) [back to overview]Overall Survival (OS)
NCT01765582 (7) [back to overview]Time to PFS2
NCT01766310 (2) [back to overview]Changes of Homocysteine Level
NCT01766310 (2) [back to overview]Prevalence of Hyperhomocysteinemia
NCT01818414 (5) [back to overview]Complications
NCT01818414 (5) [back to overview]Number of Participants With Postoperative Satisfaction
NCT01818414 (5) [back to overview]Number of Providers With Overall Satisfaction
NCT01818414 (5) [back to overview]Operative Time
NCT01818414 (5) [back to overview]Patient Pain
NCT01857310 (37) [back to overview]Fertilization Rate Per Cycle, %
NCT01857310 (37) [back to overview]Ectopic Pregnancy
NCT01857310 (37) [back to overview]Early Pregnancy Loss
NCT01857310 (37) [back to overview]Clinical Intrauterine Pregnancy
NCT01857310 (37) [back to overview]Cesarean Delivery
NCT01857310 (37) [back to overview]Cells on Day 3 Per Embryo Per Cycle
NCT01857310 (37) [back to overview]Birth Weight
NCT01857310 (37) [back to overview]Embryo Morphology on Day 5 Per Cycle, Categorical
NCT01857310 (37) [back to overview]Percentage of Good Quality Embryos on Day 5 Per Cycle
NCT01857310 (37) [back to overview]Number of Good Quality Embryos on Day 5 Per Cycle
NCT01857310 (37) [back to overview]Number of Embryos Transferred Per Cycle
NCT01857310 (37) [back to overview]Number of Embryos Cryopreserved Per Cycle
NCT01857310 (37) [back to overview]Gestational Diabetes
NCT01857310 (37) [back to overview]Major Neonatal Complications
NCT01857310 (37) [back to overview]Preeclampsia or Gestational Hypertension
NCT01857310 (37) [back to overview]Cells on Day 5 Per Embryo Per Cycle, Categorical
NCT01857310 (37) [back to overview]Chromosomal Complement of Embryo Per Cycle
NCT01857310 (37) [back to overview]DNA Fragmentation Index
NCT01857310 (37) [back to overview]Embryo Morphology on Day 3 Per Cycle, Categorical
NCT01857310 (37) [back to overview]Live Birth
NCT01857310 (37) [back to overview]Method of Fertilization Per Cycle
NCT01857310 (37) [back to overview]Quality of Embryos Transferred Per Cycle, Categorical
NCT01857310 (37) [back to overview]Gestational Age
NCT01857310 (37) [back to overview]Neonatal Mortality
NCT01857310 (37) [back to overview]Sperm Concentration
NCT01857310 (37) [back to overview]Sperm Morphology
NCT01857310 (37) [back to overview]Sperm Motility
NCT01857310 (37) [back to overview]Human Chorionic Gonadotropin (hCG) Detected Pregnancy (Implantation)
NCT01857310 (37) [back to overview]Total Motile Sperm Count
NCT01857310 (37) [back to overview]Cells on Day 3 Per Embryo Per Cycle, Categorical
NCT01857310 (37) [back to overview]Structural Malformations
NCT01857310 (37) [back to overview]Stillbirth
NCT01857310 (37) [back to overview]Sperm Penetration Per Cycle, %
NCT01857310 (37) [back to overview]Small for Gestational Age
NCT01857310 (37) [back to overview]Severe Maternal Morbidity
NCT01857310 (37) [back to overview]Preterm Delivery
NCT01857310 (37) [back to overview]Semen Volume
NCT01897454 (7) [back to overview]Overall Survival (OS)
NCT01897454 (7) [back to overview]Percentage of Participants Achieving R0 Resection (R0 Resection Rate)
NCT01897454 (7) [back to overview]Progression Free Survival (PFS)
NCT01897454 (7) [back to overview]Toxicities Associated With Chemotherapy and Radiotherapy
NCT01897454 (7) [back to overview]Vascular Reconstruction
NCT01897454 (7) [back to overview]Percentage of Patients Able to Undergo Resection
NCT01897454 (7) [back to overview]Overall Response Rate
NCT01900431 (8) [back to overview]Percentage of Participants With at Least 2-step Reduction in Vitreous Haze (VH) or Prednisone Dose <10 mg/Day at Week 16
NCT01900431 (8) [back to overview]Percentage of Participants With Anterior Chamber (AC) Cell Score = 0 or At Least 2-step Reduction in Score at Week 16
NCT01900431 (8) [back to overview]Change From Baseline in VH Scale at Week 16
NCT01900431 (8) [back to overview]Change From Baseline in Central Retinal Thickness (CRT) At Week 16
NCT01900431 (8) [back to overview]Percentage of Participants With Prednisone Dose of ≤5 mg/Day (or Equivalent Oral Corticosteroid) at Week 16
NCT01900431 (8) [back to overview]Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at Week 16
NCT01900431 (8) [back to overview]Pharmacokinetics (PK) Assessment: Serum Functional Sarilumab Concentration
NCT01900431 (8) [back to overview]Percent Change From Baseline in CRT at Week 16
NCT01949116 (14) [back to overview]Absolute Change From Baseline to Week 24 in Monocyte Levels
NCT01949116 (14) [back to overview]Change From Baseline to Week 24 in Reactive Hyperemic (RH) Flow Rate
NCT01949116 (14) [back to overview]Number of Participants Who Reached at Least One Safety Milestone Over the Duration of Study Follow-up (36 Weeks)
NCT01949116 (14) [back to overview]Change From Baseline to Week 12 in Brachial Artery FMD
NCT01949116 (14) [back to overview]Change From Baseline to Week 12 in Brachial Artery Resting Average Diameter
NCT01949116 (14) [back to overview]Change From Baseline to Week 24 in Brachial Artery Resting Average Diameter
NCT01949116 (14) [back to overview]Change From Baseline to Week 24 in Peak Reactive Hyperemic (RH) Flow Velocity
NCT01949116 (14) [back to overview]Absolute Change From Baseline to Week 24 in Homing Molecule (CX3CR1+) Expression
NCT01949116 (14) [back to overview]Absolute Change From Baseline to Week 24 in Adhesion and Activation Indices
NCT01949116 (14) [back to overview]Primary Efficacy Endpoint of Change From Baseline to Week 24 in Brachial Artery Flow-mediated Vasodilation (FMD)
NCT01949116 (14) [back to overview]Percentage Change From Baseline to Week 24 in Soluble CD 163 (sCD163)
NCT01949116 (14) [back to overview]Percentage Change From Baseline to Week 24 in Interleukin-6 (IL-6)
NCT01949116 (14) [back to overview]Percentage Change From Baseline to Week 24 in High-sensitivity C-reactive Protein (hsCRP)
NCT01949116 (14) [back to overview]Percentage Change From Baseline to Week 24 in D-Dimer
NCT01959672 (5) [back to overview]Distant Failure-free Survival
NCT01959672 (5) [back to overview]Number of Participants With CA-125-Specific T-cell Signal.
NCT01959672 (5) [back to overview]Surgical Complete Resection (Negative Margin) Rate
NCT01959672 (5) [back to overview]Overall Survival
NCT01959672 (5) [back to overview]Number of Participants With Progressive Disease,
NCT02042443 (4) [back to overview]Objective Response Rate
NCT02042443 (4) [back to overview]Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
NCT02042443 (4) [back to overview]Progression-free Survival
NCT02042443 (4) [back to overview]Overall Survival
NCT02069704 (13) [back to overview]Objective Response Rate (ORR) of BEVZ92 and Avastin®
NCT02069704 (13) [back to overview]Anti-Drug Antibody (ADA) of BEVZ92 and Avastin®
NCT02069704 (13) [back to overview]Volume of Distribution (Vd) of BEVZ92 and Avastin®
NCT02069704 (13) [back to overview]Progression-free Survival (PFS) of BEVZ92 and Avastin®
NCT02069704 (13) [back to overview]Elimination Half-life (t1/2) of BEVZ92 and Avastin®
NCT02069704 (13) [back to overview]Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Reported With BEVZ92 and Avastin®
NCT02069704 (13) [back to overview]Area Under the Concentration-versus-time Curve (AUC) at Cycle 1 (AUC0-336h) of BEVZ92 and Avastin®
NCT02069704 (13) [back to overview]Cmax,sd of BEVZ92 and Avastin®
NCT02069704 (13) [back to overview]AUC at Steady State (AUCss) of BEVZ92 and Avastin®
NCT02069704 (13) [back to overview]Ctrough,ss of BEVZ92 and Avastin®
NCT02069704 (13) [back to overview]Ctrough,sd of BEVZ92 and Avastin®
NCT02069704 (13) [back to overview]Elimination Rate Constant (Kel) of BEVZ92 and Avastin®
NCT02069704 (13) [back to overview]Cmax,ss of BEVZ92 and Avastin®
NCT02093026 (14) [back to overview]Percentage of Participants With ACR20 Response After Fifth Course
NCT02093026 (14) [back to overview]Percentage of Participants With Low Disease Activity and Clinical Remission Based on DAS28-ESR
NCT02093026 (14) [back to overview]Percentage of Participants With ACR20 Response After Third Course
NCT02093026 (14) [back to overview]Percentage of Participants With an American College of Rheumatology 20 (ACR20) Response After First Course
NCT02093026 (14) [back to overview]Time Since Last Treatment Course
NCT02093026 (14) [back to overview]American College of Rheumatology Index of Improvement (ACRn) Response
NCT02093026 (14) [back to overview]Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at 24 Weeks Following Each Course
NCT02093026 (14) [back to overview]Percentage of Participants With ACR50 and ACR70 Response
NCT02093026 (14) [back to overview]Percentage of Participants Who Discontinued Treatment Due to Insufficient Response
NCT02093026 (14) [back to overview]Percentage of Participants With European League Against Rheumatism (EULAR) Response of 'Good' or 'Moderate'
NCT02093026 (14) [back to overview]Percentage of Participants With ACR20 Response After Seventh Course
NCT02093026 (14) [back to overview]Percentage of Participants With ACR20 Response After Sixth Course
NCT02093026 (14) [back to overview]Percentage of Participants With ACR20 Response After Second Course
NCT02093026 (14) [back to overview]Percentage of Participants With ACR20 Response After Fourth Course
NCT02101853 (4) [back to overview]Overall Survival (OS) of HR and IR Relapse Patients
NCT02101853 (4) [back to overview]Disease Free Survival (DFS) of Low Risk (LR) Relapse Patients
NCT02101853 (4) [back to overview]Overall Survival (OS) of LR Relapse Patients
NCT02101853 (4) [back to overview]Disease Free Survival (DFS) of High-risk (HR) and Intermediate-risk (IR) Relapse Patients
NCT02112916 (6) [back to overview]EFS for Standard (SR) and Intermediate Risk (IR) T-ALL Patients on the Non-bortezomib Containing Arm on This Study (no Cranial Radiation Therapy [CRT]) and Similar Patients on AALL0434 (Received CRT)
NCT02112916 (6) [back to overview]Cumulative Incidence Rates of Isolated Central Nervous System (CNS) Relapse for SR and IR T-ALL Patients on the Non-bortezomib Containing Arm on This Study (no CRT) and Similar Patients on AALL0434 (Receive CRT)
NCT02112916 (6) [back to overview]Toxicity Rates Associated With Modified Standard Therapy, Including Dexamethasone and Additional Pegaspargase
NCT02112916 (6) [back to overview]Event-free Survival (EFS) for Modified Augmented Berlin-Frankfurt-Munster Backbone With or Without Bortezomib in All Randomized Patients
NCT02112916 (6) [back to overview]EFS for Very High Risk (VHR) T-LLy Patients Treated With HR Berlin-Frankfurt-Munster (BFM) Intensification Blocks Who Have Complete or Partial Remission and Those Who do Not Respond
NCT02112916 (6) [back to overview]EFS for Very High Risk (VHR) T-ALL Patients Treated With High Risk (HR) Berlin-Frankfurt-Munster (BFM) Intensification Blocks Who Become Minimal Residual Disease (MRD) Negative and Those Who Remain MRD Positive at the End of HR Block 3
NCT02141295 (14) [back to overview]Overall Survival (OS)
NCT02141295 (14) [back to overview]Number of Participants With Human Anti-human Antibodies (HAHAs) Against Vanucizumab
NCT02141295 (14) [back to overview]Duration of Objective Response, as Assessed Using RECIST v. 1.1
NCT02141295 (14) [back to overview]Cmax Accumulation Ratio (AR) of Vanucizumab
NCT02141295 (14) [back to overview]Plasma Clearance at Steady State (CLss) of Vanucizumab
NCT02141295 (14) [back to overview]Percentage of Participants With Adverse Events (AEs)
NCT02141295 (14) [back to overview]Minimum Observed Plasma Concentration (Clast) of Vanucizumab
NCT02141295 (14) [back to overview]Maximum Observed Plasma Concentration (Cmax) of Vanucizumab
NCT02141295 (14) [back to overview]Time to Reach Cmax (Tmax) of Vanucizumab
NCT02141295 (14) [back to overview]Area Under the Plasma Concentration-Time Curve (AUC) of Vanucizumab
NCT02141295 (14) [back to overview]Percentage of Participants With Objective Response (ORR) as Assessed Using RECIST v. 1.1
NCT02141295 (14) [back to overview]Volume of Distribution at Steady State (Vss) of Vanucizumab
NCT02141295 (14) [back to overview]Progression-free Survival (PFS), Time to Event
NCT02141295 (14) [back to overview]Plasma Terminal Half-Life (t1/2) of Vanucizumab
NCT02293902 (9) [back to overview]Percentage of Participants Achieving American College of Rheumatology 20 (ACR20) Response at Week 24
NCT02293902 (9) [back to overview]Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities
NCT02293902 (9) [back to overview]Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Electrolytes
NCT02293902 (9) [back to overview]Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters
NCT02293902 (9) [back to overview]Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Liver Function Parameters
NCT02293902 (9) [back to overview]Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Metabolic Parameters
NCT02293902 (9) [back to overview]Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Renal Function Parameters
NCT02293902 (9) [back to overview]Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities
NCT02293902 (9) [back to overview]Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
NCT02312219 (2) [back to overview]Change in Arterial FDG Uptake (From Baseline) in the Most Diseased Segment
NCT02312219 (2) [back to overview]Change in Arterial FDG Uptake (From Baseline) in the Aorta
NCT02373813 (16) [back to overview]Change From Baseline in SDAI Score at All Measured Timepoints
NCT02373813 (16) [back to overview]Clinical Disease Activity Index (CDAI) at All Measured Timepoints
NCT02373813 (16) [back to overview]Percentage of Participants With SDAI Remission (≤ 3.3) at All Measured Timepoints
NCT02373813 (16) [back to overview]Percentage of Participants With Disease Worsening
NCT02373813 (16) [back to overview]Percentage of Participants With Boolean Remission at All Measured Timepoints
NCT02373813 (16) [back to overview]Disease Activity Score (28 Joint) Using the C-Reactive Protein Formula (DAS28-CRP) at All Measured Timepoints
NCT02373813 (16) [back to overview]Percentage of Participants Receiving Rescue Treatment Who Experienced SDAI Remission at Week 48
NCT02373813 (16) [back to overview]Disease Activity Score (28 Joint) Calculated Using the Erythrocyte Sedimentation Rate Formula (DAS28-ESR) at All Measured Timepoints
NCT02373813 (16) [back to overview]Change From Baseline in DAS28-CRP at All Measured Timepoints
NCT02373813 (16) [back to overview]SDAI Score at All Measured Timepoints
NCT02373813 (16) [back to overview]Change From Baseline in CDAI at All Measured Timepoints
NCT02373813 (16) [back to overview]Percentage of Participants With SDAI Remission (≤ 3.3) at Week 48: Etanercept and Methotrexate vs. Methotrexate Monotherapy
NCT02373813 (16) [back to overview]Percentage of Participants With Simplified Disease Activity Index (SDAI) Remission (≤ 3.3) at Week 48: Etanercept Monotherapy vs. Methotrexate Monotherapy
NCT02373813 (16) [back to overview]Time to Recapture SDAI Remission After Starting Rescue Treatment
NCT02373813 (16) [back to overview]Time to Disease Worsening
NCT02373813 (16) [back to overview]Change From Baseline in DAS28-ESR at All Measured Timepoints
NCT02379091 (7) [back to overview]Percentage of Participants With a Reduction of Pain as Measured Using a Visual Analog Scale (VAS) at Weeks 2, 12 and 24
NCT02379091 (7) [back to overview]Percentage of Participants Achieving American College of Rheumatology 20% (ACR20), 50% (ACR 50) and 70% (ACR70) Response at Weeks 12 and 24
NCT02379091 (7) [back to overview]Change From Baseline in DAS28-CRP at Weeks 2, 6, and 10
NCT02379091 (7) [back to overview]Change From Baseline in Disease Activity Score 28 C-Reactive Protein (DAS28-CRP) at Week 12
NCT02379091 (7) [back to overview]ACR Numeric (N) Index (ACRn) at Week 12
NCT02379091 (7) [back to overview]ACR Numeric (N) Index (ACRn) at Week 24
NCT02379091 (7) [back to overview]Change From Baseline in DAS28-CRP at Week 24
NCT02384850 (5) [back to overview]Overall Response Rate
NCT02384850 (5) [back to overview]Progression Free Survival (PFS)
NCT02384850 (5) [back to overview]Numbers of Patients With Dose Limiting Toxicities
NCT02384850 (5) [back to overview]Number of Patients Experiencing Adverse Events
NCT02384850 (5) [back to overview]Number of Patients Still Alive at End of Study (Overall Survival)
NCT02393378 (6) [back to overview]Change From Baseline in DAS28-CRP Score
NCT02393378 (6) [back to overview]Change From Baseline in Synovitis, Erosion and Bone Marrow Edema (Osteitis) Score at Week 24
NCT02393378 (6) [back to overview]Number of Participants Who Achieved ACR 20, 50, and 70 at Week 24
NCT02393378 (6) [back to overview]Number of Participants Who Achieved Remission at Week 24
NCT02393378 (6) [back to overview]Number of Participants Who Achieved Low Disease Activity at Week 24
NCT02393378 (6) [back to overview]Change From Baseline in Dynamic Contrast-enhanced - Magnetic Resonance Imaging (DCE-MRI) Parameters at Week 24
NCT02467504 (20) [back to overview]Number of Participants With Adverse Events
NCT02467504 (20) [back to overview]The Change From Baseline of Patient's Assessment of Arthritis Pain (PtAAP)
NCT02467504 (20) [back to overview]The Change From Baseline of Clinical Disease Activity Index (CDAI)
NCT02467504 (20) [back to overview]The Change From Baseline of a Health Assessment Questionnaire- Disability Index (HAQ-DI)
NCT02467504 (20) [back to overview]Percentage of Participants Meeting the American College of Rheumatology 70% Response Criteria
NCT02467504 (20) [back to overview]The Change From Baseline of Patient's Global Assessment of Disease Activity (PtGADA)
NCT02467504 (20) [back to overview]Percentage of Participants Meeting the American College of Rheumatology 50% Response Criteria
NCT02467504 (20) [back to overview]Percentage of Participants Meeting the American College of Rheumatology 20% Response Criteria
NCT02467504 (20) [back to overview]Percentage of Participants Meeting the 2011 American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) Remission Criteria Simplified for Clinical Practice
NCT02467504 (20) [back to overview]Percentage of Participants Achieving DAS28 Low Disease Activity.
NCT02467504 (20) [back to overview]Percentage of Participants Achieving a Good or Moderate European League Against Rheumatism (EULAR) Response
NCT02467504 (20) [back to overview]Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]-2
NCT02467504 (20) [back to overview]The Change From Baseline of Simplified Disease Activity Index (SDAI)
NCT02467504 (20) [back to overview]The Change From Baseline of Physician's Global Assessment of Disease Activity (PhGADA)
NCT02467504 (20) [back to overview]The Scores of SF-36 Quetionnaire
NCT02467504 (20) [back to overview]Percentage of Participants Achieving DAS28 Remission.
NCT02467504 (20) [back to overview]C Reactive Protein (CRP)
NCT02467504 (20) [back to overview]Erythrocyte Sedimentation Rate (ESR)
NCT02467504 (20) [back to overview]Percentage of CD4+ Treg Cells
NCT02467504 (20) [back to overview]Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]
NCT02504671 (22) [back to overview]Percentage of Participants Who Achieved Disease Activity Score for 28 Different Joints With C-reactive Protein Value (DAS28{CRP}) Remission (DAS28 <2.6) at Week 24
NCT02504671 (22) [back to overview]Time to First DAS28(CRP) Remission
NCT02504671 (22) [back to overview]Change From Baseline in Brief Fatigue Inventory (BFI) Question 3 at All Assessment Time Points
NCT02504671 (22) [back to overview]Change From Baseline in CDAI at All Assessment Time Points
NCT02504671 (22) [back to overview]Change From Baseline in DAS28(CRP) at All Assessment Time Points
NCT02504671 (22) [back to overview]Change From Baseline in DAS28(CRP) at Week 12
NCT02504671 (22) [back to overview]Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue at All Assessment Time Points
NCT02504671 (22) [back to overview]Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at All Assessment Time Points
NCT02504671 (22) [back to overview]Change From Baseline in Pain Score at All Assessment Time Points
NCT02504671 (22) [back to overview]Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points
NCT02504671 (22) [back to overview]Change From Baseline in SDAI at All Assessment Time Points
NCT02504671 (22) [back to overview]Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
NCT02504671 (22) [back to overview]Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points
NCT02504671 (22) [back to overview]Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points
NCT02504671 (22) [back to overview]Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points
NCT02504671 (22) [back to overview]Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points
NCT02504671 (22) [back to overview]Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission
NCT02504671 (22) [back to overview]Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points
NCT02504671 (22) [back to overview]Number of Participants With Worst-case Post-Baseline Results for Pulse Oximetry
NCT02504671 (22) [back to overview]Number of Participants With Pulmonary Events
NCT02504671 (22) [back to overview]Number of Participants With Opportunistic Infections
NCT02504671 (22) [back to overview]Number of Participants With Serious Infections
NCT02508077 (1) [back to overview]4-month Progression-free Survival (PFS) Rate
NCT02578680 (6) [back to overview]Overall Response Rate (ORR) Per RECIST 1.1 as Assessed by Blinded Central Imaging
NCT02578680 (6) [back to overview]Duration of Response (DOR) Per RECIST 1.1 as Assessed by Blinded Central Imaging
NCT02578680 (6) [back to overview]Number of Participants Who Discontinued Any Study Drug Due to an AE
NCT02578680 (6) [back to overview]Number of Participants Who Experienced an Adverse Event (AE)
NCT02578680 (6) [back to overview]Overall Survival (OS)
NCT02578680 (6) [back to overview]Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Central Imaging
NCT02620865 (3) [back to overview]Median Overall Survival (OS)
NCT02620865 (3) [back to overview]Incidence of Toxicity (CTCAE Version 4.0)
NCT02620865 (3) [back to overview]Progression Free Survival (PFS)
NCT02730546 (1) [back to overview]Pathological Complete Response (PathCR) Rate
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]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]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 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 5 of Second Course of Azacitidine
NCT02833350 (30) [back to overview]Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response
NCT02833350 (30) [back to overview]Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response
NCT02833350 (30) [back to overview]Change in Disease Activity Score From Baseline Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])
NCT02833350 (30) [back to overview]Change in Disease Activity Score From Baseline Based on 28-Joints Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR])
NCT02833350 (30) [back to overview]Change in Disease Activity Score From Baseline Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP])
NCT02833350 (30) [back to overview]Change in Disease Activity Score From Baseline Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])
NCT02833350 (30) [back to overview]Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score
NCT02833350 (30) [back to overview]Maximum Observed Plasma Concentration of GDC-0853 at Steady State (Cmax,ss)
NCT02833350 (30) [back to overview]Percentage of Participants Achieving ACR50 Response at Day 84, Comparison Between GDC-0853 and Adalimumab (Cohort 1)
NCT02833350 (30) [back to overview]Percentage of Participants Achieving ACR50 Response at Day 84, Comparison Between GDC-0853 and Placebo (Cohort 2)
NCT02833350 (30) [back to overview]Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Day 84, Comparison Between GDC-0853 and Placebo (Cohort 1)
NCT02833350 (30) [back to overview]Percentage of Participants With Adverse Events
NCT02833350 (30) [back to overview]Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) Scores for Physical and Mental Components
NCT02833350 (30) [back to overview]Change From Baseline in C-Reactive Protein (CRP) Levels
NCT02833350 (30) [back to overview]Change From Baseline in Clinical Disease Activity Index (CDAI)
NCT02833350 (30) [back to overview]Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
NCT02833350 (30) [back to overview]Change From Baseline in Tender/Painful Joint Count (68 Joint Count)
NCT02833350 (30) [back to overview]Change From Baseline in Patient Assessment Score of Arthritis Pain
NCT02833350 (30) [back to overview]Change From Baseline in Patient Global Assessment Score of Arthritis Pain
NCT02833350 (30) [back to overview]Change From Baseline in Physician's Global Assessment Score of Arthritis
NCT02833350 (30) [back to overview]Change From Baseline in Simplified Disease Activity Index (SDAI)
NCT02833350 (30) [back to overview]Change From Baseline in Swollen Joint Count (66 Joint Count)
NCT02833350 (30) [back to overview]Area Under the Concentration Time Curve From Time 0 to Time 24 of GDC-0853 at Steady State (AUC0-24,ss)
NCT02833350 (30) [back to overview]Percentage of Participants With DAS Remission
NCT02833350 (30) [back to overview]Percentage of Participants With DAS Low Disease Activity
NCT02833350 (30) [back to overview]Minimum Observed Plasma Concentration of GDC-0853 at Steady State (Cmin,ss)
NCT02833350 (30) [back to overview]Percentage of Participants Meeting the SDAI-based Remission Criteria
NCT02833350 (30) [back to overview]Percentage of Participants Meeting the CDAI-based Remission Criteria
NCT02833350 (30) [back to overview]Percentage of Participants Meeting the Boolean-based Remission Criteria
NCT02833350 (30) [back to overview]Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response
NCT02890355 (6) [back to overview]Progression Free Survival (PFS)
NCT02890355 (6) [back to overview]Overall Response Rate, ORR
NCT02890355 (6) [back to overview]Disease Control Rate
NCT02890355 (6) [back to overview]Duration of Response (DoR)
NCT02890355 (6) [back to overview]Overall Survival (OS)
NCT02890355 (6) [back to overview]Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
NCT02928224 (78) [back to overview]Phase 3: Number of Participants With Shift in Visual Acuity Logarithm of the Minimum Angle of Resolution (LogMAR) Score
NCT02928224 (78) [back to overview]Phase 3: Number of Participants With Newly Occurring Clinically Notable Vital Sign Abnormalities
NCT02928224 (78) [back to overview]Phase 3: Number of Participants With Newly Occurring Clinically Notable Electrocardiogram (ECG) Values
NCT02928224 (78) [back to overview]Phase 3: Number of Participants With Clinically Notable Shifts in Serum Chemistry Laboratory Parameters
NCT02928224 (78) [back to overview]Phase 3: Number of Participants With Clinically Notable Shifts in Hematology and Coagulation Laboratory Parameters
NCT02928224 (78) [back to overview](Safety Lead-in) Incidence of Dose Interruptions, Dose Modifications and Discontinuations Due to Adverse Events (AEs) - Final Analysis
NCT02928224 (78) [back to overview](Safety Lead-in) Evaluation of the Time of Maximum Observed Concentration (Tmax) for Metabolite of Binimetinib (AR00426032)
NCT02928224 (78) [back to overview](Safety Lead-in) Evaluation of the Time of Maximum Observed Concentration (Tmax) for Encorafenib
NCT02928224 (78) [back to overview](Safety Lead-in) Evaluation of the Time of Maximum Observed Concentration (Tmax) for Cetuximab
NCT02928224 (78) [back to overview](Safety Lead-in) Evaluation of the Time of Maximum Observed Concentration (Tmax) for Binimetinib
NCT02928224 (78) [back to overview](Safety Lead-in) Evaluation of the Maximum Concentration (Cmax) for Metabolite of Binimetinib (AR00426032)
NCT02928224 (78) [back to overview](Safety Lead-in) Evaluation of the Maximum Concentration (Cmax) for Encorafenib
NCT02928224 (78) [back to overview](Safety Lead-in) Evaluation of the Maximum Concentration (Cmax) for Cetuximab
NCT02928224 (78) [back to overview](Safety Lead-in) Evaluation of the Maximum Concentration (Cmax) for Binimetinib
NCT02928224 (78) [back to overview](Safety Lead-in) Evaluation of the Area Under the Concentration-time Curve From Zero to the Last Measurable Time Point (AUClast) for Metabolite of Binimetinib (AR00426032)
NCT02928224 (78) [back to overview](Safety Lead-in) Evaluation of the Area Under the Concentration-Time Curve From Zero to the Last Measurable Time Point (AUClast) for Encorafenib
NCT02928224 (78) [back to overview](Safety Lead-in) Evaluation of the Area Under the Concentration-Time Curve From Zero to the Last Measurable Time Point (AUClast) for Cetuximab
NCT02928224 (78) [back to overview](Safety Lead-in) Evaluation of the Area Under the Concentration-Time Curve From Zero to the Last Measurable Time Point (AUClast) for Binimetinib
NCT02928224 (78) [back to overview](Phase 3) Change From Baseline in the Participant Global Impression of Change (PGIC) in Triplet Arm vs Control Arm, Doublet Arm vs Control, and Triplet vs Doublet
NCT02928224 (78) [back to overview](Phase 3) Change From Baseline in the Participant Global Impression of Change (PGIC) in Triplet Arm vs Control Arm, Doublet Arm vs Control, and Triplet vs Doublet
NCT02928224 (78) [back to overview](Phase 3) Change From Baseline in the Functional Assessment of Cancer Therapy-Colon Cancer (FACT-C) in Triplet Arm vs Control Arm, Doublet Arm vs Control, and Triplet vs Doublet
NCT02928224 (78) [back to overview](Phase 3) Change From Baseline in the Functional Assessment of Cancer Therapy-Colon Cancer (FACT-C) in Triplet Arm vs Control Arm, Doublet Arm vs Control, and Triplet vs Doublet
NCT02928224 (78) [back to overview](Phase 3) Change From Baseline in the Functional Assessment of Cancer Therapy-Colon Cancer (FACT-C) in Triplet Arm vs Control Arm, Doublet Arm vs Control, and Triplet vs Doublet
NCT02928224 (78) [back to overview](Phase 3) Change From Baseline in the EuroQol-5D-5L Visual Analog Scale (EQ-5D-5L VAS) in Triplet Arm vs Control Arm, Doublet Arm vs Control, and Triplet vs Doublet
NCT02928224 (78) [back to overview](Phase 3) Change From Baseline in the EuroQol-5D-5L Visual Analog Scale (EQ-5D-5L VAS) in Triplet Arm vs Control Arm, Doublet Arm vs Control, and Triplet vs Doublet
NCT02928224 (78) [back to overview](Phase 3) Change From Baseline in the EuroQol-5D-5L Visual Analog Scale (EQ-5D-5L VAS) in Triplet Arm vs Control Arm, Doublet Arm vs Control, and Triplet vs Doublet
NCT02928224 (78) [back to overview](Phase 3) Change From Baseline in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Cancer Participants (QLQ-C30) Triplet Arm vs Control Arm, Doublet Arm vs Control, and Triplet vs Doublet
NCT02928224 (78) [back to overview](Phase 3) Change From Baseline in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Cancer Participants (QLQ-C30) Triplet Arm vs Control Arm, Doublet Arm vs Control, and Triplet vs Doublet
NCT02928224 (78) [back to overview](Phase 3) Change From Baseline in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Cancer Participants (QLQ-C30) Triplet Arm vs Control Arm, Doublet Arm vs Control, and Triplet vs Doublet
NCT02928224 (78) [back to overview](Safety Lead-in) Evaluation of the Steady-State Concentration Measured Just Before the Next Dose of Study Drug (Ctrough) for Cetuximab
NCT02928224 (78) [back to overview](Safety Lead-in) Evaluation of the Steady-State Concentration Measured Just Before the Next Dose of Study Drug (Ctrough) for Binimetinib
NCT02928224 (78) [back to overview](Safety Lead-in) Evaluation of the Steady-State Concentration Measured Just Before the Next Dose of Study Drug (Ctrough) for a Metabolite of Binimetinib
NCT02928224 (78) [back to overview](Safety Lead-in) Duration of Response (DOR) by Investigator
NCT02928224 (78) [back to overview](Safety Lead-in) Duration of Response (DOR) by BICR
NCT02928224 (78) [back to overview](Phase 3) Overall Survival (OS) of Triplet Arm vs. Control Arm - Interim Analysis
NCT02928224 (78) [back to overview]Phase 3: Number of Participants With Clinically Notable Shifts in Urinalysis Laboratory Parameters
NCT02928224 (78) [back to overview](Safety Lead-in) Time to Response by Investigator
NCT02928224 (78) [back to overview](Safety Lead-in) Time to Response by BICR
NCT02928224 (78) [back to overview](Safety Lead-in) Progression-Free Survival (PFS) by Investigator
NCT02928224 (78) [back to overview](Safety Lead-in) Progression-Free Survival (PFS) by BICR
NCT02928224 (78) [back to overview](Safety Lead-in) Objective Response Rate (ORR) by Investigator
NCT02928224 (78) [back to overview](Safety Lead-in) Objective Response Rate (ORR) by BICR
NCT02928224 (78) [back to overview](Safety Lead-in) Number of Participants With Dose-Limiting Toxicities (DLTs)
NCT02928224 (78) [back to overview](Phase 3) Overall Survival (OS) of Triplet Arm vs. Control Arm - Final Analysis
NCT02928224 (78) [back to overview](Phase 3) Overall Survival (OS) in Triplet Arm vs. Doublet Arm
NCT02928224 (78) [back to overview](Phase 3) Objective Response Rate (ORR) by Blinded Independent Central Review (BICR) Per Response Evaluation Criteria in Solid Tumors (RECIST), v1.1 of Triplet Arm vs. Control Arm
NCT02928224 (78) [back to overview](Phase 3) Evaluation of the Model-Based Oral Clearance (CL/F) for Encorafenib
NCT02928224 (78) [back to overview](Phase 3) Evaluation of the Model-Based Oral Clearance (CL/F) for Binimetinib
NCT02928224 (78) [back to overview](Phase 3) Evaluation of the Model-Based Clearance (CL) for Cetuximab
NCT02928224 (78) [back to overview](Phase 3) Comparison of Time to Response in Triplet Arm vs Doublet Arm Per Investigator
NCT02928224 (78) [back to overview](Phase 3) Comparison of Time to Response in Triplet Arm vs Doublet Arm Per BICR
NCT02928224 (78) [back to overview](Phase 3) Comparison of Time to Response in Triplet Arm vs Control Arm Per Investigator
NCT02928224 (78) [back to overview](Phase 3) Comparison of Time to Response in Triplet Arm vs Control Arm Per BICR
NCT02928224 (78) [back to overview](Phase 3) Comparison of Time to Response in Doublet Arm vs Control Arm Per Investigator
NCT02928224 (78) [back to overview](Phase 3) Comparison of Time to Response in Doublet Arm vs Control Arm Per BICR
NCT02928224 (78) [back to overview](Phase 3) Comparison of Progression-Free Survival (PFS) in Triplet Arm vs Doublet Arm Per Investigator
NCT02928224 (78) [back to overview](Phase 3) Comparison of Progression-Free Survival (PFS) in Triplet Arm vs Doublet Arm Per BICR
NCT02928224 (78) [back to overview](Phase 3) Comparison of Progression-free Survival (PFS) in Triplet Arm vs Control Arm Per Investigator
NCT02928224 (78) [back to overview](Phase 3) Comparison of Progression-Free Survival (PFS) in Triplet Arm vs Control Arm Per BICR
NCT02928224 (78) [back to overview](Phase 3) Comparison of Progression-Free Survival (PFS) in Doublet Arm vs Control Arm Per Investigator
NCT02928224 (78) [back to overview](Phase 3) Comparison of Progression-Free Survival (PFS) in Doublet Arm vs Control Arm Per BICR
NCT02928224 (78) [back to overview](Phase 3) Comparison of Objective Response Rate (ORR) in Triplet Arm vs Doublet Arm Per Investigator
NCT02928224 (78) [back to overview](Phase 3) Comparison of Objective Response Rate (ORR) in Triplet Arm vs Doublet Arm Per BICR
NCT02928224 (78) [back to overview](Phase 3) Comparison of Objective Response Rate (ORR) in Triplet Arm vs Control Arm Per Investigator
NCT02928224 (78) [back to overview](Phase 3) Comparison of Objective Response Rate (ORR) in Doublet Arm vs Control Arm Per Investigator
NCT02928224 (78) [back to overview](Phase 3) Comparison of Objective Response Rate (ORR) in Doublet Arm vs Control Arm Per BICR
NCT02928224 (78) [back to overview](Phase 3) Comparison of Duration of Response (DOR) in Triplet Arm vs Doublet Arm by Investigator
NCT02928224 (78) [back to overview](Phase 3) Comparison of Duration of Response (DOR) in Triplet Arm vs Doublet Arm by BICR
NCT02928224 (78) [back to overview](Phase 3) Comparison of Duration of Response (DOR) in Triplet Arm vs Control Arm Per Investigator
NCT02928224 (78) [back to overview](Phase 3) Comparison of Duration of Response (DOR) in Triplet Arm vs Control Arm Per BICR
NCT02928224 (78) [back to overview](Phase 3) Comparison of Duration of Response (DOR) in Doublet Arm vs Control Arm Per Investigator
NCT02928224 (78) [back to overview](Phase 3) Comparison of Duration of Response (DOR) in Doublet Arm vs Control Arm Per BICR
NCT02928224 (78) [back to overview](Safety Lead-in) Evaluation of the Steady-State Concentration Measured Just Before the Next Dose of Study Drug (Ctrough) for Encorafenib
NCT02928224 (78) [back to overview](Phase 3) Overall Survival (OS) in Doublet Arm vs. Control Arm
NCT02928224 (78) [back to overview](Phase 3) Change From Baseline in the Participant Global Impression of Change (PGIC) in Triplet Arm vs Control Arm, Doublet Arm vs Control, and Triplet vs Doublet
NCT02928224 (78) [back to overview]Phase 3: Number of Participants With Shifts in Left Ventricular Ejection Fraction (LVEF) From Baseline to Maximum Grade On-treatment
NCT02928224 (78) [back to overview](Safety Lead-in) Number of Participants With Adverse Events (AEs)
NCT02928224 (78) [back to overview](Safety Lead-in) Incidence of Dose Interruptions, Dose Modifications and Discontinuations Due to Adverse Events (AEs) - Interim Analysis
NCT02930343 (4) [back to overview]Disease Activity as Per Ultrasound-7 (US-7) Score
NCT02930343 (4) [back to overview]Indian Health Assessment Questionnaire (iHAQ)
NCT02930343 (4) [back to overview]Number of Patients Achieving Good EULAR Response at the End of 12 Weeks
NCT02930343 (4) [back to overview]Number of Participants With Adverse Drug Reactions
NCT03028467 (16) [back to overview]Number of Participants With Emergent Clinical Chemistry Results Relative to Normal Range
NCT03028467 (16) [back to overview]Area Under the Concentration-time Curve (AUC) From Time Zero to the Time of the Last Quantifiable Concentration (AUC [0-t]), AUC From Time Zero Extrapolated to Infinity (AUC [0-inf]), AUC Over the Dosing Interval (AUCtau) of GSK3196165
NCT03028467 (16) [back to overview]Maximum Observed Concentration (Cmax) of GSK3196165
NCT03028467 (16) [back to overview]Terminal Half-life (t1/2) of GSK3196165
NCT03028467 (16) [back to overview]Number of Participants With Any Adverse Event (AE), Serious AE (SAE) and Adverse Events of Special Interest (AESI)
NCT03028467 (16) [back to overview]Number of Participants With Emergent Hematology Results Relative to Normal Range
NCT03028467 (16) [back to overview]Number of Participants With Urinalysis Dipstick Findings
NCT03028467 (16) [back to overview]Change From Baseline in Disease Activity Score for 28 Different Joints C-reactive Protein (DAS28 [CRP]) at All Indicated Timepoints
NCT03028467 (16) [back to overview]Change From Baseline in Heart Rate (HR)
NCT03028467 (16) [back to overview]Change From Baseline in Respiratory Rate
NCT03028467 (16) [back to overview]Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
NCT03028467 (16) [back to overview]Time to Reach Cmax (Tmax) of GSK3196165
NCT03028467 (16) [back to overview]Area Under the Concentration-time Curve (AUC) From Time Zero to the Time of the Last Quantifiable Concentration (AUC [0-t]), AUC From Time Zero Extrapolated to Infinity (AUC [0-inf]), AUC Over the Dosing Interval (AUCtau) of GSK3196165
NCT03028467 (16) [back to overview]Change From Baseline in Body Temperature
NCT03028467 (16) [back to overview]Number of Participants With Anti-GSK3196165 Antibody Test Results
NCT03028467 (16) [back to overview]Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings
NCT03172325 (5) [back to overview]Health Assessment Questionnaire (HAQ) Disability Index at Week 24.
NCT03172325 (5) [back to overview]Immunogenicity: Number of Participants With Anti-Drug Antibodies (ADA)
NCT03172325 (5) [back to overview]Percentage of Patients With DAS28-EULAR Good and Moderate Responses 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
NCT03349333 (18) [back to overview]Progression-Free Survival (PFS)
NCT03349333 (18) [back to overview]Overall Survival (OS)
NCT03349333 (18) [back to overview]Objective Response Rate(ORR) by International Working Group Criteria
NCT03349333 (18) [back to overview]Duration of Responses
NCT03349333 (18) [back to overview]Steady State Clearance [CLss] for R-pralatrexate
NCT03349333 (18) [back to overview]Steady State Volume of Distribution [Vdss] for R-pralatrexate
NCT03349333 (18) [back to overview]Steady State Volume of Distribution [Vdss] for S-pralatrexate
NCT03349333 (18) [back to overview]Terminal Phase Half-life [t1/2Z] for R-pralatrexate
NCT03349333 (18) [back to overview]Terminal Phase Half-life [t1/2Z] for S-pralatrexate
NCT03349333 (18) [back to overview]Steady State Clearance [CLss] for S-pralatrexate
NCT03349333 (18) [back to overview]Time of Cmax Observation [Tmax] for R-pralatrexate
NCT03349333 (18) [back to overview]Percentage of Participants With Treatment Emergent Adverse Events
NCT03349333 (18) [back to overview]Time of Cmax Observation [Tmax] for S-pralatrexate
NCT03349333 (18) [back to overview]Maximum Observed Plasma Concentration [Cmax] for S-pralatrexate
NCT03349333 (18) [back to overview]Maximum Observed Plasma Concentration [Cmax] for R-pralatrexate
NCT03349333 (18) [back to overview]Area Under the Curve [AUC] for S-pralatrexate
NCT03349333 (18) [back to overview]Area Under the Curve [AUC] for R-pralatrexate
NCT03349333 (18) [back to overview]Time to Response (TTR)
NCT03444155 (10) [back to overview]Serum Riboflavin
NCT03444155 (10) [back to overview]Serum Total Antioxidant Capacity
NCT03444155 (10) [back to overview]Serum Cobalamin
NCT03444155 (10) [back to overview]Serum Total Peroxides
NCT03444155 (10) [back to overview]Serum Thiamine
NCT03444155 (10) [back to overview]Total Homocysteine
NCT03444155 (10) [back to overview]Serum Pyridoxine
NCT03444155 (10) [back to overview]Serum Polyphenols
NCT03444155 (10) [back to overview]Serum Folic Acid
NCT03444155 (10) [back to overview]Serum Endogenous Peroxidase-activity
NCT03488225 (5) [back to overview]Number of Participants With Adverse Events
NCT03488225 (5) [back to overview]Participants to Achieve Complete Remission (CR):
NCT03488225 (5) [back to overview]Overall Survival
NCT03488225 (5) [back to overview]Number of Participants With Minimal Residual Disease (MRD) Negativity
NCT03488225 (5) [back to overview]Event-Free Survival
NCT03504423 (3) [back to overview]Overall Survival (OS)
NCT03504423 (3) [back to overview]Progression Free Survival (PFS)
NCT03504423 (3) [back to overview]Overall Response Rate (ORR)
NCT03518112 (5) [back to overview]Overall Survival
NCT03518112 (5) [back to overview]Number of Participants Negative for Minimal Residual Disease (MRD)
NCT03518112 (5) [back to overview]Event Free Survival (EFS) Where Events Defined as no Response, Loss of Response, or Death
NCT03518112 (5) [back to overview]Duration of Response
NCT03518112 (5) [back to overview]Participants With a Response
NCT03611556 (31) [back to overview]Serum Concentrations of Durvalumab
NCT03611556 (31) [back to overview]Serum Concentrations of Oleclumab
NCT03611556 (31) [back to overview]Serum Concentrations of Oleclumab
NCT03611556 (31) [back to overview]Percentage of Participants With DC According to RECIST v1.1 in Dose Expansion Phase
NCT03611556 (31) [back to overview]Duration of Response (DoR) According to RECIST v1.1 in Dose Expansion Phase
NCT03611556 (31) [back to overview]Number of Participants With Dose-limiting Toxicities (DLTs) in Dose Escalation Phase
NCT03611556 (31) [back to overview]Number of Participants With Overall Survival Events by CD73 Expression at Baseline in Dose Expansion Phase
NCT03611556 (31) [back to overview]Number of Participants With Overall Survival Events in Dose Expansion Phase
NCT03611556 (31) [back to overview]Number of Participants With Progression-free Survival Events According to RECIST v1.1 by CD73 Expression at Baseline in Dose Expansion Phase
NCT03611556 (31) [back to overview]Number of Participants With Progression-free Survival Events According to RECIST v1.1 in Dose Expansion Phase
NCT03611556 (31) [back to overview]Overall Survival by CD73 Expression at Baseline in Dose Expansion Phase
NCT03611556 (31) [back to overview]Overall Survival in Dose Expansion Phase
NCT03611556 (31) [back to overview]Percentage of Participants With Disease Control (DC) According to RECIST v1.1 in Dose Escalation Phase
NCT03611556 (31) [back to overview]Percentage of Participants With Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in Dose Expansion Phase
NCT03611556 (31) [back to overview]Percentage of Participants With OR According to RECIST v1.1 by CD73 Expression at Baseline in Dose Expansion Phase
NCT03611556 (31) [back to overview]Percentage of Participants With OR According to RECIST v1.1 in Dose Escalation Phase
NCT03611556 (31) [back to overview]Progression-free Survival According to RECIST v1.1 by CD73 Expression at Baseline in Dose Expansion Phase
NCT03611556 (31) [back to overview]Progression-free Survival According to RECIST v1.1 in Dose Expansion Phase
NCT03611556 (31) [back to overview]Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose Escalation Phase
NCT03611556 (31) [back to overview]Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose Expansion Phase
NCT03611556 (31) [back to overview]Number of Participants With Abnormal ECG Parameters Reported as TEAEs in Dose Expansion Phase
NCT03611556 (31) [back to overview]Number of Participants With Abnormal Electrocardiogram (ECG) Parameters Reported as TEAEs in Dose Escalation Phase
NCT03611556 (31) [back to overview]Plasma Concentrations of Nab-paclitaxel
NCT03611556 (31) [back to overview]Number of Participants With Abnormal Vital Signs Reported as TEAEs in Dose Escalation Phase
NCT03611556 (31) [back to overview]Number of Participants With Abnormal Vital Signs Reported as TEAEs in Dose Expansion Phase
NCT03611556 (31) [back to overview]Number of Participants With Positive ADA to Durvalumab
NCT03611556 (31) [back to overview]Number of Participants With Positive Anti-drug Antibodies (ADA) to Oleclumab
NCT03611556 (31) [back to overview]Number of Participants With TEAEs and TESAEs in Dose Expansion Phase
NCT03611556 (31) [back to overview]Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) in Dose Escalation Phase
NCT03611556 (31) [back to overview]Plasma Concentrations of Gemcitabine and Metabolite 2',2'-Difluorodeoxyuridine (dFdU)
NCT03611556 (31) [back to overview]Serum Concentrations of Durvalumab
NCT03635957 (7) [back to overview]Percentage of Serum Uric Acid (sUA < 6 mg/dL) Overall Responders
NCT03635957 (7) [back to overview]Percentage of Serum Uric Acid (sUA < 5 mg/dL) Overall Responders
NCT03635957 (7) [back to overview]Percentage of Serum Uric Acid (sUA < 5 mg/dL) Responders During Month 3
NCT03635957 (7) [back to overview]Percentage of Serum Uric Acid (sUA < 5 mg/dL) Responders During Month 6
NCT03635957 (7) [back to overview]Percentage of Serum Uric Acid (sUA < 6 mg/dL) Responders During Month 3
NCT03635957 (7) [back to overview]Mean Change in sUA From Pegloticase Baseline to Weeks 14, 24, 36, 52
NCT03635957 (7) [back to overview]Percentage of Serum Uric Acid (sUA < 6 mg/dL) Responders During Month 6
NCT03771560 (5) [back to overview]Aberrant Behavior Checklist (ABC) - Parent Reported Change
NCT03771560 (5) [back to overview]Pediatric Quality of Life (PedsQL) - Parent Reported Change
NCT03771560 (5) [back to overview]Social Responsiveness Scale (SRS) - Parent Reported Change
NCT03771560 (5) [back to overview]Social Responsiveness Scale (SRS) - Teacher Reported Change
NCT03771560 (5) [back to overview]Aberrant Behavior Checklist (ABC) - Teacher Reported Change
NCT03892707 (11) [back to overview]Change in Pain-related Disability After 10 Days of Treatment
NCT03892707 (11) [back to overview]Percentage of Patients With at Least One Pain Flare-up During the Study
NCT03892707 (11) [back to overview]Number of Treatment Days With NSAIDs
NCT03892707 (11) [back to overview]Change of Pain Intensity Over Time
NCT03892707 (11) [back to overview]Change of Pain Intensity After 5, 24 and 38 Days of Treatment
NCT03892707 (11) [back to overview]Patient Satisfaction With Treatment
NCT03892707 (11) [back to overview]Percentage of Patients With 30% Low Back Pain Relief After 5, 10, 24 and 38 Days of Treatment.
NCT03892707 (11) [back to overview]Percentage of Patients With at Least One Pain Flare-up Resulting in Consultancy With Physician, Resulting in Disruption of Daily Activity, and Resulting in NSAIDs Intake
NCT03892707 (11) [back to overview]Prescribed and Actual Number of Milgamma® Injections
NCT03892707 (11) [back to overview]Prescribed and Actual Number of Treatment Days With Milgamma® Compositum
NCT03892707 (11) [back to overview]Change of Pain Intensity After 10 Days of Treatment
NCT03950674 (7) [back to overview]Overall Response Rate (ORR) Per RECIST 1.1 as Assessed by Blinded Central Imaging
NCT03950674 (7) [back to overview]Number of Participants Who Experienced an Adverse Event (AE)
NCT03950674 (7) [back to overview]Number of Participants Who Discontinued Any Study Drug Due to an AE
NCT03950674 (7) [back to overview]Duration of Response (DOR) Per RECIST 1.1 as Assessed by Blinded Central Imaging
NCT03950674 (7) [back to overview]Progression-Free Survival (PFS) as Assessed by Investigator Immune-related RECIST (irRECIST) Response Criteria
NCT03950674 (7) [back to overview]Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Central Imaging
NCT03950674 (7) [back to overview]Overall Survival (OS)
NCT03994731 (6) [back to overview]Percentage of sUA (sUA < 6 mg/dL) Responders During Month 12
NCT03994731 (6) [back to overview]Percentage of Serum Uric Acid (sUA) Responders (sUA < 6 mg/dL) During Month 6
NCT03994731 (6) [back to overview]Percentage of Participants With Complete Resolution of ≥ 1 Tophi at Week 52
NCT03994731 (6) [back to overview]Mean Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 52
NCT03994731 (6) [back to overview]Mean Change From Baseline in HAQ Health Score at Week 52
NCT03994731 (6) [back to overview]Mean Change From Baseline HAQ Pain Score at Week 52
NCT04354428 (6) [back to overview]Number of Participants With Hospitalization or Mortality
NCT04354428 (6) [back to overview]Number of Participants With Serious Adverse Events and Adverse Events Resulting in Treatment Discontinuation
NCT04354428 (6) [back to overview]Time to Clearance of Nasal SARS-CoV-2
NCT04354428 (6) [back to overview]Time to Resolution of COVID-19 Symptom Resolution in Days
NCT04354428 (6) [back to overview]COVID-19-related Hospitalization Days
NCT04354428 (6) [back to overview]Number of Persons With Lower Respiratory Tract Infection (LRTI), Defined as Resting Blood Oxygen Saturation (SpO2<93%) Level Sustained for 2 Readings 2 Hours Apart and Presence of Subjective Dyspnea or Cough

Correlation of Early Marrow Response Status With MRD Negative.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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Correlation of Early Marrow Response Status With MRD Positive.

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

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

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

Event Free Probability. (NCT00075725)
Timeframe: 5 years

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

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Change From Baseline in EORTC QLQ-CR38 Defecation Symptom Score at Post-operative Chemotherapy

"The defecation symptom score is calculated from seven symptom questions on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ]-CR38. The question responses range from 1 not at all to 4 very much such that a higher response indicates worse symptoms. The mean of these responses is linearly transformed to a range of 0 (best) to 100 (worst). Change from baseline is calculated as the time point value - baseline value and a decrease from baseline indicates improvement in symptoms. A negative number indicates improvement in symptoms." (NCT00081289)
Timeframe: Baseline and completion of post-operative chemotherapy, approximately 32 to 40 weeks from randomization based on 18 weeks of post-operative chemotherapy

Interventionscore on a scale (Mean)
Neoadjuvant Chemoradiation With Irinotecan-1.6
Neoadjuvant Chemoradiation With Oxaliplatin14.6

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Change From Baseline in EORTC QLQ-CR38 Defecation Symptom Score at Completion of Chemoradiation

"The defecation symptom score is calculated from seven symptom questions on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ]-CR38. The question responses range from 1 not at all to 4 very much such that a higher response indicates worse symptoms. The mean of these responses is linearly transformed to a range of 0 (best) to 100 (worst). Change from baseline is calculated as the time point value - baseline value and a decrease from baseline indicates improvement in symptoms. A negative number indicates improvement in symptoms." (NCT00081289)
Timeframe: Baseline and completion of chemoradiation, approximately 6-8 weeks from randomization

Interventionscore on a scale (Mean)
Neoadjuvant Chemoradiation With Irinotecan4.8
Neoadjuvant Chemoradiation With Oxaliplatin8.8

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Change From Baseline in QLQ-C30 Global Health Status Score at Completion of Chemoradiation

"Global Health Status is calculated from two questions on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ]-C30. The question responses range from 1 very poor to 7 excellent such that a higher response indicates better quality of life (QOL). The mean of these responses is linearly transformed to a range of 0 (worst) to 100 (best). Change from baseline is calculated as the time point value - baseline value and a decrease from baseline indicates decline in quality of life. A positive number indicates improvement in QOL." (NCT00081289)
Timeframe: Baseline and completion of chemoradiation, approximately 6-8 weeks from randomization

Interventionscore on a scale (Mean)
Neoadjuvant Chemoradiation With Irinotecan-10.3
Neoadjuvant Chemoradiation With Oxaliplatin-12.2

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Distant Failure Rate at 4 Years

Time to distant failure is defined as time from randomization to date of the appearance of distant metastases, last known follow-up (censored), or death without distant failure (competing risk). Distant failure rates are estimated by the cumulative incidence method. (NCT00081289)
Timeframe: From randomization to four years

Interventionpercentage of participants (Number)
Neoadjuvant Chemoradiation With Irinotecan24
Neoadjuvant Chemoradiation With Oxaliplatin30

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Disease-free Survival Rate at 4 Years

Disease-free survival time is defined as time from randomization to date of local-regional failure, the appearance of distant metastases, the appearance of a second primary failure, or date of death from any cause/ Disease-free survival rates are estimated by the Kaplan-Meier method. Patients last known to be alive without failure are censored at the date of last contact. (NCT00081289)
Timeframe: From randomization to four years

Interventionpercentage of participants (Number)
Neoadjuvant Chemoradiation With Irinotecan68
Neoadjuvant Chemoradiation With Oxaliplatin62

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Change From Baseline in QLQ-C30 Global Health Status Score at Two Years

"Global Health Status is calculated from two questions on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ]-C30. The question responses range from 1 very poor to 7 excellent such that a higher response indicates better quality of life (QOL). The mean of these responses is linearly transformed to a range of 0 (worst) to 100 (best). Change from baseline is calculated as the time point value - baseline value and a decrease from baseline indicates decline in quality of life. A negative number indicates improvement in symptoms." (NCT00081289)
Timeframe: Baseline and two years

Interventionscore on a scale (Mean)
Neoadjuvant Chemoradiation With Irinotecan-6.8
Neoadjuvant Chemoradiation With Oxaliplatin-1.3

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Change From Baseline in QLQ-C30 Global Health Status Score at Completion of Post-operative Chemotherapy

"Global Health Status is calculated from two questions on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ]-C30. The question responses range from 1 very poor to 7 excellent such that a higher response indicates better quality of life (QOL). The mean of these responses is linearly transformed to a range of 0 (worst) to 100 (best). Change from baseline is calculated as the time point value - baseline value and a decrease from baseline indicates decline in quality of life. A positive number indicates improvement in QOL." (NCT00081289)
Timeframe: Baseline and completion of post-operative chemotherapy approximately 32 to 40 weeks from randomization based on 18 weeks of post-operative chemotherapy

Interventionscore on a scale (Mean)
Neoadjuvant Chemoradiation With Irinotecan-12.5
Neoadjuvant Chemoradiation With Oxaliplatin-7.1

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Change From Baseline in EORTC QLQ-CR38 Gastro-intestinal Symptom Score at Two Years

The gastro-intestinal (GI) symptom score is calculated from five symptom questions on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ]-CR38. The question responses range from 1 (not at all) to 4 (very much) such that a higher response indicates worse symptoms. The mean of these responses is linearly transformed to a range of 0 (best) to 100 (worst). Change from baseline is calculated as the time point value - baseline value and a decrease from baseline indicates improvement in symptoms. A negative number indicates improvement in symptoms. (NCT00081289)
Timeframe: Baseline and two years

Interventionscore on a scale (Mean)
Neoadjuvant Chemoradiation With Irinotecan0.4
Neoadjuvant Chemoradiation With Oxaliplatin6.7

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Local-regional Failure Rate at 4 Years

Local-regional failure is defined as any of the following: no clinical complete response (cCR) in the primary site and/or nodes at any time after treatment completion (persistence), recurrence and/or progression in the primary site and/or nodes after cCR, and nonprotocol surgery to the primary site after cCR. Time to local-regional failure is defined as time from randomization to date of failure, last known follow-up (censored), or death without local-regional failure (competing risk). Local-regional failure rates are estimated by the cumulative incidence method. (NCT00081289)
Timeframe: From randomization to four years

Interventionpercentage of participants (Number)
Neoadjuvant Chemoradiation With Irinotecan16
Neoadjuvant Chemoradiation With Oxaliplatin18

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Change From Baseline in EORTC QLQ-CR38 Gastro-intestinal Symptom Score at Completion of Post-operative Chemotherapy

The gastro-intestinal (GI) symptom score is calculated from five symptom questions on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ]-CR38. The question responses range from 1 (not at all) to 4 (very much) such that a higher response indicates worse symptoms. The mean of these responses is linearly transformed to a range of 0 (best) to 100 (worst). Change from baseline is calculated as the time point value - baseline value and a decrease from baseline indicates improvement in symptoms. A negative number indicates improvement in symptoms. (NCT00081289)
Timeframe: Baseline and completion of post-operative chemotherapy approximately 32 to 40 weeks from randomization based on 18 weeks of post-operative chemotherapy

Interventionscore on a scale (Mean)
Neoadjuvant Chemoradiation With Irinotecan-1.5
Neoadjuvant Chemoradiation With Oxaliplatin3.9

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Change From Baseline in EORTC QLQ-CR38 Gastro-intestinal Symptom Score at Completion of Chemoradiation

The gastro-intestinal (GI) symptom score is calculated from five symptom questions on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ]-CR38. The question responses range from 1 (not at all) to 4 (very much) such that a higher response indicates worse symptoms. The mean of these responses is linearly transformed to a range of 0 (best) to 100 (worst). Change from baseline is calculated as the time point value - baseline value and a decrease from baseline indicates improvement in symptoms. A negative number indicates improvement in symptoms. (NCT00081289)
Timeframe: Baseline and completion of chemoradiation approximately 6-8 weeks from randomization

Interventionscore on a scale (Mean)
Neoadjuvant Chemoradiation With Irinotecan5.9
Neoadjuvant Chemoradiation With Oxaliplatin20.3

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Change From Baseline in EORTC QLQ-CR38 Defecation Symptom Score at Two Years

"The defecation symptom score is calculated from seven symptom questions on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ]-CR38. The question responses range from 1 not at all to 4 very much such that a higher response indicates worse symptoms. The mean of these responses is linearly transformed to a range of 0 (best) to 100 (worst). Change from baseline is calculated as the time point value - baseline value and a decrease from baseline indicates improvement in symptoms. A negative number indicates improvement in symptoms." (NCT00081289)
Timeframe: Baseline and two years

Interventionscore on a scale (Mean)
Neoadjuvant Chemoradiation With Irinotecan0.4
Neoadjuvant Chemoradiation With Oxaliplatin-1.6

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Pathologic Complete Response Rate

"A pathologic complete response (pCR) was defined as no evidence of residual cancer histologically; disease progression or death before surgery was considered less than pCR (even without surgical specimen). All cases were reviewed by the study's surgical oncology co-chair for the determination of pCR.~Each arm was first analyzed alone. If the arm had 9 or more pCRs in 48 evaluable pts, then the null hypothesis (H0) of 10% pCR rate would be rejected in favor of the alternative hypothesis of 25%, providing 90% power with a two-sided 10% type I error rate. If both arms reject H0, then statistical selection theory would be used to choose the arm for further study in a phase III trial. If only one arm has acceptable pCR rate, then that arm would be pursued in a phase III trial." (NCT00081289)
Timeframe: After protocol surgery, approximately 10-16 weeks from randomization based on surgery occurring 4-8 weeks after chemoradiation

Interventionpercentage of participants (Number)
Neoadjuvant Chemoradiation With Irinotecan10.4
Neoadjuvant Chemoradiation With Oxaliplatin20.8

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Second Primary Rate at 4 Years

Time to second primary is defined as time from randomization to date of the appearance of a second primary cancer, last known follow-up (censored), or death without second primary (competing risk). Second primary rates are estimated by the cumulative incidence method. (NCT00081289)
Timeframe: From randomization to four years

Interventionpercentage of participants (Number)
Neoadjuvant Chemoradiation With Irinotecan2
Neoadjuvant Chemoradiation With Oxaliplatin6

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Survival Rate at 4 Years

Survival time is defined as time from registration/randomization to the date of death from any cause or last known follow-up (censored). Survival rates are estimated by the Kaplan-Meier method. (NCT00081289)
Timeframe: From randomization to four years

Interventionpercentage of participants (Number)
Neoadjuvant Chemoradiation With Irinotecan85
Neoadjuvant Chemoradiation With Oxaliplatin75

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Number of Participants Experiencing Grade 3-4 Toxicity While Receiving the Study Treatment

Toxicity event collected during Induction chemotherapy (CT) - two 3-week cycles, Concurrent CT and Radiation Therapy (CRT) (approximately 5.5 weeks), post CRT (4 weeks after the end of CRT), 2-3 months post CRT (8-12 weeks after the end of CRT) (NCT00089024)
Timeframe: From time of first dose until 30 days following final treatment, approximately 24 weeks

InterventionParticipants (Count of Participants)
Induction CT, grade 3Induction CT, grade 4CRT, grade 3CRT, grade 4Within 1 mo. post CRT, grade 3Within 1 mo. post CRT, grade 42-3 mos. post CRT, grade 32-3 mos. post CRT, grade 4
Treatment4511012190

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Surgical Exploration

Patients who completed chemotherapy & chemo-radiation had restaging imaging studies 4 weeks after completion of chemo-radiation. If there were no contraindications for surgical resection, surgical exploration was performed 6-8 weeks after completing chemo-radiation (NCT00089024)
Timeframe: After 6 weeks of chemotherapy and then after 4 weeks of chemo-radiation.

InterventionParticipants (Count of Participants)
unresectable diseaseintra-abdominal metastasisresection of the primary tumor
Treatment469

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Survival

Percentage of patients who did not experience an event where events are defined as death from any cause. (NCT00096278)
Timeframe: 5 years

Interventionpercentage of patients (Number)
Arm I (mFOLFOX6)77.6
Arm II (Bevacizumab, mFOLFOX6)78.7

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Disease-free Survival

Where events are defined as recurrence, second primary cancer, or death from any cause (NCT00096278)
Timeframe: 3 years

Interventionpercentage of patients (Number)
Arm 1: Oxaliplatin + Leucovorin + 5-Fluorouracil75.5
Arm 2: Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab77.4

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Non-fatal Stroke, Non-fatal Myocardial Infarction or Death Due to Vascular Causes

(NCT00097669)
Timeframe: The primary outcome was measured over a median follow-up period of 3.4 years (interquartile range IQR 1.0-5.5 years).

InterventionParticipants (Count of Participants)
Active VITATOPS Tablet (Folic Acid 2mg, B6 25mg , B12 500ug)616
Placebo Tablet678

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Event-free Survival (EFS) for SR-Low Patients

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. (NCT00103285)
Timeframe: 6 years

InterventionPercent probability (Number)
SR-low ALL, Arm I-combination Chemotherapy95.22
SR-low ALL, Arm II-combination Chemotherapy93.96

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Event-Free Survival Probability According to MRD Status End Induction (Day 29)

Event-Free survival by Day 29 MRD status (negative vs positive), Event Free Probability (time from study entry to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. (NCT00103285)
Timeframe: MRD at Day 29 of therapy

InterventionPercent Probability (Number)
Induction Therapy, MRD Negative91.39
Induction Therapy, MRD Positive79.86

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Event-free Survival (EFS) for SR-High Patients.

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. (NCT00103285)
Timeframe: 6 years

Interventionpercent probability (Number)
Group 3-SR-high ALL, Combination Chemotherapy85.58

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Overall Survival Probability (OS) According to Induction Day 29 MRD Status

Overall survival by Day 29 MRD status (negative vs positive), Overall survival defined as time from study entry to death or date of last contact for patients who are alive. (NCT00103285)
Timeframe: Overall Survival Probability of 6 years

Interventionpercent probability (Number)
Induction Therapy, MRD Negative97.07
Induction Therapy, MRD Positive90.47

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Event-free Survival (EFS) for SR-Average ALL Patients

EFS for SR-Average with standard and Intensified Consolidation. 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. (NCT00103285)
Timeframe: 6 years

,
Interventionpercent probability (Number)
Standard and Intensified therapy
Group 2-SR-avg ALL, Arm III-combination Chemotherapy88.34
Group 2-SR-avg ALL, Arm IV-combination Chemotherapy90.51

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Event-Free Survival (EFS) for Low MRD (Negative) Subjects by Genetic Subset (TEL/Trisomy Positive vs Negative)

Event-free probability where EFS 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. (NCT00103285)
Timeframe: 6 years

InterventionPercent probability (Number)
Group 1-SR-low ALL, Arm I-combination Chemotherapy95.22
Group 2-SR-avg ALL, Arm I-combination Chemotherapy88.52

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Event-free Survival (EFS) for SR-Average ALL Patients

EFS for SR-Average with standard and Intensified Consolidation. 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. (NCT00103285)
Timeframe: 6 years

,
Interventionpercent probability (Number)
Standard and Intensified therapyStandard therapy
Group 2-SR-avg ALL, Arm I-combination Chemotherapy83.8287.41
Group 2-SR-avg ALL, Arm II-combination Chemotherapy88.8988.29

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Early Marrow Status (EMS) by MRD Status End Induction (Day 29)

Early Marrow Status defined as M1 versus M2/M3 marrow is correlated with MRD (Positive vs. Negative) (NCT00103285)
Timeframe: Early Marrow Status at Day 15, MRD Status at Day 29 of therapy.

InterventionParticipants (Count of Participants)
All Patients for Induction, MRD Negative4378
All Patients for Induction, MRD Positive258

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Major Vascular Events (MVE)

Major vascular events (MVE) defined as major coronary events (MCE [non-fatal MI, coronary death or coronary revascularisation]), non-fatal or fatal stroke, or peripheral revascularization (peripheral artery angioplasty or arterial surgery, including amputations), during the scheduled study treatment period. (NCT00124072)
Timeframe: 6.7 years median follow-up

InterventionParticipants (Number)
Simvastatin 20 mg Daily1553
Simvastatin 80 mg Daily1477
Folic Acid 2 mg + Vitamin B12 1 mg Daily1537
Placebo1493

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Disease Free Survival (DFS)

time interval between the date of randomization and the earliest date of local, regional or distant relapse, or death due to cancer. (NCT00143403)
Timeframe: last tumor assessment date or cut-off date, whichever is earlier.

Interventionmonths (Median)
5-FU/FA21.6
Irinotecan + 5-FU/FA24.7

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Overall Survival Rates

Probability of being alive was calculated in a yearly increment. (NCT00143403)
Timeframe: Median follow-up time (42 months)

,
Interventionsurvival rate (Number)
12 months24 months36 months
5-FU/FA0.9610.8450.716
Irinotecan + 5-FU/FA0.9730.8810.727

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Overall Survival Time (OS)

Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whichever is later. (NCT00154102)
Timeframe: Time from randomisation to death or last day known to be alive, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 31 May 2009

Interventionmonths (Median)
Cetuximab Plus FOLFIRI19.9
FOLFIRI Alone18.6

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Participants With No Residual Tumor After Metastatic Surgery

Participants with no residual tumor after on-study surgery for metastases (NCT00154102)
Timeframe: time from first dose up to 30 days after last dose of study treatment reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 30 Nov 2007

InterventionParticipants (Number)
Cetuximab Plus FOLFIRI29
FOLFIRI Alone10

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Progression-free Survival Time (Chinese V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Wild-Type Population) - Independent Review Committee (IRC) Assessments

"Duration from randomization until radiological progression (based on modified WHO criteria) or death due to any cause.~Only deaths within 60 days of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment." (NCT00154102)
Timeframe: Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006

Interventionmonths (Median)
Cetuximab Plus FOLFIRI9.9
FOLFIRI Alone8.4

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Progression-free Survival Time (KRAS Mutant Population) - Independent Review Committee (IRC) Assessments

"Duration from randomization until radiological progression (based on modified WHO criteria) or death due to any cause.~Only deaths within 60 days of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment." (NCT00154102)
Timeframe: Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006

Interventionmonths (Median)
Cetuximab Plus FOLFIRI7.4
FOLFIRI Alone7.7

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Safety - Number of Patients Experiencing Any Adverse Event

Please refer to Adverse Events section for further details (NCT00154102)
Timeframe: time from first dose up to 30 days after last dose of study treatment reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 30 Nov 2007

Interventionparticipants (Number)
Cetuximab Plus FOLFIRI599
FOLFIRI Alone597

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Quality of Life (QOL) Assessment European Organisation for the Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status

Mean global health status scores (EORTC QLQ-C30) against time for each treatment group. Scores were derived from mutually exclusive sets of items, with scale scores ranging from 0 to 100 after a linear transformation. Higher scores indicate a better QoL. (NCT00154102)
Timeframe: at baseline, at week 8, at week 16, at week 24, at week 32, and at week 40, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006

,
Interventionscores on a scale (Least Squares Mean)
At baselineAt week 8At week 16At week 24At week 32At week 40
Cetuximab Plus FOLFIRI58.8859.0260.7761.8359.6863.43
FOLFIRI Alone60.3361.8363.2964.0665.0764.02

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Quality of Life Assessment (EORTC QLQ-C30) Social Functioning

Mean social functioning scores (EORTC QLQ-C30) against time for each treatment group. Scores were derived from mutually exclusive sets of items, with scale scores ranging from 0 to 100 after a linear transformation. Higher scores indicate a higher level of functioning. (NCT00154102)
Timeframe: at baseline, at week 8, at week 16, at week 24, at week 32, and at week 40, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006

,
Interventionscores on a scale (Least Squares Mean)
At baselineAt week 8At week 16At week 24At week 32At week 40
Cetuximab Plus FOLFIRI75.2174.1473.7276.3174.0476.58
FOLFIRI Alone77.2876.7176.6777.9875.6478.07

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Disease Control Rate - Independent Review Committee (IRC) Assessments

The disease control rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response + Stable Disease as best overall response according to radiological assessments (based on modified WHO criteria). (NCT00154102)
Timeframe: Evaluations were performed every 6 weeks until progression reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006

Interventionpercentage of participants (Number)
Cetuximab Plus FOLFIRI84.3
FOLFIRI Alone85.5

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Progression-free Survival (PFS) Time - Independent Review Committee (IRC) Assessments

"Duration from randomization until radiological progression (based on modified World Health Organisation (WHO) criteria) or death due to any cause.~Only deaths within 60 days of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment." (NCT00154102)
Timeframe: Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006

Interventionmonths (Median)
Cetuximab Plus FOLFIRI8.9
FOLFIRI Alone8.0

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Best Overall Response Rate - Independent Review Committee (IRC) Assessments

The best overall response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as the best overall response according to radiological assessments (based on modified WHO criteria). (NCT00154102)
Timeframe: evaluations were performed every 6 weeks until progression reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006

Interventionpercentage of participants (Number)
Cetuximab Plus FOLFIRI46.9
FOLFIRI Alone38.7

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Best Overall Response Rate (KRAS Mutant Population) - Independent Review Committee (IRC) Assessments

The best overall response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as the best overall response according to radiological assessments (based on modified WHO criteria). (NCT00154102)
Timeframe: evaluations were performed every 6 weeks until progression reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006

Interventionpercentage of participants (Number)
Cetuximab Plus FOLFIRI31.3
FOLFIRI Alone36.1

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Best Overall Response Rate (KRAS Wild-Type Population) - Independent Review Committee (IRC) Assessments

The best overall response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as the best overall response according to radiological assessments (based on modified WHO criteria). (NCT00154102)
Timeframe: evaluations were performed every 6 weeks until progression reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006

Interventionpercentage participants (Number)
Cetuximab Plus FOLFIRI57.3
FOLFIRI Alone39.7

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Duration of Response - Independent Review Committee (IRC) Assessments

"Time from first assessment of Complete Response or Partial Response to disease progression or death (within 60 days of last tumor assessment).~Patients without event are censored on the date of last tumor assessment. Tumor assessments based on modified WHO criteria." (NCT00154102)
Timeframe: Time from first assessment of complete response or partial response to disease progression, death or last tumor assessment reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006

Interventionmonths (Median)
Cetuximab Plus FOLFIRI9.6
FOLFIRI Alone7.7

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Overall Survival Time (KRAS Mutant Population)

Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whichever is later. (NCT00154102)
Timeframe: Time from randomisation to death or last day known to be alive reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 31 May 2009

Interventionmonths (Median)
Cetuximab Plus FOLFIRI16.2
FOLFIRI Alone16.7

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Overall Survival Time (KRAS Wild-Type Population)

Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whichever is later. (NCT00154102)
Timeframe: Time from randomisation to death or last day known to be alive reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 31 May 2009

Interventionmonths (Median)
Cetuximab Plus FOLFIRI23.5
FOLFIRI Alone20.0

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Time to Progressive Disease - Avastin Subgroup

Defined as the time from study enrollment to the first date of disease progression. Time to disease progression was censored at the date of death if death was due to other cause. (NCT00192075)
Timeframe: randomization to the date of first documented disease progression or death due to disease under study, whichever comes first (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)

Interventionmonths (Median)
A+FFG - Avastin Subgroup13.7
A + FOLFOX 4 - Avastin Subgroup13.8

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Survival at 12 Months and 24 Months - Avastin Subgroup

Percentage of participants who were alive at 12 months and 24 months. (NCT00192075)
Timeframe: randomization to the date of death from any cause (up to 24 months)

,
Interventionpercentage of participants alive (Number)
12-Month Survival24-Month Survival
A + FOLFOX 4 - Avastin Subgroup83.366.7
A+FFG - Avastin Subgroup75.650.4

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Toxicity - Avastin Subgroup

Includes all Grade 3-4 hematologic toxicities and all non-hematologic toxicities with either >=1 Grade 4 or >=2 Grade 3 adverse events (NCT00192075)
Timeframe: every cycle (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)

,
Interventionparticipants (Number)
Neutropenia (Grade 3)Neutropenia (Grade 4)Thrombocytopenia (Grade 3)Thrombocytopenia (Grade 4)Leukopenia (Grade 3)Leukopenia (Grade 4)Anemia (Grade 3)Anemia (Grade 4)Febrile neutropenia (Grade 3)Febrile neutropenia (Grade 4)Diarrhea (Grade 3)Diarrhea (Grade 4)Small intestinal obstruction (Grade 3)Small intestinal obstruction (Grade 4)Fatigue (Grade 3)Fatigue (Grade 4)Cerebral infarction (Grade 3)Cerebral infarction (Grade 4)Hyperglycemia (Grade 3)Hyperglycemia (Grade 4)Dehydration (Grade 3)Dehydration (Grade 4)Deep vein thrombosis (Grade 3)Deep vein thrombosis (Grade 4)Myocardial infarction (Grade 3)Myocardial infarction (Grade 4)Subdural hematoma (Grade 3)Subdural hematoma (Grade 4)Perirectal abscess (Grade 3)Perirectal abscess (Grade 4)Hypoxia (Grade 3)Hypoxia (Grade 4)
A + FOLFOX 4 - Avastin Subgroup51000000100110200000102002000000
A+FFG - Avastin Subgrouup35103100001010000000000000001000

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Tumor Response - Avastin Subgroup

Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria. (NCT00192075)
Timeframe: baseline to measured progressive disease (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)

,
Interventionparticipants (Number)
Complete Response (CR)Partial Response (PR)Overall Response Rate (CR+PR)Stable Disease (SD)Disease Control Rate (CR+PR+SD)Progressive DiseaseUnknown
A + FOLFOX 4 - Avastin Subgroup18981710
A+FFG - Avastin Subgroup000111161

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Tumor Response by Response Evaluation Criteria In Solid Tumors (RECIST)

Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria. (NCT00192075)
Timeframe: baseline to measured progressive disease (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)

,
Interventionparticipants (Number)
Complete Response (CR)Partial Response (PR)Overall Response Rate (CR+PR)Stable Disease (SD)Disease Control Rate (CR+PR+SD)Progressive DiseaseUnknown
A + FOLFOX 421517163372
A+FFG1342125143

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Duration of Response - A+FOLFOX4 - Avastin Subgroup

The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause. (NCT00192075)
Timeframe: date of first response until the first date of documented progression or death from any cause (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)

Interventionmonths (Median)
A + FOLFOX 4 - Avastin Subgroup5.2

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Progression-Free Survival - Avastin Subgroup

Defined as the time from date of first dose to the first observation of disease progression, or death due to any cause. (NCT00192075)
Timeframe: randomization to the first date of progression or death from any cause (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)

Interventionmonths (Median)
A+FFG - Avastin Subgroup13.7
A + FOLFOX 4 - Avastin Subgroup11.5

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Progression-Free Survival

Defined as the time from randomization to the first observation of disease progression, or death due to any cause. (NCT00192075)
Timeframe: randomization to the first date of progression or death from any cause (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)

Interventionmonths (Median)
A+FFG8.6
A + FOLFOX 49.5

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Overall Survival

Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact. (NCT00192075)
Timeframe: randomization to the date of death from any cause (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)

Interventionmonths (Median)
A+FFG20.6
A + FOLFOX 419.7

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Duration of Response

The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause. (NCT00192075)
Timeframe: date of first response until the first date of documented progression or death from any cause (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)

Interventionmonths (Median)
A+FFG12.7
A + FOLFOX 47.9

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Time to Progressive Disease

Defined as the time from study enrollment to the first date of disease progression. Time to disease progression was censored at the date of death if death was due to other cause. (NCT00192075)
Timeframe: randomization to the date of first documented disease progression or death due to disease under study, whichever comes first (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)

Interventionmonths (Median)
A+FFG8.6
A + FOLFOX 49.7

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Time to Progression

Progression per Response Evaluation Criteria in Solid Tumors (RECIST) or Prostate-Specific Antigen (PSA) Progression RECIST PD=at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions PSA progression=increase in PSA to >50% above lowest level recorded on study. Two consecutive increases required at least 4 weeks apart, but time to progression will be determined at time of first PSA showing increase > 50% above baseline *Note, upper confidence interval was not reached* (NCT00216099)
Timeframe: Study enrollment until progression per RECIST or PSA (for life)

Interventionmonths (Median)
Pemetrexed 500mg/m^25

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Time to Prostate-Specific Antigen (PSA)/Serological Progression

Serological Progression (sPD) - increase in PSA to >50% above lowest level recorded on study. Two consecutive increases required at least 4 weeks apart, but time to progression will be determined at time of first PSA showing increase > 50% above baseline (NCT00216099)
Timeframe: From study enrollment to progression per PSA criteria (for life)

Interventionmonths (Median)
Pemetrexed 500mg/m^22

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Best Overall PSA Response

"Best overall Prostate-Specific Antigen (PSA) response~PSA response is defined by a greater than or equal to 50% decline in PSA confirmed by a second PSA value at least 4 weeks after the first PSA response timepoint PSA Stable Disease is defined as less than a 50% decline in PSA and less than a 50% increase in PSA from baseline PSA progression is defined as greater than or equal to a 50% increase in PSA compared to baseline" (NCT00216099)
Timeframe: Start of treatment until disease progression/recurrence (for life)

Interventionpercentage of participatns (Number)
>50% decline in PSAStable PSAPSA progression
Pemetrexed 500mg/m^282065

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RFC1 G80A Genotype

Samples for RFC1 G80A pharmacogenetic analysis were collected at screening (NCT00216099)
Timeframe: Screening

Interventionparticipants (Number)
A/A GenotypeA/G GenotypeG/G Genotype
Pemetrexed 500mg/m^262218

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OBJECTIVE Overall Response Rate

"Response Evaluation Criteria in Solid Tumors (RECIST). Objective overall response rate is defined as Complete Response (CR) + Partial Response (PR)~Per RECIST:~CR= Disappearance of all target and non-target lesions and normalization of tumor marker level PR= Disappearance of all target lesions and persistence of non-target lesion(s) or maintenance of tumor marker level above normal limits OR at least a 30% decrease in the sum of the longest diameter, taking as reference the baseline sum longest diameter and disappearance of all non-target lesions or persistence of non-target lesion(s) or maintenance of tumor marker level above normal limits" (NCT00216099)
Timeframe: Start of treatment until disease progression/recurrence (for life)

Interventionpercentage of participants (Number)
Participants with PR with meas. dis. per RECISTparticipants with SD maintained at 12 weeks
Pemetrexed 500mg/m^2839

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Safety and Tolerability

Safety and Tolerability was evaluated by reporting the percentage of patient who experienced grade 3 or 4 toxicities using Common Terminology Criteria for Adverse Events CTCAE v3.0 criteria. CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death. (NCT00216099)
Timeframe: 18 months

Interventionpercentage of participants (Number)
Grade 3Grade 4
Pemetrexed 500mg/m^242.98.2

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Overall Survival

(NCT00216099)
Timeframe: From study enrollment until death (for life)

Interventionmonths (Median)
Pemetrexed 500mg/m^214

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Rate of Clinical Benefit

"A clinical benefit is defined as an improvement for at least 3 consecutive weeks in at least one of the following parameters without any sustained worsening in any other:~> 50% reduction in analgesic consumption or > 50% reduction in pain intensity or > 20 point gain in performance status." (NCT00216099)
Timeframe: Any time among evaluable subjects (for life)

Interventionpercentage of participants (Number)
Pemetrexed 500mg/m^233

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Incidence of Central Nervous System (CNS) Hemorrhagic Events

Number of events of brain or central nervous system (CNS) bleeding (NCT00227019)
Timeframe: 18 months

InterventionCNS hemorrhagic events (Number)
Bevacizumab + Pemetrexed0

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Overall Survival (OS)

"Overall Survival (OS) is defined as the duration of time from start of treatment to deat.~Kaplan-Meier survival curves for OS were generated with IBM SPSS Statistics version 19.0 (SPSS, Inc, Chicago, IL)." (NCT00227019)
Timeframe: 18 months

Interventionmonths (Median)
Bevacizumab + Pemetrexed14.8

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Progression-free Survival (PFS)

"Progression-free survival (PFS) is defined as the duration of time from start of treatment to time of documented disease progression or death.~Kaplan-Meier survival curves for PFS were generated with IBM SPSS Statistics version 19.0 (SPSS, Inc, Chicago, IL)." (NCT00227019)
Timeframe: 18 months

Interventionmonths (Median)
Bevacizumab + Pemetrexed7.2

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Correlation Between Baseline Blood Folate Levels and Dietary Intake

Baseline blood folate lab levels and dietary intake levels are reported. (NCT00249288)
Timeframe: Baseline

Interventionnanograms/mL (Mean)
Serum folate, ng/mlRBC folate, ng/ml
Overall14.5569.3

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Correlations Between Baseline Blood Homocysteine Levels and Clinical Ratings of Negative Symptoms by Comparing Lab Levels in Deficit Syndrome Versus Non-deficit Syndrome Patients

Baseline blood homocysteine lab levels are reported by deficit syndrome status. (NCT00249288)
Timeframe: Baseline

Interventionmicromoles/liter (Mean)
Deficit Syndrome9.4
Not Deficit Syndrome9.7

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Correlation Between Baseline Homocysteine Levels and Smoking Status

Baseline blood homocysteine lab levels are reported by smoking status. (NCT00249288)
Timeframe: Baseline

Interventionmicromoles per liter (Mean)
Current Smoker9.1
Past Smoker10.8
Never Smoker9

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Correlation Between Baseline Blood Homocysteine Levels and Dietary Intake

Baseline blood homocysteine lab levels and dietary intake levels are reported. (NCT00249288)
Timeframe: Baseline

Interventionmicromoles/liter (Mean)
Overall9.6

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Correlation Between Baseline Blood B12 Levels and MTHFR Genotype

Baseline blood B12 lab levels are reported by MTHFR genotype. (NCT00249288)
Timeframe: Baseline

Interventionpicograms per milliliter (Mean)
CC Genotype605.5
T- Genotype557.1

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Correlation Between Baseline Blood Folate or B12 Levels and Dietary Intake

Baseline blood folate and B12 lab levels and dietary intake levels are reported. (NCT00249288)
Timeframe: Baseline

Interventionmicrograms (Mean)
Total folate, mcgDietary folate, mcgNatural folate, mcgSynthetic folate, mcgTotal B12, mcg
Overall531.3765.7198.8333.47.5

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Correlation Between Baseline Serum B12 Levels and Dietary Intake

Baseline serum B12 lab levels and dietary intake levels are reported. (NCT00249288)
Timeframe: Baseline

Interventionpicograms/mL (Mean)
Overall566.6

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Correlation Between Baseline Serum B12 Levels and Smoking Status

Baseline serum B12 lab levels are reported by smoking status. (NCT00249288)
Timeframe: Baseline

Interventionpicograms per milliliter (Mean)
Current Smoker625
Past Smoker436
Never Smoker574

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Correlations Between Baseline Blood B12 Levels and Clinical Ratings of Negative Symptoms by Comparing Lab Levels in Deficit Syndrome Versus Non-deficit Syndrome Patients

Baseline blood B12 lab levels are reported by deficit syndrome status. (NCT00249288)
Timeframe: Baseline

Interventionpicograms/mL (Mean)
Deficit Syndrome603
Not Deficit Syndrome513

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Correlation Between Baseline Blood Homocysteine Levels and MTHFR Genotype

Baseline blood homocysteine lab levels are reported by MTHFR genotype. (NCT00249288)
Timeframe: Baseline

Interventionmicromoles/liter (Mean)
CC Genotype9.4
T- Genotype9.6

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Correlation Between Baseline Blood Folate and Smoking Status

Baseline blood folate lab levels are reported by smoking status. (NCT00249288)
Timeframe: Baseline

,,
Interventionnanograms per milliliter (Mean)
Serum folate, ng/mlRBC folate, ng/ml
Current Smoker14.6614
Never Smoker14.2475
Past Smoker14.6542

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Correlation Between Baseline Blood Folate and MTHFR Genotype

Baseline blood folate lab levels are reported by MTHFR genotype. (NCT00249288)
Timeframe: Baseline

,
Interventionnanograms/mL (Mean)
Serum folate, ng/mlRBC folate, ng/ml
CC Genotype13.3624.8
T- Genotype15.2542.8

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Efficacy of Folate Supplementation for Reducing Negative Symptoms as Measured by the SANS Modified Total

The change from baseline to week 12 on the scale for the assessment of negative symptoms (SANS) modified total score. Total SANS scores range from 0-100. The SANS is comprised of 5 sub-scales: Affective Flattening or Blunting (score range 0-35), Alogia (score range 0-20), Avolition-Apathy (score range 0-15), Anhedonia-Asociality (score range 0-20), and Attention (0-10). For each sub-scale, the higher the score the more prominent the negative symptoms were. The total score was computed by adding all the sub-scale total scores. To compute change in scores, baseline scores were subtracted from week 12 scores, resulting in a change score. Lower values signify greater improvement (i.e. week 12 score was lower than baseline score). The SANS modified total score is the SANS total score minus the Attention subscale. (NCT00249288)
Timeframe: Baseline score vs. week 12 score

InterventionUnits on a scale (Mean)
Folate-8.5
Placebo-9.7

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Correlations Between Baseline Blood Folate and Clinical Ratings of Negative Symptoms by Comparing Lab Levels in Deficit Syndrome Versus Non-deficit Syndrome Patients

Baseline blood folate lab levels are reported by deficit syndrome status. (NCT00249288)
Timeframe: Baseline

,
Interventionnanograms/mL (Mean)
Serum folate, ng/mlRBC folate, ng/ml
Deficit Syndrome14.9585
Not Deficit Syndrome14.0546

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Overall Survival

Survival time will be defined as the time from registration to death. Time to event distributions will be estimated using the Kaplan-Meier method. Overall Survival (OS) will be compared between Arm A and Arm B. (NCT00265850)
Timeframe: Up to 5 years post-treatment

Interventionmonths (Median)
Arm A: FOLFOX or FOLFIRI + Bevacizumab29.0
Arm B: FOLFOX or FOLFIRI + Cetuximab30.0

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Progression-free Survival (PFS)

PFS will be measured from study entry until first documented progression or death from any cause. Time to event distributions will be estimated using the Kaplan-Meier method. PFS will be compared between Arm A and Arm B. (NCT00265850)
Timeframe: Up to 5 years post-treatment

Interventionmonths (Median)
Arm A: FOLFOX or FOLFIRI + Bevacizumab10.6
Arm B: FOLFOX or FOLFIRI + Cetuximab10.5

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5-year Recurrence-free Survival Rate

Recurrence free survival is defined as time from surgery to disease recurrence or death without recurrence (whichever occurred first) among resected patients. 5-year recurrence-free survival rate is estimated using Kaplan-Meier method, with 90% confidence interval calculated using Greenwood's formula. (NCT00321685)
Timeframe: recurrence follow-up began after post-operative chemotherapy, assessed every 3 months for patients 3-5 years from registration, every 6 months for patients 5-10 years from registration and every 12 months for patients 10 years from registration

Interventionpercentage of participants (Number)
Arm I81

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5-year Overall Survival Rate

Overall survival is defined as time from registration to death from any cause. 5-year overall survival rate is estimated using Kaplan-Meier method. (NCT00321685)
Timeframe: survival follow-up began after post-operative chemotherapy, assessed every 3 months for patients 3-5 years from registration, every 6 months for patients 5-10 years from registration and every 12 months for patients 10 years from registration

Interventionpercentage of participants (Number)
Arm I80

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Resection Rate for T3 Rectal Cancers

Resection rate is defined as number of patients with T3 rectal cancer who underwent curative surgical resection among all eligible and treated patients with T3 rectal cancers (NCT00321685)
Timeframe: Assessed at surgery time

Interventionpercentage of participants (Number)
Arm I92

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Resection Rate for T4 Rectal Cancers

Resection rate is defined as number of patients with T4 rectal cancer who underwent curative surgical resection among all eligible and treated patients with T4 rectal cancers (NCT00321685)
Timeframe: Assessed at surgery time

Interventionpercentage of participants (Number)
Arm I75

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Pathologic Complete Response Rate

Pathologic complete response to preoperative therapy was determined at the time of surgical resection. Pathologic complete response (pCR) is defined as no evidence of invasive cells on pathologic examination of the primary rectal cancer (or tissue from the area where the tumor had been if there is a complete clinical response). Pathologic complete response rate is calculated as number of patients achieving pathologic complete response divided by all eligible and treated patients (NCT00321685)
Timeframe: Assessed at surgery time

Interventionpercentage of participants (Number)
Arm I17

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Number of Participants With Chronic Primary Hypothyroidism/Subclinical Compensatory HypothyroidismHypothyroidism/Subclinical Compensatory Hypothyroidism

"Thyroid function was assessed as per ACNS0334 Endocrine Guidelines. Normal and Abnormal are defined at each institution by the laboratory standards where the blood tests are run. Primary Hypothyroidism/Subclinical Compensatory Hypothyroidism is defined as patients with Free T4 level less than Institutional Normal or equal to Institutional Normal with TSH level greater than Institutional Normal." (NCT00336024)
Timeframe: Off-treatment up to 9 years

InterventionParticipants (Count of Participants)
Arm I (Patients Treated Without Methotrexate (MTX))3
Arm II (Patients Treated With MTX)5

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Number of Participants With Chronic Low Somatomedin C

Low Somatomedin C is defined as patients with somatomedin C value less than institutional normal. As numbers are too small, descriptive statistics such as number will be reported for this analysis. Growth hormone function was assessed as per ACNS0334 Endocrine Guidelines. Low Somatomedin C levels are defined at each institution by the laboratory standards where the blood tests are run. (NCT00336024)
Timeframe: Off-treatment up to 9 years

InterventionParticipants (Count of Participants)
Arm I (Patients Treated Without Methotrexate (MTX))2
Arm II (Patients Treated With MTX)5

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Number of Participants With Chronic Diabetes Insipidus

"The number of patients who had Diabetes Insipidus and on DDAVP will be reported for this analysis due to small numbers.." (NCT00336024)
Timeframe: Beginning of off-treatment to up to 9 years

InterventionParticipants (Count of Participants)
Arm I (Patients Treated Without Methotrexate (MTX))1
Arm II (Patients Treated With MTX)1

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Number of Participants With Chronic Central Hypothyroidism

"Thyroid function was assessed as per ACNS0334 Endocrine Guidelines. Normal and Abnormal are defined at each institution by the laboratory standards where the blood tests are run. Central Hypothyroidism is defined as Free T4 level less than Institutional Normal with TSH less than or equal to Institutional Normal." (NCT00336024)
Timeframe: Off-treatment up to 9 years

InterventionParticipants (Count of Participants)
Arm I (Patients Treated Without Methotrexate (MTX))1
Arm II (Patients Treated With MTX)1

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Rates of Nutritional Toxicities

Rates of nutritional toxicities reported as Adverse Events during therapy for each cycle will be summarized using standard descriptive methods (such as number of patients). The difference in number of patients with nutritional toxicities between the two treatment regimens will be compared using a Chi-square test. (NCT00336024)
Timeframe: Beginning of treatment to the end of consolidation

,
InterventionParticipants (Count of Participants)
Nutritional Disorders Induction Cycle INo Nutritional Disorders Induction Cycle INutritional Disorders Induction Cycle IINo Nutritional Disorders Induction Cycle IINutritional Disorders Induction Cycle IIINo Nutritional Disorders Induction Cycle IIINutritional Disorders Consolidation Cycle INo Nutritional Disorders Consolidation Cycle INutritional Disorders Consolidation Cycle IINo Nutritional Disorders Consolidation Cycle IINutritional Disorders Consolidation Cycle IIINo Nutritional Disorders Consolidation Cycle III
Arm I (Patients Treated Without Methotrexate (MTX))1029132673212279301029
Arm II (Patients Treated With MTX)172113251226830533533

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Rates of Gastrointestinal Toxicities

Rates of gastrointestinal toxicities reported as Adverse Events during therapy for each cycle will be summarized using standard descriptive methods (such as number of patients). The difference in number of patients with gastrointestinal toxicities between the two treatment regimens will be compared using a Chi-square test. (NCT00336024)
Timeframe: Beginning of treatment to the end of consolidation

,
InterventionParticipants (Count of Participants)
GI Tox Induction Cycle INo GI Tox Induction Cycle IGI Tox Induction Cycle IINo GI Tox Induction Cycle IIGI Tox Induction Cycle IIINo GI Tox Induction Cycle IIIGI Tox Consolidation Cycle INo GI Tox Consolidation Cycle IGI Tox Consolidation Cycle IINo GI Tox Consolidation Phase IIGI Tox Consolidation Cycle IIINo GI Tox Consolidation Cycle III
Arm I (Patients Treated Without Methotrexate (MTX))8314354351128732534
Arm II (Patients Treated With MTX)1226102883014241028632

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Median/Range of Patients for Total Quality of Life (QOL) Score, Intelligence Quotient (IQ) and Processing Speed Index (PSI).

"Three tools are used to assess intelligence (IQ) depending on age. The range of IQ scores is 40-160 (mean=100, SD=15); range for the Processing Speed Index (PSI)=45-155. Higher scores represent better functioning. (1) Wechsler Preschool and Primary Scale of Intelligence-4th Edition (WPPSI-IV) is used for ages 2.5 to 6 years. Bug Search and Cancellation subtests are summed to calculate PSI. (2) Wechsler Intelligence Scales for Children-5th Edition (WISC-V) is used for ages 6 - 16 years. Symbol Search and Coding subtests are summed to calculate PSI. (3) Wechsler Adult Intelligence Scales-4th Edition (WAIS-IV) is used for ages 16 and older. Symbol Search and Coding subtests are summed to calculate PSI.~The Pediatric Quality of Life Inventory Version 4 (PedsQL) measures health-related quality of life (QOL). Parents complete the measure for children ages 2-17, and patients > 18 complete a self-report version. Total scores range from 0-100, with higher scores representing better QOL." (NCT00336024)
Timeframe: 60 months (+/- 3 months)

,
Interventionscores on a scale (Median)
Total Quality of Life ScoreIntelligence QuotientProcessing Speed Index
Arm I (Patients Treated Without Methotrexate (MTX))60.577.082.0
Arm II (Patients Treated With MTX)56.578.589.0

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Percentage of Participants With Event Free Survival (EFS)

EFS was defined as time from enrollment to the occurrence of first event (disease progression/relapse, secondary malignancy, death from any cause) or date of last contact for patients who are event-free. The percentage of participants with EFS and 90% confidence interval were provided. The difference in incidence for the two treatment regimens were compared using a one-sided log-rank test with a significance level of 0.1. (NCT00336024)
Timeframe: Baseline to up to 5 years

Interventionpercentage of participants with EFS (Number)
Arm I (Patients Treated Without Methotrexate (MTX))43.6
Arm II (Patients Treated With MTX)54.9

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Percentage of Participants With Any Acute Adverse Events

Event is defined as the first occurrence of any acute toxicity. Estimates will be obtained using life-table methods. Patients who have progression or recurrence of disease will be censored in this analysis. Difference in incidence for the two treatment regimens will be compared using log-rank test. (NCT00336024)
Timeframe: Beginning of treatment to the end of consolidation

Interventionpercentage of participants (Number)
Arm I (Patients Treated Without Methotrexate (MTX))97.4
Arm II (Patients Treated With MTX)97.2

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Number of Participants With Secondary Malignancies

The number of patients who had secondary malignancy will be reported for this analysis due to small numbers. (NCT00336024)
Timeframe: Off-treatment up to 9 years

InterventionParticipants (Count of Participants)
Arm I (Patients Treated Without Methotrexate (MTX))1
Arm II (Patients Treated With MTX)0

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Disease-free Survival (DFS) for Randomized Methotrexate T-ALL Cohort (Arm I + Arm II vs. Arm III + Arm IV)

Disease Free Probability where DFS time is defined as time from randomization end of induction to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. (NCT00408005)
Timeframe: 4 years from randomization at the end of induction

Interventionpercent probability (Number)
ARM I and ARM II (Combination Chemotherapy)91.45
ARM III and ARM IV (Combination Chemotherapy)85.78

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Disease-free Survival (DFS) for T-cell Lymphoblastic Lymphoma (T-LLy) Cohort

Disease Free Probability where DFS time is defined as time from randomization end of induction to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. (NCT00408005)
Timeframe: 4 years from end of induction

Interventionpercent probability (Number)
Standard RiskHigh Risk
ARM I (Combination Chemotherapy)87.485.1

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Disease-free Survival (DFS) for Randomized Nelarabine T-ALL Cohort (Arm I vs. Arm II vs. Arm III vs. Arm IV)

Disease Free Probability where DFS time is defined as time from randomization end of induction to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. (NCT00408005)
Timeframe: 4 years from randomization at the end of induction

Interventionpercent probability (Number)
ARM I (Combination Chemotherapy)89.01
ARM II (Combination Chemotherapy)90.53
ARM III (Combination Chemotherapy)78.07
ARM IV (Combination Chemotherapy)86.46

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Cumulative Incidence of CNS Relapse for T-ALL by Risk Group

Cumulative incidence of CNS relapse adjusting for DFS events, was calculated using the method Gray et. al. High risk patients receive cranial radiation and low risk patients receive no cranial radiation. (NCT00408005)
Timeframe: 4 years from randomization at the end of induction

,
Interventionpercent probability (Number)
Intermediate RiskHigh Risk
ARM II (Combination Chemotherapy)1.080
ARM IV (Combination Chemotherapy)0.853.45

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Disease-free Survival (DFS) for Randomized Nelarabine T-ALL Cohort (Arm I + Arm III vs. Arm II + Arm IV)

Disease Free Probability where DFS time is defined as time from randomization end of induction to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event (NCT00408005)
Timeframe: 4 years from randomization at the end of induction

Interventionpercent probability (Number)
ARM I and ARM III (Combination Chemotherapy)82.96
ARM II and ARM IV (Combination Chemotherapy)88.30

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Disease-free Survival (DFS) for Randomized Methotrexate T-ALL Cohort (Arm I vs. Arm II vs. Arm III vs. Arm IV)

Disease-free survival defined as time from randomization end of induction to first event (relapse, second malignant neoplasm, remission death) or date of last contact for those who are event-free. (NCT00408005)
Timeframe: 4 years from randomization at the end of induction

Interventionpercent probability (Number)
ARM I (Combination Chemotherapy)91.76
ARM II (Combination Chemotherapy)90.53
ARM III (Combination Chemotherapy)86.06
ARM IV (Combination Chemotherapy)84.89

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Cumulative Incidence of CNS Relapse for T-ALL by Risk Group

Cumulative incidence of CNS relapse adjusting for DFS events, was calculated using the method Gray et. al. High risk patients receive cranial radiation and low risk patients receive no cranial radiation. (NCT00408005)
Timeframe: 4 years from randomization at the end of induction

,
Interventionpercent probability (Number)
Low RiskIntermediate RiskHigh Risk
ARM I (Combination Chemotherapy)1.851.163.64
ARM III (Combination Chemotherapy)1.929.16.52

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Disease-free Survival (DFS) for T-cell Lymphoblastic Lymphoma (T-LLy) Cohort

Disease Free Probability where DFS time is defined as time from randomization end of induction to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. (NCT00408005)
Timeframe: 4 years from end of induction

Interventionpercent probability (Number)
High RiskInduction Failure
ARM II (Combination Chemotherapy)85.0100

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Molar Pregnancy

(NCT00467363)
Timeframe: 8 weeks

Interventionpregnancy (Number)
Aspirin0
Placebo0

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Live Birth

Live birth was obtained prospectively by maternal report and abstraction from medical records by trained staff . (NCT00467363)
Timeframe: after delivery

Interventionlivebirths (Number)
Aspirin309
Placebo286

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hCG Recognized Pregnancy

(NCT00467363)
Timeframe: within 8-weeks of gestation

Interventionpregnancy (Number)
Aspirin394
Placebo363

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Fetal Pregnancy Loss

(NCT00467363)
Timeframe: until 40 weeks

Interventionpregnancy (Number)
Aspirin4
Placebo6

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Ectopic Pregnancy

(NCT00467363)
Timeframe: within 6 weeks

Interventionpregnancy (Number)
Aspirin3
Placebo3

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Early Pregnancy Loss (EPL)

Implantation failures (NCT00467363)
Timeframe: 8 weeks

Interventionpregnancy (Number)
Aspirin28
Placebo27

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Clinically Recognized Pregnancy

(NCT00467363)
Timeframe: 8-weeks

Interventionpregnancy (Number)
Aspirin374
Placebo346

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Stillbirth

(NCT00467363)
Timeframe: 40 weeks

Interventionparticipants (Number)
Aspirin2
Placebo2

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Preeclampsia

(NCT00467363)
Timeframe: until delivery

Interventionparticipants (Number)
Aspirin32
Placebo30

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Small for Gestational Age Infant

birthweight (NCT00467363)
Timeframe: until delivery

Interventiongrams (Mean)
Aspirin3327
Placebo3315

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Abruption

Partial or complete abruption (ie, premature separation of the placenta) (NCT00467363)
Timeframe: until delivery

Interventionparticipants (Number)
Aspirin7
Placebo5

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Preterm Birth

(NCT00467363)
Timeframe: until delivery

Interventioninfants (Number)
Aspirin22
Placebo31

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Pregnancy Losses Occurring Less Than 10 Weeks

Includes preembryonic and embryonic losses (exclusive of implantation failures) (NCT00467363)
Timeframe: less than 10-weeks

Interventionpregnancy (Number)
Aspirin56
Placebo53

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Progression-free Survival (PFS) Time

PFS time was calculated as the number of days from study day 1 to the date of PD or death, regardless of cause (date of PD or death - study day 1 + 1). (NCT00481871)
Timeframe: Response assessments were performed no less than every 3 cycles in the Phase 1 part of the study and every 8 weeks (± 1 week) in the Phase 2a part of the study

Interventiondays (Median)
Phase 153.0
Phase 2 - Group B59.0
Phase 2 - Group C54.0

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Objective Responses Assessed by International Workshop Criteria (IWC)

Number of participants who achieved an objective response. Objective response was defined as a tumor response assessment of either complete response (CR) or partial response (PR) and was determined only for patients with measurable disease at baseline. A tumor response assessment reported by IWC without PET was used for any analyses in cases where an IWC+PET evaluation was not done. (NCT00481871)
Timeframe: Assessed every 8 weeks (+/- 1 week) for Phase II and no less than every 3 cycles for Phase I

Interventionparticipants (Number)
Phase 18
Phase 2 - Group B5
Phase 2 - Group C7

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Duration of Response

Duration of response was defined as the number of days between the date of first tumor response assessment of objective response to the time of the first tumor response assessment of progressive disease (PD) or death due to any cause (date of first PD assessment or death - date of first objective response assessment + 1) (NCT00481871)
Timeframe: Response assessments were performed no less than every 3 cycles in the Phase 1 part of the study and every 8 weeks (± 1 week) in the Phase 2a part of the study

Interventiondays (Median)
Phase 1174
Phase 2 - Group B210
Phase 2 - Group C170

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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) (NCT00500292)
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 (5 March 2008 +/-3 days)

InterventionParticipants (Number)
Vandetanib 100 mg Plus FOLFOX23
Vandetanib 300 mg Plus FOLFOX27
Placebo Plus FOLFOX24

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Complete Pathologic Response Rate

"The complete pathologic response (path CR) rate after treatment calculated as the percentage of participants with path CR out of the total participants, where the path CR is defined as absence of tumor cells in the surgical specimen and all registered participants are used in the denominator for calculating the path CR rate.~Primary gastric carcinoma is not measurable by conventional criteria thus usual response criteria cannot be applied. The following criteria for response assessment applied: Pathologic Complete Response: Absence of tumor cells in the surgical specimen, 95% or more necrosis of the cancer; Complete Clinical Response: Absence of tumor on endoscopy, biopsy, cytology, or both." (NCT00525785)
Timeframe: Restaging and surgical resection at 4-6 weeks after completion of chemoradiotherapy, approximately at 16 weeks into treatment

Interventionpercentage of participants (Number)
5-Fluorouracil + Folinic Acid + Oxaliplatin14

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Describe in Vitro Sensitivity as a Molecular Mechanism of Primary Resistance to Lestaurtinib in Leukemic Blasts

Described via means and standard deviations in samples which have primary resistance to lestaurtinib (NCT00557193)
Timeframe: Sampled at the start of induction

InterventionProportion of cells that are viable (Median)
Arm A (Standard Risk MLL-G)0.75
Arm B (IR/HR MLL-R Chemotherapy)0.48
Arm C (IR/HR MLL-R Chemotherapy and Lestaurtinib)0.47

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Percent Probability for Event-free Survival (EFS) for Patients on Arm A

EFS time is defined as time from treatment assignment to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. EFS is constructed using the Kaplan-Meier life table method with confidence interval based on standard errors computed using the method of Peto and Peto. (NCT00557193)
Timeframe: From start of post-induction therapy for up to 10 years

Interventionpercentage probability (Number)
Arm A (Standard Risk MLL-G)86.67

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Percent Probability for Event-free Survival (EFS) for Patients on Arm C at Dose Level 2 (DL2)

EFS time is defined as time from randomization to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. EFS is constructed using the Kaplan-Meier life table method with confidence interval based on standard errors computed using the method of Peto and Peto. (NCT00557193)
Timeframe: From start of post-induction therapy for up to 10 years

Interventionpercentage probability (Number)
Arm C (Safety/Efficacy Dose Level 2)35.82

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Percent Probability of Event Free Survival (EFS) by MRD Status and Treatment Arm

Three-year EFS estimates and 90% CI will be reported by treatment arm and end-induction MRD status. (NCT00557193)
Timeframe: 3 Years from end of Induction)

Interventionpercent probability (Number)
Arm A (MRD Negative)86.05
Arm A (MRD Positive)87.5
Arm B (MRD Negative)47.37
Arm B (MRD Positive)22.73
Arm C (MRD Negative)51.85
Arm C (MRD Positive)27.03

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Pharmacodynamics PIA Levels in Infants Given Lestaurtinib at DL2 in Combination With Chemotherapy

Summarized with mean and standard deviation for those with available data in Arm C (NCT00557193)
Timeframe: Sampled between weeks 6-12 from start of induction

InterventionActivity percentage (Mean)
Arm C (Safety/Efficacy Dose Level 2)69.00

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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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Describe FLT3 Protein Expression as a Molecular Mechanism of Acquired Resistance to Lestaurtinib in Leukemic Blasts

Described via means and standard deviations in available Arm C relapse samples (NCT00557193)
Timeframe: At relapse (up to 3 years)

InterventionqPCR fold expression ratio (Mean)
Arm C (Safety/Efficacy Dose Level 2)5.73

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Describe FLT3 Protein Expression as a Molecular Mechanism of Primary Resistance to Lestaurtinib in Leukemic Blasts

Described via mean and standard deviation by group. (NCT00557193)
Timeframe: Sampled at the start of induction

InterventionqPCR fold expression ratio (Mean)
Arm A (Standard Risk MLL-G)1.25
Arm B (IR/HR MLL-R Chemotherapy)7.85
Arm C (IR/HR MLL-R Chemotherapy and Lestaurtinib)5.83

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Describe in Vitro Sensitivity as a Molecular Mechanism of Acquired Resistance to Lestaurtinib in Leukemic Blasts

Described via means and standard deviations in samples which have acquired resistance to lestaurtinib (NCT00557193)
Timeframe: At relapse (up to 3 years)

InterventionProportion of cells that are viable (Mean)
Arm C (IR/HR MLL-R Chemotherapy and Lestaurtinib)0.69

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Percentage of Participants With Improvement in Synovitis at Weeks 24 and 52

There were 2 definitions of improvement in synovitis. A participant met the criterion for definition 1 when there was a drop in the magnetic resonance imaging synovitis score from Baseline > 0.5. A participant met the criterion for definition 2 when there was a drop in the magnetic resonance imaging synovitis score from Baseline > than the smallest detectable change. The synovitis score was determined according to the Outcome Measures in Rheumatology (OMERACT) rheumatoid arthritis MRI (RAMRIS) scoring system in magnetic resonance images with and without gadolinium of 15 anatomical locations in each wrist and 10 locations in each hand in the hand and wrist with the most arthritic activity. If there was no difference in disease activity between the hands, the dominant hand was used. Images were assessed by 2 experienced blinded musculoskeletal radiologists. (NCT00578305)
Timeframe: Baseline to Week 52

,,
InterventionPercentage of participants (Number)
Week 24 (Definition 1)Week 24 (Definition 2)Week 52 (Definition 1)Week 52 (Definition 2)
Placebo22.222.225.425.4
Rituximab 1000 mg56.756.760.060.0
Rituximab 500 mg41.941.954.854.8

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Percentage of Participants With Improvement in Osteitis at Weeks 24 and 52

There were 2 definitions of improvement in osteitis. A participant met the criterion for definition 1 when there was a drop in the magnetic resonance imaging osteitis score from Baseline > 0.5. A participant met the criterion for definition 2 when there was a drop in the magnetic resonance imaging osteitis score from Baseline > than the smallest detectable change. The osteitis score was determined according to the Outcome Measures in Rheumatology (OMERACT) rheumatoid arthritis MRI (RAMRIS) scoring system in magnetic resonance images with and without gadolinium of 15 anatomical locations in each wrist and 10 locations in each hand in the hand and wrist with the most arthritic activity. If there was no difference in disease activity between the hands, the dominant hand was used. Images were assessed by 2 experienced blinded musculoskeletal radiologists. (NCT00578305)
Timeframe: Baseline to Week 52

,,
InterventionPercentage of participants (Number)
Week 24 (Definition 1)Week 24 (Definition 2)Week 52 (Definition 1)Week 52 (Definition 2)
Placebo22.222.227.027.0
Rituximab 1000 mg51.751.751.751.7
Rituximab 500 mg50.050.058.158.1

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Percentage of Participants With European League Against Rheumatism (EULAR) Good, Moderate, or no Response at Weeks 24 and 52

Change of the DAS28 score from Baseline was used to determine the EULAR responses. For a post-Baseline score ≤ 3.2, a change from Baseline of < -1.2 was a good response, < -0.6 to ≥ -1.2 was a moderate response, and ≥ -0.6 was no response. For a post-Baseline score > 3.2 to ≤ 5.1, a change from Baseline of < -0.6 was a moderate response and ≥ -0.6 was no response. For a post-Baseline score > 5.1, a change from Baseline < -1.2 was a moderate response and ≥ -1.2 was no response. A good response could not be achieved for post-Baseline scores > 3.2. DAS28=(0.56×√(TJC28))+(0.28×√(SJC28))+(0.7×log(CRP))+(0.014×GH), where TJC28=tender joint count (JC) and SJC28=swollen JC (28 joints), GH=a participant's global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end=no disease activity, right end=maximum disease activity), and CRP=C-reactive protein level. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. (NCT00578305)
Timeframe: Baseline to Week 52

,,
InterventionPercentage of participants (Number)
Week 24 - No responseWeek 24 - Moderate responseWeek 24 - Good responseWeek 52 (n = 63, 62, 59) - No responseWeek 52 (n = 63, 62, 59) - Moderate responseWeek 52 (n = 63, 62, 59) - Good response
Placebo58.722.219.060.331.77.9
Rituximab 1000 mg22.042.435.613.649.237.3
Rituximab 500 mg33.937.129.021.045.233.9

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Percentage of Participants With an Improvement of at Least 20%, 50%, or 70% in the American College of Rheumatology (ACR) Score (ACR20/50/70) From Baseline at Weeks 24 and 52

Improvement must be seen in tender and swollen joint counts (28 assessed joints; Joints were evaluated and classified as swollen or not swollen and tender or not tender based on pressure and joint manipulation upon physical examination) and in at least 3 (NCT00578305)
Timeframe: Baseline to Week 52

,,
InterventionPercentage of participants (Number)
Week 24 - ACR20 responseWeek 24 - ACR50 responseWeek 24 - ACR70 responseWeek 52 - ACR20 responseWeek 52 - ACR50 responseWeek 52 - ACR70 response
Placebo28.611.11.628.614.36.3
Rituximab 1000 mg51.726.78.368.335.016.7
Rituximab 500 mg51.624.211.367.737.117.7

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Percentage of Participants in Remission Response (Disease Activity Score 28 [DAS28] < 2.6) at Weeks 24 and 52

The percentage of participants in remission of their rheumatic arthritis at Weeks 24 and 52, as measured by a DAS28 score < 2.6, is reported. DAS28 is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(CRO)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints, GH = a participant's global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity [symptom-free and no arthritis symptoms], right end = maximum disease activity [maximum arthritis disease activity]), and CRP = C-reactive protein level. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. (NCT00578305)
Timeframe: Baseline to Week 52

,,
InterventionPercentage of participants (Number)
Week 24Week 52
Placebo12.77.9
Rituximab 1000 mg28.325.0
Rituximab 500 mg21.025.8

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Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 24 and 52

The HAQ-DI assesses how well the patient is able to perform 8 activities: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. The patient answers 20 questions with 1 of 4 responses with the past week as the time frame: 0=without difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. The highest score for any question in a category determines the category score. The total score ranges from 0 (no disability) to 3 (completely disabled). A negative change score indicates improvement. (NCT00578305)
Timeframe: Baseline to Week 52

,,
InterventionUnits on a scale (Mean)
Week 24 (n = 63, 62, 59)Week 52 (n = 63, 62, 59)
Placebo-0.194-0.177
Rituximab 1000 mg-0.439-0.417
Rituximab 500 mg-0.425-0.520

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Change in Magnetic Resonance Imaging (MRI) Synovitis Score From Baseline to Weeks 12, 24, and Week 52

The synovitis score was determined according to the Outcome Measures in Rheumatology (OMERACT) rheumatoid arthritis MRI scoring (RAMRIS) system in magnetic resonance images of 3 wrist regions and 5 metacarpophalangeal joints in the hand and wrist with the most arthritic activity. If there was no difference in disease activity between the hands, the dominant hand was used. Images were assessed by 2 experienced blinded musculoskeletal radiologists. Each location was scored in 0.5 increments from 0 to 3 with each integer unit increment representing a 33% enhancement of the maximum volume of enhancing tissue in the synovial compartment using the following scale: 0.0=normal, no synovitis; 0.5=1-17% estimated volume of enhancement; 1.0=18-33%; 1.5=34-50%; 2.0=51-67%; 2.5=68-83%; 3.0=84-100% estimated volume of enhancement. The individual scores were summed and normalized to a range of 0 to 100 with a higher score indicating more synovitis. A negative change score indicates improvement. (NCT00578305)
Timeframe: Baseline to Week 52

,,
InterventionUnits on a scale (Mean)
Week 12 (n = 58, 58, 56)Week 24 (n = 61, 59, 59)Week 52 (n = 61, 59, 59)
Placebo-0.220.20-0.01
Rituximab 1000 mg-1.15-1.81-2.73
Rituximab 500 mg-0.50-1.14-2.03

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Change in Magnetic Resonance Imaging (MRI) Osteitis Score From Baseline to Weeks 12, 24, and Week 52

The osteitis score was determined according to the Outcome Measures in Rheumatology (OMERACT) rheumatoid arthritis MRI scoring (RAMRIS) system in magnetic resonance images of 15 anatomical locations in each wrist and 10 locations in each hand in the hand and wrist with the most arthritic activity. If there was no difference in disease activity between the hands, the dominant hand was used. Each location was scored in 0.5 increments from 0 to 3 with each integer unit increment representing a 33% increase in the volume of the peripheral 1 cm of original (eroded + residual) articular bone using the following scale: 0.0=normal, no osteitis; 0.5=1-17% involvement of original articular bone; 1.0=18-33%; 1.5=34-50%; 2.0=51-67%; 2.5=68-83%; 3.0=84-100% involvement of original articular bone. The individual scores were summed and normalized to a range of 0 to 100 with a higher score indicating more synovitis. A negative change score indicates improvement. (NCT00578305)
Timeframe: Baseline to Week 52

,,
InterventionUnits on a scale (Mean)
Week 12 (n = 58, 58, 56)Week 24 (n = 61, 59, 59)Week 52 (n = 61, 59, 59)
Placebo-0.140.07-0.22
Rituximab 1000 mg-1.88-2.86-3.83
Rituximab 500 mg-2.11-2.91-4.75

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Change in Magnetic Resonance Imaging (MRI) Erosion Score From Baseline to Week 24

The erosion score was determined according to the Outcome Measures in Rheumatology (OMERACT) rheumatoid arthritis MRI scoring (RAMRIS) system in magnetic resonance images with and without gadolinium of 15 anatomical locations in each wrist and 10 locations in each hand in the hand and wrist with the most arthritic activity. If there was no difference in disease activity between the hands, the dominant hand was used. Images were assessed by 2 experienced blinded musculoskeletal radiologists. Each location was scored in 0.5 increments from 0 to 10 with each integer unit increment representing a 10% loss of articular bone using the following scale. 0.0=normal, no erosion; 0.5=1-5% erosion; 1.0=6-10% erosion; 1.5=11-15% erosion; 2.0=16-20% erosion; etc, up to 10.0=96-100% erosion. The individual scores were summed and normalized to a range of 0 to 100 with a higher score indicating more erosion. A negative change score indicates improvement. (NCT00578305)
Timeframe: Baseline to Week 24

InterventionUnits on a scale (Mean)
Rituximab 500 mg0.13
Rituximab 1000 mg0.39
Placebo1.33

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Change in Magnetic Resonance Imaging (MRI) Erosion Score From Baseline to Weeks 12 and 52

The erosion score was determined according to the Outcome Measures in Rheumatology (OMERACT) rheumatoid arthritis MRI scoring (RAMRIS) system in magnetic resonance images with and without gadolinium of 15 anatomical locations in each wrist and 10 locations in each hand in the hand and wrist with the most arthritic activity. If there was no difference in disease activity between the hands, the dominant hand was used. Images were assessed by 2 experienced blinded musculoskeletal radiologists. Each location was scored in 0.5 increments from 0 to 10 with each integer unit increment representing a 10% loss of articular bone using the following scale. 0.0=normal, no erosion; 0.5=1-5% erosion; 1.0=6-10% erosion; 1.5=11-15% erosion; 2.0=16-20% erosion; etc, up to 10.0=96-100% erosion. The individual scores were summed and normalized to a range of 0 to 100 with a higher score indicating more erosion. A negative change score indicates improvement. (NCT00578305)
Timeframe: Baseline to Week 52

,,
InterventionUnits on a scale (Mean)
Week 12 (n = 58, 58, 56)Week 52 (n = 56, 57, 58)
Placebo0.333.02
Rituximab 1000 mg0.13-0.30
Rituximab 500 mg0.420.11

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Change From Baseline in the Disease Activity Score 28 (DAS28) at Weeks 24 and 52

The DAS28 is a combined index for measuring disease activity in rheumatic arthritis (RA) and includes swollen and tender joint counts, C-reactive protein level (CRP), and general health (GH) status. The index is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(CRO)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints, GH = a participant's global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity [symptom-free and no arthritis symptoms], right end = maximum disease activity [maximum arthritis disease activity]). The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A negative change score indicates improvement. (NCT00578305)
Timeframe: Baseline to Week 52

,,
InterventionUnits on a scale (Mean)
Week 24 (n = 63, 62, 59)Week 52 (n = 63, 62, 59)
Placebo-0.752-0.747
Rituximab 1000 mg-1.683-1.801
Rituximab 500 mg-1.714-2.055

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Percentage of Participants Achieving a Major Clinical Response at Week 52

"A major clinical response was defined as an improvement of at least 70% in the American College of Rheumatology score from Baseline at Week 52. Improvement must be seen in tender and swollen joint counts (28 assessed joints) and in at least 3 of the following 5 parameters: Separate participant and physician assessments of participant disease activity in the previous 24 hours on a visual analog scale (VAS, the extreme left end of the line no disease activity [symptom-free and no arthritis symptoms] and the extreme right end maximum disease activity); participant assessment of pain in previous the 24 hours on a VAS (extreme left end of the line no pain and the extreme right end unbearable pain); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and C reactive protein level." (NCT00578305)
Timeframe: Baseline to Week 52

InterventionPercentage of participants (Number)
Rituximab 500 mg6.5
Rituximab 1000 mg6.7
Placebo1.6

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Correlation of Magnetic Resonance Imaging Assessments and Clinical Outcome Measures

Correlation coefficients of magnetic resonance imaging erosion, synovitis, and osteitis scores and clinical outcome measures of swollen joint count (SJC), tender joint count (TJC), C-reactive protein level (CRP), erythrocyte sedimentation rate (ESR), a participant's global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (GH), Disease Activity Score 28-C-reactive protein (DAS28-CRP), and Disease Activity Score 28-erythrocyte sedimentation rate (DAS28-ESR) are reported. Not all of these variables were specified as primary or secondary Outcome Measures in the study protocol and were not individually analyzed. (NCT00578305)
Timeframe: Baseline to Week 52

,,
InterventionCorrelation coefficient (Number)
Erosion score and SJC - Week 24Erosion score and SJC - Week 52Synovitis score and SJC - Week 24Synovitis score and SJC - Week 52Osteitis score and SJC - Week 24Osteitis score and SJC - Week 52Erosion score and TJC - Week 24Erosion score and TJC - Week 52Synovitis score and TJC - Week 24Synovitis score and TJC - Week 52Osteitis score and TJC - Week 24Osteitis score and TJC - Week 52Erosion score and CRP - Week 24Erosion score and CRP - Week 52Synovitis score and CRP - Week 24Synovitis score and CRP - Week 52Osteitis score and CRP - Week 24Osteitis score and CRP - Week 52Erosion score and ESR - Week 24Erosion score and ESR - Week 52Synovitis score and ESR - Week 24Synovitis score and ESR - Week 52Osteitis score and ESR - Week 24Osteitis score and ESR - Week 52Erosion score and GH - Week 24Erosion score and GH - Week 52Synovitis score and GH - Week 24Synovitis score and GH - Week 52Osteitis score and GH - Week 24Osteitis score and GH - Week 52Erosion score and DAS28-CRP - Week 24Erosion score and DAS28-CRP - Week 52Synovitis score and DAS28-CRP - Week 24Synovitis score and DAS28-CRP - Week 52Osteitis score and DAS28-CRP - Week 24Osteitis score and DAS28-CRP - Week 52Erosion score and DAS28-ESR - Week 24Erosion score and DAS28-ESR - Week 52Synovitis score and DAS28-ESR - Week 24Synovitis score and DAS28-ESR - Week 52Osteitis score and DAS28-ESR - Week 24Osteitis score and DAS28-ESR - Week 52
Placebo0.4460.3550.5660.5740.3700.3980.2980.4250.2820.4210.2880.3710.0060.3520.1920.3110.0400.1190.1970.3140.3580.3600.1480.2050.3260.3160.2060.2860.2050.1360.4570.4980.4370.5000.3510.3560.4390.4730.4380.5140.3530.356
Rituximab 1000 mg0.4250.2340.3890.1880.3540.1920.1150.0670.1740.0360.1180.048-0.0240.0980.0900.085-0.057-0.0100.1360.1880.2140.2480.0430.1160.043-0.0090.221-0.0370.1220.0520.1980.1270.3490.1500.2090.1430.2550.1800.3320.1470.2310.172
Rituximab 500 mg0.3410.2870.3290.1680.4070.2650.3640.2750.3360.1420.3550.2450.1850.0550.030-0.077-0.0310.0050.3210.1270.1820.1850.044-0.0410.2060.0630.186-0.0260.2740.1060.4200.2380.3930.1490.3800.1390.4290.2440.3980.1980.3530.108

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Percentage of Participants With no Progression/no Worsening in Bone Erosion at Weeks 24 and 52

There were 2 definitions of no progression/no worsening in bone erosion. A participant met the criterion for definition 1 when there was a change in the magnetic resonance imaging erosion score ≤ 0. A participant met the criteria for definition 2 when there was either (1) no change from Baseline in the MRI erosion score, (2) an increase in erosion score and the size of the increase in score was smaller than the smallest detectable change, or (3) a drop in the erosion score. The erosion score was determined according to the Outcome Measures in Rheumatology (OMERACT) rheumatoid arthritis MRI scoring (RAMRIS) system in magnetic resonance images with and without gadolinium of 15 anatomical locations in each wrist and 10 locations in each hand in the hand and wrist with the most arthritic activity. If there was no difference in disease activity between the hands, the dominant hand was used. Images were assessed by 2 experienced blinded musculoskeletal radiologists. (NCT00578305)
Timeframe: Baseline to Week 52

,,
InterventionPercentage of participants (Number)
Week 24 (Definition 1)Week 24 (Definition 2)Week 52 (Definition 1)Week 52 (Definition 2)
Placebo33.381.027.055.6
Rituximab 1000 mg51.796.755.093.3
Rituximab 500 mg50.088.748.485.5

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Percentage of Participants With no Newly Eroded Joints at Weeks 24 and 52

No newly eroded joints was defined as no new erosions in joints which were scored 0 at baseline. The erosion score was determined according to the Outcome Measures in Rheumatology (OMERACT) rheumatoid arthritis MRI scoring (RAMRIS) system in magnetic resonance images with and without gadolinium of 15 anatomical locations in each wrist and 10 locations in each hand in the hand and wrist with the most arthritic activity. If there was no difference in disease activity between the hands, the dominant hand was used. Images were assessed by 2 experienced blinded musculoskeletal radiologists. Each location was scored in 0.5 increments from 0 to 10 with each integer unit increment representing a 10% loss of articular bone using the following scale. 0.0=normal, no erosion; 0.5=1-5% erosion; 1.0=6-10% erosion; 1.5=11-15% erosion; 2.0=16-20% erosion; etc, up to 10.0=96-100% erosion. (NCT00578305)
Timeframe: Baseline to Week 52

,,
InterventionPercentage of participants (Number)
Week 24Week 52
Placebo55.560.3
Rituximab 1000 mg73.340
Rituximab 500 mg77.477.4

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Percentage of Participants With Low Disease Activity (Disease Activity Score 28 [DAS28] ≤ 3.2) at Weeks 24 and 52

The percentage of participants who had low rheumatic arthritis disease activity at Weeks 24 and 52, as measured by a DAS28 score ≤ 3.2, is reported. DAS28 is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(CRO)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints, GH = a participant's global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity [symptom-free and no arthritis symptoms], right end = maximum disease activity [maximum arthritis disease activity]), and CRP = C-reactive protein level. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. (NCT00578305)
Timeframe: Baseline to Week 52

,,
InterventionPercentage of participants (Number)
Week 24Week 52
Placebo19.09.5
Rituximab 1000 mg36.738.3
Rituximab 500 mg33.937.1

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Adverse Events of Patients Receiving Pralatrexate vs. Erlotinib

(NCT00606502)
Timeframe: Assessed every 2 weeks while on treatment through safety follow-up visit (35 +/-5 days post-last dose) or early termination visit (at time of withdrawal).

,
InterventionTreated Participants (Number)
At least one AEGrade 3 AEsGrade 4 AEsAt least one SAE
Erlotinib771802
Pralatrexate7525514

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Progression-free Survival (PFS) of Patients Receiving Pralatrexate vs. Erlotinib

PFS was calculated as the number of days from randomization to the date of radiological evidence of PD or death due to any cause. (NCT00606502)
Timeframe: Assessed every 8 weeks for the first 24 weeks, then every 16 weeks for up to 2 years or until PD or start of subsequent treatment.

Interventionmonths (Median)
Pralatrexate3.4
Erlotinib2.8

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Overall Survival (OS) of Patients Receiving Pralatrexate vs. Erlotinib

OS was defined as the length of time from randomization until death due to any cause. Patients who were alive at the time of the data cut-off date were censored at the last contact date. (NCT00606502)
Timeframe: Assessed from date of randomization no less frequently than every 16 weeks for up to 2 years after randomization.

InterventionMonths Survival (Median)
Pralatrexate6.7
Erlotinib7.0

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Response Rate (RR) to Treatment of Patients Receiving Pralatrexate vs. Erlotinib

Number of patients whose tumors responded to Pralatrexate or Erlotinib, using the Response Criteria in Solid Tumors (RECIST). (NCT00606502)
Timeframe: Assessed every 8 weeks for the first 24 weeks, then every 16 weeks for up to 2 years or until PD or start of subsequent treatment.

,
InterventionParticipants (Number)
Complete + Partial ResponseComplete Response (CR)Partial Response (PR)Stable Disease (SD)Progressive Disease (PD)Disease Control (CR+PR+SD)Unable to EvaluateMissing (off or no treatment, not confirmed)
Erlotinib716353642020
Pralatrexate202332935231

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Proportion of Participants With Best Overall Tumor Response (Response Rate)

Response defined per Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR)=disappearance of all target lesions; Partial Response (PR)=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria. Best Overall Tumor Response is complete response plus partial response. (NCT00609518)
Timeframe: Baseline until disease progression, new therapy initiated, or death from any cause, up to 12 months after enrollment.

Interventionproportion of patients (Mean)
Standard Vitamin and Steroid Schedule + Pemetrexed0.118
Simplified Vitamin and Steroid Schedule + Pemetrexed0.064

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Progression-free Survival (PFS)

Defined as the time from date of first dose to the first observation of disease progression, or death due to any cause. For patients who are alive and have not progressed, PFS is censored at the date of last radiological assessment. (NCT00609518)
Timeframe: Randomization (≤4 weeks from baseline visit) to 12 months after randomization

Interventionmonths (Median)
Standard Vitamin and Steroid Schedule + Pemetrexed3.7
Simplified Vitamin and Steroid Schedule + Pemetrexed3.8

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Overall Survival

Overall survival is the duration from randomization to death. For patients who are alive, overall survival is censored at the date of last contact. (NCT00609518)
Timeframe: Randomization (≤4 weeks from baseline visit) to 12 months after randomization

Interventionmonths (Median)
Standard Vitamin and Steroid Schedule + Pemetrexed8.2
Simplified Vitamin and Steroid Schedule + Pemetrexed9.2

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Scale for Assessment of Negative Symptoms (SANS)

The change from baseline on the scale for the assessment of negative symptoms (SANS) total score. Total SANS scores range from 0-100. The SANS is comprised of 5 subscores: Affective Flattening or Blunting (score range 0-35), Alogia (score range 0-20), Avolition-Apathy (score range 0-15), Anhedonia-Asociality (score range 0-20), and Attention (0-10). For each scale, the higher the score the more prominent the negative symptoms were. The total score was computed by adding all the sub-scale total scores. Scores reported are change in symptoms per week, relative to baseline. A negative score represents a decrease in total SANS score per week, whereas a positive score represents an increase in total SANS score per week. (NCT00611806)
Timeframe: Baseline vs. Week 16

Interventionunits on a scale (Mean)
Folate With B12-.19
Placebo.02

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Positive Sub Scale of the Positive and Negative Syndrome Scale (PANSS)

The change from baseline on the positive symptom sub-scale of the Positive and Negative Syndrome Scale (PANSS). Total PANSS positive symptom sub-scale scores range from 7-49. The PANSS positive symptom sub-scale is comprised of 7 items rated on a scale of 1-7: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. A score of one on each item 1 absent, 2 is minimal, 3 is mild, 4 is moderate, 5 is moderately severe, 6 is severe, and 7 is extreme. The total score was computed by adding all the items on the sub-scale together. Scores reported are change in symptoms per week, relative to baseline. A negative score represents a decrease in total PANSS score per week, whereas a positive score represents an increase in total PANSS score per week. (NCT00611806)
Timeframe: Baseline vs. Week 16

Interventionunits on a scale (Mean)
Folate With B12-.06
Placebo-.04

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Positive and Negative Syndrome Scale (PANSS) and FOLH1, MTHRF, MTR, and COMT Genotype

The change from baseline on the Positive and Negative Syndrome Scale (PANSS) (including FOLH1, MTHRF, MTR, and COMT genotype simultaneously into a linear mixed model).The PANNS has three sub-scales: positive (score range 7-49), negative (score range 7-49), and general psychopathology (score range 16-112). The PANSS negative and positive symptom sub-scale is comprised of 7 items rated on a scale of 1-7 representing the negative and positive symptoms of schizophrenia, respectively, and the general psychopathology sub-scale is comprised of 16 items rated on a scale of 1-7 representing symptoms of general psychopathology in mental illness. The total score was computed by adding all the items on the sub-scale together. Scores reported are change in symptoms per week, relative to baseline. A negative score represents a decrease in total PANSS score per week, whereas a positive score represents an increase in total PANSS score per week. (NCT00611806)
Timeframe: Baseline vs. Week 16

Interventionunits on a scale (Mean)
Folate With B12-.21
Placebo-.1

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Positive and Negative Syndrome Scale (PANSS)

The change from baseline on the Positive and Negative Syndrome Scale (PANSS).The PANNS has three subscales: positive (score range 7-49), negative (score range 7-49), and general psychopathology (score range 16-112). The PANSS positive symptom sub-scale is comprised of 7 items rated on a scale of 1-7, representing positive symptoms of schizophrenia. The PANSS negative symptom subscale is comprised of 7 items rated on a scale of 1-7 representing the negative symptoms of schizophrenia, and the general psychopathology subscale is comprised of 16 items rated on a scale of 1-7 representing symptoms of general psychopathology in mental illness. The total score was computed by adding all the items on the sub-scale together. Scores reported are change in symptoms per week, relative to baseline. A negative score represents a decrease in total PANSS score per week, whereas a positive score represents an increase in total PANSS score per week. (NCT00611806)
Timeframe: Baseline vs. Week 16

Interventionunits on a scale (Mean)
Folate With B12-.21
Placebo-.22

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Overall Survival (OS)

Estimated 4-year survival, where survival is calculated as the time from study enrollment to death from any cause or last follow-up alive whichever occurs first. Kaplan-Meier method is used for estimation. Patients alive at last contact are censored. (NCT00653068)
Timeframe: Up to 4 years after study enrollment

InterventionEstimated Probability (Number)
Stratum I0.3888
Stratum III0.5486

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Non-hematological Toxicity Associated With Chemotherapy: Grade 3 or Higher During Protocol Therapy

Number of Participants with Nonhematological Toxicity Associated With Chemotherapy: Grade 3 or Higher During Protocol Therapy. (NCT00653068)
Timeframe: During protocol therapy up to 1 year after enrollment.

InterventionParticipants (Count of Participants)
AcidosisAcute kidney injuryApneaAdult respiratory distress syndromeAspirationAtelectasisCatheter related infectionCentral nervous system necrosisDehydrationDiarrheaDissmeminated intravascular coagulation (DIC)EnterocolitisFebrile neutropeniaHearing impairmentHematuriaHydrocephalusHypernatremiaHypoalbuminemiaHypocalcemiaHypoglycemiaHypokalemiaHyponatremiaHypophosphatemiaHypotensionHypoxiaIncreased Alanine aminotransferaseIncreased Aspartate aminotransferaseIncreased LipaseIntracranial hemorrhagentraoperative venous injuryLaryngospasmLeft ventricular systolic dysfunctionLung infectionMulti-organ failureMucositis oralPoisoning and procedural complicationsOther gastrointestinal disordersOther infectionPneumonitisProductive coughPulmonary edemaRecurrent laryngeal nerve palsyRenal calculiRespiratory failureSeizureSepsisSinus tachycardiaStridorUpper respiratory infectionVascular access complicationVoice alterationVomitingWeight loss
All Patients11213121111161111132922465412111313117211113262211111

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Event-free Survival

Estimated 4-year EFS where EFS is calculated as the time from study enrollment to disease progression, disease relapse, occurrence of a second malignant neoplasm, death from any cause or last follow-up whichever occurs first. Kaplan-Meier method is used for estimation. Patients without an event are censored at last contact. (NCT00653068)
Timeframe: Up to 4 years after study enrollment

InterventionEstimated probability (Number)
Stratum I0.3401
Stratum III0.4500

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Toxic Death

The number of patients who experience death that is considered to be primarily attributable to complications of treatment. (NCT00653068)
Timeframe: During and after completion of study treatment up to 1 year after enrollment.

InterventionParticipants (Count of Participants)
Stratum I3
Stratum III1

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Non-fatal MI

Myocardial Infarction per Third Definition of MI (NCT00655980)
Timeframe: 30 day postoperative

InterventionParticipants (Count of Participants)
B-Vitamin Group7
Comparator15
Standard of Care8

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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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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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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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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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Contribution of Dasatinib on Minimal Residual Disease (MRD) After Induction Therapy

Percent of patients MRD Positive (MRD > 0.01%) at End of Induction. (NCT00720109)
Timeframe: At the end of induction therapy (at 5 weeks)

InterventionPercentage of participants (Number)
Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy)40.7
Standard-risk29.2
High-risk100.0

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Overall Survival (OS)

The number of days from study day 1 to death. Patients who had not died (no record of death) or were lost to follow-up were censored at the date of last contact. (NCT00722553)
Timeframe: Assessed at the end of each even-numbered cycle (every 8 weeks), or per standard of care if treatment has ended (at least every 12 weeks) for up to 2 years after enrollment. After PD or start of subsequent treatment, OS will be assessed every 4 months.

InterventionMonths (Median)
Evaluable Population9.3

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Progression Free Survival (PFS)

Length of time from study day 1 to the date of radiological evidence of PD (date of computed tomography [CT] or magnetic resonance imaging [MRI] scan, whichever indicates PD) or death, regardless of cause. (NCT00722553)
Timeframe: Assessed at the end of each even-numbered cycle (every 8 weeks), or per standard of care but no more than every 12 weeks (+/- 1 week) if treatment has ended, for up to 2 years after enrollment.

InterventionMonths (Median)
Evaluable Population4.0

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Clinical Benefit Rate (CBR)

The number of patients with a best confirmed or unconfirmed response of CR, PR, or stable disease (SD) for at least 24 weeks (approximately 5.5 months) (NCT00722553)
Timeframe: Assessed at the end of each even-numbered cycle (every 8 weeks) or per standard of care, but no more than every 12 weeks (+/- 1 week) if treatment has ended, for up to 2 years after enrollment.

Interventionparticipants (Number)
Evaluable Population3

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Duration of Response (DOR)

Duration of time from when tumor measurement criteria were met for CR or PR (whichever status was recorded first) until the first date that recurrent disease or progressive disease (PD) or death was objectively documented. Progression is defined, using RECIST, as an increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline. Calculated for those patients with a best overall confirmed or unconfirmed response of CR or PR. (NCT00722553)
Timeframe: Measured from the first day of documented response for up to 2 years after enrollment.

InterventionDays (Median)
Evaluable Patients82

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Objective Response Rate (ORR)

The number of patients with a best overall confirmed response of either complete response (CR) or partial response (PR) (NCT00722553)
Timeframe: Assessed at the end of each even-numbered cycle (every 8 weeks), or per standard of care but no more than every 12 weeks (+/- 1 week) if treatment has ended for up to 2 years after enrollment.

Interventionparticipants (Number)
Evaluable Population1

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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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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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Follow-up Analysis of Progression Free Survival (PFS) as Assessed by Investigator

Follow-up analysis was conducted at the time of overall survival analysis. Progression Free Survival (PFS) as assessed by investigator according to the modified RECIST (version 1.0) criteria. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve. (NCT00806819)
Timeframe: From randomisation until data cut-off (15 February 2013), Up to 30 months

InterventionMonths (Median)
Nintedanib Plus Pemetrexed5.3
Placebo Plus Pemetrexed4.3

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Quality of Life (QoL)

"QoL was measured by standardised questionnaires (EQ-5D, EORTC QLQ-C30, EORTC QLQ-LC13). The EORTC QLQ-C30 comprises of 30 questions, using both multi-item scales and single-item measures. EORTC LC-13 comprises of 13 questions incorporating 1 multi-item scale and a series of single items. The following were the main points of interest: Time to deterioration of cough (QLQ-LC13 question 1), Time to deterioration of dyspnoea (QLQ-LC13, composite of questions 3 to 5), Time to deterioration of pain (QLQ- C30, composite of questions 9 and 19). Time to deterioration of cough, dyspnoea and pain was defined as the time to a 10-point increase from the baseline score.~Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve." (NCT00806819)
Timeframe: From randomisation until data cut-off (15 February 2013), Up to 30 months

,
InterventionMonths (Median)
Time to deterioration of coughTime to deterioration of dyspnoeaTime to deterioration of pain
Nintedanib Plus Pemetrexed6.02.42.8
Placebo Plus Pemetrexed4.32.02.7

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Objective Tumor Response

Confirmed objective response is defined as confirmed Complete Response (CR) and Partial Response (PR) and evaluated according to the modified RECIST criteria version 1.0. This endpoint was analysed based on the central independent reviewer as well as the investigator (NCT00806819)
Timeframe: From randomisation until data cut-off (15 February 2013), Up to 30 months

,
Intervention% of participants (Number)
Central independent reviewerInvestigator assessment
Nintedanib Plus Pemetrexed9.115.0
Placebo Plus Pemetrexed8.313.3

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Incidence and Intensity of Adverse Events

"Incidence and intensity of adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. The worst CTCAE grade per patient is reported and MedDRA version 15.1 used.~Serious signs and symptoms of progressive disease were reported as an adverse event in analysis of this endpoint." (NCT00806819)
Timeframe: From the first drug administration until 28 days after the last drug administration, up to 36 months

,
Intervention% of participants (Number)
CTCAE grade 1CTCAE grade 2CTCAE grade 3CTCAE grade 4CTCAE grade 5
Nintedanib Plus Pemetrexed4.922.246.112.49.8
Placebo Plus Pemetrexed9.230.534.57.812.0

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Clinical Improvement.

"Clinical improvement was defined as the time from randomisation to deterioration in body weight and/or Eastern Cooperative Oncology group performance score (ECOG PS) whichever occurred first.~Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve." (NCT00806819)
Timeframe: From randomisation until data cut-off (15 February 2013), Up to 30 months

InterventionMonths (Median)
Nintedanib Plus Pemetrexed7.2
Placebo Plus Pemetrexed7.5

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Time to Confirmed Objective Tumour Response

"Time to confirmed objective response is defined as time from randomisation to the date of first documented (CR) or (PR) and evaluated according to the modified RECIST criteria version 1.0. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.~This endpoint was analysed based on the central independent reviewer as well as the investigator." (NCT00806819)
Timeframe: From randomisation until data cut-off (15 February 2013), Up to 30 months

,
InterventionMonths (Median)
Central independent review (N=32, 30)Investigator assessment (N=53, 48)
Nintedanib Plus Pemetrexed2.62.6
Placebo Plus Pemetrexed2.72.8

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Duration of Confirmed Objective Tumour Response

"The duration of objective response is the time from first documented (CR) or (PR) to the time of progression or death and evaluated according to the modified RECIST criteria version 1.0. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.~This endpoint was analysed based on the central independent reviewer as well as the investigator." (NCT00806819)
Timeframe: From randomisation until data cut-off (15 February 2013), Up to 30 months

,
InterventionMonths (Median)
central independent reviewer (N=32, 30)Investigator assessment (N=53, 48)
Nintedanib Plus Pemetrexed6.96.5
Placebo Plus Pemetrexed4.47.2

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Overall Survival (Key Secondary Endpoint)

Overall Survival (OS) defined as the duration from randomisation to death (irrespective of the reason of death). Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve. (NCT00806819)
Timeframe: From randomisation until data cut-off (15 February 2013), Up to 30 months

Interventionmonths (Median)
Nintedanib Plus Pemetrexed12.0
Placebo Plus Pemetrexed12.7

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Progression Free Survival (PFS) as Assessed by Central Independent Review

"Progression Free Survival (PFS) as assessed by central independent review according to the modified RECIST (version 1.0) criteria. Progression free survival (PFS) is defined as the duration of time from date of randomisation to date of progression or death (whatever occurs earlier).~Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve." (NCT00806819)
Timeframe: From randomisation until cut-off date 9 July 2012

Interventionmonths (Median)
Nintedanib Plus Pemetrexed4.4
Placebo Plus Pemetrexed3.6

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Change From Baseline in Tumour Size

Percentage change from baseline in tumour size is defined as decrease in the sum of the longest diameter of the target lesion. Presented means are in fact adjusted best means percentage changes generated from ANOVA model adjusted for baseline ECOG PS (0 vs. 1), tumour histology (adenocarcinoma vs. non-adenocarcinoma), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no) This endpoint was analysed based on the central independent reviewer as well as the investigator. (NCT00806819)
Timeframe: From randomisation until data cut-off (15 February 2013), Up to 30 months

,
Interventionpercentage of change in tumor size in mm (Mean)
Central independent review (N=298, 305)Investigator assessment (N=322, 325)
Nintedanib Plus Pemetrexed-10.10-15.60
Placebo Plus Pemetrexed-7.53-11.28

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Disease Control

"Disease control was defined as a best overall response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) and evaluated according to the modified RECIST criteria version 1.0.~This endpoint was analysed based on the central independent reviewer as well as the investigator." (NCT00806819)
Timeframe: From randomisation until data cut-off (15 February 2013), Up to 30 months

,
Intervention% of participants (Number)
Central independent review (N=215, 192)Investigator assessment (N=233, 217)
Nintedanib Plus Pemetrexed60.966.0
Placebo Plus Pemetrexed53.360.3

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Dose Normalised Predose Plasma Concentration at Steady State (Cpre,ss,Norm) of Nintedanib and of Its Metabolites BIBF 1202 and BIBF 1202 Glucuronide

Geometric mean of dose normalised predose plasma concentration (Cpre,ss,norm) of nintedanib and of its metabolites BIBF 1202 and BIBF 1202 glucuronide evaluated at steady state based on course 2 and 3. If only one value was available and valid, then this value was used for calculation of Cpre,ss,norm. (NCT00806819)
Timeframe: Before the administration of nintedanib or placebo and between a window of 30 mins to an hour after administration of trial drug during Course 2 and between 1 and 3 hours after administration of trial drug during Course 3

,
Interventionng/mL/mg (Geometric Mean)
Nintedanib BIBF 1120 (N=188, 39)Nintedanib BIBF 1202 (N=188, 40)Nintedanib BIBF 1202 glucuronide (N=184, 39)
Nintedanib 150 mg Bid Plus Pemetrexed0.1030.1511.72
Nintedanib Plus Pemetrexed0.08830.1311.40

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Follow-up Analysis of Progression Free Survival (PFS) as Assessed by Central Independent Review

Follow-up analysis was conducted at the time of overall survival analysis. Progression Free Survival (PFS) as assessed by central independent review according to the modified RECIST (version 1.0) criteria. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve. (NCT00806819)
Timeframe: From randomisation until data cut-off (15 February 2013), Up to 30 months

InterventionMonths (Median)
Nintedanib Plus Pemetrexed4.4
Placebo Plus Pemetrexed3.4

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Duration of Disease Control

"The duration of disease control was defined as the time from randomisation to the date of disease progression or death (which ever occurs first) for patients with disease control. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.~This endpoint was analysed based on the central independent reviewer as well as the investigator." (NCT00806819)
Timeframe: From randomisation until data cut-off (15 February 2013), Up to 30 months

,
InterventionMonths (Median)
Central independent review (N=215, 192)Investigator assessment (N=233, 217)
Nintedanib Plus Pemetrexed7.46.9
Placebo Plus Pemetrexed6.86.8

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Duration of Response

The duration of response was defined as the time from first confirmed CR or PR to the first time of PD or death due to any cause. CR, PR and PD were defined using RECIST v1.0 criteria. CR was defined as the disappearance of all target and non-target lesions; PR was defined as a ≥30% decrease in the sum of the LD of the target lesions, taking as reference the baseline sum of the LD; PD was defined as a ≥20% increase in the sum of LD of target lesions, taking as reference the smallest sum of the LD recorded since treatment started or the appearance of new lesions and/or unequivocal progression of existing nontarget lesions. Participants with CR or PR who had no PD or death at the time of the data inclusion cutoff, the duration of response was censored at their last contact. (NCT00835185)
Timeframe: Time of response to time of measured PD or death up to 30 months

Interventionmonths (Median)
IMC-11F8 (Necitumumab) + mFOLFOX-610.0

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Area Under the Concentration-Time Curve From Time 0 to Infinity [AUC(0-∞)] of IMC-11F8 at Study Day 1 of Cycle 1

(NCT00835185)
Timeframe: Cycle 1 Day 1 predose, immediately after infusion, and 1, 2, 4, 24, 72, 96, 144, 168 and 236 hours postdose

Interventionmicrograms*hour/milliliter (µg*h/mL)] (Geometric Mean)
IMC-11F8 (Necitumumab) + mFOLFOX-639400

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Clearance (CL) of IMC-11F8 at Study Day 1 of Cycle 1

CL is the volume of plasma (or blood) from which the drug is completely removed, or cleared, in a given time. (NCT00835185)
Timeframe: Cycle 1 Day 1 predose, immediately after infusion, and 1, 2, 4, 24, 72, 96, 144, 168 and 236 hours postdose

Interventionmilliliters/hour (mL/h) (Geometric Mean)
IMC-11F8 (Necitumumab) + mFOLFOX-620.3

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Half-Life (t1/2) of IMC-11F8 at Study Day 1 of Cycle 1

The t1/2 is the time measured for the plasma concentration of the drug to decrease by one half. (NCT00835185)
Timeframe: Cycle 1 Day 1 predose, immediately after infusion, and 1, 2, 4, 24, 72, 96, 144, 168 and 236 hours postdose

Interventionhours (h) (Geometric Mean)
IMC-11F8 (Necitumumab) + mFOLFOX-6142

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Maximum Concentration (Cmax) of IMC-11F8 at Study Day 1 of Cycle 1

(NCT00835185)
Timeframe: Cycle 1 Day 1 predose, immediately after infusion, and 1, 2, 4, 24, 72, 96, 144, 168 and 236 hours postdose

Interventionmicrograms/milliliter (µg/mL) (Geometric Mean)
IMC-11F8 (Necitumumab) + mFOLFOX-6344

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Overall Survival (OS)

OS was defined as the duration from the date of first dose to the date of death from any cause. OS was estimated by the Kaplan-Meier method. Participants who were alive at the time of the data inclusion cutoff or lost to follow-up, OS was censored at the last contact. (NCT00835185)
Timeframe: First dose to date of death from any cause up to 30 months

Interventionmonths (Median)
IMC-11F8 (Necitumumab) + mFOLFOX-622.5

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Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response )

CR and PR defined using Response Evaluation Criteria In Solid Tumors (RECIST) version (v) 1.0 criteria. CR was defined as the disappearance of all target and non-target lesions and PR defined as a ≥30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD. Percentage of participants was calculated as: (total number of participants with CR or PR from start of the treatment until disease progression or recurrence) / (total number of participants treated) * 100. (NCT00835185)
Timeframe: Up to 30 Months

Interventionpercentage of participants (Number)
IMC-11F8 (Necitumumab) + mFOLFOX-663.6

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Progression-Free Survival (PFS)

PFS was defined as the time from date of first dose to the first observation of disease progression or death due to any cause. Progressive disease (PD) was determined using RECIST v1.0 criteria. PD was defined as ≥20% increase in the sum of LD of target lesions, taking as reference the smallest sum of the LD recorded since treatment started or the appearance of new lesions and/or unequivocal progression of existing nontarget lesions. PFS was estimated by the Kaplan-Meier method. Participants who had no PD or death at the time of the data inclusion cutoff, PFS was censored at their last tumor assessment prior to the earliest of the following events: 2 or more missed visits, additional cancer treatment or the end of the follow-up period. (NCT00835185)
Timeframe: First dose to measured PD or death up to 30 months

Interventionmonths (Median)
IMC-11F8 (Necitumumab) + mFOLFOX-610.0

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Serum Anti-IMC-11F8 Antibody Assessment (Immunogenicity)

A participant was considered to have an anti-IMC-11F8 response if there were 2 consecutive positive samples or if the final sample tested is positive. Participants with a baseline sample positive for anti-IMC-11F8 antibodies were considered unevaluable for immunogenicity. A sample was considered positive for IMC-11F8 antibodies if it exhibited a post-baseline treatment emergent antibody level that exceeded the upper 95% confidence interval of the mean determined from the normal anti-IMC 11F8 level found in healthy treatment-naïve individuals. (NCT00835185)
Timeframe: Baseline up to last day of treatment plus 45 days after last treatment (127 weeks)

Interventionparticipants (Number)
IMC-11F8 (Necitumumab) + mFOLFOX-64

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Kirsten Rat Sarcoma (KRAS) Mutation Status

Tumor tissues collected prior to study drug administration were evaluated for the presence or absence of KRAS mutations by a retrospective analysis. (NCT00835185)
Timeframe: Baseline

Interventionparticipants (Number)
KRAS Mutation PositiveKRAS Mutation Negative
IMC-11F8 (Necitumumab) + mFOLFOX-6916

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Volume of Distribution (Vss) of IMC-11F8 at Study Day 1 of Cycle 1

Vss 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 at steady-state. (NCT00835185)
Timeframe: Cycle 1 Day 1 predose, immediately after infusion, and 1, 2, 4, 24, 72, 96, 144, 168 and 236 hours postdose

Interventionmilliliters (mL) (Geometric Mean)
IMC-11F8 (Necitumumab) + mFOLFOX-63660

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Number of Participants With Adverse Events (AEs), Serious AEs (SAEs) or Death

The number of participants who experienced AEs, SAEs or death during the study and within 30 days of last dose. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module. (NCT00835185)
Timeframe: First dose to end of treatment and 30-day post treatment follow-up up to 31 months

Interventionparticipants (Number)
AEsSAEsDeaths
IMC-11F8 (Necitumumab) + mFOLFOX-644163

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Progression Free Survival (PFS)

"PFS was defined as the time from the date of randomization to the date of tumor progression or death from any cause, whichever occurred first. PFS was based on tumor assessment by the Independent Review Committee (IRC). PFS was estimated from Kaplan-Meier Curves.~The study was not powered for comparison of PFS between the two arms (non-comparative, open-label study).~Progression was defined using Response Evaluation Criteria In Solid Tumors (RECIST v1.0), as at least a 20 percent increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non target-lesions." (NCT00851084)
Timeframe: From the date of the first randomization until the study data cut-off date, 14 April 2011 (approximately 26 months)

InterventionMonths (Median)
mFOLFOX6 Only8.77
mFOLFOX6 + Aflibercept8.48

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Progression Free Survival (PFS) Rate at 12 Months

PFS rate at 12 months was defined as the percentage of patients alive without disease progression at 12 months after randomization. The primary efficacy analysis was based on assessment by the Independent Review Committee (IRC). The study was not powered for comparison of PFS rate at 12 months between the two arms (non-comparative, open-label study). Progression was defined using Response Evaluation Criteria In Solid Tumors (RECIST v1.0), as at least a 20 percent increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non target-lesions. (NCT00851084)
Timeframe: 12 months

Interventionpercentage of participants (Number)
mFOLFOX6 Only21.2
mFOLFOX6 + Aflibercept25.8

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Number of Participants With Treatment-emergent Adverse Events (TEAE)

Summary of treatment-emergent adverse events in the safety population. The National Cancer Institute Common Terminology Criteria for Adverse Event (NCI-CTCAE), version 3.0 was used in this study to grade the severity of AEs. (NCT00851084)
Timeframe: From the date of the first randomization up to 30 days after the treatment discontinuation or until TEAE was resolved or stabilized

,
Interventionparticipants (Number)
Treatment Emergent Adverse Event (TEAE)Grade 3-4 TEAETreatment emergent Serious Adverse Event (SAE)TEAE leading to deathPremature treatment discontinuationPermanent treatment discontinuation
mFOLFOX6 + Aflibercept1191085583437
mFOLFOX6 Only11587322NA26

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Overall Objective Response Rate (ORR)

"Summary of overall objective response rate based on tumor assessment by the Independent Review Committee (IRC) as per Response Evaluation Criteria in Solid Tumours (RECIST) criteria. ORR was defined as the proportion of patients with confirmed Complete Response (CR) or confirmed Partial Response (PR) relative to the total number of patients in the analysis population.~Per RECIST v 1.0 target lesions evaluation and assessed by tumor imaging: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): >=30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.~The study was not powered for comparison of ORR between the two arms (non-comparative, open-label study)." (NCT00851084)
Timeframe: From the date of the first randomization until the study data cut-off date, 14 April 2011 (approximately 26 months)

Interventionpercentage of participants (Number)
mFOLFOX6 Only45.9
mFOLFOX6 + Aflibercept49.1

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Immunogenicity of Intravenous (IV) Aflibercept

The antidrug antibody (ADA) assay was evaluated for participants receiving aflibercept. (NCT00851084)
Timeframe: Any time post baseline and 90 days after the last infusion of aflibercept, according to baseline status

,
Interventionparticipants (Number)
ADA Negative post-baselineADA Positive (drug specific) post-baselineADA Negative 90 days after last doseADA Positive 90 days after last dose
Negative or Missing1057450
Positive1211

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Overall Survival (OS)

"Overall survival was defined as the time 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 earliest between the last date the patient was known to be alive and the study cutoff date.~The study was not powered for comparison of OS between the two arms (non-comparative, open-label study)." (NCT00851084)
Timeframe: From the date of the first randomization until the study data cut-off date, 14 April 2011 (approximately 26 months)

Interventionmonths (Median)
mFOLFOX6 Only22.31
mFOLFOX6 + Aflibercept19.45

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Infant Mortality Through 6 mo of Age

Infant Mortality to Age 6 months (180 days from birth) (NCT00860470)
Timeframe: 6-months post-birth

Interventionparticipants (Number)
Iron and Folate764
Multiple Micronutrient741

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Moderate to Late Preterm

Birth between 32 and 37 weeks gestation (NCT00860470)
Timeframe: Between 31 and 38 weeks of gestation

Interventionparticipants (Number)
Iron and Folate2391
Multiple Micronutrient2113

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Neonatal Mortality

Neonatal Mortality (28 days of life) (NCT00860470)
Timeframe: 1 month post-birth

Interventionparticipants (Number)
Iron and Folate625
Multiple Micronutrient626

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Post-neonatal Mortality

Risk of Post-neonatal Mortality (29th -180th day of life) (NCT00860470)
Timeframe: 1-6 months post-birth

Interventionparticipants (Number)
Iron and Folate139
Multiple Micronutrient115

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Preterm Birth

Being born before 37 weeks of gestation (NCT00860470)
Timeframe: Up to 37 weeks of gestation

Interventionparticipants (Number)
Iron and Folate2912
Multiple Micronutrient2510

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Still Birth Rates

Stillbirth (born >=24 weeks without breathing, crying, or moving limbs). (NCT00860470)
Timeframe: 24 weeks gestation to delivery

Interventionparticipants (Number)
Iron and Folate716
Multiple Micronutrient648

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Extremely Pre-term

Birth before 28 weeks gestation (NCT00860470)
Timeframe: Up to 28 weeks of gestation

Interventionparticipants (Number)
Iron and Folate136
Multiple Micronutrient106

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Small for Gestation Age

Small for Gestational Age defined as birth weight <10th percentile of a standard reference (Alexander GR, Himes JH, Kaufman RB, et al. Obstet Gynecol. 1996;87(2):163-68). (NCT00860470)
Timeframe: At delivery/birth

Interventionparticipants (Number)
Iron and Folate6479
Multiple Micronutrient6405

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Very Pre-term

Birth between 28 and 32 weeks of gestation (NCT00860470)
Timeframe: Between 27 and 33 weeks of gestation

Interventionparticipants (Number)
Iron and Folate385
Multiple Micronutrient291

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Low Birth Weight

Birth weight below 2500g (NCT00860470)
Timeframe: Measured at delivery/birth

Interventionparticipants (Number)
Iron and Folate4809
Multiple Micronutrient4275

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Duration of Response

The duration of response was defined as the time from first objective status assessment of complete response (CR) or partial response (PR) to the first time of progression or death as a result of any cause. CR or PR is classified by the investigators according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. CR is disappearance of all target and non-target lesions; PR is a ≥30% decrease in sum of longest diameter of target lesions without new lesion and progression of non-target lesion. (NCT00862784)
Timeframe: Time of response to time of measured progressive disease up to 22.2 months

Interventionmonths (Median)
IMC-1121B (Ramucirumab) + mFOLFOX-611.0

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Percentage of Participants With Complete Response or Partial Response [Objective Response Rate (ORR)]

ORR is the percentage of participants with a confirmed complete response (CR) + partial response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. CR is disappearance of all target and non-target lesions; PR is a ≥30% decrease in sum of longest diameter of target lesions without new lesion and progression of non-target lesion. ORR is calculated as a total number of participants with CR or PR from the start of study treatment until disease progression or recurrence divided by the total number of participants treated, then multiplied by 100. (NCT00862784)
Timeframe: First dose to date of objective progressive disease up to 23.8 months

Interventionpercentage of participants (Number)
IMC-1121B (Ramucirumab) + mFOLFOX-658.3

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Progression-Free Survival (PFS)

PFS was defined as the time from date of first dose to the first observation of progression of disease (PD) or death due to any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. PD is ≥20% increase in sum of longest diameter of target lesions and/or unequivocal progression of non-target lesion and/or new lesion. For participants who had no PD or death or had started new therapeutic anticancer treatment, PFS was censored at their last radiographic tumor assessment. (NCT00862784)
Timeframe: First dose to measured progressive disease or death due to any cause up to 28.1 months

Interventionmonths (Median)
IMC-1121B (Ramucirumab) + mFOLFOX-611.5

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Serum Anti-IMC-1121B (Immunogenicity) at Day 1

Data presented are the number of participants with treatment emergent anti-IMC-112B antibodies. (NCT00862784)
Timeframe: Day 1 (Cycles 1, 5, 9, and 30-day follow-up)

Interventionparticipants (Number)
Cycle 1 (n=39)Cycle 5 (n=33)Cycle 9 (n=25)30-day Follow-up (n=17)
IMC-1121B (Ramucirumab) + mFOLFOX-60202

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Overall Survival (OS)

OS was defined as the time from first dose to the date of death due to any cause. For participants who were alive or were lost to follow-up, OS was censored on the last date the participant was known to be alive. (NCT00862784)
Timeframe: First dose to death due to any cause up to 28.1 months

Interventionmonths (Median)
IMC-1121B (Ramucirumab) + mFOLFOX-620.4

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Percentage of Participants With Surgery

The surgery involving a radical rectal excision using the TME technique. (NCT00865189)
Timeframe: Arm A: approximately 28-31 weeks after initiation of treatment; Arm B: approximately 13-15 weeks after initiation of treatment

Interventionpercentage of participants (Number)
Arm A (Bevacizumab, Induction Chemotherapy, Chemoradiotherapy)91.3
Arm B (Bevacizumab, Chemoradiotherapy)97.8

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Disease-Free Survival (DFS)

The DFS was defined as the time from the first treatment intake to disease recurrence assessed (second primary cancer, local or distant recurrence, distant metastases) or death from any cause. The DFS was analyzed using Kaplan-Meier method. (NCT00865189)
Timeframe: From first time of the treatment administration to the date of second cancer, local or regional recurrence, distant metastasis or death from any cause (up to approximately 6 years)

Interventionmonths (Median)
Arm A (Bevacizumab, Induction Chemotherapy, Chemoradiotherapy)68.3
Arm B (Bevacizumab, Chemoradiotherapy)NA

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Number of Cycles of Chemotherapy

(NCT00865189)
Timeframe: Arm A: Week 16 to Week 23; Arm B: Week 1 to Week 7

Interventioncycles (Mean)
Arm A (Bevacizumab, Induction Chemotherapy, Chemoradiotherapy)4.4
Arm B (Bevacizumab, Chemoradiotherapy)4.8

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Percentage of Participants Who Died

(NCT00865189)
Timeframe: Baseline up to approximately 6 years

Interventionpercentage of participants (Number)
Arm A (Bevacizumab, Induction Chemotherapy, Chemoradiotherapy)8.7
Arm B (Bevacizumab, Chemoradiotherapy)24.4

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Number of Cycles of Radiotherapy

(NCT00865189)
Timeframe: Arm A: Week 16 to Week 23; Arm B: Week 1 to Week 7

Interventioncycles (Mean)
Arm A (Bevacizumab, Induction Chemotherapy, Chemoradiotherapy)4.5
Arm B (Bevacizumab, Chemoradiotherapy)5.0

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Overall Survival

The overall survival was defined as the time from the first treatment intake to death from any cause. (NCT00865189)
Timeframe: From the first treatment administration to the date of death (up to approximately 6 years)

Interventionmonths (Median)
Arm A (Bevacizumab, Induction Chemotherapy, Chemoradiotherapy)NA
Arm B (Bevacizumab, Chemoradiotherapy)NA

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Percentage of Participants With Tumor Sterilization Defined by ypT0-N0

Tumor sterilization was defined as the absence of residual tumor cells in the resected specimen including lymph nodes (ypT0-N0). The rate of sterilization of the tumoral specimen was assessed after surgery on the surgical specimen by local review. Analyses were performed for participants who have been operated as defined by the protocol (within the study and TME technique) and for all participants who have been operated. Reported is the percentage of participants with tumor sterilization. (NCT00865189)
Timeframe: After surgery (Arm A: approximately 28-31 weeks after initiation of treatment; Arm B: approximately 13-15 weeks after initiation of treatment)

Interventionpercentage of participants (Number)
Arm A (Bevacizumab, Induction Chemotherapy, Chemoradiotherapy)23.8
Arm B (Bevacizumab, Chemoradiotherapy)11.4

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Percentage of Participants With Local and Distant Recurrences

The percentage of participants with a recurrence was described by type of recurrence (local and distant recurrence). (NCT00865189)
Timeframe: After surgery (Arm A: approximately 28-31 weeks after initiation of treatment; Arm B: approximately 13-15 weeks after initiation of treatment)

,
Interventionpercentage of participants (Number)
Local recurrenceDistant recurrence
Arm A (Bevacizumab, Induction Chemotherapy, Chemoradiotherapy)2.217.4
Arm B (Bevacizumab, Chemoradiotherapy)6.713.3

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Number of Cycles of Induction Chemotherapy

(NCT00865189)
Timeframe: 6 cycles (12 weeks; cycle length = 14 days)

Interventioncycles (Mean)
Arm A (Bevacizumab, Induction Chemotherapy, Chemoradiotherapy)5.8

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Percentage of Participants With Tumor Down-Staging (ypT0-pT2)

A participant with a downstaging was defined as a participant with T3 (T describes the size of the original [primary] tumor) at inclusion and T2 or T1 or T0 after surgery, or with N+ (N describes lymph nodes involvement) at inclusion and N- after surgery and if T is equal at inclusion and after surgery. The clinical tumor-node-metastasis (cTNM) classification was used at inclusion and the pathological staging tumor and nodes (ypTN) classification after surgery. Reported is the percentage of participants with tumor downstaging of the surgical specimen according to the local review and centralized review. (NCT00865189)
Timeframe: After surgery (Arm A: approximately 28-31 weeks after initiation of treatment; Arm B: approximately 13-15 weeks after initiation of treatment)

,
Interventionpercentage of participants (Number)
Downstaging, local review (n=41, 44)Downstaging, centralized review (n=39, 43)
Arm A (Bevacizumab, Induction Chemotherapy, Chemoradiotherapy)65.964.1
Arm B (Bevacizumab, Chemoradiotherapy)54.555.8

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Percentage of Participants With Second Cancer, Local or Regional Recurrence, Distant Metastasis, or Death

(NCT00865189)
Timeframe: Baseline up to approximately 6 years

Interventionpercentage of participants (Number)
Arm A (Bevacizumab, Induction Chemotherapy, Chemoradiotherapy)30.4
Arm B (Bevacizumab, Chemoradiotherapy)33.3

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Change in Plasma Total Homocysteine Concentration (tHcy)

"Difference between baseline (pre-operative) and peak postoperative (i.e., maximum of postoperative value obtained within 30 minutes after anesthesia end time and morning of post-operative day 1) tHcy concentration .~Of note: there were no secondary outcomes." (NCT00901394)
Timeframe: Immediately postoperatively and on postoperative day 1

Interventionmcmol/L (Median)
Treatment 11.9
Treatment 22.7
Control Group0.5

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Phase I: Maximum Tolerated Dose (MTD) of Pemetrexed

The phase I component of the study are to determine the safety and tolerability of pemetrexed in human subjects with non small cell lung cancer (NSCLC), and to determine the maximum tolerated dose. (NCT00923273)
Timeframe: 5 weeks

Interventionmg/m^2 (Number)
Treatment Level 1: 3mg Load500
Treatment Level 2: 6mg Load500
Treatment Level 3: 6mg Load500
Treatment Level 4: 10mg Load500
Treatment Level 5: 15mg Load500

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Phase I: Maximum Tolerated Dose (MTD) of Sirolimus

The phase I component of the study are to determine the safety and tolerability of sirolimus in human subjects with non small cell lung cancer (NSCLC), and to determine the maximum tolerated dose. (NCT00923273)
Timeframe: 5 weeks

Interventionmg/m^2 (Number)
Treatment Level 1: 3mg Load10
Treatment Level 2: 6mg Load10
Treatment Level 3: 6mg Load10
Treatment Level 4: 10mg Load10
Treatment Level 5: 15mg Load10

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Phase II: Clinical Response Rate

Clinical response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is disappearance of all target lesions. Partial response (PR) at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. Progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. (NCT00923273)
Timeframe: 21 weeks

InterventionParticipants (Count of Participants)
Complete responsePartial responseStable diseaseProgressive diseaseNot evaluable
Treatment Level 4: 10mg Load051327

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Number of Participants With Serious and Non-Serious Adverse Events

Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v3.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. (NCT00923273)
Timeframe: Date treatment consent signed to date off study, approximately 45 months

,,,,
InterventionParticipants (Count of Participants)
Subjects from phase I8subjects prior peme & 12 subjects peme naive
Treatment Level 1: 3mg Load40
Treatment Level 2: 6mg Load30
Treatment Level 3: 6mg Load30
Treatment Level 4: 10 mg Load720
Treatment Level 5: 15mg Load50

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Clinical Endpoints for Psoriasis: Target Lesion Score

The lesion score of a single psoriatic plaque selected at baseline. Total range is 0 - 12 with 0 being clear and 12 representing the most severe disease. The target lesion score is composed of scale, erythema, and induration, each parameter is scored 0 (clear) through 4 (very severe). Totals are summed for target lesion score. S+E+I = TLS (NCT00932113)
Timeframe: Week 0 and Week 16

Interventionunits on a scale (Mean)
Adalimumab1.2
Methotrexate (MTX)3.4

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Clinical Endpoints for Psoriasis: Photography Completed

(NCT00932113)
Timeframe: Week 0 and Week 16

Interventionparticipants (Number)
Adalimumab15
Methotrexate (MTX)15

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Biologic Activity Endpoints

Histologic and Immunohistochemistry endpoints; Relative messenger RNA gene expression (normalized to HARP); and Gene Arrays. (NCT00932113)
Timeframe: Weeks 0, 1, 2, 4 and 16

,
Interventionfold change (Mean)
CAMP(responders)CAMP(Non responders)CCL20 (responders)CCL20 (non responders)CXCL1 (responders)CXCL1 (non responders)DEFB4A (responders)DEFB4A (non responders)IL 17F (responders)IL 17F (non responders)IL 17A (responders)IL 17A (non responders)IL 23 A (responders)IL 23A (non responders)IL 22 (responders)IL 22 (non rsponders)IFNG (responders)IFNG (non responders)MX1 (responders)MX1 (non responders)
Adalimumab-3.850.05-3.550.84-3.011.03-6.96-0.07-1.970.79-5.310.18-3.90-0.81-3.580.25-2.66-0.52-1.900.04
Methotrexate (MTX)-2.830.84-2.960.84-3.181.22-61.83-3.241.02-4.751.00-2.720.89-5.141.00-1.770.82-2.000.47

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Clinical Endpoints for Psoriasis: % Body Surface Area

(NCT00932113)
Timeframe: Week 0 and week 16

Interventionpercentage of total body surface area (Mean)
Adalimumab5.9
Methotrexate (MTX)10.7

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Clinical Endpoints for Psoriasis: PASI 75

PASI 75 is the percent of subjects who experience an improvement in PASI (Psoriasis Area and Severity Index) score of at least 75% from their baseline PASI score. (NCT00932113)
Timeframe: Weeks 0 and week 16

Interventionpercentage of subjects (Number)
Adalimumab67
Methotrexate (MTX)27

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Clinical Endpoints for Psoriasis: Physician's Global Assessment (PGA) Clear or Almost Clear (PGA 0-1)

(NCT00932113)
Timeframe: Week 0 and Week 16

Interventionpercentage of subjects (Number)
Adalimumab73
Methotrexate (MTX)27

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Number of Participants With Treatment Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation

AEs are defined as any untoward medical occurrence, that does not necessarily have a causal relationship with this treatment. SAEs are defined as an AE that: is fatal; is life threatening (places the subject at immediate risk of death); requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; other significant medical hazard. The severity of events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v 4.0: mild=grade 1, moderate=grade 2, severe=grade 3, life-threatening=grade 4, death=grade 5. (NCT00950989)
Timeframe: From first dose of study drug until the end of study; median (min, max) duration was 113 days (8, 132).

,,,
InterventionParticipants (Count of Participants)
AEsSAEsFatal AEsAEs leading to Study DiscontinuationAEs leading to Study Drug DiscontinuationCTCAE Grades 3, 4, 5 AEsAEs Related to Study DrugSAEs Related to Study DrugFatal AEs Related to Study DrugAEs Related to Study Drug Leading to Study DiscontinuationAEs Related to Study Drug Leading to Study Drug DiscontinuationCTCAE Grades 3, 4, 5 AEs Related to Study Drug
Brodalumab 140 mg40112121400000
Brodalumab 210 mg32300241100020
Brodalumab 70 mg3210113800111
Placebo32202141200100

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PK of Brodalumab: Area Under the Curve During the Dosing Interval (AUCtau)

(NCT00950989)
Timeframe: Week 8: Day 59-Day 61 (44-100 hours post-dose), Day 64 (160-176 hours post-dose), Week 10: pre-dose

Interventionµg*day/mL (Mean)
Brodalumab 70 mg18.1
Brodalumab 140 mg73.3
Brodalumab 210 mg199

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Pharmacokinetics (PK) of Brodalumab: Maximum Observed Concentration (Cmax)

(NCT00950989)
Timeframe: Week 8: Day 59-Day 61 (44-100 hours post-dose), Day 64 (160-176 hours post-dose), Week 10: pre-dose

Interventionµg/mL (Mean)
Brodalumab 70 mg3.02
Brodalumab 140 mg7.85
Brodalumab 210 mg17.9

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PK of Brodalumab: Time to Maximum Observed Concentration (Tmax)

(NCT00950989)
Timeframe: Week 8: Day 59-Day 61 (44-100 hours post-dose), Day 64 (160-176 hours post-dose), Week 10: pre-dose

Interventiondays (Median)
Brodalumab 70 mg1.94
Brodalumab 140 mg2.00
Brodalumab 210 mg1.96

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Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 12

"A positive ACR70 response is defined if the following 3 criteria for improvement from baseline were met:~70% improvement in 68 tender joint count;~70% improvement in 66 swollen joint count; and~70% improvement in at least 3 of the 5 following parameters:~Patient's assessment of joint pain (measured on a 100 mm visual analog scale [VAS]),~Patient's global assessment of disease activity (measured on a 0-10 Likert scale),~Physician's global assessment of disease activity (measured on a 0-10 Likert scale),~Patient's self assessment of disability (Health Assessment Questionnaire - Disability Index [HAQ-DI]),~Acute phase reactant: erythrocyte sedimentation rate (ESR) or C-Reactive Protein (CRP), whichever has bigger improvement." (NCT00950989)
Timeframe: Baseline, week 12

Interventionpercentage of participants (Number)
Placebo3.2
Brodalumab 70 mg3.2
Brodalumab 140 mg3.2
Brodalumab 210 mg0.0

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Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12

"A positive ACR50 response is defined if the following 3 criteria for improvement from baseline were met:~50% improvement in 68 tender joint count;~50% improvement in 66 swollen joint count; and~50% improvement in at least 3 of the 5 following parameters:~Patient's assessment of joint pain (measured on a 100 mm visual analog scale [VAS]),~Patient's global assessment of disease activity (measured on a 0-10 Likert scale),~Physician's global assessment of disease activity (measured on a 0-10 Likert scale),~Patient's self assessment of disability (Health Assessment Questionnaire - Disability Index [HAQ-DI]),~Acute phase reactant: erythrocyte sedimentation rate (ESR) or C-Reactive Protein (CRP), whichever has bigger improvement." (NCT00950989)
Timeframe: Baseline, week 12

Interventionpercentage of participants (Number)
Placebo12.7
Brodalumab 70 mg15.9
Brodalumab 140 mg15.9
Brodalumab 210 mg9.5

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Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12

"A positive ACR20 response is defined if the following 3 criteria for improvement from baseline were met:~20% improvement in 68 tender joint count;~20% improvement in 66 swollen joint count; and~20% improvement in at least 3 of the 5 following parameters:~Patient's assessment of joint pain (measured on a 100 mm visual analog scale [VAS]),~Patient's global assessment of disease activity (measured on a 0-10 Likert scale),~Physician's global assessment of disease activity (measured on a 0-10 Likert scale),~Patient's self assessment of disability (Health Assessment Questionnaire - Disability Index [HAQ-DI]),~Acute phase reactant: erythrocyte sedimentation rate (ESR) or C-Reactive Protein (CRP), whichever has bigger improvement." (NCT00950989)
Timeframe: Baseline, Week 12

Interventionpercentage of partcipants (Number)
Placebo42.9
Brodalumab 70 mg39.7
Brodalumab 140 mg36.5
Brodalumab 210 mg46.0

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Disease Activity Score 28 (DAS28) at Week 12

The DAS28 is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables: • The number of tender joints assessed using the 28-jount count and number of swollen joints assessed using the 28-joint count; • Erythrocyte sedimentation rate (ESR); • Patient's global assessment of disease activity (measured on a 0-10 Likert scale). The DAS28 score ranges from 0 to 10, with higher scores indicating more severe disease activity. (NCT00950989)
Timeframe: Week 12

Interventionscore on a scale (Least Squares Mean)
Placebo5.0
Brodalumab 70 mg4.9
Brodalumab 140 mg5.1
Brodalumab 210 mg5.1

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Part 2: Number of Participants With Each Type of Response Evaluation Criteria in Solid Tumors (RECIST)-Determined Overall Best Response

Overall best response was determined by RECIST criteria. Types of overall response could be: Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive Disease (PD), Not Assessable (NA) or Incomplete Response/Stable Disease (IR/SD). (NCT00954512)
Timeframe: Up to ~30 days after the final dose of robatumumab (Up to ~14 months)

,,,,
InterventionParticipants (Number)
Complete Response (CR)Partial Response (PR)Stable Disease (SD)Progressive Disease (PD)Not Assessable (NA)Incomplete Response/Stable Disease (IR/SD)
Regimen A: FOLFIRI (± Cetuximab) + Robatumumab000200
Regimen B: Carboplatin + Paclitaxel + Robatumumab002100
Regimen D: Trastuzumab + Robatumumab001100
Regimen E: mTor Inhibitor (Everolimus) + Robatumumab002100
Regimen F: Gemcitabine (± Erlotinib) + Robatumumab001100

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Part 1: Number of Participants Who Experienced One or More Adverse Events (AEs)

An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to this study drug. AEs may include the onset of new illness and the exacerbation of pre-existing conditions. (NCT00954512)
Timeframe: Up to ~30 days after the final dose of robatumumab (Up to ~14 months)

InterventionParticipants (Number)
Regimen A: FOLFIRI (± Cetuximab) + Robatumumab2
Regimen B: Carboplatin + Paclitaxel + Robatumumab3
Regimen D: Trastuzumab + Robatumumab2
Regimen E: mTor Inhibitor (Everolimus) + Robatumumab4
Regimen F: Gemcitabine (± Erlotinib) + Robatumumab4

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Objective Response Rate

"Number of Participants with Partial Response (PR), Stable Disease (SD), Progression of Disease (POD) Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI and/or CT: Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (POD); POD, 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" (NCT00957905)
Timeframe: Within 3 courses of treatment

,
Interventionparticipants (Number)
Partial ResponseStable DiseaseProgression of Disease
Part A (Alvocidib and Oxaliplatin)025
Part B (Alvocidib and FOLFOX)6109

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Progression Free Survival (PFS)

Progression-free survival (PFS) was the duration of time (in months) from first administration of study treatment to date of first documented progression or death from any cause. It was based on tumor assessments made according to the IWC with or without PET scans, subject to their availability. Per IWC, progression was defined as a ≥50% increase from the nadir in the individual sum of the products of the diameters of any index lesion; the reappearance of pathology, enlargement of liver/spleen, or unequivocal progression of non-measurable disease or appearance of any new lesions. (NCT00998946)
Timeframe: Up to 24 months

Interventionmonths (Median)
Pralatrexate3.6

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Overall Survival (OS)

Overall Survival was the time (in months) from first administration of study treatment until the date of death. (NCT00998946)
Timeframe: Up to 24 months

Interventionmonths (Median)
PralatrexateNA

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Objective Response Rate (ORR)

Objective response rate was defined as the percentage of participants with a complete response (CR) or a partial response (PR). Tumor response was evaluated on the basis of clinical and radiological criteria, assessed according to International Workshop Criteria (IWC) with or without positron emission tomography (PET) scans. Per IWC criteria CR is defined as complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy, and normalization of those biochemical abnormalities definitely assignable to non-Hodgkin's lymphoma (NHL) and PR is defined as >= 50% decrease in sum of the product of the perpendicular diameters (SPD) of the six largest dominant nodes or nodal masses and no increase in size of other nodes, liver or spleen. (NCT00998946)
Timeframe: Up to 24 months

Interventionpercentage of participants (Number)
Pralatrexate4

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Duration of Response (DOR)

The Duration of Response was defined as the time (in months) from the date the measurement criteria were first met for CR or PR (whichever status was recorded first) until the first subsequent date that relapse or progression was documented. It was assessed according to IWC with or without PET, subject to its availability. Per IWC, progression was defined as a ≥50% increase from the nadir in the individual sum of the products of the diameters of any index lesion; the reappearance of pathology, enlargement of liver/spleen, or unequivocal progression of non-measurable disease or appearance of any new lesions. (NCT00998946)
Timeframe: Up to 24 months

Interventionmonths (Median)
PralatrexateNA

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Percent of Participants With a Partial Response (PR) or a Complete Response (CR)

CR and PR based on RECIST Guidelines: CR is defined as the disappearance of all tumor lesions; PR is defined as at least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LDs or the complete disappearance of target lesions, with persistence (but not worsening) of one or more nontarget lesions and the appearance of no new lesions. PD is defined as at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. (NCT01057589)
Timeframe: Date of first response to PD (up to 18.7 months)

Interventionpercentage of participants (Number)
Pemetrexed Cisplatin Cetuximab29.3

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Change From Baseline in Participant Reported European-Quality of Life 5 Dimension Instrument (EQ-5D) Visual Analog Scale (VAS) at End of Triplet Combination Therapy and End of Maintenance Therapy

Vertical VAS - a 20 millimeter (mm), fractionated scale in the form of a thermometer with endpoints of 0 (worst imaginable health state) and 100 (best imaginable health state). Participants used the EQ-5D VAS scale to rate their overall health on the day the questionnaire was administered. Possible change values range from -100 (best imaginable health at baseline changed to worst possible health at visit) to 100 (worst possible health at baseline changed to best possible health at visit). (NCT01057589)
Timeframe: Baseline, End of Triplet Combination Therapy (up to Cycle 6 [4.2 months]), End of Maintenance Therapy (up to 18.7 months)

Interventionunits on a scale (Mean)
Change at End of Triplet Therapy (n=23)Change at End of Maintenance Therapy (n=11)
Pemetrexed Cisplatin Cetuximab-1.2-10.6

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Change From Baseline in Performance Status Scale for Head and Neck Cancer Patients (PSS-HNC)

PSS-HNC is a clinician-rated instrument designed to measure speaking and eating disabilities of participants with head and neck cancer and consists of 3 subscales: Normalcy of Diet (NOD) subscale measures the ability of the participants to eat a normal diet, scale ranged from 0 (non-oral feeding) to 100 (unrestricted diet); Understandability of Speech (UOS)subscale measured the degree a clinician was able to understand the participant's speech, subscale ranged from 0 (never understandable) to 100 (always understandable); Eating in Public (EIP) subscale, rating based on clinician question to the participant to report who he/she eats with and in what setting, subscale ranged from 0 (always eats alone) to 100 (no restriction of place, food, or companion). Change from baseline: negative value represents a decrease in function and a positive value represents an increase in function. (NCT01057589)
Timeframe: Baseline, Triplet Combination Therapy Cycles 2, 4, 6 (cycle = 21 days) and optional Maintenance Therapy Cycles 1, 3, 5 and 7 (cycle = 21 days)

Interventionunits on a scale (Mean)
NOD-Change at Triplet Cycle 2 (n=53)NOD-Change at Triplet Cycle 4 (n=41)NOD-Change at Triplet Cycle 6 (n=24)NOD-Change at Maintenance Cycle 1 (n=23)NOD-Change at Maintenance Cycle 3 (n=10)NOD-Change at Maintenance Cycle 5 (n=6)NOD-Change at Maintenance Cycle 7 (n=5)EIP-Change at Triplet Cycle 2 (n=46)EIP-Change at Triplet Cycle 4 (n=37)EIP-Change at Triplet Cycle 6 (n=22)EIP-Change at Maintenance Cycle 1 (n=23)EIP-Change at Maintenance Cycle 3 (n=10)EIP-Change at Maintenance Cycle 5 (n=6)EIP-Change at Maintenance Cycle 7 (n=5)UOS-Change at Triplet Cycle 2 (n=53)UOS-Change at Triplet Cycle 4 (n=41)UOS-Change at Triplet Cycle 6 (n=24)UOS-Change at Maintenance Cycle 1 (n=23)UOS-Change at Maintenance Cycle 3 (n=10)UOS-Change at Maintenance Cycle 5 (n=6)UOS-Change at Maintenance Cycle 7 (n=5)
Pemetrexed Cisplatin Cetuximab-0.43.93.30.4-1.08.3-8.02.7-6.8-3.4-8.7-10.0-4.2-15.00.5-4.3-10.4-1.1-2.5-12.5-15.0

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Progression Free Survival (PFS)

PFS based on Response Evaluation Criteria in Solid Tumors (RECIST) Guidelines defined as the time from the date of first dose of study drug to first documented objective progressive disease (PD) or death from any cause. PD is defined as at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. (NCT01057589)
Timeframe: Baseline to date of PD or death up to 18.7 months

Interventionmonths (Median)
Pemetrexed Cisplatin Cetuximab4.4

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Overall Survival (OS)

OS defined as the time from the date of first dose of study drug to the date to death from any cause. (NCT01057589)
Timeframe: Baseline to date of death up to 18.7 months

Interventionmonths (Median)
Pemetrexed Cisplatin Cetuximab9.7

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Change From Baseline in Participant Reported EQ-5D Utility Score at End of Triplet Combination Therapy and End of Maintenance Therapy

EQ-5D Index is derived by converting the Descriptive System (participant is required to rate health by checking 1 [no limitation], 2 [some limitation] or 3 [severe or complete limitation] in 5 dimensions [mobility, self-care, usual activities, pain/comfort and anxiety/depression]) to a single summary index. A utility value assigned to each individual's health state based on the absence or presence of moderate or severe problems in the 5 dimensions. A regression equation defines a utility value for these health states. The possible values for health utility ranged from -0.59 (severe problems in all 5 dimensions) to 1 (no problem in all dimensions) on a scale where 0 represents death and 1 represents the best possible health state. Possible change values range from -1.59 (no problems at baseline to severe problems at visit) to 1.59 (severe problems at baseline to no problems at visit). (NCT01057589)
Timeframe: Baseline, End of Triplet Combination Therapy (up to 6 cycles [4.2 months]) , End of Maintenance Therapy (up to 18.7 months)

Interventionunits on a scale (Mean)
Change at End of Triplet Therapy (n=29)Change at End of Maintenance Therapy (n=15)
Pemetrexed Cisplatin Cetuximab0.05-0.02

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Part A: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12

ACR20 response was defined, based on guidelines set forth by the American College of Rheumatology (ACR), as ≥20 % improvement in tender joint count and swollen joint count as well as ≥20% improvement in at least 3 of 5 following measures: C-Reactive Protein (CRP), Participant assessment of pain; Participant's global assessment of disease activity; Physician global assessment of disease activity; and Health Assessment Question-Disability Index (HAQ-DI). Missing data imputed by Last Observation Carried Forward (LOCF). (NCT01061736)
Timeframe: Baseline to Week 12

InterventionPercentage of participants (Number)
Part A: SAR 100 mg qw62
Part A: SAR 150 mg qw72
Part A: SAR 100 mg q2w49
Part A: SAR 150 mg q2w66.7
Part A: SAR 200 mg q2w65.4
Part A: Placebo qw46.2

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Part B: Percentage of Participants Achieving a Major Clinical Response at Week 52

Major clinical response was defined as an ACR70 response maintained for at least 24 consecutive weeks. ACR70 response uses the same criteria as for ACR20 but requires 70% improvement. In the primary approach, data collected after treatment discontinuation or rescue was set to missing. No imputation of missing post-baseline values was performed. Responder status was determined if possible. With these rules, participants automatically became non-responders for all time points beyond the time point they started rescue treatment or discontinued study treatment. (NCT01061736)
Timeframe: Baseline up to Week 52

InterventionPercentage of participants (Number)
Part B: SAR 150 mg q2w12.8
Part B: SAR 200 mg q2w14.8
Part B: Placebo q2w3

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Part B: Percentage of Participants Achieving ACR20 Response at Week 24

ACR20 improvement responses were determined without imputation of missing post-baseline values. In addition data collected after treatment discontinuation or rescue was set to missing. Responder status was determined if possible. With these rules, participants automatically became non-responders for all time points beyond the time point they started rescue treatment or discontinued study treatment. (NCT01061736)
Timeframe: Baseline to Week 24

InterventionPercentage of participants (Number)
Part B: SAR 150 mg q2w58
Part B: SAR 200 mg q2w66.4
Part B: Placebo q2w33.4

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Part B: Change From Baseline in Health Assessment Question Disability Index (HAQ-DI) at Week 16

HAQ-DI was a participant-reported questionnaire that assesses the difficulty of performing daily activities: dress/groom, arise, eat, walk, reach, grip, hygiene and common activities. Overall score range from 0=least difficulty to 3=extreme difficulty. An increase in the score indicates a worsening of physical function while a decrease in the score represents improvement. Data collected after treatment discontinuation was set to missing. (NCT01061736)
Timeframe: Baseline, Week 16

,,
Interventionunits on a scale (Mean)
BaselineWeek 16Change from baseline at Week 16
Part B: Placebo q2w1.611.31-0.3
Part B: SAR 150 mg q2w1.631.08-0.54
Part B: SAR 200 mg q2w1.691.11-0.58

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Part B: Change From Baseline in Van Der Heijde Modified Total Sharp Score (mTSS) at Week 52

The Sharp method modified by D. van der Heijde involves separate scores for erosions and joint space narrowing based on radiographs to assess the degree of structural damage. Total score range from 0 (normal) to 448 (worst possible total score). An increase in total score represents progression of structural damage. Missing data were imputed by the linear extrapolation method. (NCT01061736)
Timeframe: Baseline, Week 52

,,
Interventionunits on a scale (Mean)
BaselineWeek 52Change from baseline at Week 52
Part B: Placebo q2w48.0150.792.78
Part B: SAR 150 mg q2w54.6755.570.90
Part B: SAR 200 mg q2w46.3446.590.25

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Overall Survival (OS)

Number of days from first dose of pralatrexate to death. (NCT01118624)
Timeframe: Assessed at the end of each even-numbered cycle (every 8 weeks), or per standard of care but at least every 4 weeks and no more than every 12 weeks (+/- 1 week) if treatment has ended. OS will be collected for up to 2 years from start of pralatrexate.

Interventionmonths (Median)
Pralatrexate11.3

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Objective Response Rate (ORR)

Tumor response evaluation was performed using RECIST 1.0 using CT/MRI. Proportion of patients achieving a CR or PR is considered in the overall response. (NCT01118624)
Timeframe: Assessed at the end of each even-numbered cycle (every 8 weeks), or per standard of care but no less than 4 weeks and nor more than every 12 weeks (+/- 1 week) if treatment has ended.

Interventionparticipants (Number)
Pralatrexate1

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Incidence of Adverse Events (AEs) and Laboratory Abnormalities

(NCT01118624)
Timeframe: Recorded at all study visits: every 2 weeks while on treatment and at safety follow-up (35 +/- 5 days post-last dose) or early termination visit (at time of withdrawal).

Interventionparticipants (Number)
Pralatrexate21

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Duration of Response (DOR)

One patient has a PR as response and duration of response was provided for that patient. (NCT01118624)
Timeframe: Assessed at the end of each even-numbered cycle (every 8 weeks), or per standard of care but no less than 4 weeks and nor more than every 12 weeks (+/- 1 week) if treatment has ended.

Interventiondays (Number)
Pralatrexate112

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Percentage of Participants With No Viable Tumor Cells in Resected Lung Tissue [Pathological Complete Remission (pCR)]

pCR after the participant has undergone surgery was calculated as: (total number of participants with pCR) divided by (the total number of participants in pathological response population) multiplied by 100. (NCT01165021)
Timeframe: At the time of surgery (within 3 to 6 weeks of Day 1 of Cycle 3 [21-day cycles] of chemotherapy)

Interventionpercentage of participants (Number)
Pemetrexed + Cisplatin93.3

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Percentage of Participants Who Exhibit a Downward Shift in Tumor Extent From Stage IIIAN2 to Stages IIIA, II, I, or Stage 0

Tumor downstaging compared to baseline (Stage IIIAN2) were those participants who exhibited a downward shift in tumor extent from Stage IIIAN2 to Stages IIIA, II, I, or 0 were reported. Downstaging was based on radiological examination. Stage IIIAN2 was locally advanced and/or involved lymph nodes, metastasis in ipsilateral mediastinal and or subcarinal lymph nodes, tumors were ≤2 centimeters (cm) up to 5 cm in greatest dimension; Stage IIIA was locally advanced and/or involved lymph nodes, tumor extension was restricted to the affected lung; Stage II was locally advanced and/or involved lymph nodes; Stage I was small localized cancers, usually curable; Stage 0 the cancer did not spread beyond the inner lining of the lung. Missing responses were also reported. Percentage of participants calculated as: (number of participants with a downward shift in extent of their tumor) divided by (total number of evaluable participants) multiplied by 100. (NCT01165021)
Timeframe: From study enrollment until disease progression or recurrence up to completion of 3 cycles (21-day cycles) of chemotherapy

Interventionpercentage of participants (Number)
No Change or Worsening of Tumor StageChange to Stage IIIAChange to Stage IIChange to Stage IMissing
Pemetrexed + Cisplatin29.429.411.817.611.8

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Progression-Free Survival (PFS)

PFS was defined as the time from date of first dose to the first observation of disease progression or death due to any cause. For participants not known to have died or did not have objective progressive disease (PD) as of the data inclusion cut-off date, PFS was censored at the date of the last objective progression-free disease assessment. PD was defined using RECIST v1.1 criteria as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (including the baseline sum if that is the smallest). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. (NCT01165021)
Timeframe: Enrollment until the first date of objectively determined PD or death up to 64 months

Interventionmonths (Median)
Pemetrexed + Cisplatin12.4

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Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)]

Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST v1.1) criteria. CR was defined as the disappearance of all target and non-target lesions and all target and non-target lymph nodes were non-pathological or normal in size [<10 millimeter (mm) short axis]. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions taking as reference the baseline sum diameters. ORR calculated as: (sum of the number of participants with PRs and CRs) divided by (number of evaluable participants) multiplied by 100. (NCT01165021)
Timeframe: From study enrollment until disease progression or recurrence up to completion of 3 cycles (21-day cycles) of chemotherapy

Interventionpercentage of participants (Number)
Pemetrexed + Cisplatin41.2

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Overall Survival (OS)

OS was defined as duration from the date of study enrollment to the date of death from any cause. Participants not known to have died as of the data inclusion cut-off date were censored at the date of last contact. The last contact for participants in post-discontinuation was the last date participant was known to be alive. (NCT01165021)
Timeframe: Enrollment until the date of death from any cause up to 64 months

Interventionmonths (Median)
Pemetrexed + Cisplatin34.6

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To Determine the Overall Response Rate (CR+PR)

by RECIST version 1.1 criteria (NCT01183065)
Timeframe: 2 years

Interventionparticipants (Number)
Pralatrexate and Vitamin Supplementation8

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Change From Baseline in EuroQol- 5D (EQ-5D)

The EQ-5D is a generic, multidimensional, health status instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood using a 3-level scale (no problem, some problems, and major problems). These combinations of attributes were converted into a weighted health-state Index Score according to the United Kingdom (UK) population-based algorithm. The possible values for the Index Score ranged from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension). A negative change indicated a worsening of the participant's health status. (NCT01183780)
Timeframe: Baseline and 30-Day Follow-Up (FU) up to 171 Weeks

Interventionunits on a scale (Mean)
Ramucirumab + FOLFIRI-0.097
Placebo + FOLFIRI-0.103

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Change From Baseline in European Organisation for Research and Treatment of Cancer [EORTC] QLQ-C30 Global Health Status

The EORTC QLQ-C30 (v. 3.0) is a self-administered, cancer-specific questionnaire with multidimensional scales assessing 15 domains (5 functional domains, 9 symptoms, and global health status). A linear transformation was applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For the functional domains and global health status scale, higher scores represent a better level of functioning. For symptom scales, higher scores represent a greater degree of symptoms. Maximum improvement is the best post-baseline change. (NCT01183780)
Timeframe: Baseline Up to 171 Weeks

Interventionunits on a scale (Mean)
Ramucirumab + FOLFIRI4.0
Placebo + FOLFIRI6.6

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Percentage of Participants With Treatment-Emergent Anti-Ramucirumab Antibodies

Blood samples were tested to determine if a participant reacted to ramucirumab by producing anti-ramucirumab antibodies. Samples were identified as treatment emergent anti-drug antibody (TE ADA) if the post-treatment sample had an increase of at least 4 fold in titer from pre-treatment values. If the pre-treatment value was not detected or was not present, a 1:20 post-treatment titer was required to indicate treatment emergence. The percentage of participants with TE ADA was calculated as: (the number of participants with TE ADA / total number of participants with at least 1 post-treatment immunogenicity sample analyzed)*100. (NCT01183780)
Timeframe: Cycles 1, 3, 5, and 30-Day FU

,
Interventionpercentage of participants (Number)
Immunogenicity Any Time During Study (n=516, 512)Immunogenicity Post-Treatment (n=477, 473)
Placebo + FOLFIRI5.53.8
Ramucirumab + FOLFIRI5.63.1

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Progression-free Survival (PFS) Time

PFS was defined as the time from the date of randomization until the date of objectively determined progressive disease (PD) [according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v). 1.1] or death due to any cause, whichever was first. PD is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm). Participants who died without a reported prior progression were considered to have progressed on the day of their death. Participants who did not progress or were lost to follow-up were censored at the day of their last radiographic tumor assessment. (NCT01183780)
Timeframe: Randomization to Measured PD or Date of Death from Any Cause Up to 38.01 Months

Interventionmonths (Median)
Ramucirumab + FOLFIRI5.7
Placebo + FOLFIRI4.5

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Observed Maximum Concentration (Cmax) and Observed Minimum Concentration (Cmin) of Ramucirumab

(NCT01183780)
Timeframe: Preinfusion and 1 hour postinfusion in Cycles 3, 5, 9, 13, and 17

Interventionmicrograms/milliliter (ug/mL) (Geometric Mean)
Cmin Dose 3 (n=248)Cmin Dose 5 (n=154)Cmin Dose 9 (n=27)Cmin Dose 13 (n=11)Cmin Dose 17 (n=5)Cmax Dose 3 (n=88)Cmax Dose 5 (n=51)Cmax Dose 9 (n=18)Cmax Dose 13 (n=12)Cmax Dose 17 (n=7)
Ramucirumab + FOLFIRI46.365.177.975.972.0221.0243.0262.0307.0253.0

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Percentage of Participants Achieving an Objective Response (Objective Response Rate)

The objective response rate is equal to the proportion of participants achieving a best overall response of partial response or complete response (PR + CR). Response was defined using RECIST, v. 1.1 criteria. CR was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm and normalization of tumor marker level of non-target lesions; PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions taking as reference the baseline sum diameter. (NCT01183780)
Timeframe: Randomization until Disease Progression Up to 38.01 Months

Interventionpercentage of participants (Number)
Ramucirumab + FOLFIRI13.4
Placebo + FOLFIRI12.5

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Overall Survival (OS)

OS was defined as the time in months from the date of randomization to the date of death from any cause. For participants not known to have died as of the cut-off date, OS was censored at the last known date alive. (NCT01183780)
Timeframe: Randomization to Date of Death from Any Cause Up to 39.36 Months

Interventionmonths (Median)
Ramucirumab + FOLFIRI13.3
Placebo + FOLFIRI11.7

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Maximum Concentration of Drug in Plasma (Cmax)

The maximum concentration of Pralatrexate at day 1 and 15 among phase 1 participants dosed at 105 milligrams per square meter of body surface area (mg/m2). The concentration is given in micrograms per milliliter. (NCT01188876)
Timeframe: Day 1 and Day 15

Interventionug/ml (Mean)
Day 1Day 15
Carboplatin/Pralatrexate23.8717.61

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Overall Survival

The number of participants still alive at the given time points. The duration of time is measured from the start of treatment until death due to any cause, participants are censored at the date of the last evaluation. The number participants surviving at 6, 12, 18, and 24 months is shown. (NCT01188876)
Timeframe: 6, 12, 18, and 24 months

InterventionParticipants (Count of Participants)
6 Months12 Months18 Months24 Months
Carboplatin/Pralatrexate49494633

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Progression Free Survival

The number of participants alive and without disease progression at the given time-points. Time is measured from the start of treatment. Progression is defined as having at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. (NCT01188876)
Timeframe: 3 months, 6 months

InterventionParticipants (Count of Participants)
3 Months6 Months
Carboplatin/Pralatrexate4440

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Area Under the Plasma Drug Concentration-Time Curve (AUC)

Area under the plasma drug concentration-time curve (AUC) for phase 1 participants that were dosed at 105 mg/m2. AUC represents the actual body exposure to drug after administration of a dose of the drug and is expressed in micrograms * hour per milliliter (ug*h/mL). (NCT01188876)
Timeframe: Day 1 and Day 15

Interventionug*h/mL (Mean)
Day 1Day 15
Carboplatin/Pralatrexate9.898.01

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Maximum Tolerated Dose (MTD)

The maximum tolerated dose of Pralatrexate in combination with Carboplatin in this patient population. The unit is given in milligrams per square meter of body surface area. MTD was determined using a standard 3 + 3 dose escalation cohort, where 3 participants were enrolled on the starting dose of 30 mg/m2 and if no dose limiting toxicities (DLT) were experienced after a full cycle, 3 additional participants were enrolled at the next highest dose level. Each increase in dose level escalated the dose of Pralatrexate by 15 mg/m2. If during any dose level, 1 patient out of 3 develops a DLT, then 3 additional patients will be added to that dose level. If 2 out of the 3 patients placed on any dose level experience a DLT, the preceding dose is considered MTD. If 1/6 has a DLT, the next higher dose level will commence accrual (unless at level +5 and then accrual to the Phase I portion will stop). If ≥ 2 of 6 patients have a DLT, then the preceding dose will be considered MTD. (NCT01188876)
Timeframe: 1 year

Interventionmg/m^2 (Number)
Carboplatin/Pralatrexate105

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Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL at End of Maintenance Cycle 1: Left

Strength in the left ankle dorsiflexors averaged over two measurements. Age and gender standardized mean and standard deviation for the cohort will be reported. (NCT01190930)
Timeframe: 1 Year

InterventionZ-Score (Mean)
B-ALL Average Risk-0.36

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Burden of Therapy in Boy AR Patients Overall at End of Therapy: Emotional

Age standardized Quality of life, measured by the emotional subscale of Pediatric Quality of Life Inventory 4.0 Genetic Core Scales (PedsQL), will be calculated with mean and standard deviation reported. (NCT01190930)
Timeframe: 3.2 years

InterventionZ-Score (Mean)
B-ALL Average Risk-0.62

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Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Emotional

Age standardized Quality of life, measured by the emotional subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported. (NCT01190930)
Timeframe: 2.5 years

InterventionZ-Score (Mean)
B-ALL Average Risk-0.74

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Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Physical

Age standardized Quality of life, measured by the physical subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported. (NCT01190930)
Timeframe: 2.4 Years

InterventionZ-Score (Mean)
B-ALL Average Risk-0.66

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Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Social Functioning

Age standardized Quality of life, measured by the social functioning subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported. (NCT01190930)
Timeframe: 2.4 Years

InterventionZ-Score (Mean)
B-ALL Average Risk-0.30

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Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 4: Emotional

Age standardized Quality of life, measured by the emotional subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated for each group with means and standard deviation reported. (NCT01190930)
Timeframe: 1.7 years

InterventionZ-Score (Mean)
B-ALL Average Risk: VCR/DEX Pulse Every 4 Weeks-0.80
B-ALL Average Risk: VCR/DEX Pulse Every 12 Weeks-0.89

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Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 4: Physical

Age standardized Quality of life, measured by the physical subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated for each group with means and standard deviation reported. (NCT01190930)
Timeframe: 1.7 Years

InterventionZ-Score (Mean)
B-ALL Average Risk: VCR/DEX Pulse Every 4 Weeks-0.62
B-ALL Average Risk: VCR/DEX Pulse Every 12 Weeks-0.64

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Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 4: Social Functioning

Age standardized Quality of life, measured by the social functioning subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated for each group with means and standard deviation reported. (NCT01190930)
Timeframe: 1.7 Years

InterventionZ-Score (Mean)
B-ALL Average Risk: VCR/DEX Pulse Every 4 Weeks-0.16
B-ALL Average Risk: VCR/DEX Pulse Every 12 Weeks-0.25

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Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Physical

Age standardized Quality of life, measured by the physical subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated for each group with mean and standard deviation reported. (NCT01190930)
Timeframe: 2.4 Years

InterventionZ-Score (Mean)
B-ALL Average Risk: VCR/DEX Pulse Every 4 Weeks-0.64
B-ALL Average Risk: VCR/DEX Pulse Every 12 Weeks-0.67

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Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Social Functioning

Age standardized Quality of life, measured by the social functioning subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated for each group with mean and standard deviation reported. (NCT01190930)
Timeframe: 2.4 Years

InterventionZ-Score (Mean)
B-ALL Average Risk: VCR/DEX Pulse Every 4 Weeks-0.27
B-ALL Average Risk: VCR/DEX Pulse Every 12 Weeks-0.34

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Burden of Therapy in AR Patients Overall at End of Consolidation Therapy: Emotional

Age standardized Quality of life, measured by the emotional subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported. (NCT01190930)
Timeframe: 2 Months

InterventionZ-Score (Mean)
B-ALL Average Risk-1.21

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Burden of Therapy in AR Patients Overall at End of Consolidation Therapy: Physical

Age and gender standardized Quality of life, measured by the physical subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported. (NCT01190930)
Timeframe: 2 Months

InterventionZ-Score (Mean)
B-ALL Average Risk-1.44

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Burden of Therapy in AR Patients Overall at End of Consolidation Therapy: Social Functioning

Age standardized Quality of life, measured by the social functioning subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported. (NCT01190930)
Timeframe: 2 Months

InterventionZ-Score (Mean)
B-ALL Average Risk-0.42

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Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 1: Emotional

Age standardized Quality of life, measured by the emotional subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported. (NCT01190930)
Timeframe: 1 year

InterventionZ-Score (Mean)
B-ALL Average Risk-0.86

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Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 1: Physical

Age standardized Quality of life, measured by the physical subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported. (NCT01190930)
Timeframe: 1 Year

InterventionZ-Score (Mean)
B-ALL Average Risk-0.59

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Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 1: Social Functioning

Age standardized Quality of life, measured by the social functioning subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported. (NCT01190930)
Timeframe: 1 Year

InterventionZ-Score (Mean)
B-ALL Average Risk-0.19

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Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 4: Emotional

Age standardized Quality of life, measured by the emotional subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported. (NCT01190930)
Timeframe: 1.7 years

InterventionZ-Score (Mean)
B-ALL Average Risk-0.84

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Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 4: Physical

Age standardized Quality of life, measured by the physical subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported. (NCT01190930)
Timeframe: 1.7 years

InterventionZ-Score (Mean)
B-ALL Average Risk-0.63

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Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 4: Social Functioning

Age standardized Quality of life, measured by the social functioning subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported. (NCT01190930)
Timeframe: 1.7 Years

InterventionZ-Score (Mean)
B-ALL Average Risk-0.20

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Burden of Therapy in Boy AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Therapy: Emotional

Age standardized Quality of life, measured by the emotional subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated for each group with mean and standard deviation reported. (NCT01190930)
Timeframe: 3.2 Years

InterventionZ-Score (Mean)
B-ALL Average Risk: VCR/DEX Pulse Every 4 Weeks-0.71
B-ALL Average Risk: VCR/DEX Pulse Every 12 Weeks-0.51

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Burden of Therapy in Boy AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Therapy: Physical

Age standardized Quality of life, measured by the physical subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated for each group with mean and standard deviation reported. (NCT01190930)
Timeframe: 3.2 Years

InterventionZ-Score (Mean)
B-ALL Average Risk: VCR/DEX Pulse Every 4 Weeks-0.85
B-ALL Average Risk: VCR/DEX Pulse Every 12 Weeks-0.47

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Burden of Therapy in Boy AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Therapy: Social Functioning

Age standardized Quality of life, measured by the social functioning subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated for each group with mean and standard deviation reported. (NCT01190930)
Timeframe: 3.2 Years

InterventionZ-Score (Mean)
B-ALL Average Risk: VCR/DEX Pulse Every 4 Weeks-0.46
B-ALL Average Risk: VCR/DEX Pulse Every 12 Weeks-0.33

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Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Emotional

Age standardized Quality of life, measured by the emotional subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated for each group with mean and standard deviation reported. (NCT01190930)
Timeframe: 2.4 Years

InterventionZ-Score (Mean)
B-ALL Average Risk: VCR/DEX Pulse Every 4 Weeks-0.72
B-ALL Average Risk: VCR/DEX Pulse Every 12 Weeks-0.77

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Sample Collection of Central Path Review Slides in B-LLy Patients

Percent of B-LLy patients who had adequate/usable samples of samples collected will be reported. (NCT01190930)
Timeframe: Up to 1 month

Interventionpercentage of patients (Number)
B-LLy89.7

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Overall Survival (OS) for B-LLy Patients

OS is calculated as the time from study enrollment to death or date of last contact. The 5-year OS and 95% confidence interval for these patients will be estimated. (NCT01190930)
Timeframe: 5 years

Interventionpercent probability (Number)
B-LLy93.97

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Event Free Survival (EFS) for B-LLy Patients

EFS is calculated as the Time from study enrollment to first event (induction failure, relapse, second malignancy, remission death) or date of last contact. The 5-year EFS and 95% confidence interval for these patients will be estimated. (NCT01190930)
Timeframe: 5 years

Interventionpercent probability (Number)
B-LLy94.54

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Disease Free Survival (DFS) in Average Risk (AR) Patients Based on the Methotrexate Dose Randomization

DFS is calculated as the time from randomization at the end of interim maintenance II to first event (relapse, second malignancy, remission death) or date of last contact. Five year DFS estimates will be calculated from the point of randomization for both groups. Two-sided 95% confidence intervals will be calculated. (NCT01190930)
Timeframe: 5.7 years

Interventionpercent probability (Number)
B-ALL Average Risk: MTX 20 mg/m^2/Week Starting Dose95.05
B-ALL Average Risk: MTX 40 mg/m^2/Week Starting Dose94.17

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DFS in Low Risk (LR) Patients Based on Randomization to 1 of 2 Low-intensity Regimens

DFS is calculated as the time from randomization at the end of Induction to first event (relapse, second malignancy, remission death) or date of last contact. Five year DFS estimates will be calculated from the point of randomization for both groups. Two-sided 95% confidence intervals will be calculated. (NCT01190930)
Timeframe: 5.1 years

Interventionpercent probability (Number)
B-ALL Low Risk Arm I (LR-M)98.75
B-ALL Low Risk Arm II (LR-C)98.50

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Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL at End of Consolidation Therapy-Right

Strength in the right ankle dorsiflexors averaged over two measurements. Age and gender standardized mean and standard deviation for the cohort will be reported. (NCT01190930)
Timeframe: 2 Months

InterventionZ-Score (Mean)
B-ALL Average Risk-0.87

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Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL at End of Consolidation Therapy-Left

Strength in the left ankle dorsiflexors averaged over two measurements. Age and gender standardized mean and standard deviation for the cohort will be reported. (NCT01190930)
Timeframe: 2 Months

InterventionZ-Score (Mean)
B-ALL Average Risk-0.84

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Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL 12 Months Post Therapy: Right

Strength in the right ankle dorsiflexors averaged over two measurements. Age and gender standardized mean and standard deviation for the cohort will be reported. (NCT01190930)
Timeframe: 4.2 Years

InterventionZ-Score (Mean)
B-ALL Average Risk-1.12

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Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL 12 Months Post Therapy: Left

Strength in the left ankle dorsiflexors averaged over two measurements. Age and gender standardized mean and standard deviation for the cohort will be reported. (NCT01190930)
Timeframe: 4.2 Years

InterventionZ-Score (Mean)
B-ALL Average Risk-1.19

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Burden of Therapy in Boy AR Patients Overall at End of Therapy: Social Functioning

Age standardized Quality of life, measured by the Social functioning subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported. (NCT01190930)
Timeframe: 3.2 Years

InterventionZ-Score (Mean)
B-ALL Average Risk-0.40

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Burden of Therapy in Boy AR Patients Overall at End of Therapy: Physical

Age standardized Quality of life, measured by the physical subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported. (NCT01190930)
Timeframe: 3.2 years

InterventionZ-Score (Mean)
B-ALL Average Risk-0.67

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DFS in Average Risk (AR) Patients Based on the Pulse Frequency Randomization

DFS is calculated as the time from randomization at the end of interim maintenance II to first event (relapse, second malignancy, remission death) or date of last contact. Five year DFS estimates will be calculated from the point of randomization for both groups. Two-sided 95% confidence intervals will be calculated. (NCT01190930)
Timeframe: 5.7 years

Interventionpercent probability (Number)
B-ALL Average Risk: VCR/DEX Pulse Every 4 Weeks94.10
B-ALL Average Risk: VCR/DEX Pulse Every 12 Weeks95.13

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DFS for SR Down Syndrome Patients With Standardized Treatment and Enhanced Supportive Care

DFS is calculated as the time from end of Induction to first event (relapse, second malignancy, remission death) or date of last contact. The 5-year DFS and 95% confidence interval for these patients will be estimated. (NCT01190930)
Timeframe: 5.1 years

Interventionpercent probability (Number)
Standard Risk With Down Syndrome89.77

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Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Right

Strength in the right ankle dorsiflexors averaged over two measurements. Age and gender standardized mean and standard deviation for each randomization group will be reported. (NCT01190930)
Timeframe: 2.4 Years

InterventionZ-Score (Mean)
B-ALL Average Risk: VCR/DEX Pulse Every 4 Weeks-1.12
B-ALL Average Risk: VCR/DEX Pulse Every 12 Weeks-0.02

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Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Left

Strength in the left ankle dorsiflexors averaged over two measurements. Age and gender standardized mean and standard deviation for each randomization group will be reported. (NCT01190930)
Timeframe: 2.4 Years

InterventionZ-Score (Mean)
B-ALL Average Risk: VCR/DEX Pulse Every 4 Weeks-1.19
B-ALL Average Risk: VCR/DEX Pulse Every 12 Weeks0.21

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Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Right

Strength in the right ankle dorsiflexors averaged over two measurements. Age and gender standardized mean and standard deviation for the cohort will be reported. (NCT01190930)
Timeframe: 2.4 Years

InterventionZ-Score (Mean)
B-ALL Average Risk-0.27

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Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Left

Strength in the left ankle dorsiflexors averaged over two measurements. Age and gender standardized mean and standard deviation for the cohort will be reported. (NCT01190930)
Timeframe: 2.4 Years

InterventionZ-Score (Mean)
B-ALL Average Risk-0.28

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Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL at End of Maintenance Cycle 1: Right

Strength in the right ankle dorsiflexors averaged over two measurements. Age and gender standardized mean and standard deviation for the cohort will be reported. (NCT01190930)
Timeframe: 1 Year

InterventionZ-Score (Mean)
B-ALL Average Risk-0.39

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Response Rate

(NCT01194453)
Timeframe: 6 weeks

Interventionpercentage (Number)
Group A24.41
Group B14.17

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Progression Free Survival (PFS)

(NCT01194453)
Timeframe: 36months

Interventionday (Median)
Group A168
Group B140

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Haemoglobin Level

Haemoglobin level (g/L) measured by cyanmethaemoglobin method (NCT01198574)
Timeframe: at week 0, week 6 and week12

,,,
Interventiong/L (Mean)
Hb week 0 (Baseline)Hb week 6 (Midline)Hb week 12 (Endline)
Iron and Vitamin A Group88.499.2111.4
Iron Group88.398.1110.8
Placebo Group89.698.3109.7
Vitamin A Group89.298.7109.0

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Status of Tissue Iron Store

Tissue iron store was measured by serum ferritin (NCT01198574)
Timeframe: at week 0, week 6 and week12

,,,
Interventionµg/L (Geometric Mean)
serum ferritin (Baseline)serum ferritin (Midline)serum ferritin (Endline)
Iron and Vitamin A Group25.932.335.4
Iron Group32.134.539.6
Placebo Group31.126.528.2
Vitamin A Group34.432.135.0

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Status of Cellular Iron Deficiency

Cellular Iron deficiency status is also measured by serum transferrin receptor (NCT01198574)
Timeframe: at week 0, week 6 and week12

,,,
Interventionmg/L (Geometric Mean)
serum transferrin receptor (Baseline)serum transferrin receptor (Midline)serum transferrin receptor (Endline)
Iron and Vitamin A Group7.166.736.24
Iron Group7.096.696.44
Placebo Group6.746.596.61
Vitamin A Group6.566.396.27

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Pharmacokinetic (PK) Parameter: Serum Concentration of Functional and Bound Sarilumab

(NCT01217814)
Timeframe: Week 12

Interventionng/mL (Mean)
Bound ConcentrationFunctional Concentration
Sarilumab 150 mg qw4271.4342391.43

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Overall Survival (OS) Time

OS was defined as the time (in months) from randomization to death. For subjects who were still alive at the analysis data cut-off date or who lost to follow-up, survival was censored at the last recorded date that the subject was known to be alive. (NCT01228734)
Timeframe: Baseline up to 333 weeks

Interventionmonths (Median)
Cetuximab + FOLFOX-420.8
FOLFOX-416.5

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Progression Free Survival (PFS) Time

PFS was defined as the duration (in months) from randomization until the first progressive disease (PD) observation as assessed by the Independent Review Committee (IRC) according to Response Evaluation Criteria for Solid Tumors (RECIST) version 1.0, or death due to any cause when death occurred within 90 days of randomization or the last tumor assessment, whichever was later. PD was defined as at least a 20% increase in the sum of longest diameter (LD) of the target lesions, taking as references the smallest sum LD since the treatment started (including baseline), or appearance of one or more new lesions, and/or unequivocal progression of existing non-target lesions. (NCT01228734)
Timeframe: Baseline up to 333 weeks

Interventionmonths (Median)
Cetuximab + FOLFOX-49.2
FOLFOX-47.4

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Best Overall Response Rate (ORR)

The Best ORR was defined as the percentage of subjects having achieved complete response (CR) or partial response (PR) according to RECIST version 1.0 as determined by the IRC. CR: defined as disappearance of all target and all non-target lesions and no new lesions. PR: defined as at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters, no progression of non-target lesions and no new lesions. (NCT01228734)
Timeframe: Baseline up to 333 weeks

Interventionpercentage of subjects (Number)
Cetuximab + FOLFOX-466.3
FOLFOX-440.5

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Time to Treatment Failure (TTF)

TTF was defined as time from randomization to date of the first occurrence of radiologically confirmed PD as determined by IRC, Clinical PD according to the Investigator's assessment (if radiological confirmation of PD by IRC was unavailable), discontinuation of treatment due to progression or adverse event, start of new anticancer therapy, withdrawal of consent, or death within 90 days of last tumor assessment or randomization. Subjects without event were censored on the date of last tumor assessment. (NCT01228734)
Timeframe: Baseline up to 333 weeks

Interventionmonths (Median)
Cetuximab + FOLFOX-49.2
FOLFOX-45.6

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Number of Subjects With Curative Surgery of Liver Metastases

The number of subjects who underwent liver metastatic surgery after start of treatment and the outcome of surgery with respect to residual tumor after surgery (R0, R1, R2, not evaluable) were summarized. In case of resection of more than one metastasis, the worst outcome of surgery defined the overall status of a subject. R0 = No residual tumor after resection (all lesions resected completely); R1 = Metastases not resected completely with microscopic residual lesions; and R2 = Metastases not resected completely with macroscopic residual lesions. (NCT01228734)
Timeframe: Baseline up to 333 weeks

,
Interventionsubjects (Number)
Subjects with liver surgerySubjects with liver surgery outcome: R0Subjects with liver surgery outcome: R1Subjects with liver surgery outcome: R2Subjects not evaluable
Cetuximab + FOLFOX-497100
FOLFOX-462200

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Probability of Being BCR-ABL Negative in the Bone Marrow and Peripheral Blood at the Completion of the CNS Prophylaxis Course (Restricted to Those Patients Achieving a CR)

Proportions will be estimated based on the combined and individual cohorts. (NCT01256398)
Timeframe: 10 years

Interventionproportion of participants (Number)
Treatment (Chemotherapy, Transplant)0.667

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Response

Proportion of patients reaching a CR. A CR requires the following: an absolute neutrophil count (segs and bands) >1000/μL, no circulating blasts, platelets >100,000/μL; adequate bone marrow cellularity with trilineage hematopoiesis, and <5% marrow leukemia blast cells. All previous extramedullary manifestations of disease must be absent (e.g., lymphadenopathy, splenomegaly, skin or gum infiltration, testicular masses, or CNS involvement). (NCT01256398)
Timeframe: 10 years

Interventionproportion of participants (Number)
Treatment (Chemotherapy, Transplant).9846

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Overall Survival (OS)

Estimated using the Kaplan-Meier estimator. Proportions will be estimated using point as well as interval estimators. All interval estimators will be constructed using the finite sample size sampling distribution at the unadjusted two-sided level of 0.05. (NCT01256398)
Timeframe: 10 years

InterventionMonths (Median)
Treatment (Chemotherapy, Transplant)55.9

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Disease Free Survival (DFS)

Estimated using the Kaplan-Meier estimator. Proportions will be estimated using point as well as interval estimators. All interval estimators will be constructed using the finite sample size sampling distribution at the unadjusted two-sided level of 0.05. (NCT01256398)
Timeframe: 10 years

InterventionMonths (Median)
Treatment (Chemotherapy, Transplant)29.7

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Disease Free Survival Defined From the Date of First Induction Complete Response (CR) to Relapse or Death Due to Any Cause

Estimated using the Kaplan-Meier estimator. Proportions will be estimated using point as well as interval estimators. All interval estimators will be constructed using the finite sample size sampling distribution at the unadjusted two-sided level of 0.05. (NCT01256398)
Timeframe: At 3 years after CR

Interventionpercentage of patients (Number)
Treatment (Chemotherapy, Transplant)52.6

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Feasibility of Maintenance Therapy in This Patient Population (Restricted to Those Patients Achieving a CR). Feasibility Will be Defined as the Number of Deaths Ocuring.

Proportions will be estimated based on the combined and individual cohorts. (NCT01256398)
Timeframe: 10 years

InterventionParticipants (Count of Participants)
Treatment (Chemotherapy, Transplant)5

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Proportion of Participants With RBC Folate Below 906 Nmol/L in the Yasmin + Metafolin Group in the Folate Elimination Phase (Week 24 to 44)

Proportion of participants with RBC folate below 906 nmol/L in the Yasmin + Metafolin group in the folate elimination phase (week 24 to 44) (NCT01258660)
Timeframe: from week 24 to week 44

Interventionproportion of participants (Number)
week 24week 26week 28week 30week 32week 34week 36week 38week 40week 42week 44
EE 0.03 mg/DRSP 3 mg/Metafolin + Folic Acid Placebo0.0530.0670.1470.2130.4000.5330.7070.7600.8270.8670.907

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Homocysteine Concentrations in Plasma at Baseline and at the End of Treatment (Week 24) With Metafolin

Homocysteine concentrations in plasma at baseline (median of baseline concentrations) and at the end of treatment (week 24) with Metafolin (NCT01258660)
Timeframe: baseline and week 24

Interventionµmol/L (Mean)
baseline24 weeks
EE 0.03 mg/DRSP 3 mg/Metafolin + Folic Acid Placebo9.37.5

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Homocysteine Concentrations in Plasma at Baseline and at the End of Treatment (Week 24) With Folic Acid

Homocysteine concentrations in plasma at baseline (median of baseline concentrations) and at the end of treatment (week 24) with folic acid (NCT01258660)
Timeframe: baseline, and up to 24 weeks of treatment

Interventionµmol/L (Mean)
baseline24 weeks
EE 0.03 mg/DRSP 3 mg (Yasmin) + Folic Acid9.27.6

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Folate Metabolite Pattern in Plasma at Cycle 6

Folate metabolite pattern in plasma at cycle 6 (NCT01258660)
Timeframe: week 24

,
Interventionnmol/L (Mean)
THF5,10-methenyl-THF
EE 0.03 mg/DRSP 3 mg (Yasmin) + Folic Acid5.761.95
EE 0.03 mg/DRSP 3 mg/Metafolin + Folic Acid Placebo5.921.46

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Folate Metabolite Pattern in Plasma at Cycle 3

Folate metabolite pattern in plasma at cycle 3 (NCT01258660)
Timeframe: week 12

,
Interventionnmol/L (Mean)
THF5,10-methenyl-THF
EE 0.03 mg/DRSP 3 mg (Yasmin) + Folic Acid5.281.45
EE 0.03 mg/DRSP 3 mg/Metafolin + Folic Acid Placebo4.981.76

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Folate Metabolite Pattern in Plasma at Baseline

Folate metabolite pattern in plasma at baseline (NCT01258660)
Timeframe: pre-treatment

,
Interventionnmol/L (Mean)
Tetrahydrofolate (THF)5,10-methenyl-THF
EE 0.03 mg/DRSP 3 mg (Yasmin) + Folic Acid4.601.63
EE 0.03 mg/DRSP 3 mg/Metafolin + Folic Acid Placebo4.071.57

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Area Under the Curve From Time 0 to 24 Weeks [AUC(0-24weeks)] for Plasma Folate and RBC (Red Blood Cell) Folate (Baseline Corrected)

The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample. (NCT01258660)
Timeframe: up to 24 weeks of treatment

,
Interventionnmol·week/L (Geometric Mean)
plasma folateRBC folate
EE 0.03 mg/DRSP 3 mg (Yasmin) + Folic Acid5618863
EE 0.03 mg/DRSP 3 mg/Metafolin + Folic Acid Placebo64010427

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Area Under the Curve (AUC) From Time 0 to 24 Weeks [AUC(0-24weeks)] for Plasma Folate and RBC (Red Blood Cell) Folate (Baseline Uncorrected)

The Area under the curve (AUC) is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample. (NCT01258660)
Timeframe: up to 24 weeks of treatment

,
Interventionnmol·week/L (Geometric Mean)
plasma folateRBC folate
EE 0.03 mg/DRSP 3 mg (Yasmin) + Folic Acid90421876
EE 0.03 mg/DRSP 3 mg/Metafolin + Folic Acid Placebo103024176

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Progression Free Survival

"Measurements according to RECIST 1.1 criteria (Response Evaluation Criteria in Solid Tumors). Main techniques: CT-scan. Two groups will be defined based on the score built from the proposed clinical variables and biomarkers. Instead of a binomial distribution, a Log-rank method has been used to calculate the sample size in order to include all the incidents during the follow-up. Expecting a minimum 20% difference (60 vs. 40%) on PFS at 12 months between groups and with the following assumptions:~Alpha error (bilateral): 5% Beta error: 20% Results are reported by subgroups to compare outcome measure according to BRAF mutation. All patients belong to same treatment/study arm." (NCT01276379)
Timeframe: 4 years

InterventionMonths (Median)
WT BRAF - FOLFIRI (m) or FOLFOX-6 (m) + Cetuximab11.4
Mutant BRAF - FOLFIRI (m) or FOLFOX-6 (m) + Cetuximab5.9

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Response Duration

Duration of the partial or total response to the treatment. Evaluation and classification according to RECIST 1.1 criteria (Response Evaluation Criteria in Solid Tumors) (NCT01276379)
Timeframe: 4 years

InterventionMonths (Median)
FOLFIRI (m) or FOLFOX-6 (m) + Cetuximab8.66

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Secondary Biomarkers Analysis

The secondary biomarkers in serum and tumoral tissue will be analysed in order to predict the acquired resistance. (NCT01276379)
Timeframe: 4 years

InterventionParticipants (Count of Participants)
PI3K and PTEN72100462IGF-1RP/MMP772100462
UKWTMutant
FOLFIRI (m) or FOLFOX-6 (m) + Cetuximab69
FOLFIRI (m) or FOLFOX-6 (m) + Cetuximab98
FOLFIRI (m) or FOLFOX-6 (m) + Cetuximab14
FOLFIRI (m) or FOLFOX-6 (m) + Cetuximab158
FOLFIRI (m) or FOLFOX-6 (m) + Cetuximab23
FOLFIRI (m) or FOLFOX-6 (m) + Cetuximab0

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Frequency of Adverse Events

"Frequency and type of adverse events (AEs). AEs were coded according to NCI CTCAE V3.0 and classified by frequency, relatedness to study treatment (related/not related) and severity (Grade).~Severity ranges from grade 1 (low intensity) to Grade 5 (max. intensity, death)" (NCT01276379)
Timeframe: 4 years

InterventionParticipants (Count of Participants)
Any AEs72100462Grade 3 or higher AEs72100462Grade 5 AEs72100462Treatment related AEs of any grade72100462Treatment related AEs grade 3 or higher72100462
noyes
FOLFIRI (m) or FOLFOX-6 (m) + Cetuximab198
FOLFIRI (m) or FOLFOX-6 (m) + Cetuximab20
FOLFIRI (m) or FOLFOX-6 (m) + Cetuximab138
FOLFIRI (m) or FOLFOX-6 (m) + Cetuximab80
FOLFIRI (m) or FOLFOX-6 (m) + Cetuximab5
FOLFIRI (m) or FOLFOX-6 (m) + Cetuximab213
FOLFIRI (m) or FOLFOX-6 (m) + Cetuximab176
FOLFIRI (m) or FOLFOX-6 (m) + Cetuximab42
FOLFIRI (m) or FOLFOX-6 (m) + Cetuximab101
FOLFIRI (m) or FOLFOX-6 (m) + Cetuximab117

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Overall Survival

"Measured as time in months from start of study treatment to death or lost to follow up.~Results are reported by subgroups to compare outcome measure according to BRAF mutation. All patients belong to same treatment/study arm." (NCT01276379)
Timeframe: 4 years

InterventionMonths (Median)
WT BRAF - FOLFIRI (m) or FOLFOX-6 (m) + Cetuximab32.6
Mutant BRAF - FOLFIRI (m) or FOLFOX-6 (m) + Cetuximab9.3

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Duration of Response (DOR)

DOR was defined as the time from the date of first documented objective response of PR or CR, whichever was noted earlier, to first subsequent disease progression or death (if death occurred before progression was documented). DOR was defined for responders only (that is, subjects with CR or PR). DOR for subjects without disease progression or death before progression was right censored at the date of their last tumor assessment. (NCT01289821)
Timeframe: From start of treatment until 30 days after the last dose of study treatment, assessed by every 8 weeks

InterventionDays (Median)
Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6)257

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Disease Control (DC)

DC was defined as the proportion of participants who had a best response rating of CR, PR, or stable disease (SD) according to RECIST criteria that was achieved during treatment or within 30 days after termination of study treatment. CR and PR were confirmed not earlier than 4 weeks following the initial detection of response. A minimum of 8 weeks (allowing a minus 7-day time window) between start of study treatment and the first follow-up tumor assessment with SD as response was required to assign SD as best overall response. (NCT01289821)
Timeframe: From start of treatment until 30 days after the last dose of study treatment, assessed by every 8 weeks

InterventionProportion of participants (Number)
Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6)0.8537

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Duration of Stable Disease (DOSD)

DOSD was only evaluated in participants failing to achieve a best response of CR or PR, but who achieved SD. DOSR was defined as the time (in days) from date of start of study treatment to the date at which disease progression or death (if death occurred before progression was first documented). The date the tumor scan was performed was used for this calculation. DOSD for participants without disease progression or death before progression at the time of analysis were censored at the date of their last tumor assessment. (NCT01289821)
Timeframe: From start of treatment until 30 days after the last dose of study treatment, assessed by every 8 weeks

InterventionDays (Median)
Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6)231

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Progression-free Survival (PFS)

PFS was defined as time from the date of start of study treatment to the date of first observed disease progression (radiological according to central assessment or clinical), or death due to any cause, if death occurred before progression was documented. PFS for participants without disease progression or death at the date of database cutoff were right-censored at the last date of tumor assessment. Participants who had no tumor evaluation after baseline and no clinical progression post baseline and who did not die were censored at Day 1 in the analysis. PD = At least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of existing non target lesions or the appearance of one or more new lesions will also constitute PD. (NCT01289821)
Timeframe: From start of treatment until 30 days after the last dose of study treatment, assessed by every 8 weeks

InterventionDays (Median)
Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6)258

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Overall Survival (OS)

OS was calculated as the time from first date of receiving study treatment to date of death due to any cause. Participants alive at the time of analysis were censored at their last date of follow-up. (NCT01289821)
Timeframe: From start of treatment until 30 days after the last dose of study treatment, assessed by every 8 weeks

InterventionDays (Median)
Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6)772

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Objective Response (OR)

OR was defined as the best tumor response (confirmed complete response [CR] or partial response [PR]) observed by MRI or CT scan assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria, version 1.1. CR and PR were confirmed not earlier than 4 weeks following the initial detection of response. CR = Disappearance of all clinical and radiological evidence of tumor (both target and no-target). Any pathological lymph nodes (whether target or non target) must have a reduction in short axis to < 10 mm. PR = At least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum, no unequivocal progression of existing nontarget lesions and no appearance of new lesions. (NCT01289821)
Timeframe: From start of treatment until 30 days after termination of study medication, an average of 47 weeks. Assessed every 8 weeks.

InterventionProportion of participants (Number)
Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6)0.4390

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Progression-free Survival

Descriptively summarized using the method of Kaplan-Meier. Response and disease progression were assessed using RECIST criteria version 1.1 (NCT01307956)
Timeframe: Patients were followed from time of consent until the date of first documented progession or date of death from any cause, whichever came first, assessed up to 100 months.

Interventiondays (Median)
Treatment (Panitumumab, Chemotherapy, Radiation)409

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Complete Pathological Response (pCR) Rate

Based on the proportion who achieve pCR based on the first 4 courses of protocol treatment. Evaluated using the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 guidelines. Means (with associated standard errors), medians (with ranges), percentages and 95% confidence intervals will be reported as appropriate. (NCT01307956)
Timeframe: Up to 8 weeks

InterventionParticipants (Count of Participants)
Treatment (Panitumumab, Chemotherapy, Radiation)3

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Overall Survival

Descriptively summarized using the method of Kaplan-Meier. (NCT01307956)
Timeframe: From the first date of therapy until the date the patient dies, assessed up to 100 months

Interventiondays (Median)
Treatment (Panitumumab, Chemotherapy, Radiation)596

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Number of Patients Who Can Undergo Resection

Restaging with repeat imaging studies will be performed. If no contraindication for surgical resection is identified, resection will be performed. Means (with associated standard errors), medians (with ranges), percentages and 95% confidence intervals will be reported as appropriate. (NCT01307956)
Timeframe: 4 weeks after completion of the radiation

InterventionParticipants (Count of Participants)
Treatment (Panitumumab, Chemotherapy, Radiation)11

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Periventricular Leukomalacia

One of the two outcomes used to measure neonatal morbidity. (NCT01355159)
Timeframe: Infants to the participants were followed for 28 days after birth.

InterventionParticipants (Count of Participants)
Folic Acid 4 mg4
Placebo2

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Perinatal Mortality

The perinatal mortality is defined as the number of deaths (fetal deaths and neonatal deaths) of babies ≥ 500 grams birth weight or, if birth weight is unavailable, a gestational age ≥ 20+0 weeks, up to 28 completed days after birth. (NCT01355159)
Timeframe: Participants will be followed from 20+0 weeks of gestation until 28 days of life.

InterventionParticipants (Count of Participants)
Folic Acid 4 mg23
Placebo37

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Intrauterine Growth Restriction (<10th Percentile)

Intrauterine growth restriction is defined as a birth weight less than the 10th percentile of the population, adjusted for sex and gestational age, based on the current population-based Canadian reference standard. (NCT01355159)
Timeframe: Participants will be followed from 20+0 weeks of gestation until delivery

InterventionParticipants (Count of Participants)
Folic Acid 4 mg151
Placebo144

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Composite Severe Adverse Fetal/Neonatal Outcome

Composite outcome included any of retinopathy of prematurity, periventricular leukomacia, early onset sepsis, necrotizing enterocolitis, intraventricular haemorrhage, ventilation. Need for O2at 28 days, NICU admission (NCT01355159)
Timeframe: Outcomes included in the composite outcome were measured for each of their respective time frames, up to 6-weeks after birth

InterventionParticipants (Count of Participants)
Folic Acid 4 mg63
Placebo51

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Early Onset Sepsis

Within first 48hr of life, confirmed by positive blood or cerebrospinal fluid cultures (NCT01355159)
Timeframe: Infants born to the participants will be followed first 48 hours of life.

InterventionParticipants (Count of Participants)
Folic Acid 4 mg3
Placebo9

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HELLP (Hemolysis, Elevated Liver Enzyme Levels & Low Platelet Count)

Haemolysis (characteristic peripheral blood smear), Serum LDH >=600U/L, Serum AST >=70U/L, Platelet count <100 x109/L (NCT01355159)
Timeframe: Participants will be followed from 20+0 weeks of gestation until delivery

InterventionParticipants (Count of Participants)
Folic Acid 4 mg6
Placebo5

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Neonatal Intensive Care Unit (NICU) Admission

This outcome measured whether or not the infant was admitted into the NICU. (NCT01355159)
Timeframe: Infants to the participants will be followed for the duration of hospital stay, or up to 6 weeks.

InterventionParticipants (Count of Participants)
Folic Acid 4 mg299
Placebo267

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Neonatal Death

Neonatal death defined as death of the infant occurred before 28 days of life (NCT01355159)
Timeframe: Infants to the participants will be followed for 28 days after birth.

InterventionParticipants (Count of Participants)
Folic Acid 4 mg151
Placebo144

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Neonatal Death

Neonatal death defined as death of a baby that occurred during first 28 days of life. (NCT01355159)
Timeframe: Participants will be followed from birth until 28 days of life

InterventionParticipants (Count of Participants)
Folic Acid 4 mg8
Placebo11

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Need for Oxygen at 28 Days

(NCT01355159)
Timeframe: Infants to the participants will be followed for 28 days after birth.

InterventionParticipants (Count of Participants)
Folic Acid 4 mg9
Placebo3

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Necrotising Enterocolitis

Necrotizing enterocolitis (NEC) according to modified Bell's criteria stage 2 or higher (grossly bloody stool, plus absent bowel sounds with or without abdominal tenderness and radiographic findings such as intestinal dilation, ileus, pneumatosis intestinalis), excluding isolated spontaneous intestinal perforations. (NCT01355159)
Timeframe: Infants borm to the participants will be followed for the duration of hospital stay, or up to 6 weeks.

InterventionParticipants (Count of Participants)
Folic Acid 4 mg8
Placebo3

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Length of Stay in 'High Level' Neonatal Care Unit

(NCT01355159)
Timeframe: Infants to the participants will be followed for the duration of hospital stay, or up to 6 weeks.

Interventiondays (Mean)
Folic Acid 4 mg16
Placebo17

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Intraventricular Hemorrhage (IVH)

"IVH Grade 1(Blood in germinal matrix)~IVH Grade 2 (Blood in germinal matrix and extending into the ventricles)~IVH Grade 3 (Ventricular enlargement)~IVH Grade 4 (Intraparenchymal lesion)" (NCT01355159)
Timeframe: Time Frame: Infants born to the participants will be followed for the duration of hospital stay, or up to 6 weeks

InterventionParticipants (Count of Participants)
Folic Acid 4 mg18
Placebo19

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Intrauterine Growth Restriction (<3rd Percentile)

Intrauterine growth restriction is defined as a birth weight less than the 3rd percentile of the population, adjusted for sex and gestational age, based on the current population-based Canadian reference standard. (NCT01355159)
Timeframe: Participants will be followed from 20+0 weeks of gestation until delivery

InterventionParticipants (Count of Participants)
Folic Acid 4 mg20
Placebo25

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Maternal Death

"According to the World Health Organization, A maternal death is defined as the death of a woman while pregnant or within 42 days of termination of pregnancy, irrespective of the duration and site of the pregnancy, from any cause related to or aggravated by the pregnancy or its management but not from accidental or incidental causes." (NCT01355159)
Timeframe: Time Frame: Participants will be followed from 20+0 weeks of gestation until 42 days postpartum (after delivery)

InterventionParticipants (Count of Participants)
Folic Acid 4 mg0
Placebo0

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Antenatal Inpatient Length of Stay

Length of inpatient stay before admission for delivery in days (NCT01355159)
Timeframe: Participants will be followed from date of randomization (8-16 weeks' completed gestation) until admission for delivery

Interventiondays (Mean)
Folic Acid 4 mg5.6
Placebo5.2

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Ventilation

Ventilatory support after initial resuscitation, with/without intubation. (NCT01355159)
Timeframe: Infants born to the participants will be followed for the duration of hospital stay, or up to 6 weeks.

InterventionParticipants (Count of Participants)
Folic Acid 4 mg49
Placebo30

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Stillbirth

Fetal death defined as death of fetus of at least 500 grams birth weight or, if birth weight is unavailable, a gestational age of at least 20+0 weeks of gestation. (NCT01355159)
Timeframe: Participants will be followed from 20+0 weeks of gestation up to delivery.

InterventionParticipants (Count of Participants)
Folic Acid 4 mg15
Placebo26

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Spontaneous Abortion

Spontaneous abortion or miscarriage defined as death of a fetus <500g or <20 weeks of gestation (NCT01355159)
Timeframe: Participants will be followed from randomization until 20+0 weeks of gestation

InterventionParticipants (Count of Participants)
Folic Acid 4 mg27
Placebo21

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Severe Preeclampsia

Severe PE: Defined as PE with convulsion or HELLP or delivery <34 weeks. (NCT01355159)
Timeframe: Participants will be followed from 20+0 weeks of gestation until delivery.

InterventionParticipants (Count of Participants)
Folic Acid 4 mg24
Placebo16

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Retinopathy of Prematurity

Retinopathy of prematurity a retinopathy typically occurring in premature infants treated with high concentrations of oxygen, characterized by vascular dilatation, proliferation, tortuosity, edema, retinal detachment, and fibrous tissue behind the lens confirmed by retinal examination according to an International Committee for the Classification of Retinopathy of Prematurity. (NCT01355159)
Timeframe: Infants born to the participant will be followed for the duration of hospital stay, or up to 6 weeks

InterventionParticipants (Count of Participants)
Folic Acid 4 mg21
Placebo13

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Preterm Birth

Birth that occur earlier than 37+0 weeks of gestational age. (NCT01355159)
Timeframe: Participants will be followed from 20+0 weeks to 36+6 weeks of gestation

InterventionParticipants (Count of Participants)
Folic Acid 4 mg297
Placebo304

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Premature Rupture of Membranes

Rupture of the membranes (rupture of the amniotic sac) before the onset of labor. (NCT01355159)
Timeframe: Participants will be followed from randomization (8-16 weeks' completed gestation) until the onset of labor

InterventionParticipants (Count of Participants)
Folic Acid 4 mg215
Placebo224

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Preeclampsia

"PE is defined as diastolic blood pressure ≥90 mmHg on two occasions ≥4 hours apart and proteinuria developed in women greater than 20+0 weeks of gestation. Proteinuria is defined as: urinary protein ≥300mg in 24 hour urine collection OR in the absence of 24 hour collection, ≥2+ dipstick proteinuria, OR random protein-creatinine ratio ≥30mg protein/mmol.~OR HELLP (Haemolysis, Elevated, Liver Enzymes, Low Platelets) syndrome defined as: Haemolysis (characteristic peripheral blood smear), Serum LDH ≥ 600U/L, Serum AST ≥ 70U/L, and Platelet count <100 x109/L~OR Superimposed pre-eclampsia, defined as history of pre-existing hypertension (diagnosed pre-pregnancy or before 20+0 weeks' gestation) with new proteinuria." (NCT01355159)
Timeframe: Participants will be followed from 20+0 weeks of gestational age until 42 days postpartum (after delivery)

InterventionParticipants (Count of Participants)
Folic Acid 4 mg169
Placebo156

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Placenta Abruption

Placental abruption (abruptio placentae) is the premature detachment of a normally positioned placenta from the wall of the uterus. (NCT01355159)
Timeframe: Participants will be followed from 20+0 weeks of gestation until delivery

InterventionParticipants (Count of Participants)
Folic Acid 4 mg12
Placebo19

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Change in Resting Muscle Sympathetic Nerve Activity (MSNA)

(NCT01356966)
Timeframe: Baseline, 12 weeks

Interventionbursts/minute (Mean)
Tetrahydrobiopterin + Folate-7.5
Placebo + Folate3.2

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Change in Mean Central Augmentation Index (AIx)

The augmentation index (AIx) is a measure of systemic arterial stiffness, and is defined as the ratio of augmentation (Δ P) to central pulse pressure and expressed as percent. AIx = (ΔP/PP) x 100, where P = pressure and PP = Pulse Pressure. The mean AIx for each group was estimated as an average and expressed as a change from baseline to 12 weeks. (NCT01356966)
Timeframe: Baseline, 12 weeks

Interventionpercent (Mean)
Tetrahydrobiopterin + Folate-5.8
Placebo + Folate1.8

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Change in Heart-rate-corrected Augmentation Index (AIx)

The augmentation index (AIx) is a measure of systemic arterial stiffness, and is defined as the ratio of augmented aortic pressure (Δ P) to central pulse pressure expressed as a percent. AIx = (ΔP/PP) x 100, where P = pressure and PP = Pulse Pressure. Because heart rate (HR) affects AIx, AIx was corrected to a HR of 75 beats per minute (bpm) as follows: HR-corrected AIx = -0.39 x (75 - HR) + AIx. The mean AIx for each group was estimated as an average and expressed as a change from baseline to 12 weeks. (NCT01356966)
Timeframe: Baseline, 12 weeks

Interventionpercent (Mean)
Tetrahydrobiopterin + Folate-3.2
Placebo + Folate1.1

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Blood Loss

500 cc or more (NCT01436266)
Timeframe: one day following the procedure

InterventionParticipants (Count of Participants)
Active Comparator: Misoprostol0
Placebo Comparator: Placebo (Folic Acid)0

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Patient-reported Quality of Life (QOL) After Baseline Visit.

Patient reported quality of life was measured with the Functional Assessment of Cancer Therapy - Generic (FACT-G). The FACT-G is a scale for assessing general QOL of cancer patients. It consists of four subscales: Physical Well Being, Functional Well Being, Social/Family Well-Being, and Emotional Well-Being. Each item in the FACT-G was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative statements, reversal was performed prior to score calculation. According to the FACIT measurement system, a subscale score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the subscale. The FACT-G score is calculated as the sum of the subscale scores. The FACT-G score ranges 0-108. A larger score suggests better QOL. (NCT01535053)
Timeframe: Prior to cycle 3 (4 weeks after cycle 1 if off study treatment prior to cycle 3). Prior to cycle 5, Prior to cycle 7, 26 weeks after starting study treatment.

,
Interventionunits on a scale (Least Squares Mean)
Pre-cycle 3Pre-cycle 5Pre-cycle 726 weeks
Regimen I (Dactinomycin)78.375.585.091.2
Regimen II (Methotrexate)81.678.984.590.9

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Percentage of Participants With Complete Response

Complete Response is defined as 3 consecutive bi-weekly values of hCG<5 over a minimum of 4 weeks of normal hCG values with no values greater than 5 mIU/ml (NCT01535053)
Timeframe: hCG testing is performed prior to each cycle to treatment until treatment is completed, up to 10 months. For patients who have responded to treatment hCG must be obtained every 4 weeks for 1 year after completing treatment.

Interventionpercentage of participants (Number)
Regimen I (Dactinomycin)78.6
Regimen II (Methotrexate)88.5

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Patient-reported Quality of Life (QOL) at Baseline

Patient reported quality of life was measured with the Functional Assessment of Cancer Therapy - Generic (FACT-G). The FACT-G is a scale for assessing general QOL of cancer patients. It consists of four subscales: Physical Well Being, Functional Well Being, Social/Family Well-Being, and Emotional Well-Being. Each item in the FACT-G was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative statements, reversal was performed prior to score calculation. According to the FACIT measurement system, a subscale score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the subscale. The FACT-G score is calculated as the sum of the subscale scores. The FACT-G score ranges 0-108. A larger score suggests better QOL. (NCT01535053)
Timeframe: Prior to cycle 1

Interventionunits on a scale (Mean)
Regimen I (Dactinomycin)82.3
Regimen II (Methotrexate)81.9

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The Number of Participants With Post Protocol Multi-agent Chemotherapy Treatment for Each Arm.

(NCT01535053)
Timeframe: Anytime during post treatment follow-up for up to 2 years from study entry.

Interventionparticipants (Number)
Regimen I (Dactinomycin)0
Regimen II (Methotrexate)0

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The Number of Participants With Post Protocol Surgical Treatment for Each Arm.

(NCT01535053)
Timeframe: Anytime during post treatment follow-up for up to 2 years from study entry.

Interventionparticipants (Number)
Regimen I (Dactinomycin)0
Regimen II (Methotrexate)0

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Number of Participants With CTCAE v4 Graded Adverse Events With Low-risk Gestational Trophoblastic Neoplasia by Arm

Maximum grade of physician assessed adverse events reported during treatment (NCT01535053)
Timeframe: Assessed throughout the treatment period and within 2-4 weeks after discontinuation of treatment

,
Interventionparticipants (Number)
Grade 1Grade 2Grade 3Grade 4Grade 5
Regimen I (Dactinomycin)714600
Regimen II (Methotrexate)4101000

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GMDS (Griffiths Mental Development Scale)

GMDS for testing and estimate babies psychomotor development from birth to 2 years trough six subscales : Locomotor, Personal-social, Hearing and language, Eye-Hand coordination, Performance.Sub- and General Quotients (GDQ) standard score are based on a mean of 100 and a standard deviation of 16. For children with delayed development, which is the case for children with Down Syndrome, Quotient tables could be not used because sub- and General quotient floors at 50. For each subscale, a raw score was derived from the contributing items. Total raw score was obtained by adding subscale raw scores. Sum of all subscale raw scores was converted into a development age using correspondence table. Subscale and global development quotients were computed by dividing the development age by the chronological age multiplied by 100. For preterm infants, chronological age was corrected taking into account the gestational term. Higher QD's scores show a better psychomotor development outcome (NCT01576705)
Timeframe: 12 months

Interventiondeveloppement quotient (Mean)
Thyroxin + Folinic Acid51.96
Thyroxin+Folinic Acid Placebo51.27
Thyroxin Placebo+ Folinic Acid51.66
Thyroxin Placebo+ Folinic Acid Placebo51.67

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BL (Brunet Lezine Revised Scale)

BL includes 4 subscales : Locomotor, Coordination, Language, Sociability. Subscale and global developpemental quotients were computed by dividing the developpemental age by the chronological age multiplied by 100. This kind of formula do not give a min-max outcome. Higher QD's scores show a better psychomotor developpement outcome. (NCT01576705)
Timeframe: 12 months

Interventiondeveloppement quotient (Mean)
Thyroxin + Folinic Acid51.18
Thyroxin+Folinic Acid Placebo50.64
Thyroxin Placebo+ Folinic Acid51.24
Thyroxin Placebo+ Folinic Acid Placebo51.36

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Median Overall Survival (OS)

OS, defined as the time from study enrollment to death from any cause, will be analyzed and summarized with the survival probabilities over time using Kaplan-Meier method. Confidence intervals for the median OS rates at different time points will be constructed when appropriate. (NCT01581307)
Timeframe: Up to 29 months

Interventionmonths (Median)
2nd Line Chemotherapy With Radiotherapy14.09

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Rate of Progression Free Survival (PFS)

PFS defined as the time from study enrollment to progression in the liver by modified Response Evaluation Criteria in Solid Tumors (RECIST) or death, whichever occurs first will be analyzed and summarized with the survival probabilities over time using Kaplan-Meier method. Confidence intervals for the median PFS rates at different time points will be constructed when appropriate. (NCT01581307)
Timeframe: Up to 29 months

InterventionParticipants (Count of Participants)
2nd Line Chemotherapy With Radiotherapy3

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Overall Response Rate (ORR)

The overall response: ORR = complete response (CR) + partial response (PR). Rate will be summarized using both point estimates and exact confidence intervals based on the binomial distribution by groups. (NCT01581307)
Timeframe: Up to 29 months

InterventionParticipants (Count of Participants)
Complete ResponsePartial Response
2nd Line Chemotherapy With Radiotherapy05

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Pharmacokinetics: Dose-Normalized AUC(0-∞) of Irinotecan and Its Metabolite SN-38 in Cycle 2

Dose-normalized AUC(0-∞) was calculated from AUC(0-∞) divided by the dose. Data presented are Geo LS means. Geo LS means were adjusted for cycle, participant and random error. (NCT01634555)
Timeframe: Cycle 2: 0, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 22, 25, 28, 31, 34, 48, 72, 96 and 168 hours post-irinotecan infusion

Interventionnanograms*hour/milliliter/milligram (Least Squares Mean)
IrinotecanMetabolite SN-38
Ramucirumab + FOLFIRI (Cycle 2)20.560.77

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Pharmacokinetics: Dose-Normalized Cmax of Irinotecan and Its Metabolite SN-38 in Cycle 2

Dose-normalized Cmax was calculated from Cmax divided by the dose. Data presented are Geo LS means. Geo LS means were adjusted for cycle, participant and random error. (NCT01634555)
Timeframe: Cycle 2: 0, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 22, 25, 28, 31, 34, 48, 72, 96 and 168 hours post-irinotecan infusion

Interventionnanograms/milliliter/milligram (Least Squares Mean)
IrinotecanMetabolite SN-38
Ramucirumab + FOLFIRI (Cycle 2)3.310.05

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Pharmacokinetics: Dose-Normalized Maximum Observed Drug Concentration (Cmax) of Irinotecan and Its Metabolite SN-38 in Cycle 1

Dose-normalized Cmax was calculated from Cmax divided by the dose. Data presented are Geo LS means. Geo LS means were adjusted for cycle, participant and random error. (NCT01634555)
Timeframe: Cycle 1: 0, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 22, 25, 28, 31, 34, 48, 72, 96 and 168 hours post-irinotecan infusion

Interventionnanograms/milliliter/milligram (Least Squares Mean)
IrinotecanMetabolite SN-38
FOLFIRI (Cycle 1)3.180.05

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Number of Participants With Treatment Emergent Anti-Drug Antibodies (TE-ADA)

Number of participants with positive treatment emergent anti-ramucirumab antibodies was summarized by treatment group. (NCT01634555)
Timeframe: Up To 2 Years

InterventionParticipants (Count of Participants)
Ramucirumab + FOLFIRI (Cycle 2)0

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Pharmacokinetics: Cmax of Ramucirumab (IMC-1121B)

(NCT01634555)
Timeframe: Cycle 2: -2, -1, -0.5, 0, 2, 3, 4, 5, 8, 10, 25, 48, 72, 96, 168, 264, 336 hours post-ramucirumab (IMC-1121B) infusion

Interventionmicrograms/milliliter (µg/mL) (Geometric Mean)
Ramucirumab + FOLFIRI (Cycle 2)201.6

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Pharmacokinetics: Dose-Normalized Area Under the Concentration Versus Time Curve of Irinotecan and Its Metabolite SN-38 From Time Zero to Infinity [AUC(0-∞)] in Cycle 1

Dose-normalized AUC(0-∞) was calculated from AUC(0-∞) divided by the dose. Data presented are Geometric Least Squares (Geo LS) means. Geo LS means were adjusted for cycle, participant and random error. (NCT01634555)
Timeframe: Cycle 1: 0, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 22, 25, 28, 31, 34, 48, 72, 96 and 168 hours post-irinotecan infusion

Interventionnanograms*hour/milliliter/milligram (Least Squares Mean)
IrinotecanMetabolite SN-38
FOLFIRI (Cycle 1)22.120.81

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Number of Participants Within the Categories of Increasing and Decreasing Serum Magnesium

Serum magnesium (Mg) was to be measured at baseline, Week 16 (on adalimumab) and at week 28 (on adalimumab plus folic acid, vitamins B6 and B12) in adult participants age 18 or older with moderate to severe plaque psoriasis. (NCT01704599)
Timeframe: Weeks 16 and 28

Interventionparticipants (Number)
IncreasedUnchangedDecreased
Humira Then Humira Plus 3 B Vitamins122

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Number of Participants With Category Change in Vitamin B12 Blood Level

Adult participants 18 years or older with moderate to severe plaque psoriasis were to have serum B12 levels measures Weeks 0 (on no systemic psoriasis medication), 16 (on adalimumab) and week 28 (on adalimumab plus daily 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg B12. (NCT01704599)
Timeframe: At Week 16 and Week 28

Interventionparticipants (Number)
IncreasedUnchangedWorsened
Humira Then Humira Plus 3 B Vitamins500

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Number of Participants Who Fulfilled the Category of Having Height Measured

Height is the distance from the bottom (soles of feet ) to the top (top of head) of a person when that person is standing in this study using ruler in inches.Participants measured were adults age 18 or older with moderate to severe plaque psoriasis. (NCT01704599)
Timeframe: Week 0 at Start of Adalimumab

Interventionparticipants (Number)
MeasuredNot measured
Humira Then Humira Plus 3 B Vitamins80

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Number of Participants With a Categorical Change in Static Physician Global Assessment (sPGA):

Number of participants with a category change in Physician static Global Assessment (sPGA): 7 point score from 0 (clear) to 6 measuring amount of surface covered and plaque qualities: thickness & erythema plus scaling. Dynamic score compares baseline with either improvement/ worsening of the same factors measured in the sPGA using the 0-6 scoring range but focused on change. sPGA at weeks 16 AND 28. dynamic PGA to be categoically measured at.weeks16 and 28. (NCT01704599)
Timeframe: Week 16 and Week 28

Interventionparticipants (Number)
ImprovedUnchangedWorsened
Humira Then Humira Plus 3 B Vitamins313

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Number of Participants With a Categorical DLQI (Dermatology Life Quality Index) Change

DLQI is 10 questions examining impact of skin disease on quality of life: (1) symptoms & feelings (2) daily activities (3) leisure (4) work & school (5) personal relationship (6) treatment. To be administered to adults over 18 years with moderate to severe plaque psoriasis at week 0 (no systemic psoriasis medication);. weeks 16 ( after 16 weeks of adalimumab) and week 28 (after 16 weeks adalimumab then 12 weeks of adalimumab plus daily 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg B12). (NCT01704599)
Timeframe: Week 16 and Week 28

Interventionparticipants (Number)
ImprovedUnchangedWorsened
Humira Then Humira Plus 3 B Vitamins331

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Number of Participants With Category Change in Serum Folic Acid Level.

Serum folic acid level in adults ages 18 and older with mild to moderate plaque psoriasis measured at week 16 after 16 weeks adalimumab and at week 28 after 16 weeks adalimumab plus 12 weeks of adalimumab and daily 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg B12. (NCT01704599)
Timeframe: Weeks 16 and 28

Interventionparticipants (Number)
IncreasedUnchangedDecreasedNot evaluable (if >20 ng/ml only stated as such)
Humira Then Humira Plus 3 B Vitamins3002

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Number of Participants With Category Change in Serum VEGF (Vascular Endothelial Growth Factorl)

Adult particpants ages 18 or older with moderate to severe plaque psoriasis were to have serum VEGF measured at week 0 on no systemic psoriasis medication then at both weeks 16 on adalimumab and at week 28 on adalimumab plus folic acid, B6 and Vitamin B12. Subjects raniked by BMI week 0 low to high (NCT01704599)
Timeframe: At Screening visit, Week 16 on Humira, after another 12 weeks on Humira plus vitamins and if early termination

Interventionparticipants (Number)
IncreasedUnchangedDecreased
Humira Then Humira Plus 3 B Vitamins401

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Number of Participants Within Categories of Body Temperature Change

Using a thermometer for body temperature on degrees Fahrenheit. Participants to be measured were adults 18 years or older with moderate to severe plaque psoriasis with temperature to be measured at week 16 16 weeks of adalimumab and week 28 after 16 weeks of adalimumab then 12 weeks of adalimumab plus 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg of B12. (NCT01704599)
Timeframe: Weeks 16 and 28

Interventionparticipants (Number)
increasedunchangeddecreased
Humira Then Humira Plus 3 B Vitamins221

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PASI Change in Participants With Baseline VEGF Above 140 pg/ml and in Participants With Normal Baseline VEGF

Baseline VEGF level at week zero related to PASI change Week 16 on adalimumab compared to Week 28 after additonal 12 weeks of adalimumab plus folic acid, vitamin B6 and B12 in adult psoriasis patients ages 18-65 with moderate to severe plaque psoriasis.High levels were greater than or equal to 140 pg/ml. Normal VEGF was below this level. (NCT01704599)
Timeframe: Week 16 and Week 28

Interventionparticipants (Number)
PASI improved with high VEGFPASI Worsened with high VEGFPASI Unchanged with normal VEGFPASI Improved with normal VEGFPASI Worsened with normal VEGF
Humira Then Humira Plus 3 B Vitamins12130

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Number of Participants in the Categories of Normalizing, Unchanging and Newly Abnormal Electrocardiograms (EKGs)

An electrocardiogram (EKG) is used to evaluate the electrical activity of the heart by converting this activity into line tracings on paper.. Electrodes (small, plastic patches) are placed at certain locations on the chest, arms, and legs. When the electrodes are connected to an EKG machine by lead wires, the electrical activity of the heart is measured, interpreted, and printed out for the doctor's information and further interpretation. This test was to be administered to adults age 18 or older with moderate to severe plaque psoriasis patients at week 0, 16 and week 28 of this study. (NCT01704599)
Timeframe: Week 16 and then Week 28 after another 12 weeks on Humira plus vitamins and if early termination

Interventionparticipants (Number)
NormalizingUnchangedNewly abnormal
Humira Then Humira Plus 3 B Vitamins141

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Number of Particpants With a Categorical PASI (Psoriasis Area and Severity Index) Change

PASI: formula based on body surface areas on head/neck, trunk, both arms & legs with disease quality grading induration, scale and erythema on participants ages 18-65 with moderate to severe plaque psoriasis measured at weeks 16 and 28. (NCT01704599)
Timeframe: Weeks 16 and 28

Interventionparticipants (Number)
ImprovedUnchangedWorsened
Humira Then Humira Plus 3 B Vitamins412

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Number of Participants Within the Categories of Positive Urine Pregnancy Test (Urine Hcg)

Women of childbearing years over age 18 with moderate to severe plaque psoriasis on no systemic therapy at week 0 of study. (NCT01704599)
Timeframe: At screening

Interventionparticipant (Number)
NegativePositive
Humira Then Humira Plus 3 B Vitamins10

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Number of Participants Within the Categories of Elevated and Normal Helicobacter Pylori Antibody

Adult participants age 18 years or older with moderate to severe plaque psoriasis with serum IgG antibodies against Helicobacter pylori bacteria using commercial ELISA assay during the 28 week study. (NCT01704599)
Timeframe: Week 28 after 16 weeks of Adalimumab then 12 of Adalimumab-Vitamins

Interventionparticipants (Number)
ElevatedNormal
Humira Then Humira Plus 3 B Vitamins26

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Number of Participants Within the Categories of Increasing and Decreasing Serum Vitamin B6 Level

Serum vitamin B6 levels were to be measured weeks16 after 16 weeks adalimumab and at week 28 after 16 weeks adalimumab and 12 weeks on adalimuamb, folic acid 5 mg, b6 100 mg and B12 1000 mcg in adult participants with moderate to sever plque psoriasis. (NCT01704599)
Timeframe: At Week 16 and Week 28

Interventionparticipants (Number)
IncreasedUnchangedDecreased
Humira Then Humira Plus 3 B Vitamins400

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Number of Participants Within the Categories of Increasing and Decreasing Serum Phosphorus

Serum phosphorus (P) levels were to be measured weeks16 and 28 in adult participants age 18 and older with moderate to severe plaque psoriasis at week 0 on no systemic psoriasis medication; week 16 after 16 weeks of adalimumab and at week 28 after 16 weeks of adalimumab plus 12 weeks of adalimumab plus 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg of B12. (NCT01704599)
Timeframe: Week 16 then Week 28

Interventionparticipants (Number)
IncreasedUnchangedDecreased
Humira Then Humira Plus 3 B Vitamins302

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Number of Participants in Categories or Increasing and Decreasing Changes Within the CBC (Complete Blood Count)

Change in CBC parameter: white blood count or hemoglobin or hematocrit ( as measured week 16 on adalimumab and at week 28 after 12 more weeks on adalimuamb , folic acid, B6 and B12) in adults ages 18-65 with moderate to severe plaque psoriasis. (NCT01704599)
Timeframe: Week 16 and Week 28

Interventionparticipants (Number)
WBC increasedWBC unchangedWBC decreasedHemoglobin/Hematocrit increasedHemoglobin/Hematocrit unchangedHemoglobin/Hematocrit decreased
Humira Then Humira Plus 3 B Vitamins302302

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Psoriasis Change in Participants With High H. Pylori Titers and With Normal Titers.

Change in PASI from Week 16 after 16 weeks of adalimumab to Week 28 after another 12 weeks of adalimumab plus folic acid, vitamins B6 and B12 and Change reported by telephone 70 days after week 28 (NCT01704599)
Timeframe: Week 16 to Week 28 and Week 28 to post study day 70

Interventionparticipants (Number)
high titer worsenedhigh titer improved then worsened day 70normal titer improvednormal titer unchanged then improved day 70normal titer worsened
Humira Then Humira Plus 3 B Vitamins11311

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Number of Participants in the Categories of Having and of Not Having a Serious Adverse Event (SAE)

A serious adverse event is hosptalization or death or pathology leading to early termination of a participant from the study. This was to be reported at anytime during the 28 week study of adult patients ages 18-65 with moderate to severe plaque psoriasis though categorized by Week 16 (on adalimumab alone, by Week 28 (on adalimuamb plus 3 B vitaminsand by day 70 post Week 28. (NCT01704599)
Timeframe: By Week 16, by Week 28 and by Day 70 post Week 28.

Interventionparticipants (Number)
No SAESAE by Week 16SAE by Week 28SAE by Day 70 afterWeek 28
Humira Then Humira Plus 3 B Vitamins7100

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Number of Participants Within the Categories of Increasign and Decreasing Body Weight

Weight is how heavy a participant is. Weight in pounds of each study adult participant age 18-65 years with moderate to severe plaque psoriasis measured at weeks 16 and compared to week 28 of study. (NCT01704599)
Timeframe: Week 16 and Week 28

Interventionparticipants (Number)
IncreasedUnchangedDecreased
Humira Then Humira Plus 3 B Vitamins205

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Number of Participants Within the Categories of Increasing and Decreasing Blood Pressure and Pulse Measures:

Blood pressure is the force the heart exerts against the walls of arteries as it pumps the blood out to the body. The unit of measurement is millimeters of mercury (mm Hg). Pulse is the number of times your heart beats per minute. The unit of measurement is beats per minute (BPM). These test measurements compared in adults with moderate to severe plaque psoriasis week 16 after 16 weeks adalimumab and week 28 after 16 weeks adalimumab plus 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg vitamin B12. (NCT01704599)
Timeframe: Week 16 and Week 28

Interventionparticipants (Number)
Systolic BP increasedSystolic BP unchangedSystolic BP decreasedDiastolic BP increasedDiastolic BP unchangedDiastolic BP decreasedPulse increasedPulse unchangedPulse decreased
Humira Then Humira Plus 3 B Vitamins403502502

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Number of Participants Within the Categories of Increasing and Decreasing Serum Homocysteine

Serum homocysteine measured at week 16 after 16 weeks of adalimumab and week 28 after 16 weeks of adalimumaband then 12 weeks of adalimumab plus 5 mg folic acid, 100mg B6 and 1000 mcg of B12 in adults ages 18-65 with moderate to sever plaque psoriasis.. (NCT01704599)
Timeframe: Week 16 and Week 28

Interventionparticipants (Number)
IncreasedUnchangedDecreased
Humira Plus 3 B Vitamins103

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Number of Participants in the Categories of Having and Not Having an Adverse Event

"Worsening psoriasis or development or worsening of measured condition or new pathology not seen by week 16 but developed at weeks 28 or first discoved by telephone call day 70 post study:~AE Humira only" (NCT01704599)
Timeframe: After Week 16 of study

Interventionparticipants (Number)
No Adverse Event after Week 16Adverse Event Weeks 16-28Adverse event by Day 70 call after Week 28
Humira Then Humira Plus 3 B Vitamins241

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Participants Who Experienced Safety Concerns, Where Safety Concerns of Quercetin Supplementation is Indicated by Significant Change From Baseline Measures of Tests Indicated Below in Outcome Measure Description

"Note: If values for any of the measures indicated here were found, the participant would be indicated as a participant with a safety concern, and values for that particular measure would be posted specifically, but since none of the participants experienced these outlying values, results of all tests are expressed here as a composite function.~PULMONARY FUNCTION TEST:~FEV1% of predicted: decline by >20% from baseline COMPLETE BLOOD COUNTS: WBC (cells)/mm3 : <2000, Platelets (cells)/mm3: <25,000, Hemoglobin (g/dL): <7.0 COMPREHENSIVE METABOLIC PROFILE (study drug related):Sodium (mmol/L): <125 or >148, Potassium (mmol/L): < 3.0 or > 6.0, Calcium (mmol/L): <7.4 or > 11.5, LIVER FUNCTION TESTS INCREASE BY FACTOR: Enzymes ALT, AST, and Alkaline phosphate, Total bilirubin: for any of these a value >3X upper limit of normal" (NCT01708278)
Timeframe: One week in Phase I safety study

InterventionParticipants (Count of Participants)
Sugar Chew- Cohort 10
Quercetin 1-Cohort 10
Quercetin 2-Cohort 20
Quercetin 3-Cohort 30
Sugar Chew-Cohort 20
Sugar Chew-Cohort 30

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Change From Baseline in Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR)

DAS28 consisted of a composite score of the following variables: tender joint count (TJC28), swollen joint count (SJC28), erythrocyte sedimentation rate (ESR) (millimeters per hour), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using the following formula: DAS28-ESR=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.70*natural log(ESR)+0.014*Patient's Global VAS. Scores ranged 1.0-9.4, where lower scores indicated less disease activity. (NCT01711359)
Timeframe: Baseline, Week 24; Baseline, Week 52

,,
Interventionunits on a scale (Mean)
Week 24Week 52
Baricitinib-2.76-2.84
Baricitinib + MTX-3.06-3.22
Methotrexate-2.20-2.32

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Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores (Self-Perceived Health)

A second component of the EQ-5D-5L is a self-perceived health score which is assessed using a VAS that ranges from 0 to 100 millimeter (mm), where 0 indicates the worst health you can imagine and 100 indicates the best health you can imagine. (NCT01711359)
Timeframe: Baseline, Week 24; Baseline Week 52

,,
Interventionmillimeter (Mean)
Self-Perceived Health Week 24Self-Perceived Health Week 52
Baricitinib24.124.5
Baricitinib + MTX21.424.5
Methotrexate14.513.6

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Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scores

"The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale is a13-item, symptom-specific questionnaire that specifically assesses the participant's self-reported severity of fatigue and its impact upon daily activities and functioning. The FACIT-F uses a numeric rating scale of 0 (Not at all) to 4 (Very much) for each item to assess fatigue and its impact in the past 7 days. Total scores range from 0 to 52, with higher scores indicating less fatigue." (NCT01711359)
Timeframe: Baseline, Week 24; Baseline Week 52

,,
Interventionunits on a scale (Mean)
Week 24Week 52
Baricitinib13.011.3
Baricitinib + MTX12.312.6
Methotrexate9.39.1

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Change From Baseline in Joint Space Narrowing and Bone Erosion Scores

X-rays of the hands/wrists and feet were assessed for joint space narrowing (JSN) and bone erosions. Assessment of JSN for each hand (15 joints per hand) and foot (6 joints per foot), including subluxation, is scored from 0 to 4, with 0 indicating no (normal) JSN and 4 indicating complete loss of joint space, bony ankylosis or luxation. JSN scores ranged from 0-168. A score of 0 would indicate no change and higher scores represent a worsening of joint space narrowing. The bone erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints of the feet. Each joint is scored according to the surface area involved from 0 to 5 for hand joints and 0 to 10 for the foot joints, with 0 indicating no erosion and the highest score (5 for the hand and 10 for the foot) indicating extensive loss of bone from more than one half of the articulating bone. Erosion scores ranged from 0 (no erosion) to 280 (high erosion). (NCT01711359)
Timeframe: Baseline, Week 24; Baseline, Week 52

,,
Interventionunits on a scale (Mean)
JSN Week 24JSN Week 52Bone Erosion Week 24Bone Erosion Week 52
Baricitinib0.080.260.350.55
Baricitinib + MTX0.050.080.270.33
Methotrexate0.150.230.490.80

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Change From Baseline in Mental Component Score (MCS) and Physical Component Score (PCS) of the Medical Outcomes Study 36-Item Short Form Health Survey Version 2 Acute (SF-36v2 Acute)

The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (MCS and PCS). MCS consisted of social functioning, vitality, mental health, and role-emotional scales. PCS consisted of physical functioning, bodily pain, role-physical, and general health scales. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with higher scores indicating better health status or functioning. (NCT01711359)
Timeframe: Baseline, Week 24; Baseline Week 52

,,
Interventionunits on a scale (Mean)
MCS Week 24MCS Week 52PCS Week 24PCS Week 52
Baricitinib5.95.812.511.6
Baricitinib + MTX4.65.013.213.3
Methotrexate3.42.49.49.4

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Change From Baseline in the Modified Total Sharp Score (mTSS)

"X-rays of the hands/wrists and feet were scored for structural progression as measured using the mTSS (van der Heijde 2000). This methodology quantified the extent of bone erosions and joint space narrowing for 44 and 42 joints, with higher scores representing greater damage.~The mTSS at a time point is the sum of the erosion (range from 0 to 280) and JSN (range from 0 to 168) scores, for a maximum score of 448." (NCT01711359)
Timeframe: Baseline, Week 24

Interventionunits on a scale (Mean)
Methotrexate0.64
Baricitinib0.43
Baricitinib + MTX0.32

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Change From Baseline in Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Scores

The Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) questionnaire was developed to measure the effect of general health and symptom severity on work productivity and regular activities in the 7 days prior to the visit. It contains 6 items covering overall work productivity (health), overall work productivity (symptom), impairment of regular activities (health), and impairment of regular activities (symptom). Scores are calculated as impairment percentages. The WPAI-RA yields four types of scores: Absenteeism (work time missed), Presenteeism (impairment at work), Work productivity loss (overall work impairment), and Activity impairment. (NCT01711359)
Timeframe: Baseline, Week 24; Baseline Week 52

,,
InterventionPercentage of Impairment (Mean)
Absenteeism Week 24 (n=76, 56, 90)Absenteeism Week 52 (n=52, 51, 71)Presenteeism Week 24(n=70, 51, 86)Presenteeism Week 52 (n=51, 47, 75)Work Productivity Loss Week 24 (n=70, 71, 86)Work Productivity Loss Week 52 (n=51, 47, 75)Activity Impairment Week 24 (n=184, 145, 192)Activity Impairment Week 52 (n=141, 131, 172)
Baricitinib-8.7-8.4-26-27-25.6-27.6-36-34
Baricitinib + MTX-7.6-7.3-32-33-30.9-33.8-31-37
Methotrexate-3.6-3.0-19-26-17.8-24.1-25-28

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Change From Baseline in Worst Joint Pain Numeric Rating Scale (NRS)

"Participants rated their joint pain by selecting a number from 0 to 10 that best described their worst joint pain during the last 24 hours, where 0 represents no pain and 10 represents pain as bad as you can imagine." (NCT01711359)
Timeframe: Baseline, Week 24; Baseline Week 52

,,
Interventionunits on a scale (Mean)
Week 24Week 52
Baricitinib-3.9-3.9
Baricitinib + MTX-3.9-4.1
Methotrexate-2.8-3.0

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Change From Baseline in Worst Tiredness Numeric Rating Scale (NRS)

"Participants rated their tiredness by selecting a number from 0 to 10 that best described their worst tiredness during the last 24 hours, where 0 represents no tiredness and 10 represents as bad as you can imagine." (NCT01711359)
Timeframe: Baseline, Week 24; Baseline Week 52

,,
Interventionunits on a scale (Mean)
Week 24Week 52
Baricitinib-3.0-2.9
Baricitinib + MTX-3.0-3.0
Methotrexate-2.2-2.3

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Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response

"ACR50 Responder Index is composite of clinical, laboratory, and functional measures in RA. ACR50 Responder is a participant who has at least 50% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity, HAQ-DI, pain due to arthritis, and hsCRP. Participants with missing responses and participants who discontinued study or drug or were rescued before analysis time point were deemed non-responders." (NCT01711359)
Timeframe: Week 12, Week 24, Week 52

,,
InterventionPercent of participants (Number)
Week 12Week 24Week 52
Baricitinib54.759.757.2
Baricitinib + MTX60.063.361.9
Methotrexate32.943.337.6

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Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response

"ACR70 Responder Index is composite of clinical, laboratory, and functional measures in RA. ACR70 Responder is a participant who has at least 70% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity, HAQ-DI, pain due to arthritis, and hsCRP. Participants with missing responses and participants who discontinued study or drug or were rescued before analysis timepoint were deemed non-responders." (NCT01711359)
Timeframe: Week 12, Week 24, Week 52

,,
InterventionPercent of participants (Number)
Week 12Week 24Week 52
Baricitinib30.842.142.1
Baricitinib + MTX33.539.546.0
Methotrexate15.721.425.2

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Percentage of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Remission

"The ACR/EULAR definitions of RA remission include a Boolean-based definition. The Boolean-based definition of remission occurs when all 4 of the following criteria are met at the same visit: TJC28 ≤1, SJC28 ≤1, acute phase response using C-reactive protein (milligrams per deciliter) ≤1, Patient's Global Assessment of Disease Activity using VAS (cm) ≤1." (NCT01711359)
Timeframe: Week 12, Week 24, Week 52

,,
Interventionpercentage of participants (Number)
Week 12Week 24Week 52
Baricitinib13.818.917.0
Baricitinib + MTX14.416.320.9
Methotrexate5.78.611.4

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Percentage of Participants Achieving American College of Rheumatology 20% Improvement (ACR20)

"ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). ACR20 Responder is a participant who has at least 20% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity using visual analog scale (VAS), Health Assessment Questionnaire-Disability Index (HAQ-DI), pain due to arthritis, and high-sensitivity C-reactive protein (hsCRP). Participants with missing responses and participants who discontinued study or drug or were rescued before analysis time point were deemed non-responders." (NCT01711359)
Timeframe: Week 24

InterventionPercent of participants (Number)
Methotrexate61.9
Baricitinib76.7
Baricitinib + MTX78.1

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Percentage of Participants Achieving American College of Rheumatology 20% Improvement (ACR20)

"ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). ACR20 Responder is a participant who has at least 20% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity using visual analog scale (VAS), Health Assessment Questionnaire-Disability Index (HAQ-DI), pain due to arthritis, and high-sensitivity C-reactive protein (hsCRP). Participants with missing responses and participants who discontinued study or drug or were rescued before analysis time point were deemed non-responders." (NCT01711359)
Timeframe: Week 52

InterventionPercent of participants (Number)
Methotrexate55.7
Baricitinib73.0
Baricitinib + MTX72.6

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Percentage of Participants Who Achieved a Simplified Disease Activity Index (SDAI) Score ≤3.3

SDAI is a tool for measurement of disease activity in RA that integrates TJC28, SJC28, acute phase response using C-reactive protein (milligrams per liter), Patient's Global Assessment of Disease Activity using VAS centimeters (cm), and Physician's Global Assessment of Disease Activity using VAS (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity. An index-based definition of remission occurs with an SDAI score ≤3.3. (NCT01711359)
Timeframe: Week 24

Interventionpercentage of participants (Number)
Methotrexate10.5
Baricitinib22.0
Baricitinib + MTX22.8

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Population Pharmacokinetics (PK): Peak Concentration at Steady State (Cmax,ss) of Baricitinib

(NCT01711359)
Timeframe: Week 0: 15 and 60 minutes postdose; Week 4: 2 to 4 hours post-dose; Week 8: 4 to 6 hours post-dose; Week 12; Week 24; Week 32; Pre-dose

Interventionnanomole/Liter (nmol/L) (Geometric Mean)
Baricitinib135

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Population PK: Area Under the Concentration Versus Time Curve at a Dosing Interval at Steady State (AUCtau,ss) of Baricitinib

(NCT01711359)
Timeframe: Week 0: 15 and 60 minutes postdose; Week 4: 2 to 4 hours post-dose; Week 8: 4 to 6 hours post-dose; Week 12; Week 24; Week 32; Pre-dose

Interventionnanomole/Liter (nmol/L) (Geometric Mean)
Baricitinib1280

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Change From Baseline in Clinical Disease Activity Index (CDAI) Score

The CDAI is a tool for measurement of disease activity in RA that does not require a laboratory component and was scored by the investigative site. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity). The CDAI is calculated by summing the values of the 4 components. CDAI scores range from 0 to 76; lower scores indicated lower disease activity. A negative change from baseline indicates improvement in condition. (NCT01711359)
Timeframe: Baseline, Week 24; Baseline, Week 52

,,
Interventionunits on a scale (Mean)
Week 24Week 52
Baricitinib-28.20-28.94
Baricitinib + MTX-29.86-30.72
Methotrexate-22.12-21.95

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Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores

European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. One component consists of a descriptive system of the respondent's health comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1. A higher score indicates better health state. (NCT01711359)
Timeframe: Baseline, Week 24; Baseline Week 52

,,
Interventionunits on a scale (Mean)
Index Score (US Algorithm) Week 24Index Score (US Algorithm) Week 52Index Score (UK Algorithm) Week 24Index Score (UK Algorithm) Week 52
Baricitinib0.1970.1860.2850.271
Baricitinib + MTX0.1940.1850.2820.268
Methotrexate0.1420.1380.2050.197

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Change From Baseline in Duration of Morning Joint Stiffness

Participants reported the duration of their morning joint stiffness (MJS) in hours and minutes. The participants were asked about their duration of morning joint stiffness on the day prior to the study visit to capture actual symptoms, since the participant may have had an atypical morning routine on the day of the study visit. If morning joint stiffness duration was longer than 12 hours (720 minutes), it was truncated to 720 minutes for statistical presentations and analyses. A decrease in duration of morning joint stiffness indicated an improvement in the participant's condition. (NCT01711359)
Timeframe: Baseline, Week 52

InterventionMinutes (Median)
Methotrexate-40.0
Baricitinib-55.0
Baricitinib + MTX-60.0

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Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score

HAQ-DI assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area are averaged to calculate the HAQ-DI score, which ranges from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicates an improvement in the participant's condition. (NCT01711359)
Timeframe: Baseline, Week 24

Interventionunits on a scale (Mean)
Methotrexate-0.73
Baricitinib-1.01
Baricitinib + MTX-0.92

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Change From Baseline in the Disease Activity Score Based on a 28-Joint Count and High-sensitivity C-reactive Protein (DAS28-hsCRP)

Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of a composite score of the following variables: tender joint count (TJC28), swollen joint count (SJC28), C-reactive protein (CRP) (milligrams per liter), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using the following formula: DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*Patient's Global VAS+0.96. Scores ranged 1.0-9.4, where lower scores indicated less disease activity. (NCT01711359)
Timeframe: Baseline, Week 24

Interventionunits on a scale (Mean)
Methotrexate-2.01
Baricitinib-2.74
Baricitinib + MTX-2.82

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Objective Response Rate

"Objective response rate (ORR), according to Response Evaluation Criteria in Solid Tumors (RECIST),version 1.1, was the primary end point and was defined as the number of complete plus partial responses divided by the number of enrolled patients.~Per RECIST v 1.1 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." (NCT01718873)
Timeframe: Objective response was assessed by computed tomographic scan or other appropriate imaging at weeks 12 and 24 from randomization, and every 3 months thereafter, assessed up to 90 months.

Interventionparticipants (Number)
Bevacizumab Before Chemotherapy65
Bevacizumab With Chemotherapy66

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Disease Control Rate

Disease control rate was calculated by adding complete and partial responses and stable disease. (NCT01718873)
Timeframe: At weeks 12 and 24 from randomization and every 3 months thereafter, assessed up to 90 months

InterventionParticipants (Count of Participants)
Bevacizumab Before Chemotherapy107
Bevacizumab With Chemotherapy103

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Toxic Effects

Toxic effects were scored according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE), version 4.0. For the National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE), version 4.0 scale score range from 1 to 4. A high score, that is 3 and 4, represents a high level of toxicity, whereas the minimum values, that is 1 and 2, represents a mild/modest level of toxicity. (NCT01718873)
Timeframe: up to 4 weeks after the end of the treatment

InterventionParticipants (Count of Participants)
Bevacizumab Before Chemotherapy108
Bevacizumab With Chemotherapy113

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Progression-free Survival (PFS)

"Progression-free survival was defined as the time from randomization to the date of progression or death, whichever occurred first. Patients without progression were censored on the date of the last follow-up visit.~Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), 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." (NCT01718873)
Timeframe: assessed up to 90 months

Interventionmonths (Median)
Bevacizumab Before Chemotherapy11.7
Bevacizumab With Chemotherapy10.5

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Overall Survival

Overall survival was defined as the time from randomization to the date of death. Patients alive at the time of the final analysis were censored on the date of the last follow-up information available. (NCT01718873)
Timeframe: assessed up to 90 months

Interventionmonths (Median)
Bevacizumab Before Chemotherapy29.8
Bevacizumab With Chemotherapy24.1

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Postpartum Hemorrhage

"Defined as:~Estimated blood loss ≥1000 mL after cesarean delivery. A substantial fall in the haematocrit e.g. 10% The requirement for a blood transfusion" (NCT01733329)
Timeframe: 24 HOURS

Interventionpercentage of patients (Number)
Misoprostol6.6
Folic Acid20

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Blood Loss

(NCT01733329)
Timeframe: 24 hours

InterventionmL (Median)
Misoprostol470
Folic Acid653.33

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Need for Additional Uterotonic Medications

The surgeon requested additional uterotonic agents on the basis of the clinical findings during surgery (e.g. uterine atony or blood loss of at least 1000 mL) Additional oxytocin was considered additional oxytocic intervention for purposes of data analysis. (NCT01733329)
Timeframe: 24 hours

Interventionpercentage of participants (Number)
Misoprostol10
Folic Acid40

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Uterine Atony

"Uterine atony is defined as failure of the uterus to contract adequately following delivery. Recognition of a soft, boggy uterus in the setting of excessive postpartum bleeding can alert the attendant to atony and should trigger a series of interventions aimed at achieving tonic sustained uterine contraction." (NCT01733329)
Timeframe: 24 hours

Interventionpercentage of participants (Number)
Misoprostol8.3
Folic Acid25

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Proportion of Participants Who Underwent Liver Metastases Resections

Reported here is the proportion of participants who underwent liver metastases resections calculated as follows: number of participants who underwent liver metastases resections divided by total number of participants in each arm. (NCT01765582)
Timeframe: Randomization up to approximately 3 years

InterventionProportion of participants (Number)
Arm A: Concurrent FOLFOXIRI + Bevacizumab0.17
Arm B: Sequential FOLFOXIRI + Bevacizumab0.10
Arm C: FOLFOX + Bevacizumab0.08
Arms A + B: Pooled FOLFOXIRI + Bevacizumab0.14

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Proportion of Participants Considered by the Investigator to be Unresectable on Study Enrollment Who Subsequently Underwent Attempted Curative Resections of Metastases

The proportion of participants considered by the investigator to be unresectable at study enrollment who subsequently underwent attempted curative resections of metastases was calculated as follows: number of participants considered by the investigator to be unresectable at study enrollment who subsequently underwent attempted curative resections of metastases divided by total number of participants in each arm. This outcome represents a measure of the rate of conversion from unresectable to resectable disease. (NCT01765582)
Timeframe: Randomization up to approximately 3 years

InterventionProportion of participants (Number)
Arm A: Concurrent FOLFOXIRI + Bevacizumab0.24
Arm B: Sequential FOLFOXIRI + Bevacizumab0.17
Arm C: FOLFOX + Bevacizumab0.14
Arms A + B: Pooled FOLFOXIRI + Bevacizumab0.21

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Progression-Free Survival During First-Line Therapy (PFS1)

PFS1 was defined as time from randomization to the first occurrence of disease progression during first-line therapy, as assessed by the Investigator using RECIST v1.1, or death from any cause, whichever occurs first. Disease progression was defined as sum of longest diameters increased by at least 20% from the smallest value on study. The sum of longest diameters must also demonstrate an absolute increase of at least 5 mm. (NCT01765582)
Timeframe: Randomization up to disease progression during first-line therapy or death, whichever occurs first (up to approximately 3 years)

Interventionmonths (Median)
Arm A: Concurrent FOLFOXIRI + Bevacizumab11.86
Arm B: Sequential FOLFOXIRI + Bevacizumab11.37
Arm C: FOLFOX + Bevacizumab9.46
Arms A + B: Pooled FOLFOXIRI + Bevacizumab11.70

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Percentage of Participants With Overall Response During First-Line Therapy (ORR1)

ORR1 was the percentage of participants with complete response (CR) or partial response (PR) during first-line therapy as assessed by investigator according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v.1.1). CR was defined as disappearance of all extranodal target lesions and all pathological lymph nodes had to have decreased to <10 millimeter (mm) in short axis. PR was defined as at least a 30% decrease in the sum of longest diameters of target lesions, taking as reference the baseline sum diameters. ORR1 = CR + PR (NCT01765582)
Timeframe: Randomization up to disease progression during first-line therapy or death, whichever occurs first (up to approximately 3 years)

InterventionPercentage of participants (Number)
Arm A: Concurrent FOLFOXIRI + Bevacizumab72.0
Arm B: Sequential FOLFOXIRI + Bevacizumab72.8
Arm C: FOLFOX + Bevacizumab62.1
Arms A + B: Pooled FOLFOXIRI + Bevacizumab72.4

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Percentage of Participants With Adverse Events

An adverse event is any untoward medical occurrence in a subject 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. (NCT01765582)
Timeframe: Randomization up to approximately 3 years

InterventionPercentage of participants (Number)
Arm A: Concurrent FOLFOXIRI + Bevacizumab100
Arm B: Sequential FOLFOXIRI + Bevacizumab98.9
Arm C: FOLFOX + Bevacizumab100
Arms A + B: Pooled FOLFOXIRI + Bevacizumab99.4

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Overall Survival (OS)

OS was defined as the time from the date of randomization to the date of death from any cause. (NCT01765582)
Timeframe: Randomization until death due to any cause (up to approximately 3 years)

Interventionmonths (Median)
Arm A: Concurrent FOLFOXIRI + Bevacizumab33.97
Arm B: Sequential FOLFOXIRI + Bevacizumab28.32
Arm C: FOLFOX + Bevacizumab30.65
Arms A + B: Pooled FOLFOXIRI + Bevacizumab28.32

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Time to PFS2

Time to PFS2 was defined as time from randomization to the first occurrence of disease progression after reinduction of second-line therapy, as assessed by the Investigator using RECIST v1.1, or death from any cause, whichever occurs first. Disease progression was defined as sum of longest diameters increased by at least 20% from the smallest value on study. The sum of longest diameters must also demonstrate an absolute increase of at least 5mm. (NCT01765582)
Timeframe: Randomization up to disease progression during second-line therapy or death, whichever occurs first (up to approximately 3 years)

Interventionmonths (Median)
Arm A: Concurrent FOLFOXIRI + Bevacizumab18.76
Arm B: Sequential FOLFOXIRI + Bevacizumab13.17
Arm C: FOLFOX + Bevacizumab14.75
Arms A + B: Pooled FOLFOXIRI + Bevacizumab15.08

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Changes of Homocysteine Level

Mean difference of changes of homocysteine level between 2 treatment groups (NCT01766310)
Timeframe: 8 weeks

Interventionµmol/L (Mean)
Placebo-0.68
Folic Acid-1.35

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Prevalence of Hyperhomocysteinemia

prevalence of hyperhomocysteinemia in Thai obese children (NCT01766310)
Timeframe: 8 weeks

Interventionparticipants (Number)
Placebo3
Folic Acid2

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Complications

Incidence of surgical complications related to D&E (NCT01818414)
Timeframe: Day 1

Interventionparticipants (Number)
Misoprostol0
Folic Acid2

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Number of Participants With Postoperative Satisfaction

Patient postoperative satisfaction with cervical preparation method (NCT01818414)
Timeframe: Day 1

Interventionparticipants (Number)
Misoprostol10
Folic Acid14

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Number of Providers With Overall Satisfaction

Provider overall satisfaction with cervical preparation (NCT01818414)
Timeframe: Day 1

Interventionproviders (Number)
Misoprostol10
Folic Acid9

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Operative Time

The primary outcome will be operative time. Operative time will be measured from initial passage of an instrument into the uterus to start the D&E. The end of operative time will be measured by the removal of the last instrument from the uterus to complete the D&E. (NCT01818414)
Timeframe: Day 1 of the study

Interventionminutes (Mean)
Misoprostol11.1
Folic Acid13.5

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Patient Pain

"Change in pain from baseline to immediately preoperatively using a 100-mm Visual Analogue Scale (100-mm Visual Analogue Scale with 0 indicating no pain and 100 indicating worst pain in my life)" (NCT01818414)
Timeframe: Day 1

Interventionmm (Mean)
Misoprostol43.9
Folic Acid24.3

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Fertilization Rate Per Cycle, %

Among participants in the IVF stratum Oocytes will be assessed 16-18 hours after insemination or microinjection to determine whether fertilization occurred. Fertilization will be considered normal if two pronuclei and two polar bodies are identified. Oocytes without visible pronuclei will be considered unfertilized. Oocytes with more than two pronuclei will be considered abnormally fertilized, and will thus be discarded. (NCT01857310)
Timeframe: Up to 9 months of fertility treatment post-randomization

Interventionpercent per cycle (Mean)
Folic Acid and Zinc Supplementation75.3
Placebo77.7

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Ectopic Pregnancy

Either visualization of no gestational sac in the uterus with a suspicious mass in the adnexa on ultrasound, an hCG level more than 1500 mIU/ml without visualization of an intrauterine gestational sac on ultrasound, or a slowly rising or plateauing serum hCG level without visualization of an intrauterine gestation on ultrasound. (NCT01857310)
Timeframe: approximately 6.5 weeks gestation

InterventionParticipants (Count of Participants)
Folic Acid and Zinc Supplementation6
Placebo5

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Early Pregnancy Loss

hCG pregnancy loss will be defined as a serum hCG > 5 mIU/ml followed by a decline. Clinically recognized pregnancy losses will be defined as visualization of an intrauterine gestational sac followed by a loss prior to 20 weeks gestation. (NCT01857310)
Timeframe: hcG-detected pregnancy until 20 weeks of pregnancy

InterventionParticipants (Count of Participants)
Folic Acid and Zinc Supplementation137
Placebo150

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Clinical Intrauterine Pregnancy

Visualized gestational sac in the uterus on ultrasound (NCT01857310)
Timeframe: approximately 6.5 weeks gestation

InterventionParticipants (Count of Participants)
Folic Acid and Zinc Supplementation449
Placebo462

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Cesarean Delivery

Abstracted from hospital records and medical charts (NCT01857310)
Timeframe: Delivery

InterventionParticipants (Count of Participants)
Folic Acid and Zinc Supplementation143
Placebo129

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Cells on Day 3 Per Embryo Per Cycle

Among participants in the IVF stratum (NCT01857310)
Timeframe: Up to 9 months of fertility treatment post-randomization

Interventioncells per embryo (Mean)
Folic Acid and Zinc Supplementation5.60
Placebo5.98

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Birth Weight

Abstracted from hospital records and medical charts (NCT01857310)
Timeframe: Delivery

Interventiongrams (Mean)
Folic Acid and Zinc Supplementation3062
Placebo3133

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Embryo Morphology on Day 5 Per Cycle, Categorical

Among participants in the IVF stratum For couples who meet criteria for blastocyst culture, embryos will be graded 5 days after fertilization based on Society for Assisted Reproductive Technologies (SART) morphology criteria. (NCT01857310)
Timeframe: Up to 9 months of fertility treatment post-randomization

,
Interventionpredicted probability (Number)
Excellent or goodFair or poor
Folic Acid and Zinc Supplementation0.280.72
Placebo0.350.65

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Percentage of Good Quality Embryos on Day 5 Per Cycle

Among participants in the IVF stratum For couples who meet criteria for blastocyst culture, embryos will be graded 5 days after fertilization based on Society for Assisted Reproductive Technologies (SART) morphology criteria. (NCT01857310)
Timeframe: Up to 9 months of fertility treatment post-randomization

Interventionpercent per cycle (Mean)
Folic Acid and Zinc Supplementation17.2
Placebo18.5

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Number of Good Quality Embryos on Day 5 Per Cycle

Among participants in the IVF stratum For couples who meet criteria for blastocyst culture, embryos will be graded 5 days after fertilization based on Society for Assisted Reproductive Technologies (SART) morphology criteria. (NCT01857310)
Timeframe: Up to 9 months of fertility treatment post-randomization

Interventionembryos per cycle (Mean)
Folic Acid and Zinc Supplementation2.66
Placebo2.98

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Number of Embryos Transferred Per Cycle

Among participants in the IVF stratum (NCT01857310)
Timeframe: Up to 9 months of fertility treatment post-randomization

Interventionembryos per cycle (Mean)
Folic Acid and Zinc Supplementation1.50
Placebo1.51

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Number of Embryos Cryopreserved Per Cycle

Among participants in the IVF stratum (NCT01857310)
Timeframe: Up to 9 months of fertility treatment post-randomization

Interventionembryos per cycle (Mean)
Folic Acid and Zinc Supplementation4.22
Placebo4.32

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Gestational Diabetes

Abstracted from hospital records and medical charts (NCT01857310)
Timeframe: Delivery

InterventionParticipants (Count of Participants)
Folic Acid and Zinc Supplementation26
Placebo34

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Major Neonatal Complications

Abstracted from hospital records and medical charts: includes bronchopulmonary dysplasia, necrotizing enterocolitis, severe intraventricular hemorrhage, periventricular leukomalacia, and retinopathy of prematurity (NCT01857310)
Timeframe: Delivery

InterventionParticipants (Count of Participants)
Folic Acid and Zinc Supplementation2
Placebo1

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Preeclampsia or Gestational Hypertension

Abstracted from hospital records and medical charts (NCT01857310)
Timeframe: Delivery

InterventionParticipants (Count of Participants)
Folic Acid and Zinc Supplementation47
Placebo51

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Cells on Day 5 Per Embryo Per Cycle, Categorical

Among participants in the IVF stratum (NCT01857310)
Timeframe: Up to 9 months of fertility treatment post-randomization

,
Interventionpredicted probability (Number)
Fewer than 8 cells8 cells or greater
Folic Acid and Zinc Supplementation0.200.80
Placebo0.190.81

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Chromosomal Complement of Embryo Per Cycle

"Among participants in the IVF stratum Chromosomal complement in the embryo assessed using methodology cited by Rubio et al.~Rubio C, Rodrigo L, Mir P et al. Use of array comparative genomic hybridization (array-CGH) for embryo assessment: clinical results. Fertil Steril 2013 March 15;99(4):1044-8." (NCT01857310)
Timeframe: Up to 9 months of fertility treatment post-randomization

,
Interventionpredicted probability (Number)
AbnormalNormal
Folic Acid and Zinc Supplementation0.750.25
Placebo0.320.68

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DNA Fragmentation Index

Comet assay used to measure sperm DNA integrity based on excess DNA strand breaks Assessed utilizing the World Health Organization (WHO) semen analysis procedure 5th edition World Health Organization. WHO laboratory manual for the Examination and processing of human semen. 5th Edition ed. Switzerland: 2010. (NCT01857310)
Timeframe: 6 months

,
Intervention% breakage (Mean)
OverallIVF stratumOther treatment onsiteOther treatment offsite
Folic Acid and Zinc Supplementation29.727.130.030.7
Placebo27.226.827.028.5

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Embryo Morphology on Day 3 Per Cycle, Categorical

"Among participants in the IVF stratum Embryos will be scored three days after fertilization according to the size and shape of blastomeres and to their degree of fragmentation.~Veeck LL. Oocyte assessment and biological performance. Ann N Y Acad Sci 1988;541:259-74.:259-74." (NCT01857310)
Timeframe: Up to 9 months of fertility treatment post-randomization

,
Interventionpredicted probability (Number)
Excellent or goodFair or poor
Folic Acid and Zinc Supplementation0.660.34
Placebo0.680.32

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Live Birth

Based on hospital delivery records (NCT01857310)
Timeframe: At delivery

,
InterventionParticipants (Count of Participants)
OverallIVF stratumOther treatment onsiteOther treatment offsite
Folic Acid and Zinc Supplementation4049726443
Placebo4169127748

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Method of Fertilization Per Cycle

Among participants in the in vitro fertilization (IVF) stratum: method of fertilization classified into intracytoplasmic sperm injection (ICSI) and other (NCT01857310)
Timeframe: Up to 9 months of fertility treatment post-randomization

,
Interventionpredicted probability (Number)
ICSIOther
Folic Acid and Zinc Supplementation0.740.26
Placebo0.790.21

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Quality of Embryos Transferred Per Cycle, Categorical

Among participants in the IVF stratum Embryonic grading based on Society for Assisted Reproductive Technologies (SART) morphology criteria (NCT01857310)
Timeframe: Up to 9 months of fertility treatment post-randomization

,
Interventionpredicted probability (Number)
Excellent or goodFair or poor
Folic Acid and Zinc Supplementation0.750.25
Placebo0.730.27

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Gestational Age

Abstracted from hospital records and medical charts (NCT01857310)
Timeframe: Delivery

Interventionweeks (Mean)
Folic Acid and Zinc Supplementation38.6
Placebo38.8

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Neonatal Mortality

Abstracted from hospital records and medical charts (NCT01857310)
Timeframe: Delivery

InterventionParticipants (Count of Participants)
Folic Acid and Zinc Supplementation3
Placebo2

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Sperm Concentration

Number of spermatozoa per unit of volume of semen Assessed utilizing the World Health Organization (WHO) semen analysis procedure 5th edition World Health Organization. WHO laboratory manual for the Examination and processing of human semen. 5th Edition ed. Switzerland: 2010. (NCT01857310)
Timeframe: 6 months

,
Intervention10^6 spermatozoa/mL (Mean)
OverallIVF stratumOther treatment onsiteOther treatment offsite
Folic Acid and Zinc Supplementation84.881.885.087.2
Placebo89.076.192.287.7

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Sperm Morphology

% normal morphology Assessed utilizing the World Health Organization (WHO) semen analysis procedure 5th edition World Health Organization. WHO laboratory manual for the Examination and processing of human semen. 5th Edition ed. Switzerland: 2010. (NCT01857310)
Timeframe: 6 months

,
Intervention% normal (Mean)
OverallIVF stratumOther treatment onsiteOther treatment offsite
Folic Acid and Zinc Supplementation5.75.25.66.7
Placebo6.05.46.25.6

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Sperm Motility

% motile (including percentage of progressive motile sperm and percentage of nonprogressive motile sperm) Assessed utilizing the World Health Organization (WHO) semen analysis procedure 5th edition World Health Organization. WHO laboratory manual for the Examination and processing of human semen. 5th Edition ed. Switzerland: 2010. (NCT01857310)
Timeframe: 6 months

,
Intervention% motile (Mean)
OverallIVF stratumOther treatment onsiteOther treatment offsite
Folic Acid and Zinc Supplementation52.751.752.555.0
Placebo53.251.753.951.5

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Human Chorionic Gonadotropin (hCG) Detected Pregnancy (Implantation)

A quantitative hCG evaluation in serum > 5 milli-international units per milliliter (mIU/ml) (NCT01857310)
Timeframe: For IVF, 12 days post embryo transfer for day 5 embryo transfers, and 14 days post embryo transfer for day 3 embryo transfers; for couples undergoing OI/IUI, after self-report of positive pregnancy test

InterventionParticipants (Count of Participants)
Folic Acid and Zinc Supplementation479
Placebo490

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Total Motile Sperm Count

Calculated as semen volume (mL) * sperm concentration (10^6 spermatozoa/mL) * motility (% motile) (NCT01857310)
Timeframe: 6 months

,
Interventionmillion motile sperm (Mean)
OverallIVF stratumOther treatment onsiteOther treatment offsite
Folic Acid and Zinc Supplementation183165186192
Placebo182152188184

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Cells on Day 3 Per Embryo Per Cycle, Categorical

Number of cells per embryo among women in the IVF stratum (NCT01857310)
Timeframe: Up to 9 months of fertility treatment post-randomization

,
Interventionpredicted probability (Number)
Fewer than 4 cells4 cells or greater
Folic Acid and Zinc Supplementation0.270.73
Placebo0.220.78

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Structural Malformations

Abstracted from birth record: includes major (n = 21; 6 with known genetic cause), minor (n = 6), and unclassified (n = 2) defects Structural birth defects: includes hydronephrosis/ureteropelvic junction obstruction, transposition of the great arteries, renal agenesis, cleft lip, club feet, multicystic/dysplastic kidney, tetralogy of fallot, gastroschisis, atrioventricular septal defects, other oral-facial defects, other cardiovascular defects, other CNS defects, other eye defects, other oral-facial defects, other anomalies, other syndromes (NCT01857310)
Timeframe: Delivery

InterventionParticipants (Count of Participants)
Folic Acid and Zinc Supplementation15
Placebo14

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Stillbirth

Loss at or after 20 weeks gestation. Determined based on hospital records and medical chart abstraction. (NCT01857310)
Timeframe: Delivery

InterventionParticipants (Count of Participants)
Folic Acid and Zinc Supplementation1
Placebo4

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Sperm Penetration Per Cycle, %

Among participants in the IVF stratum (NCT01857310)
Timeframe: Up to 9 months of fertility treatment post-randomization

Interventionpercent penetration (Mean)
Folic Acid and Zinc Supplementation62.7
Placebo74.8

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Small for Gestational Age

Abstracted from hospital records and medical charts (NCT01857310)
Timeframe: Delivery

InterventionParticipants (Count of Participants)
Folic Acid and Zinc Supplementation62
Placebo59

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Severe Maternal Morbidity

Abstracted from delivery record: including postpartum hemorrhage, anemia requiring transfusion, sepsis, seizure, HELLP syndrome or preeclampsia with pulmonary edema (NCT01857310)
Timeframe: Delivery

InterventionParticipants (Count of Participants)
Folic Acid and Zinc Supplementation15
Placebo10

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Preterm Delivery

Abstracted from hospital records and medical charts (NCT01857310)
Timeframe: Delivery

InterventionParticipants (Count of Participants)
Folic Acid and Zinc Supplementation67
Placebo45

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Semen Volume

Volume of the ejaculate, mL Assessed utilizing the World Health Organization (WHO) semen analysis procedure 5th edition World Health Organization. WHO laboratory manual for the Examination and processing of human semen. 5th Edition ed. Switzerland: 2010. (NCT01857310)
Timeframe: 6 months

,
InterventionmL (Mean)
OverallIVF stratumOther treatment onsiteOther treatment offsite
Folic Acid and Zinc Supplementation3.53.53.53.5
Placebo3.53.53.53.4

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Overall Survival (OS)

Median Overall Survival defined as the the duration of time from diagnosis to the time of death from any cause will be determined. (NCT01897454)
Timeframe: Up to 60 months

InterventionMonths (Median)
Treatment (FOLFIRINOX, IMRT, and Gemcitabine Hydrochloride)35.1

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Percentage of Participants Achieving R0 Resection (R0 Resection Rate)

The percentage of participants achieving R0 resection, defined as the absence of gross and microscopic tumor involvement in the resection margins, will be determined for those participants who receive at least one cycle of FOLFIRINOX chemotherapy. A 90% confidence interval will be determined. (NCT01897454)
Timeframe: Up to 30 months

InterventionPercentage of Participants (Number)
Treatment (FOLFIRINOX, IMRT, and Gemcitabine Hydrochloride)55.6

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Progression Free Survival (PFS)

Progression-free Survival defined as the duration of time from start of treatment to time of disease progression will be analyzed. Median progression free survival will be presented. (NCT01897454)
Timeframe: From start of treatment to time of progression, assessed up to 60 months

InterventionMonths (Median)
Treatment (FOLFIRINOX, IMRT, and Gemcitabine Hydrochloride)34

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Toxicities Associated With Chemotherapy and Radiotherapy

The number of patients who experienced treatment related adverse events will be determined for all patients who received at least one cycle of FOLFIRINOX chemotherapy. These events will be graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. (NCT01897454)
Timeframe: Up to 30 months

InterventionParticipants (Count of Participants)
Treatment (FOLFIRINOX, IMRT, and Gemcitabine Hydrochloride)22

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Vascular Reconstruction

The percentage of patients who underwent pancreaticoduodenectomy requiring vascular reconstruction will be evaluated. (NCT01897454)
Timeframe: Up to 30 months

InterventionParticipants (Count of Participants)
Treatment (FOLFIRINOX, IMRT, and Gemcitabine Hydrochloride)5

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Percentage of Patients Able to Undergo Resection

The percentage of participants with resectable or borderline resectable disease to undergo resection will be determined. The ability for patients to complete preoperative therapy and undergo resection is correlated with more favorable overall survival outcomes. (NCT01897454)
Timeframe: Up to 30 months

InterventionParticipants (Count of Participants)
Treatment (FOLFIRINOX, IMRT, and Gemcitabine Hydrochloride)15

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Overall Response Rate

Overall Response Rate, defined as the percentage of patients that achieved Partial Response (PR) or Complete Response (CR) as per the Response evaluation in solid tumors criteria, was assessed using RECIST Version 1.1 criteria. Complete Response (CR) is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR) is defined as having at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Higher percentages of PR and CR are associated with more favorable outcomes (NCT01897454)
Timeframe: Up to 30 months

InterventionParticipants (Count of Participants)
Treatment (FOLFIRINOX, IMRT, and Gemcitabine Hydrochloride)4

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Percentage of Participants With at Least 2-step Reduction in Vitreous Haze (VH) or Prednisone Dose <10 mg/Day at Week 16

At least 2-step reduction in VH per central review from baseline was evaluated on Miami 9-step scale. VH is the obscuration of fundus by vitreous cells and protein exudation. Each of the 9-step scale (from grade 0 [low opacity] to 8 [more opacity]) images (in increasing order of opacity) are equivalent to approximately 0.3 log units of degradation in visual acuity based on the Bangerter calibration. Participants with prednisone dose <10 mg/day (or equivalent oral corticosteroid) were also evaluated. (NCT01900431)
Timeframe: Week 16

InterventionPercentage of participants (Number)
Placebo (Part A)30.0
Sarilumab 200 mg q2w (Part A)46.1

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Percentage of Participants With Anterior Chamber (AC) Cell Score = 0 or At Least 2-step Reduction in Score at Week 16

Participants with AC cell score = 0 or with ≥2 step reduction from baseline at Week 16 were evaluated. Slit lamp examinations were conducted at each visit to assess AC cell count. The number of AC cells observed within a 1 mm × 1 mm slit beam was used to determine the grade according to the Standardization of Uveitis Nomenclature (SUN) criteria: grade 0 = no cells; grade +0.5 = 1 - 5 cells; grade +1 = 6 - 25 cells; grade +2= 26 - 50 cells; grade +3 = too many to count. (NCT01900431)
Timeframe: Week 16

InterventionPercentage of participants (Number)
Placebo (Part A)86.7
Sarilumab 200 mg q2w (Part A)86.2

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Change From Baseline in VH Scale at Week 16

Change from baseline in VH scale was evaluated on Miami 9-step scale. VH is the obscuration of fundus by vitreous cells and protein exudation. Each of the 9-step scale (from grade 0 [low opacity] to 8 [more opacity]) images (in increasing order of opacity) were equivalent to approximately 0.3 log units of degradation in visual acuity based on the Bangerter calibration. Least squares (LS) mean was calculated using mixed model for repeated measurements (MMRM) model with treatment groups, visits and visit-by-treatment groups interaction as fixed categorical effects as well as fixed continuous covariate of baseline adjudicated VH. (NCT01900431)
Timeframe: Baseline to Week 16

Interventionunits on a scale (Least Squares Mean)
Placebo (Part A)-0.1
Sarilumab 200 mg q2w (Part A)-0.9

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Change From Baseline in Central Retinal Thickness (CRT) At Week 16

CRT was measured by spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. All images were transmitted to the central reading center. SD-OCT was performed in the study eye after pupil dilation. LS mean was calculated using MMRM model with treatment groups, randomization strata of VH level (<4, >=4), visits and visit-by-treatment groups interaction as fixed categorical effects, as well as, fixed continuous covariate of baseline CRT. (NCT01900431)
Timeframe: Baseline to Week 16

Interventionµm (microns) (Least Squares Mean)
Placebo (Part A)-8.9
Sarilumab 200 mg q2w (Part A)-35.4

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Percentage of Participants With Prednisone Dose of ≤5 mg/Day (or Equivalent Oral Corticosteroid) at Week 16

Participants with prednisone dose ≤5 mg/day (or equivalent oral corticosteroid) at Week 16 were evaluated. (NCT01900431)
Timeframe: Week 16

InterventionPercentage of participants (Number)
Placebo (Part A)40.0
Sarilumab 200 mg q2w (Part A)41.4

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Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at Week 16

BCVA score is based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters, and then at 1 meter. The range of ETDRS is 0 to 100 letters. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. LS mean was calculated using MMRM model with treatment groups, randomization strata of VH level (<4, >=4), visits and visit-by-treatment groups interaction as fixed categorical effects, as well as, fixed continuous covariate of baseline BCVA. (NCT01900431)
Timeframe: Baseline to Week 16

Interventionunits on a scale (Least Squares Mean)
Placebo (Part A)3.5
Sarilumab 200 mg q2w (Part A)9.3

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Pharmacokinetics (PK) Assessment: Serum Functional Sarilumab Concentration

Serum functional (unbound) sarilumab concentrations were determined using an enzyme-linked immunosorbent assay (ELISA) method with a lower limit of quantification (LLOQ) of 294 ng/mL. Concentrations below LLOQ were set to zero for samples at predose. Post-treatment concentrations below LLOQ were replaced by LLOQ/2. The samples were considered non-eligible for the analysis if the previous dosing time was <11 days or >17 days before the sampling time for every other week regimens. (NCT01900431)
Timeframe: Predose on Day 1 (Baseline), Week 2, 4, 8, 12, 16, 24, 36, 52, and end of study (EOS) (Week 56)

Interventionng/mL (Mean)
At BaselineAt Week 2At Week 4At Week 8At Week 12At Week 16At Week 24At Week 36At Week 52EOS (Week 56)
Sarilumab 200 mg q2w (Part A + Part B)0.07383.39876.615958.919705.219598.422406.824375.425046.01730.0

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Percent Change From Baseline in CRT at Week 16

CRT was measured by SD-OCT, a non-invasive diagnostic system providing high-resolution imaging sections of the retina. All images were transmitted to the central reading center. SD-OCT was performed in the study eye after pupil dilation. LS mean was calculated using MMRM model with treatment groups, randomization strata of VH level (<4, >=4), visits and visit-by-treatment groups interaction as fixed categorical effects, as well as, fixed continuous covariate of baseline CRT. (NCT01900431)
Timeframe: Baseline to Week 16

Interventionpercent change (Least Squares Mean)
Placebo (Part A)0.0
Sarilumab 200 mg q2w (Part A)-6.4

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Absolute Change From Baseline to Week 24 in Monocyte Levels

Three categories of monocyte levels are presented: classical (CD14+CD16-), intermediate (CD14+CD16+), and non-classical (CD14dimCD16+). Absolute change from baseline (Week 24 - baseline) was analyzed on the measured scale, which is the percent of parent cells that express the subset of interest. (NCT01949116)
Timeframe: From Baseline to Week 24

,
InterventionPercent of Expression in Parent Cell (Mean)
Classical (CD14+CD16-)Intermediate (CD14+CD16+)Non-classical (CD14dimCD16+)
Low-dose Methotrexate (LDMTX)-0.15-0.070.21
Placebo0.82-0.51-0.29

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Change From Baseline to Week 24 in Reactive Hyperemic (RH) Flow Rate

The absolute change in RH flow rate in cc/min of the brachial artery at week 24 from baseline. (NCT01949116)
Timeframe: From Baseline to Week 24

Interventioncc/min (Median)
Low-dose Methotrexate (LDMTX)-11.40
Placebo13.76

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Number of Participants Who Reached at Least One Safety Milestone Over the Duration of Study Follow-up (36 Weeks)

"Number of participants who experienced any one of the following safety milestones:~Entry CD4+ T-cell count less than 700 cells/mm^3, confirmed CD4+ decline greater than 33% of baseline AND to less than 350 cells/mm^3~Entry CD4+ T-cell count greater than or equal to 700 cells/mm^3, a confirmed CD4+ decline greater than 50% of baseline~Confirmed HIV-1 RNA Level Greater Than 200 Copies/mL in the Absence of an Interruption in ART~New or recurrent CDC category C AIDS-indicator condition~Evidence of HIV-associated infection including CMV end-organ disease, varicella zoster, EBV related clinical disease~Requirement for LDMTX discontinuation for confirmed Grade 3 or higher toxicity~Lymphoproliferative malignancies~Pulmonary toxicity which is defined as Grade 3 or 4 dyspnea, cough, shortness of breath which in the opinion of the local investigator is related to the study drug but not related to other clinical causes such as asthma, influenza, etc." (NCT01949116)
Timeframe: From study entry to week 36

InterventionParticipants (Count of Participants)
Low-dose Methotrexate (LDMTX)11
Placebo5

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Change From Baseline to Week 12 in Brachial Artery FMD

The absolute change from baseline to week 24 FMD (%), defined as the maximum FMD calculated from reactive hyperemia (RH) 60 and RH 90 relative to resting artery diameter. (NCT01949116)
Timeframe: From Baseline to Week 12

InterventionPercent Dilation (Median)
Low-dose Methotrexate (LDMTX)0.32
Placebo-0.06

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Change From Baseline to Week 12 in Brachial Artery Resting Average Diameter

The change in resting average diameter in millimeters of the brachial artery at week 12 from baseline. (NCT01949116)
Timeframe: From Baseline to Week 12

Interventionmm (Median)
Low-dose Methotrexate (LDMTX)0.04
Placebo0.03

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Change From Baseline to Week 24 in Brachial Artery Resting Average Diameter

The absolute change in resting average diameter in millimeters of the brachial artery at week 24 from baseline. (NCT01949116)
Timeframe: From Baseline to Week 24

Interventionmm (Median)
Low-dose Methotrexate (LDMTX)0
Placebo0.01

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Change From Baseline to Week 24 in Peak Reactive Hyperemic (RH) Flow Velocity

The absolute change in peak RH flow velocity in cm/s of the brachial artery at week 24 from baseline. (NCT01949116)
Timeframe: From Baseline to Week 24

Interventioncm/s (Median)
Low-dose Methotrexate (LDMTX)-0.20
Placebo-0.83

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Absolute Change From Baseline to Week 24 in Homing Molecule (CX3CR1+) Expression

CX3CR1+ is a cellular marker of immune activation. The outcome measured is the percentages of CX3CR1+ expressions in both parent CD4+ and CD8+ T cells. Absolute change from baseline (Week 24 - baseline) was analyzed on the measured scale, which is the percent of parent cells (either CD4+ or CD8+) that express CX3CR1+ cells. (NCT01949116)
Timeframe: From Baseline to Week 24

,
InterventionPercent of Expression in Parent Cell (Mean)
(CD3+CD4+) CX3CR1+(CD3+CD8+) CX3CR1+
Low-dose Methotrexate (LDMTX)-0.30-0.83
Placebo0.030.39

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Absolute Change From Baseline to Week 24 in Adhesion and Activation Indices

The adhesion and activation indices of interest are the percentages of CD38+HLADR+ expressions in both parent CD4+ and CD8+ T cells. Absolute change from baseline (Week 24 - baseline) was analyzed on the measured scale, which is the percent of parent cells (either CD4+ or CD8+) that express CD38+HLADR+ cells. (NCT01949116)
Timeframe: From Baseline to Week 24

,
InterventionPercent of Expression in Parent Cell (Mean)
(CD3+CD4+) CD38+HLADR+(CD3+CD8+) CD38+HLADR+
Low-dose Methotrexate (LDMTX)-0.27-1.50
Placebo0.220.90

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Primary Efficacy Endpoint of Change From Baseline to Week 24 in Brachial Artery Flow-mediated Vasodilation (FMD)

Flow-mediated vasodilation is defined as the maximum FMD (%) calculated from reactive hyperemia (RH) 60 and RH 90 relative to resting artery diameter. Absolute change of FMD at week 24 is calculated from baseline FMD. (NCT01949116)
Timeframe: From Baseline to Week 24

InterventionPercent Dilation (Mean)
Low-dose Methotrexate (LDMTX)0.24
Placebo0.15

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Percentage Change From Baseline to Week 24 in Soluble CD 163 (sCD163)

sCD163 is a marker of Macrophage activation. Change from baseline (Week 24 - baseline) was performed on the log10 scale and is thus presented as percentage change, i.e. (10^[fold-change] - 1) x 100%. (NCT01949116)
Timeframe: From Baseline to Week 24

InterventionPercentage Change (Mean)
Low-dose Methotrexate (LDMTX)2.7
Placebo7.5

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Percentage Change From Baseline to Week 24 in Interleukin-6 (IL-6)

IL-6 is a marker of systemic inflammation. Change from baseline (Week 24 - baseline) was performed on the log10 scale and is thus presented as percentage change, i.e. (10^[fold-change] - 1) x 100%. (NCT01949116)
Timeframe: From Baseline to Week 24

InterventionPercentage Change (Mean)
Low-dose Methotrexate (LDMTX)13.4
Placebo21.3

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Percentage Change From Baseline to Week 24 in High-sensitivity C-reactive Protein (hsCRP)

hsCRP is a marker of inflammation. Change from baseline (Week 24 - baseline) was performed on the log10 scale and is thus presented as percentage change, i.e. (10^[fold-change] - 1) x 100%. One single hsCRP result at week 24 was above the limit of quantification, therefore excluded from analysis. (NCT01949116)
Timeframe: From Baseline to week 24

InterventionPercentage Change (Mean)
Low-dose Methotrexate (LDMTX)-3.5
Placebo5.4

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Percentage Change From Baseline to Week 24 in D-Dimer

D-dimer (or D dimer) is a marker of coagulation activation. Change from baseline (Week 24 - baseline) was performed on the log10 scale and is thus presented as percentage change, i.e. (10^[fold-change] - 1) x 100%. (NCT01949116)
Timeframe: From Baseline to Week 24

InterventionPercentage Change (Mean)
Low-dose Methotrexate (LDMTX)-1.5
Placebo9.9

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Distant Failure-free Survival

Analyzed using Kaplan-Meier plots, medians and ranges. (NCT01959672)
Timeframe: Date of administration study drug to the date of first appearance of tumor lesions by imaging, or death, assessed up to 5 years

Interventionmonths (Median)
Treatment (Chemotherapy, Oregovomab, SBRT, Surgery)11

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Number of Participants With CA-125-Specific T-cell Signal.

The percentage of patients responding will be summarized using frequencies and percentages. (NCT01959672)
Timeframe: Baseline to up to week 12

InterventionParticipants (Count of Participants)
Treatment (Chemotherapy, Oregovomab, SBRT, Surgery)2

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Surgical Complete Resection (Negative Margin) Rate

The percentage of patients who will undergo R0 resection (NCT01959672)
Timeframe: Up to week 18

InterventionParticipants (Count of Participants)
Treatment (Chemotherapy, Oregovomab, SBRT, Surgery)4

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Overall Survival

Analyzed using Kaplan-Meier plots, medians and ranges. (NCT01959672)
Timeframe: Date of first of study drug to the date of death, assessed up to 5 years

Interventionmonths (Median)
Treatment (Chemotherapy, Oregovomab, SBRT, Surgery)14.4

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Number of Participants With Progressive Disease,

Rate of progressive disease defined as at least a 25% increase in the longest diameter of a lesion, taking as reference the longest diameter recorded since the treatment started. An exact one-sided 90% confidence interval will be constructed round the progressive disease rate. (NCT01959672)
Timeframe: Up to 4 months

InterventionParticipants (Count of Participants)
Treatment (Chemotherapy, Oregovomab, SBRT, Surgery)2

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Objective Response Rate

Confirmed response (CR) is two or more objective statuses of CR a minimum of four weeks apart documented before progression or symptomatic deterioration. Partial response (PR) is two or more objective statuses of PR or better a minimum of four weeks apart documented before progression or symptomatic deterioration. Unconfirmed CR is one objective status of CR documented before progression or symptomatic deterioration but not qualifying as CR or PR. Unconfirmed PR is one objective status of PR documented before progression or symptomatic deterioration but not qualifying as CR, PR or unconfirmed CR. (NCT02042443)
Timeframe: Up to 2 years from registration

,
InterventionParticipants (Count of Participants)
Partial ResponseUnconfirmed Partial ResponseStable/No ResponseIncreasing DiseaseSymptomatic Deterioration
Chemotherapy20981
Trametinib022191

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Progression-free Survival

From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact. (NCT02042443)
Timeframe: Up to 2 years from registration

Interventionmonths (Median)
Trametinib1.3
Chemotherapy2.8

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Overall Survival

From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact. (NCT02042443)
Timeframe: Up to 2 years from registration

Interventionmonths (Median)
Trametinib4.3
Chemotherapy7.9

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Objective Response Rate (ORR) of BEVZ92 and Avastin®

"To compare efficacy in terms of ORR between arms. Clinical and radiological tumor assessments were performed according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 using computed tomography (CT) or magnetic resonance imaging (MRI) scans.~Objective response (OR) is defined as a best overall response of partial response (PR) or complete response (CR) as defined by RECIST v1.1. All participants who did not meet the criteria for CR or PR by the end of the study were considered non-responders." (NCT02069704)
Timeframe: Every four weeks. Up to 48 weeks

,
InterventionParticipants (Count of Participants)
ORR (CR+PR)Stable diseaseProgressive diseaseunevaluable
Avastin® (Bevacizumab, Ref. Product)402524
Bevacizumab Biosimilar (BEVZ92)352745

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Anti-Drug Antibody (ADA) of BEVZ92 and Avastin®

Immunogenicity profile by means of measurement of ADA developed de novo (seroconversion) after cycle 5, cycle 8, and 12 months after first drug administration (pre-dose). (NCT02069704)
Timeframe: At baseline, and on Day 1 (pre-dose) of Cycles: 1, 5 and 8, and 12 months after first drug administration

,
Interventionparticipants (Number)
SeroconversionNo seroconversion
Avastin® (Bevacizumab, Ref. Product)071
Bevacizumab Biosimilar (BEVZ92)267

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Volume of Distribution (Vd) of BEVZ92 and Avastin®

Secondary PK endpoints included the Vd calculated at Cycle 7 (NCT02069704)
Timeframe: Vd: 0 to 336 hours after the administration of the Cycle 7 infusion.

InterventionL (Geometric Least Squares Mean)
Bevacizumab Biosimilar (BEVZ92)4.06
Avastin® (Bevacizumab, Ref. Product).3.86

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Progression-free Survival (PFS) of BEVZ92 and Avastin®

"Compare PFS between the randomized treatment arms. Progression-free survival (PFS) was defined as the time from the randomization date to the date of disease progression using RECIST v1.1, or death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions plus 5 mm absolute increase, and/or unequivocal progression of known non-target lesion, and/or the appearance of new lesions." (NCT02069704)
Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 weeks.

Interventionmonths (Median)
Bevacizumab Biosimilar (BEVZ92)10.8
Avastin® (Bevacizumab, Ref. Product)11.1

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Elimination Half-life (t1/2) of BEVZ92 and Avastin®

Secondary PK endpoints included the t1/2 calculated at Cycle 7 (NCT02069704)
Timeframe: t1/2: 0 to 336 hours after the administration of the Cycle 7 infusion.

Interventionh (Geometric Least Squares Mean)
Bevacizumab Biosimilar (BEVZ92)294
Avastin® (Bevacizumab, Ref. Product).289

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Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Reported With BEVZ92 and Avastin®

Compare the safety profile by means of the frequency and severity of TEAEs and SAEs reported in each treatment arm. (NCT02069704)
Timeframe: From first study dose and up to 30 days after the end of study treatment for each patient, for an average of 11 months

,
Interventionparticipants (Number)
Any TEAE (any causality)Any grade>=3 TEAEAny TEAE leading to discontinuationAny treatment-related TEAEAny grade >=3 treatment-related TEAEAny serious TEAEAny bleeding event
Avastin® (Bevacizumab, Ref. Product)7149670702119
Bevacizumab Biosimilar (BEVZ92)66441363631914

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Area Under the Concentration-versus-time Curve (AUC) at Cycle 1 (AUC0-336h) of BEVZ92 and Avastin®

"To compare the pharmacokinetic (PK) profile of BEVZ92 and Avastin®, both administered in combination with FOLFOX (any) or FOLFIRI, by means of comparing the truncated AUC calculated from start of the first infusion until start of the second infusion (i.e. at Cycle 1; AUC0-336h)~For the PK similarity assessments, regulatory guidelines on bioequivalence were followed whereby two treatments are judged not to be different from one another if the 90% confidence interval (CI) of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 80-125%." (NCT02069704)
Timeframe: AUC0-336 hrs: 0 to 336 hours after start of the first infusion

Interventionng.h/mL (Geometric Least Squares Mean)
Bevacizumab Biosimilar (BEVZ92)16500000
Avastin® (Bevacizumab, Ref. Product).16600000

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Cmax,sd of BEVZ92 and Avastin®

Secondary PK endpoints included the Cmax calculated at Cycle 1 (Cmax,sd ) (NCT02069704)
Timeframe: Cmax, sd: 0 to 336 hours after start of the first infusion.

Interventionng/mL (Geometric Least Squares Mean)
Bevacizumab Biosimilar (BEVZ92)120000
Avastin® (Bevacizumab, Ref. Product).123000

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AUC at Steady State (AUCss) of BEVZ92 and Avastin®

"To compare the PK profile of BEVZ92 and Avastin®, both administered in combination with FOLFOX (any) or FOLFIRI, by means of comparing the truncated area under the concentration-versus-time curve calculated over a dosage interval at steady state (i.e. at Cycle 7; AUCss).~For the PK similarity assessments, regulatory guidelines on bioequivalence were followed whereby two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 80-125%." (NCT02069704)
Timeframe: AUCss: 0 to 336 hours after the administration of Cycle 7 infusion (Week 13).

Interventionng.h/mL (Geometric Least Squares Mean)
Bevacizumab Biosimilar (BEVZ92)35900000
Avastin® (Bevacizumab, Ref. Product).35700000

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Ctrough,ss of BEVZ92 and Avastin®

Secondary PK endpoints included the Ctrough calculated at Cycle 7 (Ctrough,ss) (NCT02069704)
Timeframe: Ctrough, ss: 0 to 336 hours after the administration of the Cycle 7 infusion.

Interventionng/mL (Geometric Least Squares Mean)
Bevacizumab Biosimilar (BEVZ92)69600
Avastin® (Bevacizumab, Ref. Product).69300

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Ctrough,sd of BEVZ92 and Avastin®

Secondary PK endpoints included the Ctrough calculated at Cycle 1 (Ctrough,sd ) (NCT02069704)
Timeframe: Ctrough, sd: 0 to 336 hours after start of the first infusion.

Interventionng/mL (Geometric Least Squares Mean)
Bevacizumab Biosimilar (BEVZ92)344
Avastin® (Bevacizumab, Ref. Product).349

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Elimination Rate Constant (Kel) of BEVZ92 and Avastin®

Secondary PK endpoints included the Kel calculated at Cycle 7 (Ctrough,ss) (NCT02069704)
Timeframe: Kel: 0 to 336 hours after the administration of the Cycle 7 infusion.

Interventionl/h (Geometric Least Squares Mean)
Bevacizumab Biosimilar (BEVZ92)0.00236
Avastin® (Bevacizumab, Ref. Product).0.00240

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Cmax,ss of BEVZ92 and Avastin®

Secondary PK endpoints included the Cmax calculated at Cycle 7 (Cmax, ss ) (NCT02069704)
Timeframe: Cmax, ss: 0 to 336 hours post-dose after the administration of Cycle 7 infusion (Week 13)

Interventionng/mL (Geometric Least Squares Mean)
Bevacizumab Biosimilar (BEVZ92)195000
Avastin® (Bevacizumab, Ref. Product).200000

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Percentage of Participants With ACR20 Response After Fifth Course

A participant had an ACR20 response if there was at least a 20% improvement, ie, reduction from Baseline, in TJC and SJC (28 assessed joints) and in at least 3 of the following 5 parameters: 1) Physician's Global Assessment of Disease Activity [VAS: 0=no disease activity to 100=maximum disease activity]; 2) Patient's Global Assessment of Disease Activity [VAS: 0=no disease activity to 100=maximum disease activity]; 3) Patient's Assessment of Pain [VAS: 0=no pain to 100=unbearable pain]; 4) Health Assessment Questionnaire [20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do] and 5) an acute-phase reactant (either CRP or ESR). The ACR20 response was compared to Baseline in the precursor studies WA16291 or WA17043. (NCT02093026)
Timeframe: 24 weeks after fifth course of rituximab (median duration of 297.3 weeks)

Interventionpercentage of participants (Number)
Rituximab69.7

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Percentage of Participants With Low Disease Activity and Clinical Remission Based on DAS28-ESR

DAS28-ESR was calculated from SJC and TJC using 28 joints count, ESR (millimeters per hour [mm/hour]), and Patient's Global Assessment of Disease Activity (VAS: 0=no disease activity to 100=maximum disease activity). DAS28-ESR = 0.56*square root (sqrt)(TJC28) + 0.28*sqrt(SJC28) + 0.70*natural logarithm (ln) (ESR) + 0.014*Patient's Global Assessment of Disease Activity. Total score range: 0-10, higher score=more disease activity. DAS28-ESR <= 3.2 implied low disease activity (LDA) and DAS28-ESR <2.6 = clinical remission. (NCT02093026)
Timeframe: 24 weeks after first, second, third, fourth, fifth, sixth, and seventh course of rituximab (median duration of 26, 90.9, 162.9, 232, 297.3, 354.4, and 406.7 weeks, respectively)

Interventionpercentage of participants (Number)
LDA: 24 weeks after first courseLDA: 24 weeks after second courseLDA: 24 weeks after third courseLDA: 24 weeks after fourth courseLDA: 24 weeks after fifth courseLDA: 24 weeks after sixth courseLDA: 24 weeks after seventh courseRemission: 24 weeks after first courseRemission: 24 weeks after second courseRemission: 24 weeks after third courseRemission: 24 weeks after fourth courseRemission: 24 weeks after fifth courseRemission: 24 weeks after sixth courseRemission: 24 weeks after seventh course
Rituximab24.330.129.328.023.827.324.711.316.817.115.715.717.313.7

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Percentage of Participants With ACR20 Response After Third Course

A participant had an ACR20 response if there was at least a 20% improvement, ie, reduction from Baseline, in TJC and SJC (28 assessed joints) and in at least 3 of the following 5 parameters: 1) Physician's Global Assessment of Disease Activity [VAS: 0=no disease activity to 100=maximum disease activity]; 2) Patient's Global Assessment of Disease Activity [VAS: 0=no disease activity to 100=maximum disease activity]; 3) Patient's Assessment of Pain [VAS: 0=no pain to 100=unbearable pain]; 4) Health Assessment Questionnaire [20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do] and 5) an acute-phase reactant (either CRP or ESR). The ACR20 response was compared to Baseline in the precursor studies WA16291 or WA17043. (NCT02093026)
Timeframe: 24 weeks after third course of rituximab (median duration of 162.9 weeks)

Interventionpercentage of participants (Number)
Rituximab73.2

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Percentage of Participants With an American College of Rheumatology 20 (ACR20) Response After First Course

A participant had an ACR20 response if there was at least a 20 percent (%) improvement, ie, reduction from Baseline, in tender joint count (TJC) and swollen joint count (SJC) (28 assessed joints) and in at least 3 of the following 5 parameters: 1) Physician's Global Assessment of Disease Activity [visual analog scale (VAS): 0=no disease activity to 100=maximum disease activity]; 2) Patient's Global Assessment of Disease Activity [VAS: 0=no disease activity to 100=maximum disease activity]; 3) Patient's Assessment of Pain [VAS: 0=no pain to 100=unbearable pain]; 4) Health Assessment Questionnaire [20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do] and 5) an acute-phase reactant (either C-reactive protein [CRP] or erythrocyte sedimentation rate [ESR]). The ACR20 response was compared to Baseline in the precursor studies WA16291 or WA17043. (NCT02093026)
Timeframe: 24 weeks after first course of rituximab (up to approximately 26 weeks)

Interventionpercentage of participants (Number)
Rituximab67.1

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Time Since Last Treatment Course

Time since last treatment course = The last day of the last dose of rituximab to date of last contact. Date of last contact is the last available date of efficacy, complete medication start date, laboratory, adverse event assessments, early withdrawal visit, date of last contact, or date of death. (NCT02093026)
Timeframe: Baseline up to 10 years

Interventionyears (Mean)
Rituximab4.21

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American College of Rheumatology Index of Improvement (ACRn) Response

The ACRn is calculated for each participant by taking the lowest percentage improvement in (1) SJC or (2) TJC or (3) the median of the remaining 5 components of the ACR response (patient's assessment of disease activity; patient's global assessment of pain; physician's assessment of disease activity; participant's assessment of physical function; an acute phase reactant value [either CRP or ESR]). The index of improvement in RA, where 0 indicates no improvement and 100 indicates a 100% improvement across all signs and symptoms of RA. ACRn scores were calculated considering the original baseline in the precursor studies WA16291 or WA17043. (NCT02093026)
Timeframe: 24 weeks after first, second, third, fourth, fifth, sixth, and seventh course of rituximab (median duration of 26, 90.9, 162.9, 232, 297.3, 354.4, and 406.7 weeks, respectively)

Interventionunits on a scale (Mean)
24 weeks after first course24 weeks after second course24 weeks after third course24 weeks after fourth course24 weeks after fifth course24 weeks after sixth course24 weeks after seventh course
Rituximab31.0734.1536.9339.5933.7629.7424.87

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Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at 24 Weeks Following Each Course

The HAQ-DI is a questionnaire specific for rheumatoid arthritis and consists of 20 questions referring to 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Participants completed the questionnaire by answering the 20 questions on a scale of 0 (without difficulty) to 3 (unable to do). The total score ranges from 0 (no disability) to 3 (completely disabled). A negative change score indicates improvement. (NCT02093026)
Timeframe: 24 weeks after first, second, third, fourth, fifth, sixth, and seventh course of rituximab (median duration of 26, 90.9, 162.9, 232, 297.3, 354.4, and 406.7 weeks, respectively)

Interventionunits on a scale (Mean)
24 weeks after first course24 weeks after second course24 weeks after third course24 weeks after fourth course24 weeks after fifth course24 weeks after sixth course24 weeks after seventh course
Rituximab-0.51-0.48-0.43-0.47-0.44-0.38-0.37

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Percentage of Participants With ACR50 and ACR70 Response

A participant had an ACR50 and ACR70 response if there was at least a 50% or 70% improvement, ie, reduction from Baseline, in TJC and SJC (28 assessed joints) and in at least 3 of the following 5 parameters: 1) Physician's Global Assessment of disease activity [VAS: 0=no disease activity to 100=maximum disease activity]; 2) Patient's Global Assessment of Disease Activity [VAS: 0=no disease activity to 100=maximum disease activity]; 3) Patient's Assessment of Pain [VAS: 0=no pain to 100=unbearable pain]; 4) Health Assessment Questionnaire [20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do] and 5) an acute-phase reactant (CRP or ESR). The ACR50 and ACR70 responses were compared to Baseline in the precursor studies WA16291 or WA17043. (NCT02093026)
Timeframe: 24 weeks after first, second, third, fourth, fifth, sixth, and seventh course of rituximab (median duration of 26, 90.9, 162.9, 232, 297.3, 354.4, and 406.7 weeks, respectively)

Interventionpercentage of participants (Number)
ACR50: 24 weeks after first courseACR50: 24 weeks after second courseACR50: 24 weeks after third courseACR50: 24 weeks after fourth courseACR50: 24 weeks after fifth courseACR50: 24 weeks after sixth courseACR50: 24 weeks after seventh courseACR70: 24 weeks after first courseACR70: 24 weeks after second courseACR70: 24 weeks after third courseACR70: 24 weeks after fourth courseACR70: 24 weeks after fifth courseACR70: 24 weeks after sixth courseACR70: 24 weeks after seventh course
Rituximab39.441.944.846.940.040.036.516.321.620.020.018.920.918.9

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Percentage of Participants Who Discontinued Treatment Due to Insufficient Response

(NCT02093026)
Timeframe: First, second, third, fourth, fifth, sixth, and seventh course of rituximab (up to a median of approximately 2, 62, 124, 186, 248, 310, and 372 weeks, respectively)

Interventionpercentage of participants (Number)
First courseSecond courseThird courseFourth courseFifth courseSixth courseSeventh course
Rituximab1.12.32.02.00.80.00.6

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Percentage of Participants With European League Against Rheumatism (EULAR) Response of 'Good' or 'Moderate'

DAS28-ESR was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and Physician's Global Assessment of Disease Activity (VAS: 0=no disease activity to 100=maximum disease activity). DAS28-ESR = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*ln(ESR) + 0.014*Patient's Global Assessment of Disease Activity. 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 had a change from baseline greater than (>) 1.2 with a DAS28 score less than or equal to (≤) 3.2; moderate responders had a change from baseline >1.2 with a DAS28 score >3.2 to less than or equal to (≤) 5.1 or a change from baseline >0.6 to ≤1.2 with a DAS28 score ≤5.1. (NCT02093026)
Timeframe: 24 weeks after first, second, third, fourth, fifth, sixth, and seventh course of rituximab (median duration of 26, 90.9, 162.9, 232, 297.3, 354.4, and 406.7 weeks, respectively)

Interventionpercentage of participants (Number)
Moderate: 24 weeks after first courseModerate: 24 weeks after second courseModerate: 24 weeks after third courseModerate: 24 weeks after fourth courseModerate: 24 weeks after fifth courseModerate: 24 weeks after sixth courseModerate: 24 weeks after seventh courseGood: 24 weeks after first courseGood: 24 weeks after second courseGood: 24 weeks after third courseGood: 24 weeks after fourth courseGood: 24 weeks after fifth courseGood: 24 weeks after sixth courseGood: 24 weeks after seventh course
Rituximab57.858.559.560.962.157.060.024.330.429.127.924.327.125.7

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Percentage of Participants With ACR20 Response After Seventh Course

A participant had an ACR20 response if there was at least a 20% improvement, ie, reduction from Baseline, in TJC and SJC (28 assessed joints) and in at least 3 of the following 5 parameters: 1) Physician's Global Assessment of Disease Activity [VAS: 0=no disease activity to 100=maximum disease activity]; 2) Patient's Global Assessment of Disease Activity [VAS: 0=no disease activity to 100=maximum disease activity]; 3) Patient's Assessment of Pain [VAS: 0=no pain to 100=unbearable pain]; 4) Health Assessment Questionnaire [20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do] and 5) an acute-phase reactant (either CRP or ESR). The ACR20 response was compared to Baseline in the precursor studies WA16291 or WA17043. (NCT02093026)
Timeframe: 24 weeks after seventh course of rituximab (median duration of 406.7 weeks)

Interventionpercentage of participants (Number)
Rituximab59.5

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Percentage of Participants With ACR20 Response After Sixth Course

A participant had an ACR20 response if there was at least a 20% improvement, ie, reduction from Baseline, in TJC and SJC (28 assessed joints) and in at least 3 of the following 5 parameters: 1) Physician's Global Assessment of Disease Activity [VAS: 0=no disease activity to 100=maximum disease activity]; 2) Patient's Global Assessment of Disease Activity [VAS: 0=no disease activity to 100=maximum disease activity]; 3) Patient's Assessment of Pain [VAS: 0=no pain to 100=unbearable pain]; 4) Health Assessment Questionnaire [20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do] and 5) an acute-phase reactant (either CRP or ESR). The ACR20 response was compared to Baseline in the precursor studies WA16291 or WA17043. (NCT02093026)
Timeframe: 24 weeks after sixth course of rituximab (median duration of 354.4 weeks)

Interventionpercentage of participants (Number)
Rituximab68.2

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Percentage of Participants With ACR20 Response After Second Course

A participant had an ACR20 response if there was at least a 20% improvement, ie, reduction from Baseline, in TJC and SJC (28 assessed joints) and in at least 3 of the following 5 parameters: 1) Physician's Global Assessment of Disease Activity [VAS: 0=no disease activity to 100=maximum disease activity]; 2) Patient's Global Assessment of Disease Activity [VAS: 0=no disease activity to 100=maximum disease activity]; 3) Patient's Assessment of Pain [VAS: 0=no pain to 100=unbearable pain]; 4) Health Assessment Questionnaire [20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do] and 5) an acute-phase reactant (either CRP or ESR). The ACR20 response was compared to Baseline in the precursor studies WA16291 or WA17043. (NCT02093026)
Timeframe: 24 weeks after second course of rituximab (median duration of 90.9 weeks)

Interventionpercentage of participants (Number)
Rituximab70.8

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Percentage of Participants With ACR20 Response After Fourth Course

A participant had an ACR20 response if there was at least a 20% improvement, ie, reduction from Baseline, in TJC and SJC (28 assessed joints) and in at least 3 of the following 5 parameters: 1) Physician's Global Assessment of Disease Activity [VAS: 0=no disease activity to 100=maximum disease activity]; 2) Patient's Global Assessment of Disease Activity [VAS: 0=no disease activity to 100=maximum disease activity]; 3) Patient's Assessment of Pain [VAS: 0=no pain to 100=unbearable pain]; 4) Health Assessment Questionnaire [20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do] and 5) an acute-phase reactant (either CRP or ESR). The ACR20 response was compared to Baseline in the precursor studies WA16291 or WA17043. (NCT02093026)
Timeframe: 24 weeks after fourth course of rituximab (median duration of 232 weeks)

Interventionpercentage of participants (Number)
Rituximab75.1

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Overall Survival (OS) of HR and IR Relapse Patients

OS rates of HR and IR relapse B-ALL patients who are randomized following Induction Block 1 chemotherapy to receive either two intensive chemotherapy blocks or two 5-week blocks of blinatumomab (HR/IR Randomization). OS is calculated as the time from randomization to date of death or date of last contact. Two-year OS estimates will be calculated from date of randomization for both Arm A and Arm B. Two-sided 95% confidence intervals will be calculated. (NCT02101853)
Timeframe: Up to 2 years from date of randomization

Interventionpercentage of participants (Number)
Arm A (HR and IR Control)58.40
Arm B (HR and IR Blinatumomab)71.33

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Disease Free Survival (DFS) of Low Risk (LR) Relapse Patients

DFS rates of LR relapse B-ALL patients who are randomized following Block 1 chemotherapy to receive either chemotherapy alone or chemotherapy plus blinatumomab (LR Randomization). DFS is calculated as the time from randomization to date of first event (relapse, second malignancy, remission death) or date of last contact. Three-year DFS estimates will be calculated from date of randomization for both Arm C and Arm D. Two-sided 95% confidence intervals will be calculated. (NCT02101853)
Timeframe: Up to 3 years from date of randomization

Interventionpercentage of participants (Number)
Arm C (LR Control)58.94
Arm D (LR Blinatumomab)67.00

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Overall Survival (OS) of LR Relapse Patients

OS rates of LR relapse B-ALL patients who are randomized following Block 1 chemotherapy to receive either chemotherapy alone or chemotherapy plus blinatumomab (LR Randomization). OS is calculated as the time from randomization to date of death or date of last contact. Three-year OS estimates will be calculated from date of randomization for both Arm C and Arm D. Two-sided 95% confidence intervals will be calculated. (NCT02101853)
Timeframe: Up to 3 years from date of randomization

Interventionpercentage of participants (Number)
Arm C (LR Control)88.29
Arm D (LR Blinatumomab)90.37

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Disease Free Survival (DFS) of High-risk (HR) and Intermediate-risk (IR) Relapse Patients

DFS rates of HR and IR relapse B-ALL patients who are randomized following Induction Block 1 chemotherapy to receive either two intensive chemotherapy blocks or two 5-week blocks of blinatumomab (HR/IR Randomization). DFS is calculated as the time from randomization to date of first event (treatment failure, relapse, second malignancy, remission death) or date of last contact. Two-year DFS estimates will be calculated from date of randomization for both Arm A and Arm B. Two-sided 95% confidence intervals will be calculated. (NCT02101853)
Timeframe: Up to 2 years from date of randomization

Interventionpercentage of participants (Number)
Arm A (HR and IR Control)39.04
Arm B (HR and IR Blinatumomab)54.44

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EFS for Standard (SR) and Intermediate Risk (IR) T-ALL Patients on the Non-bortezomib Containing Arm on This Study (no Cranial Radiation Therapy [CRT]) and Similar Patients on AALL0434 (Received CRT)

EFS is calculated as time from randomization at study entry to first event (induction failure, induction death, relapse, second malignancy, remission death) or date of last contact. (NCT02112916)
Timeframe: 3 years

InterventionPercentage of participants (Number)
AALL1231 T-ALL Patients88.3
AALL0434 T-ALL Patients88.8

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Cumulative Incidence Rates of Isolated Central Nervous System (CNS) Relapse for SR and IR T-ALL Patients on the Non-bortezomib Containing Arm on This Study (no CRT) and Similar Patients on AALL0434 (Receive CRT)

Cumulative incidence of isolated CNS relapse adjusting for competing risks using the method of: Gray R, A class of K-sample tests for comparing the cumulative incidence of a competing risk. Ann Stat 1141:1154, 1988 (NCT02112916)
Timeframe: 3 years

,
InterventionPercentage of participants (Number)
Isolated CNS RelapseIsolated Bone Marrow RelapseCombined Bone Marrow Relapse
AALL0434 T-ALL Patients2.23.01.8
AALL1231 T-ALL Patients3.61.41.3

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Toxicity Rates Associated With Modified Standard Therapy, Including Dexamethasone and Additional Pegaspargase

Percentage of patients who experienced Grade 3 or higher Toxicity Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (NCT02112916)
Timeframe: 3 years from start of therapy by patient

InterventionPercentage of participants (Number)
Total Patients78.0

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Event-free Survival (EFS) for Modified Augmented Berlin-Frankfurt-Munster Backbone With or Without Bortezomib in All Randomized Patients

EFS is calculated as time from randomization at study entry to first event (induction failure, induction death, relapse, second malignancy, remission death) or date of last contact. Three-year EFS rates will be calculated for both groups. (NCT02112916)
Timeframe: 3 years

InterventionPercentage of participants (Number)
Arm A (Combination Chemotherapy)81.7
Arm B (Combination Chemotherapy, Bortezomib)85.1

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EFS for Very High Risk (VHR) T-LLy Patients Treated With HR Berlin-Frankfurt-Munster (BFM) Intensification Blocks Who Have Complete or Partial Remission and Those Who do Not Respond

EFS for very high risk (VHR) T-LLy patients treated with HR Berlin-Frankfurt-Munster (BFM) intensification blocks who have complete or partial remission and those who do not respond (NCT02112916)
Timeframe: 3 years

InterventionPercentage of participants (Number)
VHR T-LLy (CR/PR)0

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EFS for Very High Risk (VHR) T-ALL Patients Treated With High Risk (HR) Berlin-Frankfurt-Munster (BFM) Intensification Blocks Who Become Minimal Residual Disease (MRD) Negative and Those Who Remain MRD Positive at the End of HR Block 3

EFS will be calculated as time from the end of the three high-risk blocks of therapy to first event (relapse, second malignancy, remission death) or date of last contact. (NCT02112916)
Timeframe: 3 years

InterventionPercentage of participants (Number)
VHR T-ALL MRD Undetectable25.0
VHR T-ALL MRD Detectable88.9

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Overall Survival (OS)

Efficacy of vanucizumab was evaluated in terms of OS as the time from randomization until death from any cause. 99999 = data not estimable due to the low number of deaths. (NCT02141295)
Timeframe: Baseline until death from any cause (maximum up to approximately 3.5 years)

Interventiondays (Median)
Vanucizumab + mFOLFOX-6746.0
Bevacizumab + mFOLFOX-6NA

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Number of Participants With Human Anti-human Antibodies (HAHAs) Against Vanucizumab

Safety is evaluated in terms of number of participants with Human Anti-human Antibodies (HAHAs) Against Vanucizumab. (NCT02141295)
Timeframe: End of study (EoS, within 28 to 42 days after last dose, latest at 29 months)

InterventionParticipants (Count of Participants)
Safety Run-In2
Vanucizumab + mFOLFOX-61

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Duration of Objective Response, as Assessed Using RECIST v. 1.1

Efficacy of vanucizumab was evaluated in terms of duration of objective response as assessed using RECIST v. 1.1. This was computed using the PFS definition with death on study (deaths that occurred outside the 30 days window from the last study treatment are excluded). (NCT02141295)
Timeframe: Baseline (within 28 days prior to Day 1), then every 8 weeks until PD, start of other anticancer therapy, withdrawal of consent, or death (up to approximately 29 months)

Interventiondays (Median)
Vanucizumab + mFOLFOX-6342
Bevacizumab + mFOLFOX-6304

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Cmax Accumulation Ratio (AR) of Vanucizumab

PK profile of vanucizumab was evaluated in terms of Cmax Ratio, values are reported for cycle 8 of both part 1 (safety run-in) and part 2 of the study. (NCT02141295)
Timeframe: Cycle 8

InterventionRatio (Geometric Mean)
Safety Run-In1.51
Vanucizumab + mFOLFOX-61.63

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Plasma Clearance at Steady State (CLss) of Vanucizumab

PK profile of vanucizumab was evaluated in terms of CLss, values are reported for cycle 8 of both part 1 (safety run-in) and part 2 of the study. (NCT02141295)
Timeframe: Cycle 8

Interventionml/hr (Geometric Mean)
Safety Run-In15.3
Vanucizumab + mFOLFOX-618.0

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Percentage of Participants With Adverse Events (AEs)

Safety is evaluated in terms of percentage of participants with at least one serious adverse event and percentage of participants with at least one adverse event. (NCT02141295)
Timeframe: Up to approximately 29 months

,,
InterventionPercentage of Participants (Number)
Serious Adverse eventsAdverse events
Bevacizumab + mFOLFOX-643.2100.0
Safety Run-In37.5100
Vanucizumab + mFOLFOX-649.5100.0

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Minimum Observed Plasma Concentration (Clast) of Vanucizumab

PK profile of vanucizumab was evaluated in terms of Clast (NCT02141295)
Timeframe: Cycles 1 and 8 of parts 1 and 2

Interventionug/ml (Geometric Mean)
Cycle 1Cycle 8
Vanucizumab + mFOLFOX-6103361

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Maximum Observed Plasma Concentration (Cmax) of Vanucizumab

PK profile of vanucizumab was evaluated in terms of Cmax (NCT02141295)
Timeframe: Cycles 1 and 8 of parts 1 and 2

,
Interventionug/ml (Geometric Mean)
Cycle 1Cycle 8
Safety Run-In463685
Vanucizumab + mFOLFOX-6500794

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Time to Reach Cmax (Tmax) of Vanucizumab

PK profile of vanucizumab was evaluated in terms of Tmax (NCT02141295)
Timeframe: Cycles 1 and 8 of parts 1 and 2

,
Interventionhr (Median)
Cycle 1Cycle 8
Safety Run-In2.794.04
Vanucizumab + mFOLFOX-62.051.58

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Area Under the Plasma Concentration-Time Curve (AUC) of Vanucizumab

PK profile of vanucizumab was evaluated in terms of AUC (NCT02141295)
Timeframe: Cycles 1 and 8 of parts 1 and 2

,
Interventionhr*ug/ml (Geometric Mean)
Cycle 1Cycle 8
Safety Run-In73600112000
Vanucizumab + mFOLFOX-66350082100

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Percentage of Participants With Objective Response (ORR) as Assessed Using RECIST v. 1.1

Efficacy of vanucizumab was evaluated in terms of Percentage of Participants With ORR as Investigator-Assessed Using RECIST v. 1.1. Best Overall Confirmed Response. (NCT02141295)
Timeframe: Baseline (within 28 days prior to Day 1), then every 8 weeks until progressive disease (PD), start of other anticancer therapy, withdrawal of consent, or death (up to approximately 29 months)

InterventionPercentage of Participants (Number)
Safety Run-In62.5
Vanucizumab + mFOLFOX-643.6
Bevacizumab + mFOLFOX-651.6

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Volume of Distribution at Steady State (Vss) of Vanucizumab

PK profile of vanucizumab was evaluated in terms of Vss, values are reported for cycle 8 of both part 1 (safety run-in) and part 2 of the study. (NCT02141295)
Timeframe: Cycle 8

Interventionml (Geometric Mean)
Safety Run-In4400
Vanucizumab + mFOLFOX-64140

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Progression-free Survival (PFS), Time to Event

Efficacy of vanucizumab was evaluated in terms of PFS as Investigator-Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). PFS was defined as the time between randomization and the date of first documented disease progression or death from any cause on study, whichever occurred first. Death on study was defined as death from any cause within 30 days of the last study treatment. (NCT02141295)
Timeframe: Baseline, every 8 weeks, up to approximately 29 months

Interventiondays (Median)
Vanucizumab + mFOLFOX-6338.0
Bevacizumab + mFOLFOX-6309.0

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Plasma Terminal Half-Life (t1/2) of Vanucizumab

PK profile of vanucizumab was evaluated in terms of t1/2, values are reported for cycle 8 of both part 1 (safety run-in) and part 2 of the study. (NCT02141295)
Timeframe: Cycle 8

Interventionhr (Geometric Mean)
Safety Run-In202
Vanucizumab + mFOLFOX-6157

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Percentage of Participants Achieving American College of Rheumatology 20 (ACR20) Response at Week 24

American College of Rheumatology (ACR) response is a composite rating scale that includes 7 variables: tender joints count (TJC [68 joints]); Swollen joints count (SJC [66 joints]); levels of an acute phase reactant (high sensitivity C-reactive protein [hs-CRP level]); participant's assessment of pain (measured on 0 [no pain]-100 mm [worst pain] visual analog scale [VAS]); participant's global assessment of disease activity (measured on 0 [no arthritis activity]-100 mm [maximal arthritis activity] VAS); physician's global assessment of disease activity (measured on 0 [no arthritis activity]-100 mm [maximal arthritis activity] VAS); participant's assessment of physical function (measured by health assessment questionnaire disability index [HAQ-DI], with scoring range of 0 [better health] - 3 [worst health]). ACR20 response was defined as achieving at least 20% improvement in both TJC and SJC, and at least 20% improvement in at least 3 of the 5 other assessments. (NCT02293902)
Timeframe: Week 24

Interventionpercentage of participants (Number)
Placebo14.8
Sarilumab 150 mg67.9
Sarilumab 200 mg57.5

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Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities

"Criteria for potentially clinically significant ECG abnormalities:~PR Interval: >200 millisecond (ms); >200 ms and IFB >=25%; >220 ms; >220 ms and IFB >=25%; >240 ms; >240 ms and IFB >=25%~QRS Interval: >110 ms; >110 ms and IFB >=25%; >120 ms; >120 ms and IFB >=25%~QT Interval: >500 ms~QTc Bazett (QTc B): >450 ms; 480 ms; 500 ms; IFB >30 and <=60 ms; IFB >60 ms~QTc Fridericia (QTc F): >450 ms; 480 ms; 500 ms; IFB >30 and <=60 ms; IFB >60 ms" (NCT02293902)
Timeframe: For placebo arm: Baseline up to Week 24; For sarilumab 150 mg/150 mg, sarilumab 200 mg/200 mg and sarilumab rescue arm: Baseline up to Week 58; For placebo/sarilumab 150 mg and placebo/sarilumab 200 mg arm: Week 25 up to Week 58

,,,,,
Interventionparticipants (Number)
PR Interval >200 msPR Interval >200 ms and IFB >=25%PR Interval >220 msPR Interval >220 ms and IFB >=25%PR Interval >240 msPR Interval >240 ms and IFB >=25%QRS Interval >110 msQRS Interval >110 ms and IFB >=25%QRS Interval >120 msQRS Interval >120 ms and IFB >=25%QT Interval >500 msQTc B >450 msQTc B >480 msQTc B >500 msQTc B IFB >30 and <=60 msQTc B IFB >60 msQTc F>450 msQTc F>480 msQTc F>500 msQTc F IFB >30 and <=60 msQTc F IFB >60 ms
Placebo6030202020112002070040
Placebo/Sarilumab 150 mg000000101002000000000
Placebo/Sarilumab 200 mg201010101003101021010
Sarilumab 150 mg/150 mg91411020200162020110040
Sarilumab 200 mg/200 mg50200020101222020140030
Sarilumab Rescue60202031213182050121030

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Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Electrolytes

"Criteria for potentially clinically significant abnormalities:~Sodium: <=129 mmol/L; >=160 mmol/L~Potassium: <3 mmol/L; >=5.5 mmol/L~Chloride: <80 mmol/L; >115 mmol/L" (NCT02293902)
Timeframe: For placebo arm: Baseline up to Week 24; For sarilumab 150 mg/150 mg, sarilumab 200 mg/200 mg and sarilumab rescue arm: Baseline up to Week 58; For placebo/sarilumab 150 mg and placebo/sarilumab 200 mg arm: Week 25 up to Week 58

,,,,,
Interventionparticipants (Number)
Sodium <=129 mmol/LSodium >=160 mmol/LPotassium <3 mmol/LPotassium >=5.5 mmol/LChloride <80 mmol/LChloride >115 mmol/L
Placebo000000
Placebo/Sarilumab 150 mg000000
Placebo/Sarilumab 200 mg000100
Sarilumab 150 mg/150 mg000000
Sarilumab 200 mg/200 mg111200
Sarilumab Rescue010001

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Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters

"Criteria for potentially clinically significant abnormalities:~Hemoglobin: <=115 g/L (Male[M]) or <=95 g/L (Female[F]); >=185 g/L (M) or >=165 g/L (F); DFB >=20 g/L~Hematocrit: <=0.37 v/v (M) or <=0.32 v/v (F); >=0.55 v/v (M) or >=0.5 v/v (F)~Red blood cells (RBC): >=6 Tera/L~Platelets: <50 Giga/L; >=50 and <100 Giga/L; >=700 Giga/L~White blood cells (WBC): <3.0 Giga/L (Non-Black[NB]) or <2.0 Giga/L (Black[B]); >=16.0 Giga/L~Neutrophils: <1.5 Giga/L (NB) or <1.0 Giga/L (B); <1.0 Giga/L~Lymphocytes: <0.5 Giga/L; >=0.5 Giga/L and < lower limit of normal (LLN); >4.0 Giga/L~Monocytes: >0.7 Giga/L~Basophils: >0.1 Giga/L~Eosinophils: >0.5 Giga/L or >upper limit of normal (ULN) (if ULN >=0.5 Giga/L)" (NCT02293902)
Timeframe: For placebo arm: Baseline up to Week 24; For sarilumab 150 mg/150 mg, sarilumab 200 mg/200 mg and sarilumab rescue arm: Baseline up to Week 58; For placebo/sarilumab 150 mg and placebo/sarilumab 200 mg arm: Week 25 up to Week 58

,,,,,
Interventionparticipants (Number)
Hemoglobin <=115 g/L (M) or <=95 g/L (F)Hemoglobin >=185 g/L (M) or >=165 g/L (F)Hemoglobin DFB >=20 g/LHematocrit <=0.37 v/v (M) or <=0.32 v/v (F)Hematocrit >=0.55 v/v (M) or >=0.5 v/v (F)RBC >=6 Tera/LPlatelets <50 Giga/LPlatelets >=50 and <100 Giga/LPlatelets >=700 Giga/LWBC <3.0 Giga/L (NB) or <2.0 Giga/L (B)WBC >=16.0 Giga/LNeutrophils <1.5 Giga/L (NB) or <1.0 Giga/L (B)Neutrophils <1.0 Giga/LLymphocytes <0.5 Giga/LLymphocytes >=0.5 Giga/L and Lymphocytes >4.0 Giga/LMonocytes >0.7 Giga/LBasophils >0.1 Giga/LEosinophils>0.5 Giga/L or >ULN(if ULN>=0.5 Giga/L)
Placebo904170000100003230961
Placebo/Sarilumab 150 mg0000000005053140011
Placebo/Sarilumab 200 mg1003000006060220200
Sarilumab 150 mg/150 mg40010001203053111629010112
Sarilumab 200 mg/200 mg50314000402352463320791
Sarilumab Rescue5016000101721881180392

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Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Liver Function Parameters

"Criteria for potentially clinically significant abnormalities:~Alanine Aminotransferase (ALT): >1 ULN and <=1.5 ULN; >1.5 ULN and <=3 ULN; >3 ULN and <=5 ULN; >5 ULN and <=10 ULN; >10 ULN and <=20 ULN; >20 ULN~Aspartate aminotransferase (AST): >1 ULN and <=1.5 ULN; >1.5 ULN and <=3 ULN; >3 ULN and <=5 ULN; >5 ULN and <=10 ULN; >10 ULN and <=20 ULN; >20 ULN~Alkaline phosphatase: >1.5 ULN~Total bilirubin (TBILI): >1.5 ULN; >2 ULN~Conjugated bilirubin (CBILI): >1.5 ULN; >2 ULN~Unconjugated bilirubin: >1.5 ULN; >2 ULN~ALT and TBILI: ALT >3 ULN and TBILI >2 ULN~CBILI and TBILI: CBILI >35% TBILI and TBILI >1.5 ULN~Albumin: <=25 g/L" (NCT02293902)
Timeframe: For placebo arm: Baseline up to Week 24; For sarilumab 150 mg/150 mg, sarilumab 200 mg/200 mg and sarilumab rescue arm : Baseline up to Week 58; For placebo/sarilumab 150 mg and placebo/sarilumab 200 mg arm: Week 25 up to Week 58

,,,,,
Interventionparticipants (Number)
ALT >1 ULN and <=1.5 ULNALT >1.5 ULN and <=3 ULNALT >3 ULN and <=5 ULNALT >5 ULN and <=10 ULNALT >10 ULN and <=20 ULNALT >20 ULNAST >1 ULN and <=1.5 ULNAST >1.5 ULN and <=3 ULNAST >3 ULN and <=5 ULNAST >5 ULN and <=10 ULNAST >10 ULN and <=20 ULNAST >20 ULNAlkaline phosphatase >1.5 ULNTBILI >1.5 ULNTBILI >2 ULNCBILI >1.5 ULNCBILI >2 ULNUnconjugated bilirubin >1.5 ULNUnconjugated bilirubin >2 ULNALT >3 ULN and TBILI >2 ULNCBILI >35% TBILI and TBILI >1.5Albumin <=25 g/L
Placebo37600071110000000000000
Placebo/Sarilumab 150 mg3420006310000100000000
Placebo/Sarilumab 200 mg6401008110000000000000
Sarilumab 150 mg/150 mg172411100341850002100000000
Sarilumab 200 mg/200 mg24195200321021000210010000
Sarilumab Rescue1694200221130000311110010

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Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Metabolic Parameters

"Criteria for potentially clinically significant abnormalities:~Glucose: <=3.9 mmol/L and =11.1 mmol/L unfasted or >=7 mmol/L fasted~Hemoglobin A1c (HbA1c): >8%~Total cholesterol: >=6.2 mmol/L; >=7.74 mmol/L~LDL cholesterol: >=4.1 mmol/L; >=4.9 mmol/L~Triglycerides: >=4.6 mmol/L; >=5.6 mmol/L" (NCT02293902)
Timeframe: For placebo arm: Baseline up to Week 24; For sarilumab 150 mg/150 mg, sarilumab 200 mg/200 mg and sarilumab rescue arm: Baseline up to Week 58; For placebo/sarilumab 150 mg and placebo/sarilumab 200 mg arm: Week 25 up to Week 58

,,,,,
Interventionparticipants (Number)
Glucose <=3.9 mmol/L and Glucose>=11.1 mmol/L unfasted or >=7 mmol/L fastedHbA1c >8%Total cholesterol >=6.2 mmol/LTotal cholesterol >=7.74 mmol/LLDL cholesterol >=4.1 mmol/LLDL cholesterol >=4.9 mmol/LTriglycerides >=4.6 mmol/LTriglycerides >=5.6 mmol/L
Placebo030903000
Placebo/Sarilumab 150 mg100403000
Placebo/Sarilumab 200 mg100211111
Sarilumab 150 mg/150 mg08040720400
Sarilumab 200 mg/200 mg24032517633
Sarilumab Rescue2101737222

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Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Renal Function Parameters

"Criteria for potentially clinically significant abnormalities:~Creatinine: >=150 micromol/L; >=30% change from baseline; >=100% change from baseline~Creatinine clearance: <15 mL/min; >=15 to <30 mL/min; >=30 to < 60 mL/min; >=60 to <90 mL/min~Blood urea nitrogen: >=17 mmol/L~Uric acid: <120 micromol/L; >408 micromol/L" (NCT02293902)
Timeframe: For placebo arm: Baseline up to Week 24; For sarilumab 150 mg/150 mg, sarilumab 200 mg/200 mg and sarilumab rescue arm: Baseline up to Week 58; For placebo/sarilumab 150 mg and placebo/sarilumab 200 mg arm: Week 25 up to Week 58

,,,,,
Interventionparticipants (Number)
Creatinine >=150 micromol/LCreatinine >=30% change from baselineCreatinine >=100% change from baselineCreatinine clearance <15 mL/minCreatinine clearance >=15 to <30 mL/minCreatinine clearance >=30 to <60 mL/minCreatinine clearance >=60 to <90 mL/minBlood urea nitrogen >=17 mmol/LUric acid <120 micromol/LUric acid >408 micromol/L
Placebo05000641008
Placebo/Sarilumab 150 mg0000007003
Placebo/Sarilumab 200 mg1410125103
Sarilumab 150 mg/150 mg11810112450113
Sarilumab 200 mg/200 mg12210014420214
Sarilumab Rescue017000735005

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Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities

"Criteria for potentially clinically significant vital sign abnormalities:~Systolic blood pressure supine (SBP[S]): <=95 mmHg and decrease from baseline (DFB) >=20 mmHg; >=160 mmHg and increase from baseline (IFB) >=20 mmHg~Diastolic blood pressure supine (DBP[S]): <=45 mmHg and DFB >=10 mmHg; >=110 mmHg and IFB >=10 mmHg~Orthostatic systolic blood pressure (SBP[O]): <=-20 mmHg~Orthostatic diastolic blood pressure (DBP[O]): <=-10 mmHg~Heart rate supine (HR[S]): <=50 beats per minute (bpm) and DFB >=20 bpm; >=120 bpm and IFB >=20 bpm~Weight: >=5% DFB; >=5% IFB" (NCT02293902)
Timeframe: For placebo arm: Baseline up to Week 24; For sarilumab 150 mg/150 mg, sarilumab 200 mg/200 mg and sarilumab rescue arm: Baseline up to Week 58; For placebo/sarilumab 150 mg and placebo/sarilumab 200 mg arm: Week 25 up to Week 58

,,,,,
Interventionparticipants (Number)
SBP(S) <=95 mmHg and DFB >=20 mmHgSBP(S) >=160 mmHg and IFB >=20 mmHgDBP(S) <=45 mmHg and DFB >=10 mmHgDBP(S)>=110 mmHg and IFB >=10 mmHgSBP(O) <=-20 mmHgDBP(O) <=-10 mmHgHR(S) <=50 bpm and DFB >=20 bpmHR(S) >=120 bpm and IFB >=20 bpmWeight >=5% DFBWeight >=5% IFB
Placebo2210880155
Placebo/Sarilumab 150 mg0000200007
Placebo/Sarilumab 200 mg0100210006
Sarilumab 150 mg/150 mg4511211740531
Sarilumab 200 mg/200 mg1510231210727
Sarilumab Rescue0800121010415

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Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

AE: any untoward medical occurrence in a participant during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after informed consent form is signed. AE includes serious as well as non-serious AEs. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, In-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Any AEs that developed or worsened or became serious during double-blind on-treatment period, single-blind on-treatment period up to 6-week post-treatment follow-up period (up to Week 58) were considered treatment-emergent. (NCT02293902)
Timeframe: For placebo arm: Baseline up to Week 24; For sarilumab 150 mg/150 mg, sarilumab 200 mg/200 mg and sarilumab rescue arm: Baseline up to Week 58; For placebo/sarilumab 150 mg and placebo/sarilumab 200 mg arm: Week 25 up to Week 58

,,,,,
Interventionparticipants (Number)
Treatment Emergent AEsTreatment Emergent SAEs
Placebo496
Placebo/Sarilumab 150 mg120
Placebo/Sarilumab 200 mg132
Sarilumab 150 mg/150 mg768
Sarilumab 200 mg/200 mg715
Sarilumab Rescue544

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Change in Arterial FDG Uptake (From Baseline) in the Most Diseased Segment

"Arterial FDG Uptake provides a measure of inflammation in the artery wall.~TBR is target-to-background ratio (a measure of the ratio of the activity in the vessel wall divided by the blood background). A negative number for the change in TBR implies a reduction in activity over time.~The most diseased segment is the approx 1-cm section of the vessel with the highest activity at baseline.~The results are expressed as the change in the median value, of the TBR, from baseline to week 24" (NCT02312219)
Timeframe: baseline and 24 weeks

InterventionTBR (Median)
Low Dose Methotrexate-0.126
Placebo0.026

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Change in Arterial FDG Uptake (From Baseline) in the Aorta

"Arterial FDG Uptake provides a measure of inflammation in the artery wall.~TBR is target-to-background ratio (a measure of the ratio of the activity in the vessel wall divided by the blood background). A negative number for the change in TBR implies a reduction in activity over time.~The entire ascending aorta is used for this analysis.~The results are expressed as the change in the median value, of the TBR, from baseline to week 24" (NCT02312219)
Timeframe: baseline and 24 weeks

InterventionTBR (Median)
Low Dose Methotrexate-0.064
Placebo0.063

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Change From Baseline in SDAI Score at All Measured Timepoints

The SDAI is a composite score that is based on the number of tender and swollen joints using a 28-joint count, Physician's Global Assessment of Disease Activity using a visual analog scale (VAS) where 0=no activity at all and 100=worst activity imaginable, Patient's Global Assessment of Disease Activity using a VAS where 0=no arthritis activity at all and 100=worst arthritis activity imaginable, and C-reactive protein (CRP) in mg/dL. The SDAI score ranges from 0 to 86, with higher scores representing worse disease. SDAI remission was defined as a score of ≤ 3.3. A negative change from baseline indicates improvement. (NCT02373813)
Timeframe: Baseline, Week 12, Week 24, Week 36 and Week 48

,,
Interventionscore on a scale (Mean)
Change at Week 12Change at Week 24Change at Week 36Change at Week 48
Double-Blind Treatment: Etanercept Monotherapy3.143.781.061.16
Double-Blind Treatment: Etanercept Plus Methotrexate3.212.141.301.77
Double-Blind Treatment: Methotrexate Monotherapy5.674.422.902.27

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Clinical Disease Activity Index (CDAI) at All Measured Timepoints

The CDAI is a composite score that is based on the number of tender and swollen joints using a 28-joint count, Physician's Global Assessment of Disease Activity using a visual analog scale (VAS) where 0=no activity at all and 100=worst activity imaginable, and Patient's Global Assessment of Disease Activity using a VAS where 0=no arthritis activity at all and 100=worst arthritis activity imaginable. The CDAI score ranges from 0 to 76, where a higher score represents worse disease. (NCT02373813)
Timeframe: Baseline, Week 12, Week 24, Week 36 and Week 48

,,
Interventionscore on a scale (Mean)
BaselineWeek 12Week 24Week 36Week 48
Double-Blind Treatment: Etanercept Monotherapy0.924.084.631.932.00
Double-Blind Treatment: Etanercept Plus Methotrexate0.713.952.352.042.61
Double-Blind Treatment: Methotrexate Monotherapy1.016.425.073.603.06

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Percentage of Participants With SDAI Remission (≤ 3.3) at All Measured Timepoints

The SDAI is a composite score that is based on the number of tender and swollen joints using a 28-joint count, Physician's Global Assessment of Disease Activity using a visual analog scale (VAS) where 0=no activity at all and 100=worst activity imaginable, Patient's Global Assessment of Disease Activity using a VAS where 0=no arthritis activity at all and 100=worst arthritis activity imaginable, and C-reactive protein (CRP) in mg/dL. The SDAI score ranges from 0 to 86, with higher scores representing worse disease. SDAI remission was defined as a score of ≤ 3.3. (NCT02373813)
Timeframe: Baseline, Week 12, Week 24, Week 36 and Week 48

,,
Interventionpercentage of participants (Number)
BaselineWeek 12Week 24Week 36Week 48
Double-Blind Treatment: Etanercept Monotherapy92.164.056.655.652.1
Double-Blind Treatment: Etanercept Plus Methotrexate96.174.562.055.156.3
Double-Blind Treatment: Methotrexate Monotherapy96.050.038.836.130.5

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Percentage of Participants With Disease Worsening

"Percentage of participants who fulfilled disease-worsening criteria for the first time is presented. Disease worsening is defined as any of the following:~an SDAI > 3.3 and ≤ 11 during 2 consecutive visits at least 2 weeks apart~SDAI > 3.3 and ≤ 11 on 3 or more separate visits~SDAI > 11 after randomization.~The SDAI is a composite score that is based on the number of tender and swollen joints using a 28-joint count, Physician's Global Assessment of Disease Activity using a visual analog scale (VAS) where 0=no activity at all and 100=worst activity imaginable, Patient's Global Assessment of Disease Activity using a VAS where 0=no arthritis activity at all and 100=worst arthritis activity imaginable, and C-reactive protein (CRP) in mg/dL. The SDAI score ranges from 0 to 86, with higher scores representing worse disease. SDAI remission was defined as a score of ≤ 3.3." (NCT02373813)
Timeframe: Baseline, Week 12, Week 24, Week 36 and Week 48

,,
Interventionpercentage of participants (Number)
BaselineWeek 12Week 24Week 36Week 48
Double-Blind Treatment: Etanercept Monotherapy0.023.014.63.20.0
Double-Blind Treatment: Etanercept Plus Methotrexate0.017.66.18.34.3
Double-Blind Treatment: Methotrexate Monotherapy0.042.08.710.14.8

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Percentage of Participants With Boolean Remission at All Measured Timepoints

"A participant achieves Boolean remission (66/68-joint count) if all of the following criteria are met at a single timepoint:~68-joint tender joint count ≤ 1~66-joint swollen joint count ≤ 1~CRP (mg/dL) ≤ 1~Patient's Global Assessment of Disease Activity using a VAS (where 0=no arthritis activity at all and 10=worst arthritis activity imaginable) ≤ 1." (NCT02373813)
Timeframe: Baseline, Week 12, Week 24, Week 36 and Week 48

,,
Interventionpercentage of participants (Number)
BaselineWeek 12Week 24Week 36Week 48
Double-Blind Treatment: Etanercept Monotherapy34.723.016.720.413.3
Double-Blind Treatment: Etanercept Plus Methotrexate45.119.626.527.125.5
Double-Blind Treatment: Methotrexate Monotherapy34.018.015.214.620.2

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Disease Activity Score (28 Joint) Using the C-Reactive Protein Formula (DAS28-CRP) at All Measured Timepoints

The DAS28-CRP is a composite index that was designed to measure disease activity using the number of tender and swollen joints based upon a 28-joint count, CRP in mg/L, and a 100 mm VAS measuring the participant's general health from 0 (best) to 100 (worst). DAS28-CRP scores range from 0 to 9.4, where higher scores represent higher disease activity. (NCT02373813)
Timeframe: Baseline, Week 12, Week 24, Week 36 and Week 48

,,
Interventionscore on a scale (Mean)
BaselineWeek 12Week 24Week 36Week 48
Double-Blind Treatment: Etanercept Monotherapy1.501.912.001.671.67
Double-Blind Treatment: Etanercept Plus Methotrexate1.541.941.771.721.72
Double-Blind Treatment: Methotrexate Monotherapy1.502.362.151.961.87

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Percentage of Participants Receiving Rescue Treatment Who Experienced SDAI Remission at Week 48

The SDAI is a composite score that is based on the number of tender and swollen joints using a 28-joint count, Physician's Global Assessment of Disease Activity using a visual analog scale (VAS) where 0=no activity at all and 100=worst activity imaginable, Patient's Global Assessment of Disease Activity using a VAS where 0=no arthritis activity at all and 100=worst arthritis activity imaginable, and C-reactive protein (CRP) in mg/dL. The SDAI score ranges from 0 to 86, with higher scores representing worse disease. SDAI remission was defined as a score of ≤ 3.3. (NCT02373813)
Timeframe: Week 48

Interventionpercentage of participants (Number)
Double-Blind Treatment: Methotrexate Monotherapy54.2
Double-Blind Treatment: Etanercept Monotherapy55.9
Double-Blind Treatment: Etanercept Plus Methotrexate66.7

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Disease Activity Score (28 Joint) Calculated Using the Erythrocyte Sedimentation Rate Formula (DAS28-ESR) at All Measured Timepoints

The DAS28-ESR is a modified composite index that was designed to measure disease activity using the number of tender and swollen joints based upon a 28-joint count, ESR in mm/hr, and a 100 mm VAS measuring the participant's general health, from 0 (best) to 100 (worst). DAS28-ESR scores range from 0 to 9.4, where higher scores represent higher disease activity. (NCT02373813)
Timeframe: Baseline, Week 12, Week 24, Week 36 and Week 48

,,
Interventionscore on a scale (Mean)
BaselineWeek 12Week 24Week 36Week 48
Double-Blind Treatment: Etanercept Monotherapy1.882.372.542.172.21
Double-Blind Treatment: Etanercept Plus Methotrexate1.842.322.172.162.11
Double-Blind Treatment: Methotrexate Monotherapy1.802.782.412.322.22

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Change From Baseline in DAS28-CRP at All Measured Timepoints

The DAS28-CRP is a composite index that was designed to measure disease activity using the number of tender and swollen joints based upon a 28-joint count, CRP in mg/L, and a 100 mm VAS measuring the participant's general health from 0 (best) to 100 (worst). DAS28-CRP scores range from 0 to 9.4, where higher scores represent higher disease activity. A negative change from baseline indicates improvement. (NCT02373813)
Timeframe: Baseline, Week 12, Week 24, Week 36 and Week 48

,,
Interventionscore on a scale (Mean)
Change at Week 12Change at Week 24Change at Week 36Change at Week 48
Double-Blind Treatment: Etanercept Monotherapy0.420.520.180.19
Double-Blind Treatment: Etanercept Plus Methotrexate0.410.250.200.21
Double-Blind Treatment: Methotrexate Monotherapy0.840.670.490.40

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SDAI Score at All Measured Timepoints

The SDAI is a composite score that is based on the number of tender and swollen joints using a 28-joint count, Physician's Global Assessment of Disease Activity using a visual analog scale (VAS) where 0=no activity at all and 100=worst activity imaginable, Patient's Global Assessment of Disease Activity using a VAS where 0=no arthritis activity at all and 100=worst arthritis activity imaginable, and C-reactive protein (CRP) in mg/dL. The SDAI score ranges from 0 to 86, with higher scores representing worse disease. (NCT02373813)
Timeframe: Baseline, Week 12, Week 24, Week 36 and Week 48

,,
Interventionscore on a scale (Mean)
BaselineWeek 12Week 24Week 36Week 48
Double-Blind Treatment: Etanercept Monotherapy1.264.374.982.252.33
Double-Blind Treatment: Etanercept Plus Methotrexate1.184.393.282.412.86
Double-Blind Treatment: Methotrexate Monotherapy1.297.015.614.033.41

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Change From Baseline in CDAI at All Measured Timepoints

The CDAI is a composite score that is based on the number of tender and swollen joints using a 28-joint count, Physician's Global Assessment of Disease Activity using a visual analog scale (VAS) where 0=no activity at all and 100=worst activity imaginable, and Patient's Global Assessment of Disease Activity using a VAS where 0=no arthritis activity at all and 100=worst arthritis activity imaginable. The CDAI score ranges from 0 to 76, where a higher score represents worse disease. A negative change from baseline indicates improvement. (NCT02373813)
Timeframe: Baseline, Week 12, Week 24, Week 36 and Week 48

,,
Interventionscore on a scale (Mean)
Change at Week 12Change at Week 24Change at Week 36Change at Week 48
Double-Blind Treatment: Etanercept Monotherapy3.153.751.071.15
Double-Blind Treatment: Etanercept Plus Methotrexate3.241.701.412.00
Double-Blind Treatment: Methotrexate Monotherapy5.394.092.692.17

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Percentage of Participants With SDAI Remission (≤ 3.3) at Week 48: Etanercept and Methotrexate vs. Methotrexate Monotherapy

The SDAI is a composite score that is based on the number of tender and swollen joints using a 28-joint count, Physician's Global Assessment of Disease Activity using a visual analog scale (VAS) where 0=no activity at all and 100=worst activity imaginable, Patient's Global Assessment of Disease Activity using a VAS where 0=no arthritis activity at all and 100=worst arthritis activity imaginable, and C-reactive protein (CRP) in mg/dL. The SDAI score ranges from 0 to 86, with higher scores representing worse disease. SDAI remission was defined as a score of ≤ 3.3. (NCT02373813)
Timeframe: Week 48

Interventionpercentage of participants (Number)
Double-Blind Treatment: Methotrexate Monotherapy28.7
Double-Blind Treatment: Etanercept Plus Methotrexate52.9

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Percentage of Participants With Simplified Disease Activity Index (SDAI) Remission (≤ 3.3) at Week 48: Etanercept Monotherapy vs. Methotrexate Monotherapy

The SDAI is a composite score that is based on the number of tender and swollen joints using a 28-joint count, Physician's Global Assessment of Disease Activity using a visual analog scale (VAS) where 0=no activity at all and 100=worst activity imaginable, Patient's Global Assessment of Disease Activity using a VAS where 0=no arthritis activity at all and 100=worst arthritis activity imaginable, and C-reactive protein (CRP) in mg/dL. The SDAI score ranges from 0 to 86, with higher scores representing worse disease. SDAI remission was defined as a score of ≤ 3.3. (NCT02373813)
Timeframe: Week 48

Interventionpercentage of participants (Number)
Double-Blind Treatment: Methotrexate Monotherapy28.7
Double-Blind Treatment: Etanercept Monotherapy49.5

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Time to Recapture SDAI Remission After Starting Rescue Treatment

"In participants who receive rescue treatment during the double-blind treatment period.~The SDAI is a composite score that is based on the number of tender and swollen joints using a 28-joint count, Physician's Global Assessment of Disease Activity using a visual analog scale (VAS) where 0=no activity at all and 100=worst activity imaginable, Patient's Global Assessment of Disease Activity using a VAS where 0=no arthritis activity at all and 100=worst arthritis activity imaginable, and C-reactive protein (CRP) in mg/dL. The SDAI score ranges from 0 to 86, with higher scores representing worse disease. SDAI remission was defined as a score of ≤ 3.3." (NCT02373813)
Timeframe: Between rescue and remission or Week 48, whichever comes first.

Interventionweeks (Median)
Double-Blind Treatment: Methotrexate Monotherapy11.00
Double-Blind Treatment: Etanercept Monotherapy12.00
Double-Blind Treatment: Etanercept Plus Methotrexate11.36

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Time to Disease Worsening

"Disease worsening is defined as any of the following:~an SDAI > 3.3 and ≤ 11 during 2 consecutive visits at least 2 weeks apart~SDAI > 3.3 and ≤ 11 on 3 or more separate visits~SDAI > 11 after randomization.~The SDAI is a composite score that is based on the number of tender and swollen joints using a 28-joint count, Physician's Global Assessment of Disease Activity using a visual analog scale (VAS) where 0=no activity at all and 100=worst activity imaginable, Patient's Global Assessment of Disease Activity using a VAS where 0=no arthritis activity at all and 100=worst arthritis activity imaginable, and C-reactive protein (CRP) in mg/dL. The SDAI score ranges from 0 to 86, with higher scores representing worse disease. SDAI remission was defined as a score of ≤ 3.3." (NCT02373813)
Timeframe: up to Week 48

Interventionweeks (Median)
Double-Blind Treatment: Methotrexate Monotherapy12.14
Double-Blind Treatment: Etanercept Monotherapy13.21
Double-Blind Treatment: Etanercept Plus Methotrexate18.93

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Change From Baseline in DAS28-ESR at All Measured Timepoints

The DAS28-ESR is a modified composite index that was designed to measure disease activity using the number of tender and swollen joints based upon a 28-joint count, ESR in mm/hr, and a 100 mm VAS measuring the participant's general health, from 0 (best) to 100 (worst). DAS28-ESR scores range from 0 to 9.4, where higher scores represent higher disease activity. A negative change from baseline indicates improvement. (NCT02373813)
Timeframe: Baseline, Week 12, Week 24, Week 36 and Week 48

,,
Interventionscore on a scale (Mean)
Change at Week 12Change at Week 24Change at Week 36Change at Week 48
Double-Blind Treatment: Etanercept Monotherapy0.500.690.310.34
Double-Blind Treatment: Etanercept Plus Methotrexate0.480.340.350.32
Double-Blind Treatment: Methotrexate Monotherapy0.960.650.530.43

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Percentage of Participants With a Reduction of Pain as Measured Using a Visual Analog Scale (VAS) at Weeks 2, 12 and 24

Reduction of Pain, defined as a ≥40% change from Baseline as measured using a 100 mm Visual Analog Scale (VAS); left end of the line 0=no pain to right end of the line 100=unbearable pain at weeks 2, 12 and 24. (NCT02379091)
Timeframe: Baseline and Week 2, 12 and 24

,,,
Interventionpercentage of participants (Number)
Week 2Week 12Week 24
Namilumab 150 mg/mL3.630.824.0
Namilumab 20 mg/mL14.344.043.5
Namilumab 80 mg/mL8.739.147.8
Placebo7.720.822.7

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Percentage of Participants Achieving American College of Rheumatology 20% (ACR20), 50% (ACR 50) and 70% (ACR70) Response at Weeks 12 and 24

"ACR20/50/70 response is defined as a ≥20/50/70% reduction from Baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), and the following:~Patient's Assessment of Pain over the previous 24 hours using a Visual Analog Scale (VAS); left end of the line 0=no pain to right end of the line 100=unbearable pain~Patient's Global Assessment of Disease Activity~Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity~Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do~Acute-phase reactant: C-reactive Protein (CRP)." (NCT02379091)
Timeframe: Baseline and Weeks 12 and 24

,,,
Interventionpercentage of participants (Number)
ACR 20, Week 12ACR 50, Week 12ACR 70, Week 12ACR 20, Week 24ACR 50, Week 24ACR 70, Week 24
Namilumab 150 mg/mL53.838.515.456.036.020.0
Namilumab 20 mg/mL72.020.04.065.234.813.0
Namilumab 80 mg/mL52.230.421.747.847.830.4
Placebo37.516.78.333.323.819.0

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Change From Baseline in DAS28-CRP at Weeks 2, 6, and 10

The DAS28-CRP 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], general health: patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and acute phase response: C-Reactive Protein (CRP) for a total possible score of 0 (best) to approximately 10 (worst). Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicates improvement. A MMRM model with main effects for study site, treatment, visit, and previously failed medication with interactions between visit and treatment, visit and previously failed medication, and visit and baseline value as a covariate and participant as a random effect with an unstructured covariance structure was used for analysis. (NCT02379091)
Timeframe: Baseline and Weeks 2, 6 and 10

,,,
Interventionscore on a scale (Least Squares Mean)
Change at Week 2Change at Week 6Change at Week 10
Namilumab 150 mg/mL-0.95-1.42-1.51
Namilumab 20 mg/mL-0.58-1.13-1.19
Namilumab 80 mg/mL-0.84-1.37-1.39
Placebo-0.33-0.70-0.75

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Change From Baseline in Disease Activity Score 28 C-Reactive Protein (DAS28-CRP) at Week 12

The DAS28-CRP 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], general health: patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and acute phase response: C-Reactive Protein (CRP) for a total possible score of 0 (best) to approximately 10 (worst). Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicates improvement. A mixed model repeated measures (MMRM) model with main effects for study site, treatment, visit, and previously failed medication with interactions between visit and treatment, visit and previously failed medication, and visit and baseline value as a covariate and participant as a random effect with an unstructured covariance structure was used for analysis. (NCT02379091)
Timeframe: Baseline and Week 12

Interventionscore on a scale (Least Squares Mean)
Placebo-0.77
Namilumab 20 mg/mL-1.38
Namilumab 80 mg/mL-1.36
Namilumab 150 mg/mL-1.69

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ACR Numeric (N) Index (ACRn) at Week 12

ACRn is defined as the lowest % improvement for TJC68, SJC66 and the median of 5 ACR components. These are • Patient's Assessment of Pain over previous 24 hours using a VAS; left end of line 0=no pain to right end of line 100=unbearable pain • Patient's Global Assessment of Disease Activity • Physician's Global Assessment of Disease Activity over previous 24 hours using a VAS where left end of line 0=no disease activity to right end of line 100=maximum disease activity • Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do • Acute-phase reactant: CRP. A positive % change indicates improvement. MMRM model with main effects for study site, treatment, visit, and previously failed medication with interactions between visit and treatment and visit and previously failed medication and participant used as a random effect with an unstructured covariance structure. (NCT02379091)
Timeframe: Baseline and Week 12

Interventionpercentage change (Least Squares Mean)
Placebo-17.25
Namilumab 20 mg/mL3.97
Namilumab 80 mg/mL19.68
Namilumab 150 mg/mL17.14

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ACR Numeric (N) Index (ACRn) at Week 24

ACRn is defined as the lowest % improvement for TJC68, SJC66 and the median of 5 ACR components. These are • Patient's Assessment of Pain over previous 24 hours using a VAS; left end of line 0=no pain to right end of line 100=unbearable pain • Patient's Global Assessment of Disease Activity • Physician's Global Assessment of Disease Activity over previous 24 hours using a VAS where left end of line 0=no disease activity to right end of line 100=maximum disease activity • Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do • Acute-phase reactant: CRP. A positive % change indicates improvement. MMRM model with main effects for study site, treatment, visit, and previously failed medication with interactions between visit and treatment and visit and previously failed medication and participant used as a random effect with an unstructured covariance structure. (NCT02379091)
Timeframe: Baseline and Week 24

Interventionpercentage change (Mean)
Placebo34.04
Namilumab 20 mg/mL35.35
Namilumab 80 mg/mL44.66
Namilumab 150 mg/mL36.57

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Change From Baseline in DAS28-CRP at Week 24

The DAS28-CRP 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], general health: patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and acute phase response: C-Reactive Protein (CRP) for a total possible score of 0 (best) to approximately 10 (worst). Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicates improvement. (NCT02379091)
Timeframe: Baseline and Week 24

Interventionscore on a scale (Mean)
Placebo-1.75
Namilumab 20 mg/mL-2.37
Namilumab 80 mg/mL-2.20
Namilumab 150 mg/mL-2.26

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Overall Response Rate

"Secondary objectives are to determine the efficacy and tolerability of selinexor in combination with mFOLFOX6 in patients with metastatic colorectal cancer by~- Overall response rate (RR) (acc. to RECIST v1.1)~Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed byCT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR." (NCT02384850)
Timeframe: 2 years

InterventionParticipants (Count of Participants)
Selinexor 40 mg+ mFOLFOX60
Selinexor 20mg + mFOLFOX61

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Progression Free Survival (PFS)

"Secondary objectives are to determine the efficacy and tolerability of selinexor in combination with mFOLFOX6 in patients with metastatic colorectal cancer by~- Progression free survival (PFS) The disease status was measured by CT/MRI and evaluated according to RECIST 1.1 criteria every 8 weeks during treatment, at End of Treatment and every 3 weeks during Follow-up to determine time until patient has Progressive Disease (PD). PD is defined according to RECIST v1.1 at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression." (NCT02384850)
Timeframe: 2 years

Interventionmonths (Mean)
Selinexor 40 mg+ mFOLFOX6NA
Selinexor 20mg + mFOLFOX6NA

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Numbers of Patients With Dose Limiting Toxicities

"Primary objective is the determination of the maximum tolerated dose (MTD) of selinexor in combination with mFOLFOX6 in patients with metastatic colorectal cancer.~Criteria to assess MTD was the experience of AEs > grade 3, discontinuation from study treatment due to adverse events or withdrawal of consent by the patients." (NCT02384850)
Timeframe: 28 days of treatment

,
InterventionParticipants (Count of Participants)
Discontinuation due to Adverse eventsDiscontinuation due to Withdrawal of ConsentDiscontinuation due to Progressive Disease
Selinexor 20mg + mFOLFOX6222
Selinexor 40 mg+ mFOLFOX6220

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Number of Patients Experiencing Adverse Events

"Secondary objectives are to determine the efficacy and tolerability of selinexor in combination with mFOLFOX6 in patients with metastatic colorectal cancer by~- Toxicity (acc. to NCI Common Terminology Criteria for Adverse Events (CTC AE) v4.03)" (NCT02384850)
Timeframe: treatment start to up to 30 days after last dose

,
InterventionParticipants (Count of Participants)
Patients with AEs of any CTCAE GradePatients with AEs of at least CTCAE Grade 3Patients with Selinexor related AEs of any GradePatients with Selinexor related AEs of at least Grade 3Patients with chemotherapy related AEs of any GradePatients with chemotherapy related AEs of at least Grade 3Patients with AEs leading to discontinuationPatients with at least 1 SAEPatients with at least 1 SAE related to SelinexorPatients with at least 1 SAE related to chemotherapy
Selinexor 20mg + mFOLFOX66645632313
Selinexor 40 mg+ mFOLFOX64444442211

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Number of Patients Still Alive at End of Study (Overall Survival)

"Secondary objectives are to determine the efficacy and tolerability of selinexor in combination with mFOLFOX6 in patients with metastatic colorectal cancer by~- Overall survival (OS)~Overall survial is defined as length of time from start of treatment that patients are still alive. For this time-to-event variables the Kaplan-Meier method was intended to be used" (NCT02384850)
Timeframe: 2 years

InterventionParticipants (Count of Participants)
Selinexor 40 mg+ mFOLFOX60
Selinexor 20mg + mFOLFOX62

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Change From Baseline in DAS28-CRP Score

The DAS28-CRP is a composite measure of inflammation in RA 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. (NCT02393378)
Timeframe: Baseline Up to Week 42

,
Interventionscore on a scale (Mean)
Week 2Week 6Week 10Week 12Week 18Week 24Week 32Week 42
Adalimumab 40 mg-0.55-1.36-1.74-1.94-2.05-2.04-1.89-1.99
Namilumab 150 mg-0.78-1.58-1.83-2.12-2.72-2.99-2.38-1.57

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Change From Baseline in Synovitis, Erosion and Bone Marrow Edema (Osteitis) Score at Week 24

A Magnetic Resonance Imaging (MRI) of Metacarpophalangeal (MCP) and Wrist of the dominant hand was performed at the baseline and at week 24. Change from the Baseline was assessed according to the Outcome Measures in Rheumatoid Arthritis (RA) Clinical Trials RA-MRI scoring (OMERACT RAMRIS) Standard. RAMRIS score is the sum of its core components: Synovitis Score, Edema Score, and Erosion Score. Synovitis is scored from 0 (normal) to 9 (maximum distension of synovial cavity). Edema is scored 0 (normal) to 69 (maximum articular bone involvement). Erosion is scored from 0 (normal) to 230 (maximum erosion of articular bone). Total RAMRIS score=0 (normal), maximum RAMRIS score=308 (severe structural damage). For Synovial Score, Edema Score, Erosion Score, and RAMRIS score, increasing number = increasing severity. (NCT02393378)
Timeframe: Baseline and Week 24

,
Interventionscore on a scale (Mean)
Erosion Score, Change at Week 24Synovitis Score, Change at Week 24Osteitis Score, Change at Week 24
Adalimumab 40 mg0.500.17-0.33
Namilumab 150 mg0.00-1.50-2.00

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Number of Participants Who Achieved ACR 20, 50, and 70 at Week 24

The American College of Rheumatology (ACR) 20 is composite index of improvement in RA proposed by the ACR. ACR20 refers to a composite improvement of 20% in swollen joint count, tender joint count, and 3 or more of the following 5 measures: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity, Patient Pain VAS, Patient's self-addressed disability (HAQ), Acute-phase reactant (ESR or CRP) The ACR 50 and ACR 70 are similar tools, used to indicate 50% and 70% improvement, respectively. (NCT02393378)
Timeframe: Week 24

,
InterventionParticipants (Count of Participants)
ACR 20ACR 50ACR 70
Adalimumab 40 mg221
Namilumab 150 mg432

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Number of Participants Who Achieved Remission at Week 24

Remission is defined as the number of participants who achieved Disease Activity Score 28 based on C-reactive protein (DAS28-CRP) score <2.6. The DAS28-CRP is a composite measure of inflammation in rheumatoid arthritis (RA) 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 ≤2.6 with disease flare accompanying scores of ≥5.1; well-controlled disease is best characterized as fitting in between these two scores. (NCT02393378)
Timeframe: Week 24

InterventionParticipants (Count of Participants)
Adalimumab 40 mg0
Namilumab 150 mg2

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Number of Participants Who Achieved Low Disease Activity at Week 24

Disease Activity Score 28 based on C-reactive protein (DAS28-CRP) low disease activity is defined as a score <3.2. The DAS28-CRP is a composite measure of inflammation in RA 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 ≤2.6 with disease flare accompanying scores of ≥5.1; well-controlled disease is best characterized as fitting in between these two scores. (NCT02393378)
Timeframe: Week 24

InterventionParticipants (Count of Participants)
Adalimumab 40 mg2
Namilumab 150 mg4

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Change From Baseline in Dynamic Contrast-enhanced - Magnetic Resonance Imaging (DCE-MRI) Parameters at Week 24

DCE-MRI was used to measure synovial vascular perfusion. The change from baseline in DCE-MRI parameters of synovial vascular perfusion at Week 24 were measured. (NCT02393378)
Timeframe: Baseline and Week 24

InterventionmL (Mean)
Adalimumab 40 mg0.016
Namilumab 150 mg-0.052

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Number of Participants With Adverse Events

adverse events includes injection site reactions, influenza-like symptoms, infection, fever, tumor, cardiovascular event, drug-induced liver and kidney damage. (NCT02467504)
Timeframe: Up to week 24

InterventionParticipants (Count of Participants)
Experimental11
Placebo Comparator9

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The Change From Baseline of Patient's Assessment of Arthritis Pain (PtAAP)

VAS score from 0 to 100 for Patient's Assessment of Arthritis Pain higher scores mean a worse outcome. The change from baseline of PtAAP, the minimum is -100, the maximum is 100. (NCT02467504)
Timeframe: week 12, week 24

,
Interventionscore on a scale (Median)
week 24week 12
Experimental-57.5-57.1
Placebo Comparator-33.3-27.3

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The Change From Baseline of Clinical Disease Activity Index (CDAI)

"Clinical Disease Activity Index(CDAI), the minimum is 0, the maximum is 76. higher scores mean a worse outcome.~The change of from baseline of CDAI, the minimum is -76, the maximum is 76. higher scores mean a worse outcome." (NCT02467504)
Timeframe: week 12, week 24

,
Interventionscore on a scale (Median)
week 24week 12
Experimental-17.5-15.0
Placebo Comparator-11-8.0

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The Change From Baseline of a Health Assessment Questionnaire- Disability Index (HAQ-DI)

"The domains of the HAQ-DI are dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. The total score ranges from 0 to 3 with lower scores meaning lower disability.~The change from baseline of HAQ-DI, minimum is -3, the maximum is 3. higher scores mean a worse outcome." (NCT02467504)
Timeframe: week 12, week 24

,
Interventionscore on a scale (Median)
week 24week 12
Experimental-0.63-0.50
Placebo Comparator-0.38-0.25

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Percentage of Participants Meeting the American College of Rheumatology 70% Response Criteria

The assessments are based on a 70% or greater improvement from Baseline in the number of tender joints, a 70%, or more improvement in the number of swollen joints, and a 70% or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). (NCT02467504)
Timeframe: week 12, week 24

,
InterventionParticipants (Count of Participants)
week 24week 12
Experimental42
Placebo Comparator20

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The Change From Baseline of Patient's Global Assessment of Disease Activity (PtGADA)

VAS score from 0 to 100 for Patient's Global Assessment of Disease Activity Higher scores mean a worse outcome. The change from baseline of PtGADA, the minimum is -100, the maximum is 100. Higher scores mean a worse outcome. (NCT02467504)
Timeframe: week 12, week 24

,
Interventionscore on a scale (Median)
week 24week 12
Experimental-57.5-57.1
Placebo Comparator-33.3-33.3

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Percentage of Participants Meeting the American College of Rheumatology 50% Response Criteria

The assessments are based on a 50% or greater improvement from Baseline in the number of tender joints, a 50%, or more improvement in the number of swollen joints, and a 50% or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). (NCT02467504)
Timeframe: week 12, week 24

,
InterventionParticipants (Count of Participants)
week 24weed 12
Experimental106
Placebo Comparator83

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Percentage of Participants Meeting the American College of Rheumatology 20% Response Criteria

The assessments are based on a 20% or greater improvement from Baseline in the number of tender joints, a 20%, or more improvement in the number of swollen joints, and a 20% or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). (NCT02467504)
Timeframe: week 12, week 24

,
InterventionParticipants (Count of Participants)
week 24week 12
Experimental1312
Placebo Comparator1310

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Percentage of Participants Meeting the 2011 American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) Remission Criteria Simplified for Clinical Practice

The 2011 ACR/EULAR remission criteria simplified for clinical practice is defined as:Tender Joint Count (TJC) ≤ 1, Swollen Joint Count (SJC) ≤ 1 and Patient's Global Assessment of Disease Activity (PtGADA) ≤ 1. (NCT02467504)
Timeframe: week 12, week 24

,
InterventionParticipants (Count of Participants)
week 24week 12
Experimental20
Placebo Comparator10

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Percentage of Participants Achieving DAS28 Low Disease Activity.

Low disease activity is defined by a disease activity score (28 joint) calculated using the erythrocyte sedimentation rate (DAS28-ESR) of less than 3.2 (NCT02467504)
Timeframe: week 12, week 24

,
InterventionParticipants (Count of Participants)
week 24week 12
Experimental87
Placebo Comparator97

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Percentage of Participants Achieving a Good or Moderate European League Against Rheumatism (EULAR) Response

"Good response is defined as: DAS28-ESR ≤ 3.2 and decrease from Baseline by > 1.2.~moderate response is defined as achievement of one of the following: DAS28-ESR ≤ 3.2 and decrease from Baseline > 0.6 and ≤ 1.2 DAS28-ESR > 3.2 and ≤ 5.1 and decrease from Baseline > 0.6 DAS28-ESR > 5.1 and decrease from Baseline >1.2." (NCT02467504)
Timeframe: week 12, week 24

,
InterventionParticipants (Count of Participants)
week 24week 12
Experimental1715
Placebo Comparator2014

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Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]-2

In the last month, number of work days missed, number of work days with reduced productivity. In the last month, number of days with no household work, number of days with reduced household work productivity, number of days with hired outside help, number of days missed of family/social/leisure activities in the last month.higher scores mean a worse outcome. (NCT02467504)
Timeframe: week 24

,
Interventiondays (Median)
number of work days with reduced productivitynumber of work days missedHousehold work days missed due to arthritisDays with household work productivity reducedDays with activities missed due to arthritisDays with outside help hired due to arthritis
Experimental3.5001550
Placebo Comparator0001200

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The Change From Baseline of Simplified Disease Activity Index (SDAI)

"Simplified Disease Activity Index(SDAI). the minimum is 0, the maximum is 96. higher scores mean worse outcome.~The change from baseline of SDAI. the minimum is -96, the maximum is 96. higher scores mean worse outcome." (NCT02467504)
Timeframe: week 12, week 24

,
Interventionscore on a scale (Median)
week 24week 12
Experimental-19.0-16.9
Placebo Comparator-12.1-9.2

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The Change From Baseline of Physician's Global Assessment of Disease Activity (PhGADA)

VAS score from 0 to 100 for Physician's Global Assessment of Disease Activity higher scores mean a worse outcome. The change from baseline, the minimum is -100, the maximum is 100. (NCT02467504)
Timeframe: week 12, week 24

,
Interventionscore on a scale (Median)
week 24week 12
Experimental-58.3-57.1
Placebo Comparator-44.4-25.0

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The Scores of SF-36 Quetionnaire

Score ranging from 0 to 100 with higher scores a better outcome. (NCT02467504)
Timeframe: week 12, week 24

,
Interventionscore on a scale (Median)
week 24week 12
Experimental15.2924.32
Placebo Comparator6.9027.25

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Percentage of Participants Achieving DAS28 Remission.

DAS 28 remission is defined by a disease activity score (28 joint) calculated using the erythrocyte sedimentation rate (DAS28-ESR) of less than 2.6 (NCT02467504)
Timeframe: week 24

InterventionParticipants (Count of Participants)
Experimental6
Placebo Comparator6

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C Reactive Protein (CRP)

(NCT02467504)
Timeframe: week 12, week 24

,
Interventionmg/L (Mean)
week 24week 12
Experimental21.69.5
Placebo Comparator15.327.8

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Erythrocyte Sedimentation Rate (ESR)

(NCT02467504)
Timeframe: week 12, week 24

,
Interventionmillimeter/hour (Mean)
Week 24Week 12
Experimental43.329.6
Placebo Comparator36.828.3

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Percentage of CD4+ Treg Cells

analysis regulatory CD4+ T(Treg) cells before and during IL-2 treatment. P values<0.05 are considered statistically significant. (NCT02467504)
Timeframe: week 12, week 24

,
Interventionpercentage of CD4+ T cells (Mean)
Week 24Week 12
Experimental6.946.84
Placebo Comparator6.465.37

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Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]

The Arthritis interference in the last month with work productivity is measured on a scale that ranges from 0 (no interference) to 10 (complete interference). The Arthritis interference in the last month with household work productivity is measured on a scale that ranges from 0 (no interference) to 10 (complete interference).higher scores mean a worse outcome. (NCT02467504)
Timeframe: week 24

,
Interventionunits on a scale (Median)
rate of Arthritis interferenceRate of arthritis interference with household work
Experimental35
Placebo Comparator25

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Percentage of Participants Who Achieved Disease Activity Score for 28 Different Joints With C-reactive Protein Value (DAS28{CRP}) Remission (DAS28 <2.6) at Week 24

DAS28 is a modification of the original DAS and is based on a count of 28 swollen and tender joints and is used to evaluate a participant's response to treatment. DAS 28 CRP utilizing joint scores from the following 28 joints: elbows, shoulders, elbow, wrists, metacarpal- phalangeal I-V, proximal interphalangeal I-V and knees and is calculated using the following formula: DAS28 (CRP) = 0.56*√(TJC28) +0.28*√(SJC28)+0.014*GH+0.36*ln(CRP+1)+0.96. Where TJC - Tender joint Count, SJC= Swollen Joint Count, (GH=participant assessment of disease activity using a 100 millimeter [mm] visual analogue scale with 0 = best, 100 = worst) and CRP= C reactive Protein (in [milligrams/liter] mg/L). It ranges between 0.96 and 8.61. High score (worse outcome) and low scores (better outcome). ITT population comprised of all participants who were randomized to treatment and who received at least one dose of study treatment (GSK3196165 or placebo). (NCT02504671)
Timeframe: Week 24

InterventionPercentage of participants (Number)
Placebo3
GSK3196165 22.5 mg5
GSK3196165 45 mg16
GSK3196165 90 mg19
GSK3196165 135 mg14
GSK3196165 180 mg14

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Time to First DAS28(CRP) Remission

The DAS index combines information relating to the number of swollen and tender joints. The DAS28 is a modification of the original DAS and is based on a count of 28 swollen and tender joints and is used to evaluate a participant's response to treatment. DAS 28 CRP utilizing joint scores from the following 28 joints: elbows, shoulders, elbow, wrists, metacarpal- phalangeal I-V, proximal interphalangeal I-V and knees and is calculated using the following formula: DAS28 (CRP) = 0.56*√(TJC28) +0.28*√(SJC28)+0.014*GH+0.36*ln(CRP+1)+0.96. Where TJC - Tender joint Count, SJC= Swollen Joint Count, (GH=participant assessment of disease activity using a 100 mm visual analogue scale with 0 = best, 100 = worst) and CRP= C reactive Protein (in mg/L). It ranges between 0.96 and 8.61. High score (worse outcome) and low scores (better outcome). Median time, to remission has been presented. (NCT02504671)
Timeframe: Up to Week 62

InterventionWeeks (Median)
Placebo9.10
GSK3196165 22.5 mg12.05
GSK3196165 45 mg16.10
GSK3196165 90 mg8.10
GSK3196165 135 mg19.90
GSK3196165 180 mg18.20

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Change From Baseline in Brief Fatigue Inventory (BFI) Question 3 at All Assessment Time Points

BFI is a self-reported instrument consisting of nine questions which correlate well with quality-of-life measures. For this study, Question 3 only was used which asked about fatigue severity at its worst in the last 24 hours. A discrete 11 unit numeric reporting scale was used where 0 =No fatigue, and 10=As bad as you can imagine. Baseline was defined as the last available assessment prior to the start of study treatment. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. (NCT02504671)
Timeframe: Baseline and Weeks 4, 12, 24

,,,,,
InterventionScores on a scale (Least Squares Mean)
Week 4,n=34,34,36,37, 36, 36Week 12,n=34,35,35,37, 35, 36Week 24,n=8,14,21,24, 19, 34
GSK3196165 135 mg-1.86-2.07-2.59
GSK3196165 180 mg-1.53-2.20-2.41
GSK3196165 22.5 mg-0.67-1.26-2.19
GSK3196165 45 mg-1.10-1.83-1.76
GSK3196165 90 mg-1.60-2.02-2.03
Placebo-0.60-0.63-1.83

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Change From Baseline in CDAI at All Assessment Time Points

CDAI combines information relating to the number of swollen and tender joints, in addition to a measure of general health from both the participants and the physician. CDAI utilizing joint scores from the following 28 joints: elbows, shoulders, elbow, wrists, metacarpal- phalangeal I-V, proximal interphalangeal I-V and knees and is calculated using the following formula: CDAI =TJC28 + SJC28 + GH + GP Where TJC - Tender joint Count, SJC= Swollen Joint Count, (GH=participant assessment of disease activity and GP=physician assessment of disease activity using a 10 cm visual analogue scale with 0 = best, 100 = worst). It ranges between 0 and 76. High score indicates worse outcome, low score indicates better outcome. Baseline was defined as the last available assessment prior to the start of study treatment. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. (NCT02504671)
Timeframe: Baseline and Weeks 1, 2, 4, 6, 8, 12, 16, 20 and 24

,,,,,
InterventionScores on a scale (Least Squares Mean)
CDAI, Week 1, n=36,36,33,36, 35, 37CDAI, Week 2,n=35,34,36,37, 36, 37CDAI, Week 4,n=33,33,35,36, 36, 36CDAI, Week 6,n=35,35,33,37, 34, 36CDAI, Week 8,n=34,33,35,37, 35, 34CDAI, Week 12,n=34,35,35,37, 35, 36CDAI, Week 16,n=8,16,21,23, 18, 36CDAI, Week 20,n=8,15,21,25, 18, 35CDAI, Week 24,n=8,14,21,24, 19, 33
GSK3196165 135 mg-5.23-10.35-12.88-13.82-17.94-16.26-21.14-23.46-21.19
GSK3196165 180 mg-8.73-11.10-17.14-18.37-21.36-23.23-24.47-25.58-25.65
GSK3196165 22.5 mg-5.18-8.42-12.15-13.68-13.98-13.40-17.30-15.87-15.14
GSK3196165 45 mg-5.18-7.72-11.68-14.05-16.17-16.39-21.94-22.31-20.88
GSK3196165 90 mg-5.76-9.45-14.15-14.83-16.31-20.47-22.05-22.81-20.67
Placebo-1.34-4.25-4.95-8.20-7.57-6.59-15.61-16.91-5.77

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Change From Baseline in DAS28(CRP) at All Assessment Time Points

DAS28 is a modification of the original DAS and is based on a count of 28 swollen and tender joints and is used to evaluate a participant's response to treatment. DAS 28 CRP utilizing joint scores from the following 28 joints: elbows, shoulders, elbow, wrists, metacarpal- phalangeal I-V, proximal interphalangeal I-V and knees and is calculated using the following formula: DAS28 (CRP) = 0.56*√(TJC28) +0.28*√(SJC28)+0.014*GH+0.36*ln(CRP+1)+0.96. Where TJC - Tender joint Count, SJC= Swollen Joint Count, (GH=participant assessment of disease activity using a 100 mm visual analogue scale with 0 = best, 100 = worst) and CRP= C reactive Protein (in mg/L). It ranges between 0.96 and 8.61. High score (worse outcome) and low scores (better outcome). Baseline was defined as the last available assessment prior to the start of study treatment. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline. (NCT02504671)
Timeframe: Baseline and Weeks 1, 2, 4, 6, 8, 12, 16, 20 and 24

,,,,,
InterventionScores on a scale (Least Squares Mean)
Week 1; n=35, 36, 33, 35, 34, 37Week 2; n=36, 35, 34, 36, 36, 36Week 4; n=32, 33, 34, 36, 36, 36Week 6; n=35, 34, 34, 36, 33, 36Week 8; n=34, 33, 34, 37, 35, 32Week 12; n=34, 35, 33, 37, 34, 36Week 16; n=8, 16, 20, 24, 18, 36Week 20; n=8, 15, 20, 25, 19, 36Week 24; n=8, 14, 20, 24, 19, 33
GSK3196165 135 mg-0.55-0.84-1.12-1.12-1.51-1.28-1.64-2.00-1.71
GSK3196165 180 mg-0.63-0.88-1.46-1.51-1.72-1.87-1.98-2.03-2.05
GSK3196165 22.5 mg-0.47-0.64-0.85-1.07-1.04-1.13-1.16-1.30-1.45
GSK3196165 45 mg-0.44-0.69-1.01-1.12-1.40-1.48-1.86-1.81-1.76
GSK3196165 90 mg-0.52-0.78-1.21-1.26-1.44-1.84-1.88-1.89-1.62
Placebo-0.14-0.37-0.45-0.65-0.61-0.60-0.87-1.23-0.23

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Change From Baseline in DAS28(CRP) at Week 12

DAS28 is a modification of the original DAS and is based on a count of 28 swollen and tender joints and is used to evaluate a participant's response to treatment. DAS 28 CRP utilizing joint scores from the following 28 joints: elbows, shoulders, elbow, wrists, metacarpal- phalangeal I-V, proximal interphalangeal I-V and knees and is calculated using the following formula: DAS28 (CRP) = 0.56*√(TJC28) +0.28*√(SJC28)+0.014*GH+0.36*ln(CRP+1)+0.96. Where TJC - Tender joint Count, SJC= Swollen Joint Count, (GH=participant global assessment of disease activity (PtGA) using a 100 mm visual analogue scale with 0 = best, 100 = worst) and CRP= C reactive Protein (in mg/L). It ranges between 0.96 and 8.61. High score (worse outcome) and low scores (better outcome). Baseline was defined as the last available assessment prior to the start of study treatment. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. (NCT02504671)
Timeframe: Baseline and Week 12

,,,,,
InterventionScores on a scale (Least Squares Mean)
CRPPtGASJC28TJC28
GSK3196165 135 mg-7.71-19.35-5.33-6.43
GSK3196165 180 mg-7.21-23.90-8.39-9.13
GSK3196165 22.5 mg-4.75-14.40-4.77-5.11
GSK3196165 45 mg-8.57-20.40-5.52-6.73
GSK3196165 90 mg-7.79-24.11-6.91-8.53
Placebo-5.21-6.72-2.35-2.81

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Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue at All Assessment Time Points

The FACIT-fatigue questionnaire is a participant reported measure developed to assess fatigue consisting of 13 statements regarding feeling fatigue using a numeric rating scale ranging from 0 to 4. For only two of the items (i.e. Answer 5 [An5] and An7) a higher value represents a lower fatigue; 11 of the item scores (i.e. HI7, HI12, An1, An2, An3, An4, An8, An12, An14, An15, An16) have to be reversed by subtracting the captured value from 4 (0 is turned to a 4; 1 into 3; 3 into 1; 4 into 0). After performing the reversals the sum of the non-missing individual items were multiplied by 13 and divided by the number of the non-missing individual items. The final score ranges from 0 to 52 with higher values representing a lower fatigue (i.e. a better quality of life). Baseline was defined as the last available assessment prior to the start of study treatment. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. (NCT02504671)
Timeframe: Baseline and Weeks 4, 12, 24

,,,,,
InterventionScores on a scale (Least Squares Mean)
Week 4,n=34,34,36,37, 36, 36Week 12,n=34,35,35,37, 35, 36Week 24,n=8,14,21,24, 19, 34
GSK3196165 135 mg6.737.288.28
GSK3196165 180 mg5.978.709.43
GSK3196165 22.5 mg2.515.298.31
GSK3196165 45 mg4.665.917.09
GSK3196165 90 mg5.716.446.74
Placebo3.163.377.56

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Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at All Assessment Time Points

HAQ-DI is 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in eight functional areas;dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. Each functional area contains at least two questions. For each question, there is a four level response set that is scored from 0 (without any difficulty) to 3 (unable to do). If aids or devices or physical assistance are used for a specific functional area and the maximum response of this functional area is 0 or 1 the according value is increased to a score of 2. HAQ-DI is only calculated if there are at least 6 functional area scores available. The average of these non-missing functional area scores defines the continuous HAQ-DI score ranging from 0 to 3. Baseline was defined as the last available assessment prior to the start of study treatment. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. (NCT02504671)
Timeframe: Baseline and Weeks 1, 2, 4, 6, 8, 12, 16, 20 and 24

,,,,,
InterventionScores on a scale (Least Squares Mean)
HAQ-DI, Week 1,n=36,36,35,36, 36, 37HAQ-DI, Week 2,n=36,35,37,37, 36, 37HAQ-DI, Week 4,n=34,34,36,37, 36, 36HAQ-DI, Week 6,n=35,35,35,37, 36, 36HAQ-DI, Week 8,n=34,34,35,37, 35, 34HAQ-DI, Week 12,n=34,35, 35, 37,35, 36HAQ-DI, Week 16,n=8,16,21,24, 18, 36HAQ-DI, Week 20,n=8,15,21,25, 19, 36HAQ-DI, Week 24,n=8,14,21,24, 19, 34
GSK3196165 135 mg-0.13-0.25-0.29-0.21-0.35-0.38-0.40-0.49-0.42
GSK3196165 180 mg-0.17-0.26-0.40-0.43-0.42-0.50-0.50-0.56-0.54
GSK3196165 22.5 mg-0.08-0.13-0.18-0.22-0.18-0.31-0.33-0.37-0.32
GSK3196165 45 mg-0.08-0.16-0.17-0.27-0.33-0.30-0.38-0.42-0.41
GSK3196165 90 mg-0.10-0.23-0.29-0.33-0.31-0.37-0.57-0.51-0.43
Placebo-0.09-0.17-0.22-0.23-0.22-0.26-0.49-0.35-0.34

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Change From Baseline in Pain Score at All Assessment Time Points

Participants assessed the severity of their current arthritis pain using a 100 unit visual analog scale (VAS) by placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponds to the magnitude of their pain. Baseline was defined as the last available assessment prior to the start of study treatment. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. (NCT02504671)
Timeframe: Baseline and Weeks 1, 2, 4, 6, 8, 12, 16, 20 and Week 24

,,,,,
InterventionScores on a scale (Least Squares Mean)
Week 1,n=36,36,35,36, 36,37Week 2,n=36,35,37,37,36,37Week 4,n=34,34,36,37, 36,36Week 6,n=35,35,35,37, 36, 36Week 8,n=34,34,35,37, 35,34Week 12,n=34, 35,35,37, 35, 36Week 16,n=8,16,21,24, 18, 16Week 20,n=8,15,21,25, 19,36Week 24,n=8,14,21,24, 19, 34
GSK3196165 135 mg-7.18-11.63-13.39-14.05-20.49-19.07-25.80-27.86-26.61
GSK3196165 180 mg-7.89-14.22-19.40-19.12-24.38-25.01-24.48-27.17-30.08
GSK3196165 22.5 mg-4.71-6.71-8.47-11.18-9.60-14.09-17.50-14.64-19.76
GSK3196165 45 mg-5.02-9.77-14.83-14.71-18.55-21.22-28.56-27.12-23.52
GSK3196165 90 mg-9.96-11.37-17.65-15.05-17.92-25.25-26.46-27.44-25.45
Placebo-2.25-3.79-5.44-6.69-3.98-7.07-12.60-13.95-13.38

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Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points

SF-36 is a generic health survey containing 36 questions covering 8 domains of health. SF-36 yields an 8-scale profile of functional health and well-being scores as well as PCS and MCS health summary scores. The version 2, 1-week recall questionnaire was used. Recoding, calculations and standardization were done as per the User's manual of SF-36. Domain scores were only calculated if less than half of the item scores were missing. All raw domain scores were transformed on a 0-100 scale (transformed domain scores) and then standardized into norm-based scores using Z-score. Following the transformation of the 8 domain scores into z-scores, the MCS and PCS were aggregated (AGG) using weights as PCS/MCS = 50 + (AGG_PHYS *10/AGG_MENT *10). High score (worse outcome) and low score (better outcome). Baseline was defined as the last available assessment prior to the start of study treatment. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. (NCT02504671)
Timeframe: Baseline and Weeks 4, 12, 24

,,,,,
InterventionScores on a scale (Least Squares Mean)
PCS, Week 4,n=34,34,36,37,36,36,PCS Week 12,n=34,35,35,37,35,36PCS, Week 24,n=8,14,21,24,19,34MCS, Week 4,n=34,34,36,37,36,36,MCS, Week 12,n=34,35,35,37,35,36,MCS, Week 24,n=8,14,21,24,19,34Bodily pain, Week 4,n=34,34,36,37,36,36,Bodily pain, Week 12,n=34,35,35,37,35,36Bodily pain, Week 24,n=8,14,21,24,19,34General Health, Week 4,n=34,34,36,37,36,36General health, Week 12,n=34,35,35,37,35,36General health, Week 24,n=8,14,21,24,19,34Mental health, Week 4,n=34,34,36,37,36,36Mental health, Week 12,n=34,35,35,37,35,36Mental health, Week 24,n=8,14,21,24,19,34Physical functioning, Week 4,n=34,34,36,37,36,36Physical functioning, Week 12,n=34,35,35,37,35,36Physical functioning, Week 24,n=8,14,21,24,19,34Role emotional, Week 4,n=34,34,36,37,36,36Role emotional, Week 12,n=34,35,35,37,35,36Role emotional, Week 24,n=8,14,21,24,19,34Role physical, Week 4,n=34,34,36,37,36,36Role physical, Week 12,n=34,35,35,37,35,36Role physical, Week 24,n=8,14,21,24,19,34Social functioning, Week 4,n=34,34,36,37,36,36Social functioning, Week 12,n=34,35,35,37,35,36Social functioning, Week 24,n=8,14,21,24,19,34Vitality, Week 4,n=34,34,36,37,36,36Vitality, Week 12,n=34,35,35,37,35,36Vitality, Week 24,n=8,14,21,24,19,34
GSK3196165 135 mg4.805.317.504.525.515.425.976.018.873.433.143.843.494.684.965.185.847.404.965.936.064.025.997.595.226.327.976.556.838.04
GSK3196165 180 mg5.976.976.993.466.797.867.607.349.353.724.735.423.695.727.825.757.767.583.777.548.184.807.917.255.678.698.605.258.167.81
GSK3196165 22.5 mg2.464.887.032.864.864.502.415.437.011.273.075.363.774.874.133.975.806.293.095.196.573.015.167.651.954.905.412.946.166.62
GSK3196165 45 mg5.055.846.633.815.006.366.246.729.202.774.304.834.525.496.095.685.996.523.085.526.164.046.286.275.444.347.875.487.107.83
GSK3196165 90 mg4.475.157.802.824.663.025.445.997.361.903.024.603.624.773.424.845.987.163.355.104.364.565.497.502.844.624.524.546.377.65
Placebo1.863.425.343.363.544.072.523.904.151.782.442.073.642.272.813.302.986.934.374.855.662.154.566.382.274.348.311.914.194.68

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Change From Baseline in SDAI at All Assessment Time Points

SDAI combines information relating to the number of swollen and tender joints, in addition to a measure of general health from both the participants and the physician and acute phase reactants. The SDAI utilizing joint scores from the following 28 joints: elbows, shoulders, elbow, wrists, metacarpal-phalangeal I-V, proximal interphalangeal I-V and knees. It is calculated using the following formula: SDAI = TJC28 + SJC28 + GH + GP + CRP Where TJC - Tender joint Count, SJC= Swollen Joint Count, (GH=participant assessment, GP= physician assessment of disease activity using a 10 centimetre [cm] visual analogue scale [VAS] with 0 = best, 10 = worst), and CRP= C reactive Protein (in mg/L). It ranges between 0.1 and 86. High score indicates worse outcome, low score indicates better outcome. Baseline was defined as the last available assessment prior to the start of study treatment. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. (NCT02504671)
Timeframe: Baseline and Weeks 1, 2, 4, 6, 8, 12, 16, 20 and 24

,,,,,
InterventionScores on a scale (Least Squares Mean)
SDAI, Week 1,n=35,36,32,35, 34, 37SDAI, Week 2,n=35,34,34,36,36,36SDAI, Week 4,n=32,33,34,35, 36, 36SDAI, Week 6,n=35,34,33,36,32, 36SDAI, Week 8,n=34,33,34,37, 35, 32SDAI, Week 12,n=34,35,33,37, 34, 36SDAI, Week 16,n=8,16,20,23, 18, 36SDAI, Week 20,n=8,15,20,25, 18, 35SDAI, Week 24,n=8,14,20,24, 19, 33
GSK3196165 135 mg-6.31-11.22-13.97-15.70-19.26-16.73-21.68-24.06-21.28
GSK3196165 180 mg-9.30-11.40-18.03-18.86-22.09-23.90-25.08-26.17-26.27
GSK3196165 22.5 mg-5.62-8.62-12.30-14.36-14.66-13.95-17.53-16.67-16.05
GSK3196165 45 mg-5.20-9.28-12.81-14.99-17.23-17.41-22.64-23.17-21.77
GSK3196165 90 mg-5.86-10.03-14.76-15.50-16.95-21.20-22.91-23.47-21.07
Placebo-1.53-4.56-5.53-8.70-8.08-7.05-15.64-17.47-5.40

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Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs)

An AE is any untoward medical occurrence in a participant or clinical investigation participants, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is associated with liver injury and impaired liver function or any other situations as per Medical or Scientific judgment. Overall AEs and SAEs for the entire study duration until follow-up have been presented. (NCT02504671)
Timeframe: Up to 62 weeks

,,,,,
InterventionParticipants (Count of Participants)
Any AEAny SAE
GSK3196165 135 mg282
GSK3196165 180 mg240
GSK3196165 22.5 mg242
GSK3196165 45 mg261
GSK3196165 90 mg282
Placebo261

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Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points

Index-based remission was achieved if the following requirement was met: SDAI <= 3.3. If the SDAI value was missing at an individual assessment point, Index-based remission for that assessment was set to missing. (NCT02504671)
Timeframe: Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and Week 62 (follow-up)

,,,,,
InterventionPercentage of participants (Number)
Index based ACR/EULAR, Week 1Index based ACR/EULAR, Week 2Index based ACR/EULAR, Week 4Index based ACR/EULAR, Week 6Index based ACR/EULAR, Week 8Index based ACR/EULAR, Week 12Index based ACR/EULAR, Week 16Index based ACR/EULAR, Week 20Index based ACR/EULAR, Week 24Index based ACR/EULAR, Week 28Index based ACR/EULAR, Week 32Index based ACR/EULAR, Week 36Index based ACR/EULAR, Week 40Index based ACR/EULAR, Week 44Index based ACR/EULAR, Week 48Index based ACR/EULAR, Week 52Index based ACR/EULAR, Week 62 (follow-up)
GSK3196165 135 mg0003333388814551155
GSK3196165 180 mg033333555141151483814
GSK3196165 22.5 mg00000000000333350
GSK3196165 45 mg0000003555141111811148
GSK3196165 90 mg003333141181188811853
Placebo00003300000000000

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Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points

Boolean-based remission was achieved if all of the following requirements were met at the same time: TJC68 <= 1,SJC66 <= 1,CRP <= 1mg/dL, PtGA <= 10. If one of the components was missing at an individual assessment point, Boolean-based remission for that assessment was set to missing. (NCT02504671)
Timeframe: Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and Week 62 (follow-up)

,,,,,
InterventionPercentage of participants (Number)
Boolean based ACR/EULAR, Week 1Boolean based ACR/EULAR, Week 2Boolean based ACR/EULAR, Week 4Boolean based ACR/EULAR, Week 6Boolean based ACR/EULAR, Week 8Boolean based ACR/EULAR, Week 12Boolean based ACR/EULAR, Week 16Boolean based ACR/EULAR, Week 20Boolean based ACR/EULAR, Week 24Boolean based ACR/EULAR, Week 28Boolean based ACR/EULAR, Week 32Boolean based ACR/EULAR, Week 36Boolean based ACR/EULAR, Week 40Boolean based ACR/EULAR, Week 44Boolean based ACR/EULAR, Week 48Boolean based ACR/EULAR, Week 52Boolean based ACR/EULAR, Week 62 (follow-up)
GSK3196165 135 mg000330335558551153
GSK3196165 180 mg03035355355385355
GSK3196165 22.5 mg00000000000000300
GSK3196165 45 mg0000003535588118118
GSK3196165 90 mg00003858885588333
Placebo00000000000000000

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Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points

The ACR definition for calculating improvement in rheumatoid arthritis is calculated as a 20% improvement (ACR20) in both tender and swollen joint counts and 20% improvement in 3 of the 5 remaining ACR-core set measures: participant and physician global assessments, participant's assessment of arthritis pain, disability, and an acute-phase reactant (i.e. CRP value). Similarly, ACR50 and ACR70 were calculated with the respective percent improvement. The specific components of the ACR assessments are as follows: Tender/Painful Joint count 68 (TJC68), Swollen Joint Count 66 (SJC66), Participant's Assessment of Arthritis Pain, Participant's Global Assessment of Arthritis Disease Activity, Physician's Global Assessment of Arthritis, CRP (mg/L) and Health Assessment Questionnaire - Disability Index (HAQ-DI). For all visits, if any of the component scores were missing, then those scores were considered as not having met the criteria for improvement. (NCT02504671)
Timeframe: Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and Week 62 (follow-up)

,,,,,
InterventionPercentage of participants (Number)
Week 1, ACR 20Week 1, ACR 50Week 1, ACR 70Week 2, ACR 20Week 2, ACR 50Week 2, ACR 70Week 4, ACR 20Week 4, ACR 50Week 4, ACR 70Week 6, ACR 20Week 6, ACR 50Week 6, ACR 70Week 8, ACR 20Week 8, ACR 50Week 8, ACR 70Week 12, ACR 20Week 12, ACR 50Week 12, ACR 70Week 16, ACR 20Week 16, ACR 50Week 16, ACR 70Week 20, ACR 20Week 20, ACR 50Week 20, ACR 70Week 24, ACR 20Week 24, ACR 50Week 24, ACR 70Week 28, ACR 20Week 28, ACR 50Week 28, ACR 70Week 32, ACR 20Week 32, ACR 50Week 32, ACR 70Week 36, ACR 20Week 36, ACR 50Week 36, ACR 70Week 40, ACR 20Week 40, ACR 50Week 40, ACR 70Week 44, ACR 20Week 44, ACR 50Week 44, ACR 70Week 48, ACR 20Week 48, ACR 50Week 48, ACR 70Week 52, ACR 20Week 52, ACR 50Week 52, ACR 70Week 62 (follow-up), ACR 20Week 62 (follow-up), ACR 50Week 62 (follow-up), ACR 70
GSK3196165 135 mg50035504680351434924841308412711383224412419161611161614161616161411161411161614161614161614
GSK3196165 180 mg1900435046854614551198512211682211593019592719682414543016593514543216543819573522512714432719
GSK3196165 22.5 mg5001930245032502411035113302232411324115888885855885883885885850
GSK3196165 45 mg83014303550308341143412714462714382416412714191614222219191919191616191919191919161616161616
GSK3196165 90 mg110016803211332113461911512419512719542214573014191914221614161111221414191611191681616111183
Placebo00050085022110163311851685168514115333333330333330330330333

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Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points

DAS28(CRP) remission is defined as a DAS28 score of <2.6 points. The DAS index combines information relating to the number of swollen and tender joints. The DAS28 is a modification of the original DAS and is based on a count of 28 swollen and tender joints and is used to evaluate a participant's response to treatment. DAS 28 CRP utilizing joint scores from the following 28 joints: elbows, shoulders, elbow, wrists, metacarpal- phalangeal I-V, proximal interphalangeal I-V and knees and is calculated using the following formula: DAS28 (CRP) = 0.56*√(TJC28) +0.28*√(SJC28)+0.014*GH+0.36*ln(CRP+1)+0.96. Where TJC - Tender joint Count, SJC= Swollen Joint Count, (GH=participant assessment of disease activity using a 100 mm visual analogue scale with 0 = best, 100 = worst) and CRP= C reactive Protein (in mg/L). It ranges between 0.96 and 8.61. High score (worse outcome) and low scores (better outcome). (NCT02504671)
Timeframe: Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and Week 62 (follow-up)

,,,,,
InterventionPercentage of participants (Number)
Week 1Week 2Week 4Week 6Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52Week 62 (follow-up)
GSK3196165 135 mg003353514141411161114141411
GSK3196165 180 mg01488161916142219192416191419
GSK3196165 22.5 mg00050830535555550
GSK3196165 45 mg000055141616162219141414148
GSK3196165 90 mg0055142427191916148141614113
Placebo00053303333303033

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Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission

CDAI combines information relating to the number of swollen and tender joints, in addition to a measure of general health from both the participants and the physician. CDAI utilizing joint scores from the following 28 joints: elbows, shoulders, elbow, wrists, metacarpal- phalangeal I-V, proximal interphalangeal I-V and knees and is calculated using the following formula: CDAI =TJC28 + SJC28 + GH + GP Where TJC - Tender joint Count, SJC= Swollen Joint Count, (GH=participant assessment of disease activity and GP=physician assessment of disease activity using a 10 cm visual analogue scale with 0 = best, 100 = worst). It ranges between 0 and 76. High score indicates worse outcome, low score indicates better outcome. Remission was achieved for a non-missing CDAI value <=2.8. (NCT02504671)
Timeframe: Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and Week 62 (follow-up)

,,,,,
InterventionPercentage of participants (Number)
CDAI, Week 1CDAI, Week 2CDAI, Week 4CDAI, Week 6CDAI, Week 8CDAI, Week 12CDAI, Week 16CDAI, Week 20CDAI, Week 24CDAI, Week 28CDAI, Week 32CDAI, Week 36CDAI, Week 40CDAI, Week 44CDAI, Week 48CDAI, Week 52CDAI, Week 62 (follow-up)
GSK3196165 135 mg0003333385814551155
GSK3196165 180 mg053335555141151458816
GSK3196165 22.5 mg00000030000333300
GSK3196165 45 mg00000033531411111114148
GSK3196165 90 mg0053311161151188811853
Placebo00003300000000000

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Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points

DAS28(CRP) scores were categorized using EULAR response criteria. Response at a given time point was defined based on the combination of current DAS28 score and the improvement in the current DAS28 score relative to Baseline. The definition of no response, moderate response and good response was as follows: Current DAS28 <=3.2 and DAS28 decrease from Baseline (>1.2=good response), (>0.6 to <=1.2 = moderate response) and (<=0.6 =no response). Current DAS28 >3.2 to <=5.1 and DAS28 decrease from Baseline value (>1.2 =moderate response), (>0.6 to <=1.2 = moderate response) and (<=0.6 =no response). Current DAS28 >5.1 and DAS28 decrease from Baseline value (>1.2=moderate response), (>0.6 to <=1.2 = no response) and (<=0.6 =no response). If the post-Baseline DAS28(CRP) score was missing, then the corresponding EULAR category was set to missing. (NCT02504671)
Timeframe: Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and Week 62 (follow-up)

,,,,,
InterventionPercentage of participants (Number)
Week 1Week 2Week 4Week 6Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52Week 62 (follow-up)
GSK3196165 135 mg1932434659494343431616161616161616
GSK3196165 180 mg2738686568767373707873736559655154
GSK3196165 22.5 mg22194646434335353288888885
GSK3196165 45 mg1616384359515451461922191919191616
GSK3196165 90 mg2438465165685965541922222219191616
Placebo5141624322222161633333333

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Number of Participants With Worst-case Post-Baseline Results for Pulse Oximetry

Oxygen saturation measures the capacity of blood to transport oxygen to other parts of the body. Oxygen binds to hemoglobin in red blood cells when moving through the lungs. A pulse oximeter uses two frequencies of light (red and infrared) to determine the percentage of hemoglobin in the blood that is saturated with oxygen, that is called as blood oxygen saturation. Baseline was defined as the last available assessment prior to the start of study treatment. The number of participants with blood oxygen level < 80%, 80% to <90% and >=90% have been reported. (NCT02504671)
Timeframe: Up to 62 weeks

,,,,,
InterventionParticipants (Count of Participants)
< 80%; n=37, 36, 37, 37, 36, 3780% to <90%; n=37, 36, 37, 37, 36, 37>= 90%; n=37, 36, 37, 37, 36, 37
GSK3196165 135 mg0135
GSK3196165 180 mg0037
GSK3196165 22.5 mg0036
GSK3196165 45 mg0037
GSK3196165 90 mg0037
Placebo0037

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Number of Participants With Pulmonary Events

Pulmonary assessments were performed to determine the number of participants with pulmonary events including persistent cough, persistent dyspnea, and persistent Diffusing capacity of the lung for carbon monoxide (DLCO). Persistent is defined as any event with duration >=15 days. Baseline was defined as the last available assessment prior to the start of study treatment. The number of participants experiencing pulmonary events have been reported. (NCT02504671)
Timeframe: Up to 62 weeks

,,,,,
InterventionParticipants (Count of Participants)
Persistent CoughPersistent DyspneaPersistent DLCO decrease >15% from Baseline
GSK3196165 135 mg003
GSK3196165 180 mg001
GSK3196165 22.5 mg003
GSK3196165 45 mg001
GSK3196165 90 mg010
Placebo112

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Number of Participants With Opportunistic Infections

An AE is any untoward medical occurrence in a participant or clinical investigation participants, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Opportunistic infections were categorized as AE of special interest. The number of participants with overall opportunistic infections have been presented. (NCT02504671)
Timeframe: Up to 62 weeks

InterventionParticipants (Count of Participants)
Placebo0
GSK3196165 22.5 mg0
GSK3196165 45 mg0
GSK3196165 90 mg0
GSK3196165 135 mg0
GSK3196165 180 mg0

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Number of Participants With Serious Infections

An AE is any untoward medical occurrence in a participant or clinical investigation participants, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Serious infections were categorized as AE of special interest. The number of participants with overall serious infections have been presented. (NCT02504671)
Timeframe: Up to 62 weeks

InterventionParticipants (Count of Participants)
Placebo0
GSK3196165 22.5 mg1
GSK3196165 45 mg0
GSK3196165 90 mg0
GSK3196165 135 mg0
GSK3196165 180 mg0

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4-month Progression-free Survival (PFS) Rate

PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. Will be estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum on study (including baseline sum), or a measurable increase in a non-target lesion, or the appearance of new lesions. (NCT02508077)
Timeframe: At 4 months

Interventionpercentage of participants (Number)
Treatment (Panitumumab and FOLFIRI)0

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Overall Response Rate (ORR) Per RECIST 1.1 as Assessed by Blinded Central Imaging

ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per RECIST 1.1. The percentage of participants who experienced a CR or PR is presented. (NCT02578680)
Timeframe: Through Database Cutoff Date of 08-Nov-2017 (Up to approximately 21 months)

InterventionPercentage of Participants (Number)
Pembrolizumab47.6
Control18.9

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Duration of Response (DOR) Per RECIST 1.1 as Assessed by Blinded Central Imaging

For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR was defined as the time from first documented evidence of a CR or PR until PD or death. DOR for participants who had not progressed or died at the time of analysis was to be censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD. DOR assessments were based on blinded central imaging review with confirmation. The DOR per RECIST 1.1 for all participants who experienced a confirmed CR or PR is presented. (NCT02578680)
Timeframe: From time of first documented evidence of CR or PR through database cutoff date of 08-Nov-2017 (Up to approximately 21 months)

InterventionMonths (Median)
Pembrolizumab11.2
Control7.8

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Number of Participants Who Discontinued Any Study Drug Due to an AE

The number of participants who discontinued any randomized study drug due to an AE is presented. (NCT02578680)
Timeframe: Through Database Cutoff Date of 08-Nov-2017 (Up to approximately 21 months)

InterventionParticipants (Count of Participants)
Pembrolizumab112
Control30

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Number of Participants Who Experienced an Adverse Event (AE)

An AE was defined as any untoward medical occurrence in a study participant administered study drug and which does not necessarily have to have a causal relationship with this study drug. For participants who switched from the Control group to receiving pembro, AEs that occurred after the first dose of pembro are excluded from this interim analysis, but will be included in the final analysis. The number of participants who experienced an AE is presented. (NCT02578680)
Timeframe: Through Database Cutoff Date of 08-Nov-2017 (Up to approximately 21 months); Serious AEs: Up to 90 days after last dose of study treatment, Other AEs: Up to 30 days after last dose of study treatment

InterventionParticipants (Count of Participants)
Pembrolizumab404
Control200

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Overall Survival (OS)

OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the interim analysis were censored at the date of the last follow-up. The OS is presented. (NCT02578680)
Timeframe: Through Database Cutoff Date of 08-Nov-2017 (Up to approximately 21 months)

InterventionMonths (Median)
PembrolizumabNA
Control11.3

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Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Central Imaging

PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD. The PFS per RECIST 1.1 is presented. (NCT02578680)
Timeframe: Through Database Cutoff Date of 08-Nov-2017 (Up to approximately 21 months)

InterventionMonths (Median)
Pembrolizumab8.8
Control4.9

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Median Overall Survival (OS)

Descriptive statistics (point and exact 90% confidence interval estimates from the resultant Kaplan-Meier curve) will be generated for OS. The median OS will be estimated on an intention-to-treat basis (using all registered patients), and on a response-evaluable basis (using all patients who completed all BAT infusions) using the Kaplan-Meier method. (NCT02620865)
Timeframe: Up to 18 months

Interventionyears (Median)
Treatment (Anti-CD3 x Anti-EGFR BATs)0.934

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Incidence of Toxicity (CTCAE Version 4.0)

Toxicity rates will be estimated using all treated patients. (NCT02620865)
Timeframe: Up to 18 months

InterventionParticipants (Count of Participants)
AnorexiaAnxietyChillsDepressionDiarrheaDizzinessDry MouthFatigueFeverGastroesophageal reflux diseaseHeadacheMyalgiaNauseaRash maculo-papularVomiting
Treatment (Anti-CD3 x Anti-EGFR BATs)112121122121221

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Progression Free Survival (PFS)

Descriptive statistics (point and exact 90% confidence interval estimates from the resultant Kaplan-Meier curve) will be generated for PFS. The median PFS will be estimated on an intention-to-treat basis (using all registered patients), and on a response-evaluable basis (using all patients who completed all BAT infusions) using the Kaplan-Meier method. (NCT02620865)
Timeframe: Up to 18 months

InterventionYears (Median)
Treatment (Anti-CD3 x Anti-EGFR BATs)0.934

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Pathological Complete Response (PathCR) Rate

Defined as number of patients with pathologic complete responses (pCR) divided by total evaluable patients. pCR is defined as no recognized cancer and margins free of tumor as found by the pathologist following resection of the esophageal specimen and accompanying lymph nodes. (NCT02730546)
Timeframe: Up to 3 years

Interventionpercentage of patients (Number)
Treatment (Pembrolizumab, Chemotherapy, Radiation, Surgery)22.6

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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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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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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 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 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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Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response

ACR50 response is defined as a ≥ 50% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate]. (NCT02833350)
Timeframe: Days 7, 14, 28, 56, and 84

,,,,,,
InterventionPercentage (Number)
Week 1 Day 7Week 2 Day 14Week 4 day 28Week 8 Day 56Week 12 Day 84
Cohort 1: GDC-0853 High Dose + Adalimumab Placebo3.67.310.022.734.5
Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo2.50.05.015.017.5
Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo2.81.89.218.327.5
Cohort 1: GDC-0853 Placebo + Adalimumab4.59.025.232.436.0
Cohort 1: GDC-0853 Placebo + Adalimumab Placebo2.72.76.417.314.5
Cohort 2: GDC-0853 High Dose6.310.410.422.925.0
Cohort 2: GDC-0853 Placebo2.00.006.010.012.0

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Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response

ACR20 response is defined as a ≥ 20% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate] (NCT02833350)
Timeframe: Days 7, 14, 28, 56, and 84

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InterventionPercentage (Number)
Week 1 Day 7Week 2 Day 14Week 4 Day 28Week 8 Day 56Week 12 Day 84
Cohort 1: GDC-0853 High Dose + Adalimumab Placebo13.627.341.858.259.1
Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo10.012.530.050.060.0
Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo14.719.334.952.356.0
Cohort 1: GDC-0853 Placebo + Adalimumab25.248.659.571.272.1
Cohort 1: GDC-0853 Placebo + Adalimumab Placebo10.016.425.537.336.4
Cohort 2: GDC-0853 High Dose22.925.035.447.958.3
Cohort 2: GDC-0853 Placebo2.010.024.018.024.0

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Change in Disease Activity Score From Baseline Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])

The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score < 2.6. (NCT02833350)
Timeframe: Days 7, 14, 28, 56, and 84

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InterventionScore on a scale (Mean)
Week 1 Day 7Week 2 Day 14Week 4 Day 28Week 8 Day 56Week 12 Day 84
Cohort 1: GDC-0853 High Dose + Adalimumab Placebo-0.52-0.84-1.15-1.63-2.05
Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo-0.45-0.63-1.00-1.43-1.76
Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo-0.54-0.85-1.16-1.67-2.06
Cohort 1: GDC-0853 Placebo + Adalimumab-0.93-1.22-1.65-2.00-2.08
Cohort 1: GDC-0853 Placebo + Adalimumab Placebo-0.37-0.58-0.79-1.29-1.46
Cohort 2: GDC-0853 High Dose-0.65-0.81-1.04-1.54-1.89
Cohort 2: GDC-0853 Placebo-0.36-0.60-0.61-0.81-1.08

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Change in Disease Activity Score From Baseline Based on 28-Joints Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR])

The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score < 2.6. (NCT02833350)
Timeframe: Days 7, 14, 28, 56, and 84

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InterventionScore on a scale (Mean)
Week 1 Day 7Week 2 Day 14Week 4 Day 28Week 8 Day 56Week 12 Day 84
Cohort 1: GDC-0853 High Dose + Adalimumab Placebo-0.39-0.68-0.97-1.40-1.80
Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo-0.35-0.60-0.88-1.25-1.51
Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo-0.42-0.69-0.99-1.44-1.80
Cohort 1: GDC-0853 Placebo + Adalimumab-0.72-1.02-1.47-1.74-1.85
Cohort 1: GDC-0853 Placebo + Adalimumab Placebo-0.34-0.55-0.75-1.15-1.30
Cohort 2: GDC-0853 High Dose-0.50-0.64-0.85-1.35-1.65
Cohort 2: GDC-0853 Placebo-0.31-0.51-0.50-0.70-0.94

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Change in Disease Activity Score From Baseline Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP])

The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score < 2.6. (NCT02833350)
Timeframe: Days 7, 14, 28, 56, and 84

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InterventionScore on a scale (Mean)
Week 1 Day 7Week 2 Day 14Week 4 Day 28Week 8 Day 56Week 12 Day 84
Cohort 1: GDC-0853 High Dose + Adalimumab Placebo-0.49-0.84-1.08-1.57-1.93
Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo-0.43-0.51-0.88-1.31-1.53
Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo-0.48-0.77-1.06-1.56-1.97
Cohort 1: GDC-0853 Placebo + Adalimumab-1.10-1.26-1.61-1.97-2.06
Cohort 1: GDC-0853 Placebo + Adalimumab Placebo-0.37-0.57-0.651.20-1.33
Cohort 2: GDC-0853 High Dose-0.63-0.81-0.95-1.51-1.83
Cohort 2: GDC-0853 Placebo-.40-0.54-0.55-0.67-1.00

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Change in Disease Activity Score From Baseline Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])

The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score < 2.6. (NCT02833350)
Timeframe: Days 7, 14, 28, 56, and 84

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InterventionScore on a scale (Mean)
Week 1 Day 7Week 2 Day 14Week 4 Day 28Week 8 Day 56Week 12 Day 84
Cohort 1: GDC-0853 High Dose + Adalimumab Placebo-0.37-0.70-0.91-1.37-1.70
Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo-0.34-0.47-0.75-1.14-1.30
Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo-0.35-0.63-0.90-1.35-1.72
Cohort 1: GDC-0853 Placebo + Adalimumab-0.92-1.09-1.45-1.75-1.87
Cohort 1: GDC-0853 Placebo + Adalimumab Placebo-0.33-.54-0.62-1.08-1.17
Cohort 2: GDC-0853 High Dose-0.49-0.65-0.77-1.33-1.62
Cohort 2: GDC-0853 Placebo-0.36-0.45-0.44-0.56-0.86

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Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score

"The FACIT-Fatigue Scale consists of 13 items designed to measure the degree of fatigue experienced by the patient in the previous 7 days. For each question, there are five possible responses: 0 (not at all), 1 (a little bit), 2 (somewhat), 3 (quite a bit), 4 (very much).~A total fatigue score is calculated by summing all items, and possible total scores range from 0 (maximum fatigue) to 52 (no fatigue). A positive change from baseline indicates an improvement in the patient's fatigue (less fatigue)." (NCT02833350)
Timeframe: Day 84

InterventionScore on a scale (Mean)
Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo9.00
Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo8.21
Cohort 1: GDC-0853 High Dose + Adalimumab Placebo8.95
Cohort 1: GDC-0853 Placebo + Adalimumab Placebo7.08
Cohort 1: GDC-0853 Placebo + Adalimumab9.59
Cohort 2: GDC-0853 High Dose8.85
Cohort 2: GDC-0853 Placebo5.71

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Maximum Observed Plasma Concentration of GDC-0853 at Steady State (Cmax,ss)

Cmax is the maximum (peak) plasma concentration over the dosing interval at steady state (ss) (NCT02833350)
Timeframe: Pre-dose (0 hours) up to 10 hours post-dose on Day 28

InterventionNanogram per Milliliter (ng/mL) (Mean)
Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo110
Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo280
Cohort 1: GDC-0853 High Dose + Adalimumab Placebo591
Cohort 2: GDC-0853 High Dose621

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Percentage of Participants Achieving ACR50 Response at Day 84, Comparison Between GDC-0853 and Adalimumab (Cohort 1)

ACR50 response is defined as a ≥ 50% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate]. (NCT02833350)
Timeframe: Day 84

InterventionPercentage (Number)
Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo17.5
Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo27.5
Cohort 1: GDC-0853 High Dose + Adalimumab Placebo34.5
Cohort 1: GDC-0853 Placebo + Adalimumab Placebo14.5
Cohort 1: GDC-0853 Placebo + Adalimumab36.0

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Percentage of Participants Achieving ACR50 Response at Day 84, Comparison Between GDC-0853 and Placebo (Cohort 2)

ACR50 response is defined as a ≥ 50% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate]. (NCT02833350)
Timeframe: Day 84

InterventionPercentage (Number)
Cohort 2: GDC-0853 High Dose25.0
Cohort 2: GDC-0853 Placebo12.0

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Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Day 84, Comparison Between GDC-0853 and Placebo (Cohort 1)

ACR50 response is defined as a ≥ 50% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate]. (NCT02833350)
Timeframe: Day 84

InterventionPercentage (Number)
Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo17.5
Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo27.5
Cohort 1: GDC-0853 High Dose + Adalimumab Placebo34.5
Cohort 1: GDC-0853 Placebo + Adalimumab Placebo14.5
Cohort 1: GDC-0853 Placebo + Adalimumab36.0

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Percentage of Participants With Adverse Events

An Adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events. A SAE was any experience that suggested a significant hazard, contraindication, side effect or precaution that: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically significant. (NCT02833350)
Timeframe: Day 1 up to 8 weeks after last dose (up to Week 20)

InterventionPercentage (Number)
Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo37.5
Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo42.2
Cohort 1: GDC-0853 High Dose + Adalimumab Placebo50.9
Cohort 1: GDC-0853 Placebo + Adalimumab Placebo45.5
Cohort 1: GDC-0853 Placebo + Adalimumab45.0
Cohort 2: GDC-0853 High Dose22.4
Cohort 2: GDC-0853 Placebo44.9

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Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) Scores for Physical and Mental Components

"The 36-Item Short Form Health Survey (SF-36v2) is a questionnaire used to assess functional health and well-being and consists of eight domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health.~The SF-36v2 is summarized into Physical Component Summary (PCS) and Mental Component Summary (MCS) scores. The PCS and MCS scores range from 0 to 100, with 0=worst score (or quality of life) and 100=best score. A positive change from baseline indicates improvement." (NCT02833350)
Timeframe: Day 84

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InterventionNumber on a scale (Mean)
Physical component score change: baseline-week 12Mental component score change: baseline-week 12
Cohort 1: GDC-0853 High Dose + Adalimumab Placebo6.596.92
Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo5.577.04
Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo5.714.89
Cohort 1: GDC-0853 Placebo + Adalimumab6.416.50
Cohort 1: GDC-0853 Placebo + Adalimumab Placebo3.544.29
Cohort 2: GDC-0853 High Dose5.355.76
Cohort 2: GDC-0853 Placebo1.755.11

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Change From Baseline in C-Reactive Protein (CRP) Levels

C-reactive protein is a biological marker of inflammation and is measured in nanograms per milliliter (ng/mL) (NCT02833350)
Timeframe: Days 7, 14, 28, 56, and 84

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Intervention(ng/mL) nanograms per milliliter (Mean)
Week 1 Day 7Week 2 Day 14Week 4 Day 28Week 8 Day 56Week 12 Day 84
Cohort 1: GDC-0853 High Dose + Adalimumab Placebo0.22-0.21-0.44-0.89-1.30
Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo0.140.270.15-0.49-0.59
Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo0.30-0.10-0.25-0.52-0.77
Cohort 1: GDC-0853 Placebo + Adalimumab-1.21-0.93-1.11-1.14-1.03
Cohort 1: GDC-0853 Placebo + Adalimumab Placebo0.01-0.120.14-0.39-0.45
Cohort 2: GDC-0853 High Dose-0.12-0.20-0.30-1.19-1.55
Cohort 2: GDC-0853 Placebo-0.10-0.25-0.24-0.26-0.56

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Change From Baseline in Clinical Disease Activity Index (CDAI)

CDAI was derived as the sum of the following: tender joint count (TJC), swollen joint count (SJC), participant global assessment (PGA) of disease activity, and physician assessment of disease activity. TJC and SJC were taken as the number of tender and swollen joints, respectively, out of 28 assessed joints. PGA and physician assessment of disease activity were scored 0-100 millimeters (mm) and rounded to the nearest centimeter (cm) on a visual analog scale (VAS), where higher scores indicate greater perceived disease activity. The total CDAI score range was 0-76, where higher scores indicate increased disease activity. Change from baseline at a particular time point was calculated among patients with data available at both baseline and the time point of interest. Negative values indicate improvement/reduction in RA disease activity. (NCT02833350)
Timeframe: Baseline, Days 7, 14, 28, 56 and 84

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InterventionScore on a scale (Mean)
Week 1 Day 7Week 2 Day 14Week 4 Day 28Week 8 Day 56Week 12 Day 84
Cohort 1: GDC-0853 High Dose + Adalimumab Placebo-7.40-11.33-13.78-18.10-22.10
Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo-5.45-6.85-10.36-14.76-16.99
Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo-6.70-10.33-13.84-18.61-22.05
Cohort 1: GDC-0853 Placebo + Adalimumab-9.64-13.44-17.74-21.36-22.22
Cohort 1: GDC-0853 Placebo + Adalimumab Placebo-4.71-7.44-9.43-15.49-17.02
Cohort 2: GDC-0853 High Dose-8.61-9.64-11.83-17.38-20.42
Cohort 2: GDC-0853 Placebo-5.26-7.70-7.49-7.57-12.23

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Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score

"The Stanford Health Assessment Questionnaire disability index is a patient-reported outcome used to assess difficulty in performing activities of daily living. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities.~To respond to each question, a four-level response with higher scores showing larger functional limitations, was chosen. Scoring is as follows with respect to performance of participant's everyday activities: 0 (equals)=without difficulties; 1= with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. The composite HAQ-DI score is the mean of the eight domain scores and the score ranges from 0 (no functional impairment) to 3 (maximum functional impairment). A negative change from baseline indicates improvement." (NCT02833350)
Timeframe: Days 7, 14, 28, 56, and 84

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InterventionScore on a scale (Mean)
Week 1 Day 7Week 2 Day 14Week 4 Day 28Week 8 Day 56Week 12 Day 84
Cohort 1: GDC-0853 High Dose + Adalimumab Placebo-0.22-0.28-0.40-0.56-0.65
Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo-0.20-0.24-0.34-0.49-0.51
Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo-0.15-0.23-0.32-0.44-0.57
Cohort 1: GDC-0853 Placebo + Adalimumab-0.26-0.35-0.50-0.60-0.65
Cohort 1: GDC-0853 Placebo + Adalimumab Placebo-0.10-0.17-0.19-0.40-0.35
Cohort 2: GDC-0853 High Dose-0.19-0.23-0.23-0.45-0.53
Cohort 2: GDC-0853 Placebo-0.14-0.13-0.17-0.23-0.30

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Change From Baseline in Tender/Painful Joint Count (68 Joint Count)

Tender Joint Count: a total of 68 joints will be assessed for tenderness. Each joint is assessed for the presence/absence of tenderness. 68 joints are assessed for tenderness and joints are classified as tender/not tender giving a total possible tender joint count score of 0 to 68. A negative change from Baseline indicated improvement. (NCT02833350)
Timeframe: Days 7, 14, 28, 56, and 84

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InterventionScore on a scale (Mean)
Week 1 Day 7Week 2 Day 19Week 4 Day 28Week 8 Day 56Week 12 Day 84
Cohort 1: GDC-0853 High Dose + Adalimumab Placebo-3.33-5.91-6.84-9.75-11.49
Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo-2.79-4.33-6.00-9.72-10.33
Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo-4.12-6.36-7.90-11.57-12.72
Cohort 1: GDC-0853 Placebo + Adalimumab-5.58-8.62-11.61-14.12-15.49
Cohort 1: GDC-0853 Placebo + Adalimumab Placebo-3.81-5.78-7.55-10.75-10.55
Cohort 2: GDC-0853 High Dose-6.57-6.08-7.79-11.65-13.73
Cohort 2: GDC-0853 Placebo-3.06-3.92-4.40-4.60-7.14

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Change From Baseline in Patient Assessment Score of Arthritis Pain

Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain (NCT02833350)
Timeframe: Days 7, 14, 28, 56, and 84

,,,,,,
InterventionScore on a scale (Mean)
Week 1 Day 7Week 2 Day 14Week 4 Day 28Week 8 Day 56Week 12 Day 84
Cohort 1: GDC-0853 High Dose + Adalimumab Placebo-11.18-17.08-18.63-25.95-30.63
Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo-9.00-6.08-13.41-18.38-23.14
Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo-9.20-12.16-15.75-23.21-26.48
Cohort 1: GDC-0853 Placebo + Adalimumab-15.75-18.13-20.21-24.70-26.30
Cohort 1: GDC-0853 Placebo + Adalimumab Placebo-4.12-8.22-10.08-16.37-17.88
Cohort 2: GDC-0853 High Dose-11.94-15.08-16.64-21.21-26.49
Cohort 2: GDC-0853 Placebo-2.76-4.72-7.54-7.13-13.98

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Change From Baseline in Patient Global Assessment Score of Arthritis Pain

Participant-assessed arthritis pain was scored on a 100-mm VAS, where the distance from 0 mm represented the participant's self evaluation of arthritis pain (0 mm=none; 100 mm=very severe). Change from baseline at a particular time point was calculated among patients with data available at both baseline and the time point of interest, where negative change indicated a decrease in participant-assessed arthritis pain. (NCT02833350)
Timeframe: Days 7, 14, 28, 56, and 84

,,,,,,
InterventionScore on a scale (Mean)
Week 1 Day 7Week 2 Day 14Week 4 Day 28Week 8 Day 56Week 12 Day 84
Cohort 1: GDC-0853 High Dose + Adalimumab Placebo-11.82-14.84-17.75-22.59-27.33
Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo-9.00-5.50-12.11-19.19-23.33
Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo-10.30-13.7016.10-24.06-26.67
Cohort 1: GDC-0853 Placebo + Adalimumab-18.33-18.94-21.78-26.77-26.24
Cohort 1: GDC-0853 Placebo + Adalimumab Placebo-3.07-5.39-6.36-14.19-16.87
Cohort 2: GDC-0853 High Dose-13.15-15.46-18.26-21.17-25.55
Cohort 2: GDC-0853 Placebo-4.96-8.64-10.96-11.82-13.80

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Change From Baseline in Physician's Global Assessment Score of Arthritis

Physician's assessment of participant's disease activity was scored on a 100-mm VAS, where the distance from 0 mm represented the physician's assessment of the participant's disease activity (0 mm=very good; 100 mm=very poor). Change from baseline at a particular time point was calculated among patients with data available at both baseline and the time point of interest, where negative change from baseline indicated an improvement in physician-assessed disease activity. (NCT02833350)
Timeframe: Days 7, 14, 28, 56, and 84

,,,,,,
InterventionScore on a scale (Mean)
Week 1 Day 7Week 2 Day 14Week 4 Day 28Week 8 Day 56Week 12 Day 84
Cohort 1: GDC-0853 High Dose + Adalimumab Placebo-12.82-18.30-20.92-29.67-34.48
Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo-7.89-11.10-16.89-24.59-26.81
Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo-10.68-15.86-22.02-28.52-32.43
Cohort 1: GDC-0853 Placebo + Adalimumab-14.23-21.33-28.81-36.16-37.18
Cohort 1: GDC-0853 Placebo + Adalimumab Placebo-5.85-9.01-14.01-20.87-23.19
Cohort 2: GDC-0853 High Dose-9.57-14.23-17.70-22.40-30.82
Cohort 2: GDC-0853 Placebo-7.66-9.85-12.73-9.91-18.44

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Change From Baseline in Simplified Disease Activity Index (SDAI)

Simplified Disease Activity Index (SDAI) is the numerical sum of five outcome parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PhGA (based on 0-10 cm VAS, where 0 = no disease activity and 10 = worst disease activity), and CRP. SDAI total score ranges from 0 (no disease activity) to 86 (maximal disease activity), where higher scores represents higher disease activity. The SDAI =< 3.3 indicates disease remission, > 3.4 to 11 indicates low disease activity, > 11 to 26 indicates moderate disease activity, and > 26 indicates high disease activity (NCT02833350)
Timeframe: Baseline, Days 7, 14, 28, 56 and 84

,,,,,,
InterventionScore on a scale (Mean)
Week 1 Day 7Week 2 Day 14Week 4 Day 28Week 8 Day 56Week 12 Day 84
Cohort 1: GDC-0853 High Dose + Adalimumab Placebo-6.99-11.44-14.21-18.97-23.24
Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo-5.36-6.50-10.53-15.25-17.54
Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo-6.48-10.46-14.47-18.95-22.89
Cohort 1: GDC-0853 Placebo + Adalimumab-10.86-14.39-18.87-22.62-23.33
Cohort 1: GDC-0853 Placebo + Adalimumab Placebo-4.75-7.54-8.92-15.74-17.47
Cohort 2: GDC-0853 High Dose-8.73-9.84-12.13-18.57-21.97
Cohort 2: GDC-0853 Placebo-5.37-8.13-7.74-7.82-12.92

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Change From Baseline in Swollen Joint Count (66 Joint Count)

Swollen Joint Count: a total of 66 joints will be assessed for swelling. Each joint is assessed for the presence/absence of swelling. 66 joints were assessed for swelling and joints are classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 66. A negative change from Baseline indicated improvement. (NCT02833350)
Timeframe: Days 7, 14, 28, 56, and 84

,,,,,,
InterventionScore on a scale (Mean)
Week 1 Day 7Week 2 Day 14Week 4 Day 28Week 8 Day 56Week 12 Day 84
Cohort 1: GDC-0853 High Dose + Adalimumab Placebo-3.45-5.06-5.95-7.72-8.48
Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo-1.84-3.95-4.38-6.54-7.36
Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo-2.89-4.78-6.33-8.06-8.89
Cohort 1: GDC-0853 Placebo + Adalimumab-3.94-6.26-8.50-9.60-9.94
Cohort 1: GDC-0853 Placebo + Adalimumab Placebo-3.35-4.23-5.47-7.41-8.26
Cohort 2: GDC-0853 High Dose-3.45-3.29-4.21-6.81-7.65
Cohort 2: GDC-0853 Placebo-1.49-2.96-3.46-3.02-4.86

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Area Under the Concentration Time Curve From Time 0 to Time 24 of GDC-0853 at Steady State (AUC0-24,ss)

The Pharmacokinetics (PK) evaluation may include, but will not be limited to, plasma GDC-0853 concentrations and population PK model estimated PK exposures (area under the plasma concentration-time curve [AUC]. AUC was measured in Nanograms(ng) per millilitre(mL)*hour (hr) (NCT02833350)
Timeframe: Pre-dose (0 hours) up to 10 hours post-dose on Day 28

InterventionNg/mL*(hr) (Mean)
Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo1170
Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo2910
Cohort 1: GDC-0853 High Dose + Adalimumab Placebo9380
Cohort 2: GDC-0853 High Dose9890

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Percentage of Participants With DAS Remission

The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score < 2.6 (NCT02833350)
Timeframe: Days 7, 14, 28, 56, and 84

,,,,,,
InterventionPercentage of participants (Number)
Week 1 Day 7Week 2 Day 14Week 4 Day 28Week 8 Day 56Week 12 Day 84
Cohort 1: GDC-0853 High Dose + Adalimumab Placebo0.00.91.84.58.2
Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo0.00.00.00.02.5
Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo0.00.00.03.77.3
Cohort 1: GDC-0853 Placebo + Adalimumab0.00.94.59.09.0
Cohort 1: GDC-0853 Placebo + Adalimumab Placebo0.00.00.91.83.6
Cohort 2: GDC-0853 High Dose2.10.000.000.004.2
Cohort 2: GDC-0853 Placebo0.00.00.00.04.0

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Percentage of Participants With DAS Low Disease Activity

The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. LDAS is defined as DAS28 ≤ 3.2 (NCT02833350)
Timeframe: Days 7, 14, 28, 56, and 84

,,,,,,
InterventionPercentage of participants (Number)
Week 1 Day 7Week 2 day 14Week 4 Day 28Week 8 Day 56Week 12 Day 84
Cohort 1: GDC-0853 High Dose + Adalimumab Placebo1.81.86.411.814.5
Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo0.00.00.00.07.5
Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo0.90.01.88.319.3
Cohort 1: GDC-0853 Placebo + Adalimumab1.84.511.718.017.1
Cohort 1: GDC-0853 Placebo + Adalimumab Placebo0.00.91.83.63.6
Cohort 2: GDC-0853 High Dose2.12.12.12.114.6
Cohort 2: GDC-0853 Placebo0.02.00.02.04.0

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Minimum Observed Plasma Concentration of GDC-0853 at Steady State (Cmin,ss)

Cmin is the minimum concentration over the dosing interval at steady state (ss) (NCT02833350)
Timeframe: Pre-dose (0 hours) up to 10 hours post-dose on Day 28

InterventionNanogram per Milliliter (ng/mL) (Mean)
Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo22.4
Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo54.7
Cohort 1: GDC-0853 High Dose + Adalimumab Placebo250
Cohort 2: GDC-0853 High Dose263

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Percentage of Participants Meeting the SDAI-based Remission Criteria

The SDAI was the numerical sum of five outcome parameter: SJC and TJC (based on a 28-joint assessment), PGA and MDG (based on 0-10 cm VAS, where 0 = no disease activity and 10 = worst disease activity), and CRP. The SDAI =< 3.3 indicates disease remission (NCT02833350)
Timeframe: Days 7, 14, 28, 56, and 84

,,,,,,
InterventionPercentage of participants (Number)
Week 1 Day 7Week 2 Day 14Week 4 Day 28Week 8 Day 56Week 12 Day 84
Cohort 1: GDC-0853 High Dose + Adalimumab Placebo0.000.000.93.66.4
Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo0.000.000.000.000.00
Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo0.90.000.92.84.6
Cohort 1: GDC-0853 Placebo + Adalimumab0.001.84.56.39.0
Cohort 1: GDC-0853 Placebo + Adalimumab Placebo0.000.000.000.000.9
Cohort 2: GDC-0853 High Dose0.000.002.10.006.3
Cohort 2: GDC-0853 Placebo0.000.000.000.006.0

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Percentage of Participants Meeting the CDAI-based Remission Criteria

Clinical Disease Activity Index is defined as CDAI= : SJC(28) + TJC(28) + PGA + MDG where TJC and SJC are the tender and swollen joint counts from 28 joints, PGA is the patient's global assessment of disease activity (on a 0-10 scale) and MDG is physician global assessment of disease activity (on a 0-10 scale). The cutoff value for CDAI remission is <=2.8. (NCT02833350)
Timeframe: Days 7, 14, 28, 56, and 84

,,,,,,
InterventionPercentage of participants (Number)
Week 1 Day 7Week 2 Day 14Week 4 Day 28Week 8 Day 56Week 12 Day 84
Cohort 1: GDC-0853 High Dose + Adalimumab Placebo0.90.00.95.56.4
Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo0.00.00.00.00.0
Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo0.90.00.92.85.5
Cohort 1: GDC-0853 Placebo + Adalimumab0.01.84.57.29.9
Cohort 1: GDC-0853 Placebo + Adalimumab Placebo0.00.00.00.000.9
Cohort 2: GDC-0853 High Dose0.00.02.14.26.3
Cohort 2: GDC-0853 Placebo0.00.00.00.06.0

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Percentage of Participants Meeting the Boolean-based Remission Criteria

Boolean Remission is defined as Tender joint count less than 1, Swollen joint count less than 1, CRP less than 1 mg/dL, patient global assessment less than 1 (on 0 to 10 VAS scale). (NCT02833350)
Timeframe: Days 7, 14, 28, 56, and 84

,,,,,,
InterventionPercentage of participants (Number)
Week 1 Day 7Week 2 Day 14Week 4 Day 28Week 8 Day 56Week 12 Day 84
Cohort 1: GDC-0853 High Dose + Adalimumab Placebo0.00.00.01.904.1
Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo0.00.00.00.00.0
Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo0.90.01.02.02.0
Cohort 1: GDC-0853 Placebo + Adalimumab0.00.02.83.76.5
Cohort 1: GDC-0853 Placebo + Adalimumab Placebo0.00.00.91.01.0
Cohort 2: GDC-0853 High Dose0.00.02.10.08.5
Cohort 2: GDC-0853 Placebo0.00.00.00.00.0

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Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response

ACR70 response is defined as a ≥ 70% improvement (reduction) compared with Baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate]. (NCT02833350)
Timeframe: Days 7, 14, 28, 56, and 84

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InterventionPercentage (Number)
Week 1 Day 7Week 2 Day 14Week 4 Day 28Week 8 Day 56Week 12 Day 84
Cohort 1: GDC-0853 High Dose + Adalimumab Placebo0.90.04.59.112.7
Cohort 1: GDC-0853 Low Dose + Adalimumab Placebo0.00.000.05.0
Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo0.90.92.87.39.2
Cohort 1: GDC-0853 Placebo + Adalimumab0.03.66.314.418.0
Cohort 1: GDC-0853 Placebo + Adalimumab Placebo0.00.000.93.67.3
Cohort 2: GDC-0853 High Dose0.04.22.16.314.6
Cohort 2: GDC-0853 Placebo0.00.02.04.04.0

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Progression Free Survival (PFS)

From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive without report of progression are censored at date of last contact. (NCT02890355)
Timeframe: From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 3 years

Interventionmonths (Median)
Arm I (Veliparib and mFOLFIRI)2.1
Arm II (FOLFIRI)2.9

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Overall Response Rate, ORR

Overall response rate (ORR) is defined as the proportion of participants who have a confirmed and unconfirmed, partial or complete response to therapy. (NCT02890355)
Timeframe: Up to 3 years post registration

Interventionproportion of participants (Number)
Arm I (Veliparib and mFOLFIRI)0.09
Arm II (FOLFIRI)0.10

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Disease Control Rate

Disease control rate (DCR) is defined as the proportion of participants who have a confirmed and unconfirmed, partial, complete or stable response to therapy. (NCT02890355)
Timeframe: Up to 3 years post registration

Interventionproportion of participants (Number)
Arm I (Veliparib and mFOLFIRI)0.32
Arm II (FOLFIRI)0.47

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Duration of Response (DoR)

"DoR: time from date of first documentation of response (complete response, CR, or partial response, PR) to date of first documentation of progression or symptomatic deterioration, or death due to any cause among participants, who achieve a response (CR or PR).~The distribution of DoR in each treatment arm will be estimated using the Kaplan-Meier method." (NCT02890355)
Timeframe: Up to 3 years post registration

Interventionmonths (Median)
Arm I (Veliparib and mFOLFIRI)3.4
Arm II (FOLFIRI)5.1

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Overall Survival (OS)

"OS: time to death by any cause from randomized treatment arm assignment.~The log-rank test with stratification was used by prior systemic treatment for metastatic disease. Distributions of overall survival in arms 1 and 2 were estimated using the method of Kaplan-Meier." (NCT02890355)
Timeframe: Up to 3 years

Interventionmonths (Median)
Arm I (Veliparib and mFOLFIRI)5.4
Arm II (FOLFIRI)6.5

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Phase 3: Number of Participants With Shift in Visual Acuity Logarithm of the Minimum Angle of Resolution (LogMAR) Score

Visual acuity was measured using the Snellen visual acuity conversion chart. This was determined by establishing the smallest optotypes that could be identified correctly by the participant at a given observation distance. Snellen visual acuity was reported as a Snellen fraction (m/M) in which the numerator (m) indicated the test distance and the denominator (M) indicated the distance at which the gap of the equivalent Landolt ring subtends 1 minute of arc. The LogMAR score was calculated as - log(m/M). The maximum increase in score of <= 0, 0 to < 0.1, 0.1 to < 0.2, 0.2 to < 0.3 and >=0.3 relative to baseline in LogMAR were reported in this endpoint. (NCT02928224)
Timeframe: From start of study treatment until 30 days post last dose of study treatment (for triplet arm: maximum treatment exposure of 277.4 weeks; for doublet arm: maximum treatment exposure of 268 weeks; for Control arm: maximum treatment exposure of 108 weeks)

,,
InterventionParticipants (Count of Participants)
Baseline <=0 to >0-<0.1Baseline <=0 to 0.1-<0.2Baseline <=0 to 0.2-<0.3Baseline <=0 to >=0.3Baseline <=0 to missing scoreBaseline >0-<0.1 to <=0Baseline >0-<0.1 to 0.1-<0.2Baseline >0-<0.1 to 0.2-<0.3Baseline >0-<0.1 to >=0.3Baseline >0-<0.1 to missing scoreBaseline 0.1-<0.2 to <=0Baseline 0.1-<0.2 to >0-<0.1Baseline 0.2-<0.3 to <=0Baseline 0.2-<0.3 to >0-<0.1Baseline 0.2-<0.3 to 0.1-<0.2Baseline 0.2-<0.3 to missing scoreBaseline >=0.3 to <=0Baseline >=0.3 to >0-<0.1Baseline >=0.3 to 0.1-<0.2Baseline >=0.3 to 0.2-<0.3Baseline >=0.3 to missing scoreBaseline 0.1-<0.2 to 0.2-<0.3Baseline 0.1-<0.2 to missing score
Phase 3: Control Arm000012900003000000500001307
Phase 3: Doublet Arm83018662102510001420101939
Phase 3: Triplet Arm33154691774335113319412100

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Phase 3: Number of Participants With Newly Occurring Clinically Notable Vital Sign Abnormalities

Newly occurring clinically notable changes was defined as participants not meeting the criterion at baseline and meeting criterion post-baseline. The criterion included: low/high systolic blood pressure (SBP): <= 90 millimeters of mercury (mmHg) with decrease from baseline of >= 20mmHg or >= 160mmHg with increase from baseline of >= 20mmHg, low or high diastolic blood pressure (DBP): <= 50mmHg with decrease from baseline of >= 15mmHg or >= 100mmHg with increase from baseline of >= 15mmHg, low or high pulse: <= 50 beats/min with decrease from baseline of >= 15 beats/min or >= 120 beats/min with increase from baseline of >= 15 beats/min, low or high temperature: <= 36 degree Celsius (deg C) or >= 37.5 deg C. (NCT02928224)
Timeframe: From start of study treatment until 30 days post last dose of study treatment (for triplet arm: maximum treatment exposure of 277.4 weeks; for doublet arm: maximum treatment exposure of 268 weeks; for Control arm: maximum treatment exposure of 108 weeks)

,,
InterventionParticipants (Count of Participants)
Diastolic Blood Pressure - HighDiastolic Blood Pressure - LowPulse Rate - HighPulse Rate - LowSystolic Blood Pressure - HighSystolic Blood Pressure - LowTemperature - HighTemperature - Low
Phase 3: Control Arm752035102555
Phase 3: Doublet Arm62714413282384
Phase 3: Triplet Arm82123319373393

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Phase 3: Number of Participants With Newly Occurring Clinically Notable Electrocardiogram (ECG) Values

Newly occurring clinically notable changes was defined as participants not meeting the criterion at baseline and meeting criterion post-baseline. The criterion included: heart rate- decrease from baseline > 25% and to a value < 50 and increase from baseline > 25% and to a value > 100. QT interval- new > 450 (millisecond) msec, new > 480 msec, new > 500 msec, increase from baseline > 30 msec and increase from baseline > 60 msec. QTcF- new > 450 msec, new > 480 msec, new > 500 msec, increase from baseline > 30 msec and increase from baseline > 60 msec. (NCT02928224)
Timeframe: From start of study treatment until 30 days post last dose of study treatment (for triplet arm: maximum treatment exposure of 277.4 weeks; for doublet arm: maximum treatment exposure of 268 weeks; for Control arm: maximum treatment exposure of 108 weeks)

,,
InterventionParticipants (Count of Participants)
Heart Rate - Decrease from baseline > 25% and to a value < 50Heart Rate - Increase from baseline > 25% and to a value > 100QT Interval - New > 450 millisecond (msec)QT Interval - New > 480 msecQT Interval - New > 500 msecQT Interval - increase from baseline > 30 msecQT Interval - increase from baseline > 60 msecQTcF - New > 450 msecQTcF - New > 480 msecQTcF - New > 500 msecQTcF - increase from baseline > 30 msecQTcF - increase from baseline > 60 msec
Phase 3: Control Arm02872032102352245
Phase 3: Doublet Arm42430759921511867520
Phase 3: Triplet Arm1271743972239915912

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Phase 3: Number of Participants With Clinically Notable Shifts in Serum Chemistry Laboratory Parameters

Clinically notable shifts was defined as worsening by at least 2 grades or to >= Grade 3 based on CTCAE version 4.03 where Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: life threatening and Grade 5: death. (NCT02928224)
Timeframe: From start of study treatment until 30 days post last dose of study treatment (for triplet arm: maximum treatment exposure of 277.4 weeks; for doublet arm: maximum treatment exposure of 268 weeks; for Control arm: maximum treatment exposure of 108 weeks)

,,
InterventionParticipants (Count of Participants)
Alanine Aminotransferase - HyperAlbumin - HypoAlkaline Phosphatase - HyperAspartate Aminotransferase - HyperBilirubin - HyperCalcium - HyperCalcium - HypoCreatine Kinase - HyperCreatinine - HyperGlucose - HyperGlucose - HypoMagnesium - HyperMagnesium - HypoPotassium - HyperPotassium - HypoSodium - HyperSodium - HypoTroponin I - HyperUrate - Hyper
Phase 3: Control Arm10171891207364129592501
Phase 3: Doublet Arm7161271308111160141071402
Phase 3: Triplet Arm115013111111518458401114511004

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Phase 3: Number of Participants With Clinically Notable Shifts in Hematology and Coagulation Laboratory Parameters

Clinically notable shifts was defined as worsening by at least 2 grades or to more than or equal to (>=) Grade 3 based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 where Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: life threatening and Grade 5: death. (NCT02928224)
Timeframe: From start of study treatment until 30 days post last dose of study treatment (for triplet arm: maximum treatment exposure of 277.4 weeks; for doublet arm: maximum treatment exposure of 268 weeks; for Control arm: maximum treatment exposure of 108 weeks)

,,
InterventionParticipants (Count of Participants)
Activated Partial Thromboplastin Time - HyperHemoglobin - HyperHemoglobin - HypoLeukocytes - HyperLeukocytes - HypoLymphocytes - HyperLymphocytes - HypoNeutrophils - HypoPlatelets - HypoProthrombin Intl. Normalized Ratio - Hyper
Phase 3: Doublet Arm903009347852
Phase 3: Triplet Arm9097021225413
Phase 3:Control Arm40170514576542

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(Safety Lead-in) Incidence of Dose Interruptions, Dose Modifications and Discontinuations Due to Adverse Events (AEs) - Final Analysis

An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Number of participants according to incidence of dose interruptions, dose modifications and dose discontinuations due to AEs were reported in this outcome measure. (NCT02928224)
Timeframe: From start of study treatment until 30 days post last dose of study treatment (maximum treatment exposure of 280 weeks)

InterventionParticipants (Count of Participants)
Dose interruptionsDose modificationsDiscontinuation due to AEs
Combined Safety Lead-in30168

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(Safety Lead-in) Evaluation of the Time of Maximum Observed Concentration (Tmax) for Metabolite of Binimetinib (AR00426032)

(NCT02928224)
Timeframe: Predose and 1, 2, 4 and 6 hours post-dose on Day 1 of Cycles 1 and 2 (each cycle of 28 days)

InterventionHours (Median)
Cycle 1Cycle 2
Combined Safety Lead-in2.001.58

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(Safety Lead-in) Evaluation of the Time of Maximum Observed Concentration (Tmax) for Encorafenib

(NCT02928224)
Timeframe: Predose and 1, 2, 4 and 6 hours post-dose on Day 1 of Cycles 1 and 2 (each cycle of 28 days)

InterventionHours (Median)
Cycle 1Cycle 2
Combined Safety Lead-in2.002.00

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(Safety Lead-in) Evaluation of the Time of Maximum Observed Concentration (Tmax) for Cetuximab

(NCT02928224)
Timeframe: Predose and 1, 2, 4 and 6 hours post-dose on Day 1 of Cycles 1 and 2 (each cycle of 28 days)

InterventionHours (Median)
Cycle 1Cycle 2
Combined Safety Lead-in3.773.05

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(Safety Lead-in) Evaluation of the Time of Maximum Observed Concentration (Tmax) for Binimetinib

(NCT02928224)
Timeframe: Predose and 1, 2, 4 and 6 hours post-dose on Day 1 of Cycles 1 and 2 (each cycle of 28 days)

InterventionHours (Median)
Cycle 1Cycle 2
Combined Safety Lead-in1.981.04

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(Safety Lead-in) Evaluation of the Maximum Concentration (Cmax) for Metabolite of Binimetinib (AR00426032)

(NCT02928224)
Timeframe: Predose and 1, 2, 4 and 6 hours post-dose on Day 1 of Cycles 1 and 2 (each cycle of 28 days)

InterventionNanogram/milliliter (Geometric Mean)
Cycle 1Cycle 2
Combined Safety Lead-in59.920.5

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(Safety Lead-in) Evaluation of the Maximum Concentration (Cmax) for Encorafenib

(NCT02928224)
Timeframe: Predose and 1, 2, 4 and 6 hours post-dose on Day 1 of Cycles 1 and 2 (each cycle of 28 days)

InterventionNanogram/milliliter (Geometric Mean)
Cycle 1Cycle 2
Combined Safety Lead-in33602490

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(Safety Lead-in) Evaluation of the Maximum Concentration (Cmax) for Cetuximab

(NCT02928224)
Timeframe: Predose and 1, 2, 4 and 6 hours post-dose on Day 1 of Cycles 1 and 2 (each cycle of 28 days)

InterventionNanogram/milliliter (Geometric Mean)
Cycle 1Cycle 2
Combined Safety Lead-in195000199000

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(Safety Lead-in) Evaluation of the Maximum Concentration (Cmax) for Binimetinib

(NCT02928224)
Timeframe: Predose and 1, 2, 4 and 6 hours post-dose on Day 1 of Cycles 1 and 2 (each cycle of 28 days)

InterventionNanogram/milliliter (Geometric Mean)
Cycle 1Cycle 2
Combined Safety Lead-in654524

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(Safety Lead-in) Evaluation of the Area Under the Concentration-time Curve From Zero to the Last Measurable Time Point (AUClast) for Metabolite of Binimetinib (AR00426032)

(NCT02928224)
Timeframe: Predose and 1, 2, 4 and 6 hours post-dose on Day 1 of Cycles 1 and 2 (each cycle of 28 days)

InterventionNanogram/milliliter *hour (Geometric Mean)
Cycle 1Cycle 2
Combined Safety Lead-in20670.0

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(Safety Lead-in) Evaluation of the Area Under the Concentration-Time Curve From Zero to the Last Measurable Time Point (AUClast) for Encorafenib

(NCT02928224)
Timeframe: Predose and 1, 2, 4 and 6 hours post-dose on Day 1 of Cycles 1 and 2 (each cycle of 28 days)

InterventionNanogram/milliliter *hour (Geometric Mean)
Cycle 1Cycle 2
Combined Safety Lead-in113006660

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(Safety Lead-in) Evaluation of the Area Under the Concentration-Time Curve From Zero to the Last Measurable Time Point (AUClast) for Cetuximab

(NCT02928224)
Timeframe: Predose and 1, 2, 4 and 6 hours post-dose on Day 1 of Cycles 1 and 2 (each cycle of 28 days)

InterventionNanogram/milliliter *hour (Geometric Mean)
Cycle 1Cycle 2
Combined Safety Lead-in841000970000

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(Safety Lead-in) Evaluation of the Area Under the Concentration-Time Curve From Zero to the Last Measurable Time Point (AUClast) for Binimetinib

(NCT02928224)
Timeframe: Predose and 1, 2, 4 and 6 hours post-dose on Day 1 of Cycles 1 and 2 (each cycle of 28 days)

InterventionNanogram/milliliter *hour (Geometric Mean)
Cycle 1Cycle 2
Combined Safety Lead-in19601540

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(Phase 3) Change From Baseline in the Participant Global Impression of Change (PGIC) in Triplet Arm vs Control Arm, Doublet Arm vs Control, and Triplet vs Doublet

"The PGIC is a measure of participant's perceptions of change in their symptoms over time that can be used as an anchoring method to determine the minimal clinically important difference for other participant reported outcome (PROs). For this assessment, participants answered the following question: Since starting treatment, my colorectal cancer symptoms are: (1) very much improved, (2) much improved, (3) minimally improved, (4) no change, (5) minimally worse, (6) much worse or (7) very much worse." (NCT02928224)
Timeframe: Baseline,Cycle (C)1 Day (D)1, C2 D1, C3 D1, C4 D1, C5 D1, C6 D1, C7 D1, C8 D1, C9 D1, C10 D1, C11 D1, C12 D1, C13 D1, C14 D1, C15 D1, C16 D1, C17 D1, C18 D1, C19 D1, C20 D1, C21 D1, C22 D1, C23 D1, End of Treatment, 30 Day Follow Up(each cycle of 28 days)

InterventionUnits on a scale (Mean)
BaselineChange at Cycle 1 Day 1Change at Cycle 2 Day 1Change at Cycle 3 Day 1Change at Cycle 4 Day 1Change at Cycle 5 Day 1Change at Cycle 6 Day 1Change at Cycle 7 Day 1Change at Cycle 8 Day 1Change at Cycle 9 Day 1Change at Cycle 10 Day 1Change at Cycle 11 Day 1Change at Cycle 12 Day 1Change at Cycle 13 Day 1Change at Cycle 14 Day 1Change at Cycle 15 Day 1Change at Cycle 16 Day 1Change at Cycle 17 Day 1Change at Cycle 18 Day 1Change at Cycle 19 Day 1Change at Cycle 20 Day 1Change at Cycle 21 Day 1Change at Cycle 22 Day 1Change at Cycle 23 Day 1Change at End of TreatmentChange at 30 Day Follow Up
Phase 3:Doublet Arm3.80.1-0.8-1.2-1.1-1.1-1.2-1.0-1.1-0.9-0.6-1.1-0.8-0.9-1.5-1.6-0.7-1.0-1.0-0.5-2.0-2.0-2.0-2.00.10.5

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(Phase 3) Change From Baseline in the Participant Global Impression of Change (PGIC) in Triplet Arm vs Control Arm, Doublet Arm vs Control, and Triplet vs Doublet

"The PGIC is a measure of participant's perceptions of change in their symptoms over time that can be used as an anchoring method to determine the minimal clinically important difference for other participant reported outcome (PROs). For this assessment, participants answered the following question: Since starting treatment, my colorectal cancer symptoms are: (1) very much improved, (2) much improved, (3) minimally improved, (4) no change, (5) minimally worse, (6) much worse or (7) very much worse." (NCT02928224)
Timeframe: Baseline,Cycle (C)1 Day (D)1, C2 D1, C3 D1, C4 D1, C5 D1, C6 D1, C7 D1, C8 D1, C9 D1, C10 D1, C11 D1, C12 D1, C13 D1, C14 D1, C15 D1, C16 D1, C17 D1, C18 D1, C19 D1, C20 D1, C21 D1, C22 D1, C23 D1, End of Treatment, 30 Day Follow Up(each cycle of 28 days)

InterventionUnits on a scale (Mean)
BaselineChange at Cycle 1 Day 1Change at Cycle 2 Day 1Change at Cycle 3 Day 1Change at Cycle 4 Day 1Change at Cycle 5 Day 1Change at Cycle 6 Day 1Change at Cycle 7 Day 1Change at Cycle 8 Day 1Change at Cycle 9 Day 1Change at Cycle 10 Day 1Change at Cycle 11 Day 1Change at Cycle 12 Day 1Change at Cycle 13 Day 1Change at End of TreatmentChange at 30 Day Follow Up
Phase 3:Control Arm3.90.0-0.3-0.5-0.5-0.7-0.8-1.1-1.0-1.0-0.30.0-0.5-1.00.40.7

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(Phase 3) Change From Baseline in the Functional Assessment of Cancer Therapy-Colon Cancer (FACT-C) in Triplet Arm vs Control Arm, Doublet Arm vs Control, and Triplet vs Doublet

FACT-C= Functional Assessment of Chronic Illness Therapy (FACIT), which assessed HRQoL of cancer participants & participants with other chronic illnesses. It consists of total 36 items (27 items of general version of FACT-C and disease-specific subscale containing 9 CRC-specific items), summarized to 5 subscales: physical well-being (7 items), functional well-being (7 items), social/family well-being (7 items); all 3 subscales range:0-28, emotional well-being (6 items) range: 0-24, colorectal cancer subscale (9 items) range: 0-36; higher subscale score= better QoL. All single-item measures range: 0= 'Not at all' to 4= 'Very much'. Table summarizes functional well-being subscale, individual questions are linearly scaled & combined to form functional well-being subscale score (range 0-28). High score represents better QoL. (NCT02928224)
Timeframe: Baseline,Cycle (C)1 Day (D)1, C2 D1, C3 D1, C4 D1, C5 D1, C6 D1, C7 D1, C8 D1, C9 D1, C10 D1, C11 D1, C12 D1, C13 D1, C14 D1, C15 D1, C16 D1, C17 D1, C18 D1, C19 D1, C20 D1, C21 D1, C22 D1, C23 D1, End of Treatment, 30 Day Follow Up(each cycle of 28 days)

InterventionUnits on a scale (Mean)
BaselineChange at Cycle 1 Day 1Change at Cycle 2 Day 1Change at Cycle 3 Day 1Change at Cycle 4 Day 1Change at Cycle 5 Day 1Change at Cycle 6 Day 1Change at Cycle 7 Day 1Change at Cycle 8 Day 1Change at Cycle 9 Day 1Change at Cycle 10 Day 1Change at Cycle 11 Day 1Change at Cycle 12 Day 1Change at Cycle 13 Day 1Change at Cycle 14 Day 1Change at Cycle 15 Day 1Change at Cycle 16 Day 1Change at Cycle 17 Day 1Change at Cycle 18 Day 1Change at Cycle 19 Day 1Change at Cycle 20 Day 1Change at Cycle 21 Day 1Change at Cycle 22 Day 1Change at Cycle 23 Day 1Change at End of TreatmentChange at 30 Day Follow Up
Phase 3:Doublet Arm16.2-0.9-0.6-0.2-0.1-0.20.6-0.10.2-0.8-1.3-0.5-1.1-3.2-4.0-1.5-0.7-0.7-3.0-6.0-5.0-5.0-12.0-9.0-2.2-0.8

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(Phase 3) Change From Baseline in the Functional Assessment of Cancer Therapy-Colon Cancer (FACT-C) in Triplet Arm vs Control Arm, Doublet Arm vs Control, and Triplet vs Doublet

FACT-C= Functional Assessment of Chronic Illness Therapy (FACIT), which assessed HRQoL of cancer participants & participants with other chronic illnesses. It consists of total 36 items (27 items of general version of FACT-C and disease-specific subscale containing 9 CRC-specific items), summarized to 5 subscales: physical well-being (7 items), functional well-being (7 items), social/family well-being (7 items); all 3 subscales range:0-28, emotional well-being (6 items) range: 0-24, colorectal cancer subscale (9 items) range: 0-36; higher subscale score= better QoL. All single-item measures range: 0= 'Not at all' to 4= 'Very much'. Table summarizes functional well-being subscale, individual questions are linearly scaled & combined to form functional well-being subscale score (range 0-28). High score represents better QoL. (NCT02928224)
Timeframe: Baseline,Cycle (C)1 Day (D)1, C2 D1, C3 D1, C4 D1, C5 D1, C6 D1, C7 D1, C8 D1, C9 D1, C10 D1, C11 D1, C12 D1, C13 D1, C14 D1, C15 D1, C16 D1, C17 D1, C18 D1, C19 D1, C20 D1, C21 D1, C22 D1, C23 D1, End of Treatment, 30 Day Follow Up(each cycle of 28 days)

InterventionUnits on a scale (Mean)
BaselineChange at Cycle 1 Day 1Change at Cycle 2 Day 1Change at Cycle 3 Day 1Change at Cycle 4 Day 1Change at Cycle 5 Day 1Change at Cycle 6 Day 1Change at Cycle 7 Day 1Change at Cycle 8 Day 1Change at Cycle 9 Day 1Change at Cycle 10 Day 1Change at Cycle 11 Day 1Change at Cycle 12 Day 1Change at Cycle 13 Day 1Change at Cycle 14 Day 1Change at Cycle 15 Day 1Change at Cycle 16 Day 1Change at Cycle 17 Day 1Change at Cycle 18 Day 1Change at Cycle 19 Day 1Change at Cycle 20 Day 1Change at Cycle 21 Day 1Change at End of TreatmentChange at 30 Day Follow Up
Phase 3: Triplet Arm16.3-0.2-0.3-0.20.40.70.70.50.9-1.9-1.7-1.5-1.5-2.0-2.4-2.3-4.2-6.7-5.0-7.0-6.0-9.0-2.4-3.5

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(Phase 3) Change From Baseline in the Functional Assessment of Cancer Therapy-Colon Cancer (FACT-C) in Triplet Arm vs Control Arm, Doublet Arm vs Control, and Triplet vs Doublet

FACT-C= Functional Assessment of Chronic Illness Therapy (FACIT), which assessed HRQoL of cancer participants & participants with other chronic illnesses. It consists of total 36 items (27 items of general version of FACT-C and disease-specific subscale containing 9 CRC-specific items), summarized to 5 subscales: physical well-being (7 items), functional well-being (7 items), social/family well-being (7 items); all 3 subscales range:0-28, emotional well-being (6 items) range: 0-24, colorectal cancer subscale (9 items) range: 0-36; higher subscale score= better QoL. All single-item measures range: 0= 'Not at all' to 4= 'Very much'. Table summarizes functional well-being subscale, individual questions are linearly scaled & combined to form functional well-being subscale score (range 0-28). High score represents better QoL. (NCT02928224)
Timeframe: Baseline,Cycle (C)1 Day (D)1, C2 D1, C3 D1, C4 D1, C5 D1, C6 D1, C7 D1, C8 D1, C9 D1, C10 D1, C11 D1, C12 D1, C13 D1, C14 D1, C15 D1, C16 D1, C17 D1, C18 D1, C19 D1, C20 D1, C21 D1, C22 D1, C23 D1, End of Treatment, 30 Day Follow Up(each cycle of 28 days)

InterventionUnits on a scale (Mean)
BaselineChange at Cycle 1 Day 1Change at Cycle 2 Day 1Change at Cycle 3 Day 1Change at Cycle 4 Day 1Change at Cycle 5 Day 1Change at Cycle 6 Day 1Change at Cycle 7 Day 1Change at Cycle 8 Day 1Change at Cycle 9 Day 1Change at Cycle 10 Day 1Change at Cycle 11 Day 1Change at Cycle 12 Day 1Change at Cycle 13 Day 1Change at End of TreatmentChange at 30 Day Follow Up
Phase 3:Control Arm16.8-1.4-0.9-0.7-1.8-1.6-1.9-0.5-2.1-2.60.5-4.5-4.5-8.0-3.1-4.2

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(Phase 3) Change From Baseline in the EuroQol-5D-5L Visual Analog Scale (EQ-5D-5L VAS) in Triplet Arm vs Control Arm, Doublet Arm vs Control, and Triplet vs Doublet

The EQ-5D-5L contains 1 item for each of 5 dimensions of health-related QoL (i.e., mobility, self-care, usual activities, pain or discomfort and anxiety or depression). Response options for each item varied from having no problems to moderate problems or extreme problems. The EQ-5D-5L (v4.0) is a standardized measure of health utility that provides a single index value for one's health status. The EQ-5D-5L is frequently used for economic evaluations of health care and has been recognized as a valid and reliable instrument for this purpose. The EQ visual analog scale (VAS) is a score that is directly reported by the participant and ranges from 0 to 100 (higher is better quality health). (NCT02928224)
Timeframe: Baseline,Cycle (C)1 Day (D)1, C2 D1, C3 D1, C4 D1, C5 D1, C6 D1, C7 D1, C8 D1, C9 D1, C10 D1, C11 D1, C12 D1, C13 D1, C14 D1, C15 D1, C16 D1, C17 D1, C18 D1, C19 D1, C20 D1, C21 D1, C22 D1, C23 D1, End of Treatment, 30 Day Follow Up(each cycle of 28 days)

InterventionUnits on a scale (Mean)
BaselineChange at Cycle 1 Day 1Change at Cycle 2 Day 1Change at Cycle 3 Day 1Change at Cycle 4 Day 1Change at Cycle 5 Day 1Change at Cycle 6 Day 1Change at Cycle 7 Day 1Change at Cycle 8 Day 1Change at Cycle 9 Day 1Change at Cycle 10 Day 1Change at Cycle 11 Day 1Change at Cycle 12 Day 1Change at Cycle 13 Day 1Change at Cycle 14 Day 1Change at Cycle 15 Day 1Change at Cycle 16 Day 1Change at Cycle 17 Day 1Change at Cycle 18 Day 1Change at Cycle 19 Day 1Change at Cycle 20 Day 1Change at Cycle 21 Day 1Change at Cycle 22 Day 1Change at Cycle 23 Day 1Change at End of TreatmentChange at 30 Day Follow Up
Phase 3:Doublet Arm66.5-0.91.94.25.65.12.93.62.0-4.0-8.1-0.1-0.6-4.1-0.44.23.31.7-3.3-5.52.0-5.0-5.0-5.0-8.0-5.9

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(Phase 3) Change From Baseline in the EuroQol-5D-5L Visual Analog Scale (EQ-5D-5L VAS) in Triplet Arm vs Control Arm, Doublet Arm vs Control, and Triplet vs Doublet

The EQ-5D-5L contains 1 item for each of 5 dimensions of health-related QoL (i.e., mobility, self-care, usual activities, pain or discomfort and anxiety or depression). Response options for each item varied from having no problems to moderate problems or extreme problems. The EQ-5D-5L (v4.0) is a standardized measure of health utility that provides a single index value for one's health status. The EQ-5D-5L is frequently used for economic evaluations of health care and has been recognized as a valid and reliable instrument for this purpose. The EQ visual analog scale (VAS) is a score that is directly reported by the participant and ranges from 0 to 100 (higher is better quality health). (NCT02928224)
Timeframe: Baseline,Cycle (C)1 Day (D)1, C2 D1, C3 D1, C4 D1, C5 D1, C6 D1, C7 D1, C8 D1, C9 D1, C10 D1, C11 D1, C12 D1, C13 D1, C14 D1, C15 D1, C16 D1, C17 D1, C18 D1, C19 D1, C20 D1, C21 D1, C22 D1, C23 D1, End of Treatment, 30 Day Follow Up(each cycle of 28 days)

InterventionUnits on a scale (Mean)
BaselineChange at Cycle 1 Day 1Change at Cycle 2 Day 1Change at Cycle 3 Day 1Change at Cycle 4 Day 1Change at Cycle 5 Day 1Change at Cycle 6 Day 1Change at Cycle 7 Day 1Change at Cycle 8 Day 1Change at Cycle 9 Day 1Change at Cycle 10 Day 1Change at Cycle 11 Day 1Change at Cycle 12 Day 1Change at Cycle 13 Day 1Change at Cycle 14 Day 1Change at Cycle 15 Day 1Change at Cycle 16 Day 1Change at Cycle 17 Day 1Change at Cycle 18 Day 1Change at Cycle 19 Day 1Change at Cycle 20 Day 1Change at Cycle 21 Day 1Change at End of TreatmentChange at 30 Day Follow Up
Phase 3: Triplet Arm69.00.81.43.04.03.31.31.44.10.30.20.2-4.0-3.0-4.0-3.4-10.4-18.37.08.08.08.0-8.5-11.1

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(Phase 3) Change From Baseline in the EuroQol-5D-5L Visual Analog Scale (EQ-5D-5L VAS) in Triplet Arm vs Control Arm, Doublet Arm vs Control, and Triplet vs Doublet

The EQ-5D-5L contains 1 item for each of 5 dimensions of health-related QoL (i.e., mobility, self-care, usual activities, pain or discomfort and anxiety or depression). Response options for each item varied from having no problems to moderate problems or extreme problems. The EQ-5D-5L (v4.0) is a standardized measure of health utility that provides a single index value for one's health status. The EQ-5D-5L is frequently used for economic evaluations of health care and has been recognized as a valid and reliable instrument for this purpose. The EQ visual analog scale (VAS) is a score that is directly reported by the participant and ranges from 0 to 100 (higher is better quality health). (NCT02928224)
Timeframe: Baseline,Cycle (C)1 Day (D)1, C2 D1, C3 D1, C4 D1, C5 D1, C6 D1, C7 D1, C8 D1, C9 D1, C10 D1, C11 D1, C12 D1, C13 D1, C14 D1, C15 D1, C16 D1, C17 D1, C18 D1, C19 D1, C20 D1, C21 D1, C22 D1, C23 D1, End of Treatment, 30 Day Follow Up(each cycle of 28 days)

InterventionUnits on a scale (Mean)
BaselineChange at Cycle 1 Day 1Change at Cycle 2 Day 1Change at Cycle 3 Day 1Change at Cycle 4 Day 1Change at Cycle 5 Day 1Change at Cycle 6 Day 1Change at Cycle 7 Day 1Change at Cycle 8 Day 1Change at Cycle 9 Day 1Change at Cycle 10 Day 1Change at Cycle 11 Day 1Change at Cycle 12 Day 1Change at Cycle 13 Day 1Change at End of TreatmentChange at 30 Day Follow Up
Phase 3:Control Arm68.3-2.1-2.4-1.4-0.42.5-3.62.4-2.8-8.1-1.84.01.5-2.0-12.7-11.0

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(Phase 3) Change From Baseline in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Cancer Participants (QLQ-C30) Triplet Arm vs Control Arm, Doublet Arm vs Control, and Triplet vs Doublet

The EORTC QLQ-C30 questionnaire consisted of 30 questions generating 5 functional scores (physical, role, cognitive, emotional, & social); a global health (GH) status/global quality of life scale score; 3 symptom scale scores (fatigue, pain, & nausea & vomiting); & 6 standalone one-item scores that capture additional symptoms (dyspnea, appetite loss, sleep disturbance, constipation, & diarrhea) & perceived financial burden. All items were graded by severity experienced during previous week & used 4-point-scale (1: not at all, 2: a little, 3: quite a bit, 4: very much). The scores were converted to health-related quality of life (HRQoL) scale ranging from 0-100. Higher scores indicating higher response levels (i.e., higher functioning, higher symptom severity). (NCT02928224)
Timeframe: Baseline, Cycle(C)1 Day(D)1 , C2 D1, C3 D1, C4 D1, C5 D1, C6 D1, C7 D1, C8 D1, C9 D1, C10 D1, C11 D1, C12 D1, C13 D1, C14 D1, C15 D1, C16 D1, C17 D1, C18 D1, C19 D1, C20 D1, C21 D1, C22 D1, C23 D1, End of Treatment, 30 Day Follow Up(each cycle of 28 days)

InterventionUnits on a scale (Mean)
BaselineChange at Cycle 1 Day 1Change at Cycle 2 Day 1Change at Cycle 3 Day 1Change at Cycle 4 Day 1Change at Cycle 5 Day 1Change at Cycle 6 Day 1Change at Cycle 7 Day 1Change at Cycle 8 Day 1Change at Cycle 9 Day 1Change at Cycle 10 Day 1Change at Cycle 11 Day 1Change at Cycle 12 Day 1Change at Cycle 13 Day 1Change at Cycle 14 Day 1Change at Cycle 15 Day 1Change at Cycle 16 Day 1Change at Cycle 17 Day 1Change at Cycle 18 Day 1Change at Cycle 19 Day 1Change at Cycle 20 Day 1Change at Cycle 21 Day 1Change at Cycle 22 Day 1Change at Cycle 23 Day 1Change at End of TreatmentChange at 30 Day Follow Up
Phase 3:Doublet Arm60.7-4.33.83.54.24.35.64.34.2-5.6-2.83.9-4.6-3.2-6.02.8-5.6-2.8-8.3-8.3-8-16.7-16.70.0-13.1-10.4

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(Phase 3) Change From Baseline in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Cancer Participants (QLQ-C30) Triplet Arm vs Control Arm, Doublet Arm vs Control, and Triplet vs Doublet

The EORTC QLQ-C30 questionnaire consisted of 30 questions generating 5 functional scores (physical, role, cognitive, emotional, & social); a global health (GH) status/global quality of life scale score; 3 symptom scale scores (fatigue, pain, & nausea & vomiting); & 6 standalone one-item scores that capture additional symptoms (dyspnea, appetite loss, sleep disturbance, constipation, & diarrhea) & perceived financial burden. All items were graded by severity experienced during previous week & used 4-point-scale (1: not at all, 2: a little, 3: quite a bit, 4: very much). The scores were converted to health-related quality of life (HRQoL) scale ranging from 0-100. Higher scores indicating higher response levels (i.e., higher functioning, higher symptom severity). (NCT02928224)
Timeframe: Baseline, Cycle(C)1 Day(D)1 , C2 D1, C3 D1, C4 D1, C5 D1, C6 D1, C7 D1, C8 D1, C9 D1, C10 D1, C11 D1, C12 D1, C13 D1, C14 D1, C15 D1, C16 D1, C17 D1, C18 D1, C19 D1, C20 D1, C21 D1, C22 D1, C23 D1, End of Treatment, 30 Day Follow Up(each cycle of 28 days)

InterventionUnits on a scale (Mean)
BaselineChange at Cycle 1 Day 1Change at Cycle 2 Day 1Change at Cycle 3 Day 1Change at Cycle 4 Day 1Change at Cycle 5 Day 1Change at Cycle 6 Day 1Change at Cycle 7 Day 1Change at Cycle 8 Day 1Change at Cycle 9 Day 1Change at Cycle 10 Day 1Change at Cycle 11 Day 1Change at Cycle 12 Day 1Change at Cycle 13 Day 1Change at Cycle 14 Day 1Change at Cycle 15 Day 1Change at Cycle 16 Day 1Change at Cycle 17 Day 1Change at Cycle 18 Day 1Change at Cycle 19 Day 1Change at Cycle 20 Day 1Change at Cycle 21 Day 1Change at End of TreatmentChange at 30 Day Follow Up
Phase 3: Triplet Arm62.8-2.4-1.60.70.2-1.1-4.0-2.5-2.6-5.8-3.3-5.20.00.0-1.23.6-16.7-27.8-16.70.0-250.0-14.1-17.4

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(Phase 3) Change From Baseline in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Cancer Participants (QLQ-C30) Triplet Arm vs Control Arm, Doublet Arm vs Control, and Triplet vs Doublet

The EORTC QLQ-C30 questionnaire consisted of 30 questions generating 5 functional scores (physical, role, cognitive, emotional, & social); a global health (GH) status/global quality of life scale score; 3 symptom scale scores (fatigue, pain, & nausea & vomiting); & 6 standalone one-item scores that capture additional symptoms (dyspnea, appetite loss, sleep disturbance, constipation, & diarrhea) & perceived financial burden. All items were graded by severity experienced during previous week & used 4-point-scale (1: not at all, 2: a little, 3: quite a bit, 4: very much). The scores were converted to health-related quality of life (HRQoL) scale ranging from 0-100. Higher scores indicating higher response levels (i.e., higher functioning, higher symptom severity). (NCT02928224)
Timeframe: Baseline, Cycle(C)1 Day(D)1 , C2 D1, C3 D1, C4 D1, C5 D1, C6 D1, C7 D1, C8 D1, C9 D1, C10 D1, C11 D1, C12 D1, C13 D1, C14 D1, C15 D1, C16 D1, C17 D1, C18 D1, C19 D1, C20 D1, C21 D1, C22 D1, C23 D1, End of Treatment, 30 Day Follow Up(each cycle of 28 days)

InterventionUnits on a scale (Mean)
BaselineChange at Cycle 1 Day 1Change at Cycle 2 Day 1Change at Cycle 3 Day 1Change at Cycle 4 Day 1Change at Cycle 5 Day 1Change at Cycle 6 Day 1Change at Cycle 7 Day 1Change at Cycle 8 Day 1Change at Cycle 9 Day 1Change at Cycle 10 Day 1Change at Cycle 11 Day 1Change at Cycle 12 Day 1Change at Cycle 13 Day 1Change at End of TreatmentChange at 30 Day Follow Up
Phase 3:Control Arm62.8-3.4-1.9-0.21.4-2.2-4.51.70.0-4.82.133.34.20.0-15.5-24.6

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(Safety Lead-in) Duration of Response (DOR) by Investigator

DOR was defined as the time from first radiographic evidence of response to the earliest documented disease progression (PD) or death due to underlying disease. PD: at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions were evaluated. (NCT02928224)
Timeframe: From time of response to the earliest documented PD or death due to underlying disease (maximum treatment exposure of 280 weeks)

InterventionMonths (Median)
Combined Safety Lead-in6.47

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(Safety Lead-in) Duration of Response (DOR) by BICR

DOR was defined as the time from first radiographic evidence of response to the earliest documented PD or death due to underlying disease. PD: at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions were evaluated. (NCT02928224)
Timeframe: From time of response to the earliest documented PD or death due to underlying disease (maximum treatment exposure of 280 weeks)

InterventionMonths (Median)
Combined Safety Lead-in8.15

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(Phase 3) Overall Survival (OS) of Triplet Arm vs. Control Arm - Interim Analysis

OS was defined as the time from randomization to death due to any cause. (NCT02928224)
Timeframe: From randomization to death due to any cause until 204 deaths were observed (maximum treatment exposure of 89.1 weeks for triplet arm and 52.4 weeks for control arm)

InterventionMonths (Median)
Phase 3: Triplet Arm9.03
Phase 3: Control Arm5.42

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Phase 3: Number of Participants With Clinically Notable Shifts in Urinalysis Laboratory Parameters

Clinically notable shifts was defined as worsening by at least 2 grades or to >= Grade 3 based on CTCAE version 4.03 where Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: life threatening and Grade 5: death. (NCT02928224)
Timeframe: From start of study treatment until 30 days post last dose of study treatment (for triplet arm: maximum treatment exposure of 277.4 weeks; for doublet arm: maximum treatment exposure of 268 weeks; for Control arm: maximum treatment exposure of 108 weeks)

InterventionParticipants (Count of Participants)
Phase 3: Triplet Arm8
Phase 3: Doublet Arm8
Phase 3: Control Arm5

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(Safety Lead-in) Time to Response by Investigator

Time to response was defined as the time from first dose to first radiographic evidence of response. (NCT02928224)
Timeframe: From first dose to first radiographic evidence of response (maximum treatment exposure of 280 weeks)

InterventionMonths (Median)
Combined Safety Lead-in1.45

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(Safety Lead-in) Time to Response by BICR

Time to response was defined as the time from first dose to first radiographic evidence of response. (NCT02928224)
Timeframe: From first dose to first radiographic evidence of response (maximum treatment exposure of 280 weeks)

InterventionMonths (Median)
Combined Safety Lead-in1.45

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(Safety Lead-in) Progression-Free Survival (PFS) by Investigator

PFS was defined as the time from first dose to the earliest documented PD or death due to any cause. PD: at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions were evaluated. (NCT02928224)
Timeframe: From first dose to the earliest documented PD or death due to any cause (maximum treatment exposure of 280 weeks)

InterventionMonths (Median)
Combined Safety Lead-in8.08

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(Safety Lead-in) Progression-Free Survival (PFS) by BICR

PFS was defined as the time from first dose to the earliest documented PD or death due to any cause. PD: at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions were evaluated. (NCT02928224)
Timeframe: From first dose to the earliest documented PD or death due to any cause (maximum treatment exposure of 280 weeks)

InterventionMonths (Median)
Combined Safety Lead-in5.59

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(Safety Lead-in) Objective Response Rate (ORR) by Investigator

ORR per RECIST, v1.1, was defined as the percentage of participants achieving an overall best response of CR or PR, where CR: disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (<10 mm short axis), and PR: at least 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters persistence of one or more non-target lesions and/or maintenance of tumor marker level above the normal limits. (NCT02928224)
Timeframe: From start of study treatment until 30 days post last dose of study treatment (maximum treatment exposure of 280 weeks)

InterventionPercentage of participants (Number)
Combined Safety Lead-in52.8

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(Safety Lead-in) Objective Response Rate (ORR) by BICR

ORR per RECIST, v1.1, was defined as the percentage of participants achieving an overall best response of CR or PR, where CR: disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (<10 mm short axis), and PR: at least 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters persistence of one or more non-target lesions and/or maintenance of tumor marker level above the normal limits. (NCT02928224)
Timeframe: From start of study treatment until 30 days post last dose of study treatment (maximum treatment exposure of 280 weeks)

InterventionPercentage of participants (Number)
Combined Safety Lead-in41.7

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(Safety Lead-in) Number of Participants With Dose-Limiting Toxicities (DLTs)

(NCT02928224)
Timeframe: Cycle 1 (up to 28 days)

InterventionParticipants (Count of Participants)
Combined Safety Lead-in (CSLI)5

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(Phase 3) Overall Survival (OS) of Triplet Arm vs. Control Arm - Final Analysis

OS was defined as the time from randomization to death due to any cause. (NCT02928224)
Timeframe: From randomization to death due to any cause (maximum treatment exposure of 277.4 weeks for triplet arm and 108 weeks for control arm)

InterventionMonths (Median)
Phase 3: Triplet Arm9.82
Phase 3:Control Arm5.88

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(Phase 3) Overall Survival (OS) in Triplet Arm vs. Doublet Arm

OS was defined as the time from randomization to death due to any cause. (NCT02928224)
Timeframe: From randomization to death due to any cause until 204 deaths were observed (maximum treatment exposure of 89.7 weeks for doublet arm and 89.1 weeks for triplet arm)

InterventionMonths (Median)
Phase 3: Triplet Arm9.82
Phase 3: Doublet Arm9.40

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(Phase 3) Objective Response Rate (ORR) by Blinded Independent Central Review (BICR) Per Response Evaluation Criteria in Solid Tumors (RECIST), v1.1 of Triplet Arm vs. Control Arm

ORR per RECIST, v1.1, was defined as the percentage of participants achieving an overall best response of complete response (CR) or partial response (PR), where CR: disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (<10 millimeter [mm] short axis), and PR: at least 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters persistence of one or more non-target lesions and/or maintenance of tumor marker level above the normal limits. (NCT02928224)
Timeframe: Duration of Phase 3, approximately 6 months (up to 28 days per cycle)

InterventionPercentage of participants (Number)
Phase 3: Triplet Arm26.1
Phase 3:Control Arm1.9

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(Phase 3) Evaluation of the Model-Based Oral Clearance (CL/F) for Encorafenib

The reported cross-arm CL/F value is a fixed-effect parameter determined from a population PK analysis. The analysis included pooled data from participants enrolled in multiple studies including those who were not enrolled in this study. The NCTID include: NCT01719380, NCT01543698, and NCT01436656. An additional study ARRAY-162-105 is not required to register. (NCT02928224)
Timeframe: 2 and 6 hours post-dose on Day 1 of Cycle 1, Predose and 2 hours post-dose on Day 1 of Cycle 2 (each cycle of 28 days)

InterventionLiter/hour (Geometric Mean)
Pharmacokinetic Population of Encorafenib16.4

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(Phase 3) Evaluation of the Model-Based Oral Clearance (CL/F) for Binimetinib

The reported cross-arm CL/F value is a fixed-effect parameter determined from a population PK analysis. The analysis included pooled data from participants enrolled in multiple studies including those who were not enrolled in this study. The NCTID include: NCT01719380, NCT01543698, and NCT01436656. An additional study ARRAY-162-105 is not required to register. (NCT02928224)
Timeframe: 2 and 6 hours post-dose on Day 1 of Cycle 1, Predose and 2 hours post-dose on Day 1 of Cycle 2 (each cycle of 28 days)

InterventionLiter/hour (Geometric Mean)
Pharmacokinetic Population of Encorafenib19.0

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(Phase 3) Evaluation of the Model-Based Clearance (CL) for Cetuximab

The reported cross-arm CL/F value is a fixed-effect parameter determined from a population PK analysis. The analysis included pooled data from participants enrolled in multiple studies including those who were not enrolled in this study. The NCTID include: NCT01719380, NCT01543698, and NCT01436656. An additional study ARRAY-162-105 is not required to register. (NCT02928224)
Timeframe: 2 and 6 hours post-dose on Day 1 of Cycle 1, Predose and 2 hours post-dose on Day 1 of Cycle 2 (each cycle of 28 days)

InterventionLiter/hour (Geometric Mean)
Pharmacokinetic Population of Encorafenib0.0154

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(Phase 3) Comparison of Time to Response in Triplet Arm vs Doublet Arm Per Investigator

Time to response was defined as the time from first dose to first radiographic evidence of response. (NCT02928224)
Timeframe: From first dose to first radiographic evidence of response (maximum treatment exposure of 277.4 weeks for triplet arm and 268 weeks for doublet arm)

InterventionMonths (Median)
Phase 3: Triplet Arm1.48
Phase 3:Doublet Arm1.48

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(Phase 3) Comparison of Time to Response in Triplet Arm vs Doublet Arm Per BICR

Time to response was defined as the time from first dose to first radiographic evidence of response. (NCT02928224)
Timeframe: From first dose to first radiographic evidence of response (maximum treatment exposure of 277.4 weeks for triplet arm and 268 weeks for doublet arm)

InterventionMonths (Median)
Phase 3: Triplet Arm1.43
Phase 3:Doublet Arm1.48

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(Phase 3) Comparison of Time to Response in Triplet Arm vs Control Arm Per Investigator

Time to response was defined as the time from first dose to first radiographic evidence of response. (NCT02928224)
Timeframe: From first dose to first radiographic evidence of response (maximum treatment exposure of 277.4 weeks for triplet arm and 108 weeks for control arm)

InterventionMonths (Median)
Phase 3: Triplet Arm1.48
Phase 3:Control Arm2.63

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(Phase 3) Comparison of Time to Response in Triplet Arm vs Control Arm Per BICR

Time to response was defined as the time from first dose to first radiographic evidence of response. (NCT02928224)
Timeframe: From first dose to first radiographic evidence of response (maximum treatment exposure of 277.4 weeks for triplet arm and 108 weeks for control arm)

InterventionMonths (Median)
Phase 3: Triplet Arm1.43
Phase 3:Control Arm1.45

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(Phase 3) Comparison of Time to Response in Doublet Arm vs Control Arm Per Investigator

Time to response was defined as the time from first dose to first radiographic evidence of response. (NCT02928224)
Timeframe: From first dose to first radiographic evidence of response (maximum treatment exposure of 268 weeks for doublet arm and 108 weeks for control arm)

InterventionMonths (Median)
Phase 3: Doublet Arm1.48
Phase 3:Control Arm2.63

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(Phase 3) Comparison of Time to Response in Doublet Arm vs Control Arm Per BICR

Time to response was defined as the time from first dose to first radiographic evidence of response. (NCT02928224)
Timeframe: From first dose to first radiographic evidence of response (maximum treatment exposure of 268 weeks for doublet arm and 108 weeks for control arm)

InterventionMonths (Median)
Phase 3: Doublet Arm1.48
Phase 3:Control Arm1.45

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(Phase 3) Comparison of Progression-Free Survival (PFS) in Triplet Arm vs Doublet Arm Per Investigator

PFS was defined as the time from first dose to the earliest documented PD or death due to any cause. PD: at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions were evaluated. (NCT02928224)
Timeframe: From first dose to the earliest documented PD or death due to any cause (maximum treatment exposure of 277.4 weeks for triplet arm and 268 weeks for doublet arm)

InterventionMonths (Median)
Phase 3: Triplet Arm4.47
Phase 3: Doublet Arm4.27

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(Phase 3) Comparison of Progression-Free Survival (PFS) in Triplet Arm vs Doublet Arm Per BICR

PFS was defined as the time from first dose to the earliest documented PD or death due to any cause. PD: at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions were evaluated. (NCT02928224)
Timeframe: From first dose to the earliest documented PD or death due to any cause (maximum treatment exposure of 277.4 weeks for triplet arm and 268 weeks for doublet arm)

InterventionMonths (Median)
Phase 3: Triplet Arm4.30
Phase 3: Doublet Arm4.21

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(Phase 3) Comparison of Progression-free Survival (PFS) in Triplet Arm vs Control Arm Per Investigator

PFS was defined as the time from first dose to the earliest documented PD or death due to any cause. PD: at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions were evaluated. (NCT02928224)
Timeframe: From first dose to the earliest documented PD or death due to any cause (maximum treatment exposure of 277.4 weeks for triplet arm and 108 weeks for control arm)

InterventionMonths (Median)
Phase 3: Triplet Arm4.47
Phase 3:Control Arm1.58

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(Phase 3) Comparison of Progression-Free Survival (PFS) in Triplet Arm vs Control Arm Per BICR

PFS was defined as the time from first dose to the earliest documented PD or death due to any cause. PD: at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions were evaluated. (NCT02928224)
Timeframe: From first dose to the earliest documented PD or death due to any cause (maximum treatment exposure of 277.4 weeks for triplet arm and 108 weeks for control arm)

InterventionMonths (Median)
Phase 3: Triplet Arm4.30
Phase 3:Control Arm1.51

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(Phase 3) Comparison of Progression-Free Survival (PFS) in Doublet Arm vs Control Arm Per Investigator

PFS was defined as the time from first dose to the earliest documented PD or death due to any cause. PD: at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions were evaluated. (NCT02928224)
Timeframe: From first dose to the earliest documented PD or death due to any cause (maximum treatment exposure of 268 weeks for doublet arm and 108 weeks for control arm)

InterventionMonths (Median)
Phase 3: Doublet Arm4.27
Phase 3:Control Arm1.58

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(Phase 3) Comparison of Progression-Free Survival (PFS) in Doublet Arm vs Control Arm Per BICR

PFS was defined as the time from first dose to the earliest documented PD or death due to any cause. PD: at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions were evaluated. (NCT02928224)
Timeframe: From first dose to the earliest documented PD or death due to any cause (maximum treatment exposure of 268 weeks for doublet arm and 108 weeks for control arm)

InterventionMonths (Median)
Phase 3: Doublet Arm4.21
Phase 3:Control Arm1.51

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(Phase 3) Comparison of Objective Response Rate (ORR) in Triplet Arm vs Doublet Arm Per Investigator

ORR per RECIST, v1.1, was defined as the percentage of participants achieving an overall best response of CR or PR, where CR: disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (<10 mm short axis), and PR: at least 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters persistence of one or more non-target lesions and/or maintenance of tumor marker level above the normal limits. (NCT02928224)
Timeframe: Duration of Phase 3, approximately 6 months (up to 28 days per cycle)

InterventionPercentage of participants (Number)
Phase 3: Triplet Arm26.1
Phase 3: Doublet Arm15.9

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(Phase 3) Comparison of Objective Response Rate (ORR) in Triplet Arm vs Doublet Arm Per BICR

ORR per RECIST, v1.1, was defined as the percentage of participants achieving an overall best response of CR or PR, where CR: disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (<10 mm short axis), and PR: at least 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters persistence of one or more non-target lesions and/or maintenance of tumor marker level above the normal limits. (NCT02928224)
Timeframe: Duration of Phase 3, approximately 6 months (up to 28 days per cycle)

InterventionPercentage of participants (Number)
Phase 3: Triplet Arm26.1
Phase 3: Doublet Arm20.4

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(Phase 3) Comparison of Objective Response Rate (ORR) in Triplet Arm vs Control Arm Per Investigator

ORR per RECIST, v1.1, was defined as the percentage of participants achieving an overall best response of CR or PR, where CR: disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (<10 mm short axis), and PR: at least 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters persistence of one or more non-target lesions and/or maintenance of tumor marker level above the normal limits. (NCT02928224)
Timeframe: Duration of Phase 3, approximately 6 months (up to 28 days per cycle)

InterventionPercentage of participants (Number)
Phase 3: Triplet Arm26.1
Phase 3:Control Arm3.7

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(Phase 3) Comparison of Objective Response Rate (ORR) in Doublet Arm vs Control Arm Per Investigator

ORR per RECIST, v1.1, was defined as the percentage of participants achieving an overall best response of CR or PR, where CR: disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (<10 mm short axis), and PR: at least 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters persistence of one or more non-target lesions and/or maintenance of tumor marker level above the normal limits. (NCT02928224)
Timeframe: Duration of Phase 3, approximately 6 months (up to 28 days per cycle)

InterventionPercentage of participants (Number)
Phase 3: Doublet Arm15.9
Phase 3:Control Arm3.7

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(Phase 3) Comparison of Objective Response Rate (ORR) in Doublet Arm vs Control Arm Per BICR

ORR per RECIST, v1.1, was defined as the percentage of participants achieving an overall best response of CR or PR, where CR: disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (<10 mm short axis), and PR: at least 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters persistence of one or more non-target lesions and/or maintenance of tumor marker level above the normal limits. (NCT02928224)
Timeframe: Duration of Phase 3, approximately 6 months (up to 28 days per cycle)

InterventionPercentage of participants (Number)
Phase 3: Doublet Arm20.4
Phase 3:Control Arm1.9

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(Phase 3) Comparison of Duration of Response (DOR) in Triplet Arm vs Doublet Arm by Investigator

DOR was defined as the time from first radiographic evidence of response to the earliest documented PD or death due to underlying disease. PD: at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions were evaluated. (NCT02928224)
Timeframe: From time of response to PD or death due to underlying disease (maximum treatment exposure of 277.4 weeks for triplet arm and 268 weeks for doublet arm)

InterventionMonths (Median)
Phase 3: Triplet Arm4.80
Phase 3:Doublet Arm5.70

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(Phase 3) Comparison of Duration of Response (DOR) in Triplet Arm vs Doublet Arm by BICR

DOR was defined as the time from first radiographic evidence of response to the earliest documented PD or death due to underlying disease. PD: at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions were evaluated. (NCT02928224)
Timeframe: From time of response to PD or death due to underlying disease (maximum treatment exposure of 277.4 weeks for triplet arm and 268 weeks for doublet arm)

InterventionMonths (Median)
Phase 3: Triplet Arm4.80
Phase 3:Doublet Arm6.06

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(Phase 3) Comparison of Duration of Response (DOR) in Triplet Arm vs Control Arm Per Investigator

DOR was defined as the time from first radiographic evidence of response to the earliest documented disease progression (PD) or death due to underlying disease. PD: at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions were evaluated. (NCT02928224)
Timeframe: From time of response to PD or death due to underlying disease (maximum treatment exposure of 277.4 weeks for triplet arm and 108 weeks for control arm)

InterventionMonths (Median)
Phase 3: Triplet Arm4.80
Phase 3:Control Arm5.75

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(Phase 3) Comparison of Duration of Response (DOR) in Triplet Arm vs Control Arm Per BICR

DOR was defined as the time from first radiographic evidence of response to the earliest documented PD or death due to underlying disease. PD: at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions were evaluated. (NCT02928224)
Timeframe: From time of response to PD or death due to underlying disease (maximum treatment exposure of 277.4 weeks for triplet arm and 108 weeks for control arm)

InterventionMonths (Median)
Phase 3: Triplet Arm4.80
Phase 3:Control ArmNA

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(Phase 3) Comparison of Duration of Response (DOR) in Doublet Arm vs Control Arm Per Investigator

DOR was defined as the time from first radiographic evidence of response to the earliest documented PD or death due to underlying disease. PD: at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions were evaluated. (NCT02928224)
Timeframe: From time of response to PD or death due to underlying disease (maximum treatment exposure of 268 weeks for doublet arm and 108 weeks for control arm)

InterventionMonths (Median)
Phase 3: Doublet Arm5.70
Phase 3:Control Arm5.75

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(Phase 3) Comparison of Duration of Response (DOR) in Doublet Arm vs Control Arm Per BICR

DOR was defined as the time from first radiographic evidence of response to the earliest documented PD or death due to underlying disease. PD: at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions were evaluated. (NCT02928224)
Timeframe: From time of response to PD or death due to underlying disease (maximum treatment exposure of 268 weeks for doublet arm and 108 weeks for control arm)

InterventionMonths (Median)
Phase 3: Doublet Arm6.06
Phase 3:Control ArmNA

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(Phase 3) Overall Survival (OS) in Doublet Arm vs. Control Arm

OS was defined as the time from randomization to death due to any cause. (NCT02928224)
Timeframe: From randomization to death due to any cause until 204 deaths were observed (maximum treatment exposure of 89.7 weeks for doublet arm and 52.4 weeks for control arm)

InterventionMonths (Median)
Phase 3: Doublet Arm9.40
Phase 3:Control Arm5.88

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(Phase 3) Change From Baseline in the Participant Global Impression of Change (PGIC) in Triplet Arm vs Control Arm, Doublet Arm vs Control, and Triplet vs Doublet

"The PGIC is a measure of participant's perceptions of change in their symptoms over time that can be used as an anchoring method to determine the minimal clinically important difference for other participant reported outcome (PROs). For this assessment, participants answered the following question: Since starting treatment, my colorectal cancer symptoms are: (1) very much improved, (2) much improved, (3) minimally improved, (4) no change, (5) minimally worse, (6) much worse or (7) very much worse." (NCT02928224)
Timeframe: Baseline,Cycle (C)1 Day (D)1, C2 D1, C3 D1, C4 D1, C5 D1, C6 D1, C7 D1, C8 D1, C9 D1, C10 D1, C11 D1, C12 D1, C13 D1, C14 D1, C15 D1, C16 D1, C17 D1, C18 D1, C19 D1, C20 D1, C21 D1, C22 D1, C23 D1, End of Treatment, 30 Day Follow Up(each cycle of 28 days)

InterventionUnits on a scale (Mean)
BaselineChange at Cycle 1 Day 1Change at Cycle 2 Day 1Change at Cycle 3 Day 1Change at Cycle 4 Day 1Change at Cycle 5 Day 1Change at Cycle 6 Day 1Change at Cycle 7 Day 1Change at Cycle 8 Day 1Change at Cycle 9 Day 1Change at Cycle 10 Day 1Change at Cycle 11 Day 1Change at Cycle 12 Day 1Change at Cycle 13 Day 1Change at Cycle 14 Day 1Change at Cycle 15 Day 1Change at Cycle 16 Day 1Change at Cycle 17 Day 1Change at Cycle 18 Day 1Change at Cycle 19 Day 1Change at Cycle 20 Day 1Change at Cycle 21 Day 1Change at End of TreatmentChange at 30 Day Follow Up
Phase 3: Triplet Arm3.8-0.1-0.7-0.9-0.9-0.9-0.8-1.1-1.2-0.8-0.5-0.9-0.9-1.3-1.1-1.2-2.0-1.3-2.0-3.0-3.0-3.00.3-0.1

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Phase 3: Number of Participants With Shifts in Left Ventricular Ejection Fraction (LVEF) From Baseline to Maximum Grade On-treatment

Left ventricular ejection fraction (LVEF) abnormalities were defined according to CTCAE version 4.03 where Grade 0: Non-missing value below Grade 2, Grade 2: LVEF between 40% and 50% or absolute change from baseline between -10% and < -20%, Grade 3: LVEF between 20% and 39% or absolute change from baseline <= -20%, Grade 4: LVEF lower than 20%. Categories with at least 1 non-zero data values showing any shift in Grade from baseline to 1 day after dose 1 (post-baseline) were reported. Participants whose grade category was unchanged (e.g. Grade 0 to Grade 0) were not reported. (NCT02928224)
Timeframe: From start of study treatment until 30 days post last dose of study treatment (for triplet arm: maximum treatment exposure of 277.4 weeks; for doublet arm: maximum treatment exposure of 268 weeks; for Control arm: maximum treatment exposure of 108 weeks)

,,
InterventionParticipants (Count of Participants)
Baseline Grade 0 to Grade 2 post baselineBaseline Grade 0 to Grade 3 post baselineBaseline Grade 0 to missing gradeBaseline Grade 2 to missing gradeBaseline missing grade to Grade 0 post baseline
Phase 3: Control Arm0018620
Phase 3: Doublet Arm0120530
Phase 3: Triplet Arm2711701

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(Safety Lead-in) Number of Participants With Adverse Events (AEs)

An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Number of participants reporting AEs were reported in this outcome measure. (NCT02928224)
Timeframe: Duration of safety lead-in, approximately 6 months (up to 28 days per cycle)

InterventionParticipants (Count of Participants)
Combined Safety Lead-in37

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(Safety Lead-in) Incidence of Dose Interruptions, Dose Modifications and Discontinuations Due to Adverse Events (AEs) - Interim Analysis

An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Number of participants with dose interruptions, dose modifications and dose discontinuations due to AEs were reported in this outcome measure. (NCT02928224)
Timeframe: Duration of safety lead-in, approximately 6 months (up to 28 days per cycle)

InterventionParticipants (Count of Participants)
Combined Safety Lead-in26

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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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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 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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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 Participants With Emergent Clinical Chemistry Results Relative to Normal Range

Blood samples were collected to evaluate Albumin, Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Total Bilirubin, Calcium, Cholesterol, Creatine Kinase, C-Reactive protein (CRP), Creatinine, Gamma Glutamyl Transferase (GGT), Glucose, High Density Lipids (HDL), Potassium, Lactate Dehydrogenase, Low Density Lipids (LDL), Sodium, Phosphorus inorganic, Triglycerides, Total Protein and Urea. Participants were counted in the worst case category that their value changes to (low, normal or high), unless there is no change in their category. Participants whose lab value category was unchanged (e.g. High to High), or whose value became normal, are recorded in the 'To Normal or No Change' category. Participants were counted twice if they had values that changed 'To Low' and 'To High', so the percentages may not add to 100% in such instances. (NCT03028467)
Timeframe: Up to 22 weeks

,,,
InterventionParticipants (Count of Participants)
Albumin, To LowAlbumin, To Normal or No changeAlbumin, To HighALP, To LowALP, To Normal or No changeALP, To HighALT, To LowALT, To Normal or No changeALT, To HighAST, To LowAST, To Normal or No changeAST, To HighTotal Bilirubin, To LowTotal Bilirubin, To Normal or No changeTotal Bilirubin, To HighCalcium, To LowCalcium, To Normal or No changeCalcium, To HighCholesterol, To LowCholesterol, To Normal or No changeCholesterol, To HighCreatine Kinase, To LowCreatine Kinase, To Normal or No changeCreatine Kinase, To HighCRP, To LowCRP, To Normal or No changeCRP, To HighCreatinine, To LowCreatinine, To Normal or No changeCreatinine, To HighGGT, To LowGGT, To Normal or No changeGGT, To HighGlucose, To LowGlucose, To Normal or No changeGlucose, To HighHDL, To LowHDL, To Normal or No changeHDL, To HighPotassium To LowPotassium, To Normal or No changePotassium, To HighLactate Dehydrogenase, To LowLactate Dehydrogenase, To Normal or No changeLactate Dehydrogenase, To HighLDL, To LowLDL, To Normal or No changeLDL, To HighSodium, To LowSodium, To Normal or No changeSodium, To HighPhosphorus inorganic, To LowPhosphorus inorganic, To Normal or No changePhosphorus inorganic, To HighTriglycerides, To LowTriglycerides, To Normal or No changeTriglycerides, To HighTotal Protein, To LowTotal Protein, To Normal or No changeTotal Protein, To HighUrea, To LowUrea, To Normal or No changeUrea, To High
GSK3196165 180 mg040040040031040130040031040040040121040040031040040040130040130
GSK3196165 45 mg030030030030030030021120030120030021120120030021030030030120030
GSK3196165 90 mg220040040040040130040040040130040031040130031040040040040130031
Placebo040022040040220130022031022040040013040220031022040040040130130

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Area Under the Concentration-time Curve (AUC) From Time Zero to the Time of the Last Quantifiable Concentration (AUC [0-t]), AUC From Time Zero Extrapolated to Infinity (AUC [0-inf]), AUC Over the Dosing Interval (AUCtau) of GSK3196165

Blood samples were collected at pre-dose on Days 1, 8, 15, 29, 57 and 71; and at any time during visit on Days 3, 74, 85, 106, 127 and 155. PK parameters were calculated by non-compartmental analysis using the concentration data after last dosing (Day 71). NA indicates data was not available as geometric mean and/or 95 percent confidence interval could not be calculated when number of participant was not sufficient. (NCT03028467)
Timeframe: Pre-dose on Days 1, 8, 15, 29, 57 and 71; anytime during visit on Days 3, 74, 85, 106, 127 and 155

,
InterventionHour*Nanogram per milliliter (hr*ng/mL) (Geometric Mean)
AUC (0-t), n=2, 3, 4AUC (0-inf), n=0, 1, 2AUCtau, n=1, 3, 4
GSK3196165 180 mg1186604.7461097422.958787570.414
GSK3196165 90 mg386497.495732243.847303167.467

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Maximum Observed Concentration (Cmax) of GSK3196165

Blood samples were collected at pre-dose on Days 1, 8, 15, 29, 57 and 71; and at any time during visit on Days 3, 74, 85, 106, 127 and 155. PK parameters were calculated by non-compartmental analysis using the concentration data after last dosing (Day 71). Only those participants whose parameters could be determined were analyzed. PK Population included all GSK3196165-treated participants from whom PK samples were collected and analyzed. (NCT03028467)
Timeframe: Pre-dose on Days 1, 8, 15, 29, 57 and 71; anytime during visit on Days 3, 74, 85, 106, 127 and 155

InterventionNanogram per milliliter (ng/mL) (Geometric Mean)
GSK3196165 45 mg699.92
GSK3196165 90 mg1444.88
GSK3196165 180 mg3924.10

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Terminal Half-life (t1/2) of GSK3196165

Blood samples were collected at pre-dose on Days 1, 8, 15, 29, 57 and 71; and at any time during visit on Days 3, 74, 85, 106, 127 and 155. PK parameters were calculated by standard non-compartmental analysis from the concentration data after last dosing (Day 71). NA indicates data was not available as 95 percent confidence interval could not be calculated when number of participant was not sufficient. (NCT03028467)
Timeframe: Pre-dose on Days 1, 8, 15, 29, 57 and 71; anytime during visit on Days 3, 74, 85, 106, 127 and 155.

InterventionHour (Geometric Mean)
GSK3196165 90 mg282.85265
GSK3196165 180 mg245.12966

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Number of Participants With Any Adverse Event (AE), Serious AE (SAE) and Adverse Events of Special Interest (AESI)

An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. 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 or event associated with liver injury and impaired liver function were categorized as SAE. AESI included serious infections including serious respiratory infections and tuberculosis and opportunistic infections, neutropenia (grade 3 or 4), respiratory events, pulmonary alveolar proteinosis, hypersensitivity reactions including anaphylaxis and injection site reactions. (NCT03028467)
Timeframe: Up to 22 weeks

,,,
InterventionParticipants (Count of Participants)
Any AEAny SAEAny AESI
GSK3196165 180 mg200
GSK3196165 45 mg200
GSK3196165 90 mg301
Placebo312

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Number of Participants With Emergent Hematology Results Relative to Normal Range

Blood samples were collected to evaluate hemoglobin, hematocrit, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), erythrocytes, reticulocytes, white blood cells (WBC), total neutrophils, eosinophils, basophils, monocytes, lymphocytes, platelet count, activated partial thromboplastin time (APTT), prothrombin time (PT), fibrinogen, erythrocyte sedimentation rate (ESR). Participants were counted in the worst case category that their value changes to (low, normal or high), unless there is no change in their category. Participants whose lab value category was unchanged (e.g. High to High), or whose value became normal, are recorded in the 'To Normal or No Change' category. Participants were counted twice if they had values that changed 'To Low' and 'To High', so the percentages may not add to 100% in such instances. (NCT03028467)
Timeframe: Up to 22 weeks

,,,
InterventionParticipants (Count of Participants)
APTT, To LowAPTT, To Normal or No changeAPTT, To HighBasophils, To LowBasophils, To Normal or No changeBasophils, To HighEosinophils, To LowEosinophils, To Normal or No changeEosinophils, To HighESR, To lowESR, To Normal or No changeESR, To HighFibrinogen, To LowFibrinogen, To Normal or No changeFibrinogen, To HighHemoglobin, To LowHemoglobin, To Normal or No changeHemoglobin, To HighHematocrit, To LowHematocrit, To Normal or No changeHematocrit, To HighLymphocytes, To LowLymphocytes, To Normal or No changeLymphocytes, To HighMCHC, To LowMCHC, To Normal or No changeMCHC, To HighMCH, To LowMCH, To Normal or No changeMCH, To HighMCV, To LowMCV, To Normal or No changeMCV, To HighMonocytes, To LowMonocytes, To Normal or No changeMonocytes, To HighTotal neutrophils, To LowTotal neutrophils, To Normal or No changeTotal neutrophils, To HighPlatelet count, To LowPlatelet count, To Normal or No changePlatelet count, To HighPT, To LowPT, To Normal or No changePT, To HighRBC, To LowRBC, To Normal or No changeRBC, To HighReticulocytes, To LowReticulocytes, To Normal or No changeReticulocytes, To HighWBC, To LowWBC, To Normal or No changeWBC, To High
GSK3196165 180 mg040040040040040040040040040040040040130040040040040031
GSK3196165 45 mg030030030030030120210120120030030030120030021030030030
GSK3196165 90 mg130040040040040220130310040040040040031040040310040040
Placebo130040040022031130130220130130031121040040040040040040

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Number of Participants With Urinalysis Dipstick Findings

Urine samples were collected for analysis of presence of glucose and protein in urine by dipstick method. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameter of urine protein and glucose can be read as negative, Trace, 1+, 2+ and 3+, indicating proportional concentrations in the urine sample (NCT03028467)
Timeframe: Up to 22 weeks

,,,
InterventionParticipants (Count of Participants)
Week 4, Glucose, 1+Week 4, Glucose, 2+Week 4, Glucose, 3+Week 4, Glucose, NegativeWeek 4, Glucose, TraceWeek 4, Protein, 1+Week 4, Protein, 2+Week 4, Protein, 3+Week 4, Protein, NegativeWeek 4, Protein, TraceWeek 8, Glucose, 1+Week 8, Glucose, 2+Week 8, Glucose, 3+Week 8, Glucose, NegativeWeek 8, Glucose, TraceWeek 8, Protein, 1+Week 8, Protein, 2+Week 8, Protein, 3+Week 8, Protein, NegativeWeek 8, Protein, TraceWeek 12, Glucose, 1+Week 12, Glucose, 2+Week 12, Glucose, 3+Week 12, Glucose, NegativeWeek 12, Glucose, TraceWeek 12, Protein, 1+Week 12, Protein, 2+Week 12, Protein, 3+Week 12, Protein, NegativeWeek 12, Protein, TraceFollow up (Week 22), Glucose, 1+Follow up (Week 22), Glucose, 2+Follow up (Week 22), Glucose, 3+Follow up (Week 22), Glucose, NegativeFollow up (Week 22), Glucose, TraceFollow up (Week 22), Protein, 1+Follow up (Week 22), Protein, 2+Follow up (Week 22), Protein, 3+Follow up (Week 22), Protein, NegativeFollow up (Week 22), Protein, Trace
GSK3196165 180 mg0013000040100300002200040100300004000031
GSK3196165 45 mg0003000030000300003000030000300003000030
GSK3196165 90 mg0004010021000401003000040000310004010030
Placebo0004010012000400001300040000310004010021

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Change From Baseline in Disease Activity Score for 28 Different Joints C-reactive Protein (DAS28 [CRP]) at All Indicated Timepoints

DAS28 (CRP) is a measure of disease activity in rheumatoid arthritis obtained by examination of 28 joints for swelling and tenderness using CRP as a blood biomarker for inflammation. Its components include: Tender/Painful Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), CRP and Patient's Global Assessment of Arthritis. DAS28 (CRP) was calculated by 0.56 (square root of TJC28)+ 0.28 (square root of SJC28)+ 0.36 (natural logarithm [CRP+1])+ (0.014*patients global assessment)+0.96. Scores ranges from 0 to infinity, where higher scores indicates high disease activity. Scores higher than 5.1 indicates high disease activity and scores lower than 2.6 indicates remission. Baseline was considered as the latest pre-dose assessment. The change from Baseline is defined as the difference between the post-dose visit value and Baseline value. Adjusted mean and standard error of adjusted mean are presented using Mixed Model for Repeated Measures. (NCT03028467)
Timeframe: Baseline, up to Week 22

,,,
InterventionScores on a scale (Mean)
Week 1Week 2Week 4Week 6Week 8Week 12Week 22 (Follow-up)
GSK3196165 180 mg-0.7511-0.6404-1.2502-1.0048-1.2375-0.9415-1.0976
GSK3196165 45 mg-1.3289-0.9744-1.5462-0.8664-0.9231-1.1810-1.7320
GSK3196165 90 mg-0.7356-0.7262-0.9781-0.7330-0.8209-0.63830.2371
Placebo-0.21790.1643-0.0887-0.5455-0.2710-0.8234-0.3044

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Change From Baseline in Heart Rate (HR)

Vital sign measurements including HR was measured after 5 minutes rest before each reading. Baseline was considered as the latest pre-dose assessment. The change from Baseline is defined as the difference between the post-dose visit value and Baseline value. (NCT03028467)
Timeframe: Baseline and up to 22 weeks

,,,
InterventionBeats per minute (Mean)
Week 1Week 2Week 3Week 4Week 6Week 8Week 10Week 12Follow up (Week 22)
GSK3196165 180 mg-0.8-5.0-7.0-7.8-0.5-11.5-8.8-7.8-1.3
GSK3196165 45 mg-8.0-5.3-5.3-5.7-7.3-2.71.3-10.0-6.0
GSK3196165 90 mg11.59.510.812.011.01.80.812.56.3
Placebo0.33.01.32.57.35.88.3-2.0-2.3

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Change From Baseline in Respiratory Rate

Vital sign measurements including respiratory rate was measured after 5 minutes rest before each reading. Baseline was considered as the latest pre-dose assessment. The change from Baseline is defined as the difference between the post-dose visit value and Baseline value. (NCT03028467)
Timeframe: Baseline and up to 22 weeks

,,,
InterventionBreaths per minute (Mean)
Week 1Week 2Week 3Week 4Week 6Week 8Week 10Week 12Follow up (Week 22)
GSK3196165 180 mg0.80.31.50.32.30.31.00.80.5
GSK3196165 45 mg0.70.01.3-1.7-1.01.3-0.7-0.30.3
GSK3196165 90 mg-1.0-1.00.8-0.5-0.3-1.3-2.3-2.5-1.5
Placebo-2.0-0.50.3-2.51.5-0.30.01.00.0

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Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

Vital sign measurements including SBP and DBP were measured after 5 minutes rest before each reading. Baseline was considered as the latest pre-dose assessment. The change from Baseline is defined as the difference between the post-dose visit value and Baseline value. (NCT03028467)
Timeframe: Baseline and up to 22 weeks

,,,
InterventionMillimeter of mercury (Mean)
SBP, Week 1SBP, Week 2SBP, Week 3SBP, Week 4SBP, Week 6SBP, Week 8SBP, Week 10SBP, Week 12SBP, Follow up (Week 22)DBP, Week 1DBP, Week 2DBP, Week 3DBP, Week 4DBP, Week 6DBP, Week 8DBP, Week 10DBP, Week 12DBP, Follow up (Week 22)
GSK3196165 180 mg-1.01.5-0.86.3-2.33.8-1.50.8-4.3-0.5-0.3-4.31.3-5.5-2.0-4.5-4.3-3.5
GSK3196165 45 mg-7.7-6.7-1.7-11.3-12.7-3.06.7-5.3-4.7-3.30.3-1.0-1.37.711.32.7-1.7-1.0
GSK3196165 90 mg-15.0-4.5-10.5-3.3-1.3-5.8-11.8-2.5-2.5-6.82.0-5.31.35.3-1.5-3.0-3.83.0
Placebo-0.3-1.80.5-5.8-2.0-6.32.32.04.0-1.0-1.5-4.3-1.0-1.0-2.5-2.33.52.8

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Time to Reach Cmax (Tmax) of GSK3196165

Blood samples were collected at pre-dose on Days 1, 8, 15, 29, 57 and 71; and at any time during visit on Days 3, 74, 85, 106, 127 and 155. PK parameters were calculated by non-compartmental analysis using the concentration data after last dosing (Day 71). (NCT03028467)
Timeframe: Pre-dose on Days 1, 8, 15, 29, 57 and 71; anytime during visit on Days 3, 74, 85, 106, 127 and 155

InterventionHour (Median)
GSK3196165 45 mg48.99167
GSK3196165 90 mg70.61667
GSK3196165 180 mg69.80000

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Area Under the Concentration-time Curve (AUC) From Time Zero to the Time of the Last Quantifiable Concentration (AUC [0-t]), AUC From Time Zero Extrapolated to Infinity (AUC [0-inf]), AUC Over the Dosing Interval (AUCtau) of GSK3196165

Blood samples were collected at pre-dose on Days 1, 8, 15, 29, 57 and 71; and at any time during visit on Days 3, 74, 85, 106, 127 and 155. PK parameters were calculated by non-compartmental analysis using the concentration data after last dosing (Day 71). NA indicates data was not available as geometric mean and/or 95 percent confidence interval could not be calculated when number of participant was not sufficient. (NCT03028467)
Timeframe: Pre-dose on Days 1, 8, 15, 29, 57 and 71; anytime during visit on Days 3, 74, 85, 106, 127 and 155

InterventionHour*Nanogram per milliliter (hr*ng/mL) (Geometric Mean)
AUC (0-t), n=2, 3, 4AUCtau, n=1, 3, 4
GSK3196165 45 mg189948.606196562.287

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Change From Baseline in Body Temperature

Vital sign measurements including body temperature was measured after 5 minutes rest before each reading. Baseline was considered as the latest pre-dose assessment. The change from Baseline is defined as the difference between the post-dose visit value and Baseline value. (NCT03028467)
Timeframe: Baseline and up to 22 weeks

,,,
InterventionCelsius (Mean)
Week 1Week 2Week 3Week 4Week 6Week 8Week 10Week 12Follow up (Week 22)
GSK3196165 180 mg0.050.220.15-0.15-0.020.050.170.02-0.18
GSK3196165 45 mg-0.200.03-0.30-0.470.070.030.130.00-0.13
GSK3196165 90 mg0.18-0.130.180.20-0.10-0.07-0.02-0.250.25
Placebo0.000.07-0.10-0.20-0.03-0.200.00-0.07-0.47

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Number of Participants With Anti-GSK3196165 Antibody Test Results

Serum samples were collected and tested for presence of antibodies that bind to GSK3196165. The presence of treatment emergent anti-drug antibodies (ADA) were determined using a GSK3196165 bridging style ADA assay with a bio-analytically determined cut point determined during assay validation. Samples taken after dosing with GSK3196165 that have a value at or above the cut-point were considered treatment-emergent ADA-positive. These ADA positive samples were further evaluated in a confirmatory assay, and confirmed positive samples were further characterized by assessment of titer. Baseline was considered as the latest pre-dose assessment. Number of participants with post-Baseline negative or positive anti-GSK3196165 antibody test results were presented. (NCT03028467)
Timeframe: Weeks 2, 4, 12 and 22

,,,
InterventionParticipants (Count of Participants)
Week 2, PositiveWeek 2, NegativeWeek 4, PositiveWeek 4, NegativeWeek 12, PositiveWeek 12, NegativeWeek 22 (Follow up), PositiveWeek 22 (Follow up), Negative
GSK3196165 180 mg04040404
GSK3196165 45 mg03030303
GSK3196165 90 mg04040404
Placebo04040404

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Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings

12-Lead ECGs were taken using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT and corrected QT (QTc) intervals. Number of participants with any abnormal findings in ECG recordings were summarized as clinically significant and not clinically significant. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. (NCT03028467)
Timeframe: At Week 12

,,,
InterventionParticipants (Count of Participants)
Abnormal - Not clinically significantAbnormal - Clinically significant
GSK3196165 180 mg00
GSK3196165 45 mg10
GSK3196165 90 mg10
Placebo10

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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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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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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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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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Progression-Free Survival (PFS)

PFS was measured from treatment day 1 until event or censoring. An event was defined as the earliest of the following: death from any cause or disease progression. Subjects undergoing transplant or any other subsequent therapy prior to documentation of PD was censored at that time. Progression of disease deems as 1. 50% increase from nadir in the SPD of any previously identified abnormal node for PRs or nonresponders, 2.Appearance of any new lesion during or at the end of therapy as per IWC criteria. (NCT03349333)
Timeframe: 2 years

Interventionmonths (Median)
Pralatrexate4.76

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Overall Survival (OS)

OS was measured from treatment day 1 until death or censoring. (NCT03349333)
Timeframe: 4 years

Interventionmonths (Median)
Pralatrexate18.00

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Objective Response Rate(ORR) by International Working Group Criteria

"ORR defined as the percentage of subjects with CR, CRu or PR as Best Overall Response.Evaluation of response must be performed within 7 days prior to the projected first dose of cycle 2-4 and then within 7 days prior to the projected first dose of every even-numbered subsequent cycle (i.e. prior to cycles 6, 8, etc). Unscheduled radiological response assessments will be performed earlier if clinical progression is suspected.The primary analysis will be conducted once all subjects have completed cycle 5 treatment or discontinued before. Study treatment may continue per investigator judgment for a maximum of 24 months.~Response will be assessed on the basis of clinical, radiological, and pathological criteria. Response will be assessed by independent central review and by the treating investigator. Central review assessors will be blinded to the response assessments by the treating investigator. The primary analysis will be based on response assessed by central review." (NCT03349333)
Timeframe: 2 years

InterventionParticipants (Count of Participants)
Pralatrexate37

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Duration of Responses

Duration of response was measured from first day of documented response to disease progression or death, whatever comes first. (NCT03349333)
Timeframe: 4 years

Interventionmonths (Median)
Pralatrexate8.67

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Steady State Clearance [CLss] for R-pralatrexate

The PK endpoints was analysed using the PK population. The overall PK population is defined as all subjects who receive at least one dose of Investigational Medicinal Product (IMP) and have at least one primary PK parameter. Subjects with non-zero baseline concentrations of >5% of Cmax for either analyte (R-pralatrexate or S-pralatrexate) will be removed from the PK population. (NCT03349333)
Timeframe: Cycle 1 day 1, Cycle 1 week 6(Pre-injection, end-injection, 30 and 60 minutes, and 3, 5, 8, 12, 18, 24, 48, and 72 hours post-end injection)

InterventionL/h (Mean)
Pralatrexate-R Cycle 1 Day 1 (30 mg/m2)Pralatrexate-R Cycle 1 Week 6 (20 mg/m2)Pralatrexate-R Cycle 1 Week 6 (30 mg/m2)
Pralatrexate17.191416.378919.8406

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Steady State Volume of Distribution [Vdss] for R-pralatrexate

The PK endpoints was analysed using the PK population. The overall PK population is defined as all subjects who receive at least one dose of Investigational Medicinal Product (IMP) and have at least one primary PK parameter. Subjects with non-zero baseline concentrations of >5% of Cmax for either analyte (R-pralatrexate or S-pralatrexate) will be removed from the PK population. (NCT03349333)
Timeframe: Cycle 1 day 1, Cycle 1 week6(Pre-injection, end-injection, 30 and 60 minutes, and 3, 5, 8, 12, 18, 24, 48, and 72 hours post-end injection)

InterventionL (Mean)
Pralatrexate-R Cycle 1 day1(30mg/m2)Pralatrexate-R Cycle 1 week6(20mg/m2)Pralatrexate-R Cycle 1 week6(30mg/m2)
Pralatrexate194.1589344.2511329.1892

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Steady State Volume of Distribution [Vdss] for S-pralatrexate

The PK endpoints was analysed using the PK population. The overall PK population is defined as all subjects who receive at least one dose of Investigational Medicinal Product (IMP) and have at least one primary PK parameter. Subjects with non-zero baseline concentrations of >5% of Cmax for either analyte (R-pralatrexate or S-pralatrexate) will be removed from the PK population. (NCT03349333)
Timeframe: Cycle 1 day 1, Cycle 1 week 6(Pre-injection, end-injection, 30 and 60 minutes, and 3, 5, 8, 12, 18, 24, 48, and 72 hours post-end injection)

InterventionL (Mean)
Pralatrexate-S Cycle 1 Day 1 (30 mg/m2)Pralatrexate-S Cycle 1 Week 6 (20 mg/m2)Pralatrexate-S Cycle 1 Week 6 (30 mg/m2)
Pralatrexate517.16281110.65411680.6116

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Terminal Phase Half-life [t1/2Z] for R-pralatrexate

The PK endpoints was analysed using the PK population. The overall PK population is defined as all subjects who receive at least one dose of Investigational Medicinal Product (IMP) and have at least one primary PK parameter. Subjects with non-zero baseline concentrations of >5% of Cmax for either analyte (R-pralatrexate or S-pralatrexate) will be removed from the PK population. (NCT03349333)
Timeframe: Cycle 1 day 1, Cycle 1 week 6(Pre-injection, end-injection, 30 and 60 minutes, and 3, 5, 8, 12, 18, 24, 48, and 72 hours post-end injection)

Interventionh (Mean)
Pralatrexate-R Cycle 1 Day 1 (30 mg/m2)Pralatrexate-R Cycle 1 Week 6 (20 mg/m2)Pralatrexate-R Cycle 1 Week 6 (30 mg/m2)
Pralatrexate8.504014.608911.8249

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Terminal Phase Half-life [t1/2Z] for S-pralatrexate

The PK endpoints was analysed using the PK population. The overall PK population is defined as all subjects who receive at least one dose of Investigational Medicinal Product (IMP) and have at least one primary PK parameter. Subjects with non-zero baseline concentrations of >5% of Cmax for either analyte (R-pralatrexate or S-pralatrexate) will be removed from the PK population. (NCT03349333)
Timeframe: Cycle 1 day 1, Cycle 1 week 6(Pre-injection, end-injection, 30 and 60 minutes, and 3, 5, 8, 12, 18, 24, 48, and 72 hours post-end injection)

Interventionh (Mean)
Pralatrexate-S Cycle 1 Day 1 (30 mg/m2)Pralatrexate-S Cycle 1 Week 6 (20 mg/m2)Pralatrexate-S Cycle 1 Week 6 (30 mg/m2)
Pralatrexate10.863426.250524.8987

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Steady State Clearance [CLss] for S-pralatrexate

The PK endpoints was analysed using the PK population. The overall PK population is defined as all subjects who receive at least one dose of Investigational Medicinal Product (IMP) and have at least one primary PK parameter. Subjects with non-zero baseline concentrations of >5% of Cmax for either analyte (R-pralatrexate or S-pralatrexate) will be removed from the PK population. (NCT03349333)
Timeframe: Cycle 1 day 1, Cycle 1 week 6(Pre-injection, end-injection, 30 and 60 minutes, and 3, 5, 8, 12, 18, 24, 48, and 72 hours post-end injection)

InterventionL/h (Mean)
Pralatrexate-S Cycle 1 Day 1 (30 mg/m2)Pralatrexate-S Cycle 1 Week 6 (20 mg/m2)Pralatrexate-S Cycle 1 Week 6 (30 mg/m2)
Pralatrexate34.634127.979445.2022

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Time of Cmax Observation [Tmax] for R-pralatrexate

The PK endpoints was analysed using the PK population. The overall PK population is defined as all subjects who receive at least one dose of Investigational Medicinal Product (IMP) and have at least one primary PK parameter. Subjects with non-zero baseline concentrations of >5% of Cmax for either analyte (R-pralatrexate or S-pralatrexate) will be removed from the PK population. (NCT03349333)
Timeframe: Cycle 1 day 1, Cycle 1 week 6(Pre-injection, end-injection, 30 and 60 minutes, and 3, 5, 8, 12, 18, 24, 48, and 72 hours post-end injection)

Interventionh (Median)
Pralatrexate-R in Cycle 1 day 1(30mg/m2)Pralatrexate-R in Cycle 1 week 6(20mg/m2)Pralatrexate-R in Cycle 1 week 6(30mg/m2)
Pralatrexate0.10000.10000.1000

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Percentage of Participants With Treatment Emergent Adverse Events

treatment emergent AE was scheduled to be collected during all subject visits, the data evaluated as clinical significant will be summarized and presented. (NCT03349333)
Timeframe: 4 years

Interventionpercentage of participants (Number)
Pralatrexate98.6

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Time of Cmax Observation [Tmax] for S-pralatrexate

The PK endpoints was analysed using the PK population. The overall PK population is defined as all subjects who receive at least one dose of Investigational Medicinal Product (IMP) and have at least one primary PK parameter. Subjects with non-zero baseline concentrations of >5% of Cmax for either analyte (R-pralatrexate or S-pralatrexate) will be removed from the PK population. (NCT03349333)
Timeframe: Cycle 1 day 1, Cycle 1 week 6(Pre-injection, end-injection, 30 and 60 minutes, and 3, 5, 8, 12, 18, 24, 48, and 72 hours post-end injection)

Interventionh (Median)
Pralatrexate-S in Cycle 1 day 1(30mg/m2)Pralatrexate-S in Cycle 1 week 6(20mg/m2)Pralatrexate-S in Cycle 1 week 6(30mg/m2)
Pralatrexate0.10000.10000.1000

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Maximum Observed Plasma Concentration [Cmax] for S-pralatrexate

The PK endpoints was analysed using the PK population. The overall PK population is defined as all subjects who receive at least one dose of Investigational Medicinal Product (IMP) and have at least one primary PK parameter. Subjects with non-zero baseline concentrations of >5% of Cmax for either analyte (R-pralatrexate or S-pralatrexate) will be removed from the PK population. (NCT03349333)
Timeframe: Cycle 1 day 1, Cycle 1 week 6(Pre-injection, end-injection, 30 and 60 minutes, and 3, 5, 8, 12, 18, 24, 48, and 72 hours post-end injection)

Interventionng/mL (Geometric Mean)
Pralatrexate-S in Cycle 1 day 1(30mg/m2)Pralatrexate-S in Cycle 1 week 6(20mg/m2)Pralatrexate-S in Cycle 1 week 6(30mg/m2)
Pralatrexate3727.85822325.51053439.9695

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Maximum Observed Plasma Concentration [Cmax] for R-pralatrexate

The PK endpoints was analysed using the PK population. The overall PK population is defined as all subjects who receive at least one dose of Investigational Medicinal Product (IMP) and have at least one primary PK parameter. Subjects with non-zero baseline concentrations of >5% of Cmax for either analyte (R-pralatrexate or S-pralatrexate) will be removed from the PK population. (NCT03349333)
Timeframe: Cycle 1 day 1, Cycle 1 week 6(Pre-injection, end-injection, 30 and 60 minutes, and 3, 5, 8, 12, 18, 24, 48, and 72 hours post-end injection)

Interventionng/mL (Geometric Mean)
Pralatrexate-R in Cycle 1 day 1(30mg/m2)Pralatrexate-R in Cycle 1 week 6(20mg/m2)Pralatrexate-R in Cycle 1 week 6(30mg/m2)
Pralatrexate4649.68112488.15025064.6667

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Area Under the Curve [AUC] for S-pralatrexate

The PK endpoints was analysed using the PK population. The overall PK population is defined as all subjects who receive at least one dose of Investigational Medicinal Product (IMP) and have at least one primary PK parameter. Subjects with non-zero baseline concentrations of >5% of Cmax for either analyte (R-pralatrexate or S-pralatrexate) will be removed from the PK population. (NCT03349333)
Timeframe: Cycle 1 day 1, Cycle 1 week 6(Pre-injection, end-injection, 30 and 60 minutes, and 3, 5, 8, 12, 18, 24, 48, and 72 hours post-end injection)

Interventionh*ng/ml (Geometric Mean)
Pralatrexate-S in Cycle 1 week 6(20mg/m2)Pralatrexate-S in Cycle 1 week 6(30mg/m2)Pralatrexate-S in Cycle 1 day 1(30mg/m2)
Pralatrexate1364.76862182.50781674.8773

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Area Under the Curve [AUC] for R-pralatrexate

The PK endpoints was analysed using the PK population. The overall PK population is defined as all subjects who receive at least one dose of Investigational Medicinal Product (IMP) and have at least one primary PK parameter. Subjects with non-zero baseline concentrations of >5% of Cmax for either analyte (R-pralatrexate or S-pralatrexate) will be removed from the PK population. (NCT03349333)
Timeframe: Cycle 1 day1,Cycle 1 week 6(Pre-injection, end-injection, 30 and 60 minutes, and 3, 5, 8, 12, 18, 24, 48, and 72 hours post-end injection)

Interventionh*ng/ml (Geometric Mean)
Pralatrexate-R in Cycle 1 week 6(20mg/m2)Pralatrexate-R in Cycle 1 week 6(30mg/m2)Pralatrexate-R in Cycle 1 day 1(30mg/m2)
Pralatrexate2350.74023979.10693586.2925

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Time to Response (TTR)

Time to response was measured from first day of treatment to the first date of documented response. (NCT03349333)
Timeframe: 2 years

Interventionmonths (Mean)
Pralatrexate2.0947

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Serum Riboflavin

Serum Riboflavin in microgram per liter Minimum: 190 Maximum: 341 (NCT03444155)
Timeframe: 20 weeks

,
Intervention"µg/L" (Mean)
Baseline1.5 hours4 hours7 hours6 weeks8 weeks8 weeks - 1.5 hours8 weeks - 4 hours8 weeks - 7 hours14 weeks20 weeks
Panmol-B-Complex231.93233.86240.36247.21264.21232.29230.43237.36244.64258.14257.93
Synthetic Vitamin B-complex234.67245.60254.33252.87265.00238.73233.27243.20250.13271.07274.67

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Serum Total Antioxidant Capacity

Serum total antioxidant capacity in millimole per liter Minimum: 0.31 Maximum: 2.45 (NCT03444155)
Timeframe: 20 weeks

,
Intervention"mM/L" (Mean)
Baseline1.5 hours4 hours7 hours6 weeks8 weeks8 weeks - 1.5 hours8 weeks - 4 hours8 weeks - 7 hours14 weeks20 weeks
Panmol-B-Complex1.151.271.131.221.451.201.681.141.381.461.34
Synthetic Vitamin B-complex1.451.241.231.391.541.311.861.301.181.481.47

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Serum Cobalamin

Serum Cobalamin in picogram per liter Minimum: 159 Maximum: 1230 (NCT03444155)
Timeframe: 20 weeks

,
Intervention"pg/L" (Mean)
Baseline1.5 hours4 hours7 hours6 weeks8 weeks8 weeks - 1.5 hours8 weeks - 4 hours8 weeks - 7 hours14 weeks20 weeks
Panmol-B-Complex381.71387.79384.50388.57442.36414.79414.57389.21404.93483.57421.07
Synthetic Vitamin B-complex440.47453.67447.00442.27506.47450.33454.07432.07453.13564.27494.80

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Serum Total Peroxides

Serum Total peroxides in micromol per liter Minimum: 23 Maximum: 443 (NCT03444155)
Timeframe: 20 weeks

,
Intervention"µM/L" (Mean)
Baseline1.5 hours4 hours7 hours6 weeks8 weeks8 weeks - 1.5 hours8 weeks - 4 hours8 weeks - 7 hours14 weeks20 weeks
Panmol-B-Complex100.00101.64132.55122.1897.3679.2797.2799.9189.18102.91104.91
Synthetic Vitamin B-complex111.17112.67137.08132.7599.5871.2586.9292.5090.17115.83116.33

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Serum Thiamine

Serum Thiamine in microgram per liter Minimum: 36 Maximum: 98 (NCT03444155)
Timeframe: 20 weeks

,
Intervention"µg/L" (Mean)
Baseline1.5 hours4 hours7 hours6 weeks8 weeks8 weeks - 1.5 hours8 weeks - 4 hours8 weeks - 7 hours14 weeks20 weeks
Panmol-B-Complex50.2151.2153.5752.0061.8670.1470.2164.7164.6458.8658.43
Synthetic Vitamin B-complex48.3350.6051.0750.2761.3372.3369.1365.1364.2061.6059.20

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Total Homocysteine

Total Homocysteine in Micromole Minimum: 4.00 Maximum: 40.40 (NCT03444155)
Timeframe: 20 weeks

,
Intervention"µM" (Mean)
Baseline1.5 hours4 hours7 hours6 weeks8 weeks8 weeks - 1.5 hours8 weeks - 4 hours8 weeks - 7 hours14 weeks20 weeks
Panmol-B-Complex8.898.968.688.917.767.897.917.348.007.017.62
Synthetic Vitamin B-complex11.4911.8911.3811.317.858.167.977.398.137.447.95

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Serum Pyridoxine

Serum Pyridoxine in microgram per liter Minimum: 3.8 Maximum: 161.8 (NCT03444155)
Timeframe: 20 weeks

,
Intervention"µg/L" (Mean)
Baseline1.5 hours4 hours7 hours6 weeks8 weeks8 weeks - 1.5 hours8 weeks - 4 hours8 weeks - 7 hours14 weeks20 weeks
Panmol-B-Complex23.1135.4532.9636.6646.4429.2333.7939.1442.9342.2428.38
Synthetic Vitamin B-complex24.3133.8033.2836.5948.9426.9936.9335.7640.4139.9721.39

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Serum Polyphenols

Serum Polyphenols in millimole per liter Minimum: 7.45 Maximum: 10.91 (NCT03444155)
Timeframe: 20 weeks

,
Intervention"mM/L" (Mean)
Baseline1.5 hours4 hours7 hours6 weeks8 weeks8 weeks - 1.5 hours8 weeks - 4 hours8 weeks - 7 hours14 weeks20 weeks
Panmol-B-Complex9.889.739.979.729.499.738.878.258.688.729.67
Synthetic Vitamin B-complex9.579.779.819.549.469.548.718.188.578.829.46

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Serum Folic Acid

Serum Folic acid in nanogram per liter Minimum: 2.20 Maximum: 58.10 (NCT03444155)
Timeframe: 20 weeks

,
Intervention"ng/L" (Mean)
Baseline1.5 hours4 hours7 hours6 weeks8 weeks8 weeks - 1.5 hours8 weeks - 4 hours8 weeks - 7 hours14 weeks20 weeks
Panmol-B-Complex7.4525.2112.8710.3813.8611.0426.6316.3912.6318.5910.46
Synthetic Vitamin B-complex6.0020.7510.938.2315.1810.4331.8714.4312.1918.709.93

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Serum Endogenous Peroxidase-activity

Serum endogenous peroxidase-activity in milliunits per milliliter Minimum: 0.79 Maximum: 9.87 (NCT03444155)
Timeframe: 20 weeks

,
Intervention"mU/mL" (Mean)
Baseline1.5 hours4 hours7 hours6 weeks8 weeks8 weeks - 1.5 hours8 weeks - 4 hours8 weeks - 7 hours14 weeks20 weeks
Panmol-B-Complex3.373.354.375.314.366.053.973.994.353.893.04
Synthetic Vitamin B-complex3.073.904.224.844.345.153.603.935.484.952.96

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Number of Participants With Adverse Events

For the purpose of toxicity monitoring, toxicities are defined as any treatment -related grade 3 or 4 non-hematologic AEs occurred any time during the trial.NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 utilized for adverse event reporting. (NCT03488225)
Timeframe: Start of treatment up to 30 days after last dose received.

InterventionParticipants (Count of Participants)
Neutropenic FeverPeripheral Sensory NeuropathyAllergic ReactionMuscle Weakness
Treatment (Hyper-CVAD, Inotuzumab Ozogamicin)2111

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Participants to Achieve Complete Remission (CR):

Complete Remission (CR) is defined as - Normalization of the peripheral blood and bone marrow blasts /= 100X10^9/L and complete resolution of all sites of extramedullary disease. (NCT03488225)
Timeframe: Start of treatment up to 2 years

InterventionParticipants (Count of Participants)
Treatment (Hyper-CVAD, Inotuzumab Ozogamicin)4

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Overall Survival

Time from date of treatment start until date of death due to any cause or last Follow-up. (NCT03488225)
Timeframe: Start of treatment up to 2 years

InterventionMonths (Median)
Treatment (Hyper-CVAD, Inotuzumab Ozogamicin)24

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Number of Participants With Minimal Residual Disease (MRD) Negativity

MRD levels continuously assessed during induction and consolidation therapy by 6-color multiparameter flow. MRD negativity defined by a value of at least 10-4 and confirmed on a second bone marrow aspiration/biopsy performed after a subsequent cycle. (NCT03488225)
Timeframe: Start of treatment up to 2 years

InterventionParticipants (Count of Participants)
Treatment (Hyper-CVAD, Inotuzumab Ozogamicin)4

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Event-Free Survival

Event-free survival defined as the time interval from date of treatment start until the date of death, disease progression or relapse. (NCT03488225)
Timeframe: Start of treatment up to 2 years

InterventionMonths (Median)
Treatment (Hyper-CVAD, Inotuzumab Ozogamicin)24

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Overall Survival (OS)

Defined as the duration from the date of randomization to the date of death from any cause (NCT03504423)
Timeframe: 38 months

Interventionmonths (Median)
CPI-613, mFolfirinox11.10
Folfirinox11.73

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Progression Free Survival (PFS)

"Defined as the duration from the date of randomization to the date of progressive disease or death from any cause.~Progressive Disease is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as at least 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression." (NCT03504423)
Timeframe: 38 months

Interventionmonths (Median)
CPI-613, mFolfirinox7.82
Folfirinox7.98

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Overall Response Rate (ORR)

Defined as the rate of Complete Response (CR) plus Partial Response (PR): Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), at least 30% decrease in the sum of diameters of target lesions; (NCT03504423)
Timeframe: 38 months

InterventionParticipants (Count of Participants)
CPI-613, mFolfirinox104
Folfirinox90

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Overall Survival

Time from date of treatment start until date of death due to any cause or last Follow-up. (NCT03518112)
Timeframe: Time from the first day of treatment assessed up to 3 years, 1 month

InterventionMonths (Median)
Treatment (Blinatumomab, Combination Chemotherapy)16.7

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Number of Participants Negative for Minimal Residual Disease (MRD)

Minimal Residual Disease (MRD) was assessed by flow cytometry. MRD negativity: Absence of detectable leukemia using multiparameter flow cytometry with a sensitivity of NCT03518112)
Timeframe: Up to 3 years

InterventionParticipants (Count of Participants)
Treatment (Blinatumomab, Combination Chemotherapy)4

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Event Free Survival (EFS) Where Events Defined as no Response, Loss of Response, or Death

"Time from date of treatment start until the date of first objective documentation of disease-relapse. Relapse and resistant disease will be defined based on morphological assessment of bone marrow and peripheral blood.~Complete Remission (CR): Normalization of the peripheral blood and bone marrow with 5% or less blasts in normocellular or hypercellular marrow with a granulocyte count of 1 x 10^9/L or above, and platelet count of 100 x 10^9/L. Complete resolution of all sites of extramedullary disease is required for CR.~Complete remission without recovery of counts (CRi): Peripheral blood and marrow results as for CR, but with incomplete recover of counts (platelets < 100 x 10^9/L; neutrophils < 1 x 10^9/L).~Partial Response (PR): As above for CR except for the presence of 6-25% marrow blasts." (NCT03518112)
Timeframe: Time from the first day of treatment assessed up to 3 years, 1 month

InterventionMonths (Median)
Treatment (Blinatumomab, Combination Chemotherapy)5.7

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Duration of Response

"Response date to loss of response or last follow up. Complete Remission (CR): Normalization of the peripheral blood and bone marrow with 5% or less blasts in normocellular or hypercellular marrow with a granulocyte count of 1 x 10^9/L or above, and platelet count of 100 x 10^9/L. Complete resolution of all sites of extramedullary disease is required for CR.~Complete remission without recovery of counts (CRi): Peripheral blood and marrow results as for CR, but with incomplete recover of counts (platelets < 100 x 10^9/L; neutrophils < 1 x 10^9/L).~Partial Response (PR): As above for CR except for the presence of 6-25% marrow blasts." (NCT03518112)
Timeframe: Time from the first day of treatment assessed up to 3 years, 1 month

InterventionMonths (Median)
Treatment (Blinatumomab, Combination Chemotherapy)4.4

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Participants With a Response

"defined as the percentage of patients achieving complete response (CR) or CR with inadequate count recovery (CRi). Complete Remission (CR): Normalization of the peripheral blood and bone marrow with 5% or less blasts in normocellular or hypercellular marrow with a granulocyte count of 1 x 10^9/L or above, and platelet count of 100 x 10^9/L. Complete resolution of all sites of extramedullary disease is required for CR.~Complete remission without recovery of counts (CRi): Peripheral blood and marrow results as for CR, but with incomplete recover of counts (platelets < 100 x 10^9/L; neutrophils < 1 x 10^9/L)." (NCT03518112)
Timeframe: Up to 3 years

InterventionParticipants (Count of Participants)
Treatment (Blinatumomab, Combination Chemotherapy)4

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Serum Concentrations of Durvalumab

Serum concentrations of durvalumab are reported. (NCT03611556)
Timeframe: Ten mins (± 5 mins) post EOI, approximately 1 hour (+ 15 mins) after start of infusion on C1D1 and C5D1; and pre-dose on C2D1 and C5D1

,,,
Interventionμg/mL (Geometric Mean)
C1D1 (EOI)C2D1 (pre-dose)C5D1 (pre-dose)C5D1 (EOI)
Dose-escalation, Oleclumab 1500 mg + Durvalumab + Gemcitabine + Nab-paclitaxel292.535.97NANA
Dose-escalation, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel374.514.3974.52522.1
Dose-escalation, Oleclumab 3000 mg + Durvalumab + mFOLFOX380.759.97175.9664.5
Dose-expansion, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel345.886.20137.9597.9

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Serum Concentrations of Oleclumab

Serum concentrations of oleclumab are reported. (NCT03611556)
Timeframe: Ten minutes (mins) (± 5 mins) post end of infusion (EOI), approximately 1 hour (+ 15 mins) after start of infusion on C1D1, C3D1, and C5D1; and pre-dose on C3D1 and C5D1

Interventionμg/mL (Geometric Mean)
C1D1 (EOI)C3D1 (pre-dose)C3D1 (EOI)
Dose-escalation, Oleclumab 1500 mg + Durvalumab + mFOLFOX412.7134.3571.1

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Serum Concentrations of Oleclumab

Serum concentrations of oleclumab are reported. (NCT03611556)
Timeframe: Ten minutes (mins) (± 5 mins) post end of infusion (EOI), approximately 1 hour (+ 15 mins) after start of infusion on C1D1, C3D1, and C5D1; and pre-dose on C3D1 and C5D1

,,,,
Interventionμg/mL (Geometric Mean)
C1D1 (EOI)C3D1 (pre-dose)C3D1 (EOI)C5D1 (pre-dose)C5D1 (EOI)
Dose-escalation, Oleclumab 1500 mg + Durvalumab + Gemcitabine + Nab-paclitaxel297.6128.6NANANA
Dose-escalation, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel710.2211.5870.373.19948.3
Dose-escalation, Oleclumab 3000 mg + Durvalumab + mFOLFOX734.6368.91181235.71057
Dose-expansion, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel725.9226.8894.4116.4753.2
Dose-expansion, Oleclumab 3000 mg + Gemcitabine + Nab-paclitaxel704.4164.8893.085.99852.8

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Percentage of Participants With DC According to RECIST v1.1 in Dose Expansion Phase

The DC is defined as confirmed CR, PR, or stable disease (SD) (maintained for >=8 weeks). The CR is defined as disappearance of all TLs and NTLs, any pathological lymph nodes (target and non-target) must have reduction in short axis <10 mm, and no new lesions. The PR is defined as at least a 30% decrease in the SoD of TLs (compared to baseline) and no new lesions. Confirmation of CR and PR is required by a repeat, consecutive assessment no less than 4 weeks from date of first documentation. The SD is defined as neither sufficient shrinkage of TLs to qualify for PR nor sufficient increase of TLs to qualify for PD, taking as reference the smallest SoD while on study, and no new lesions. The PD is defined as at least a 20% increase in SoD of TLs, taking as reference the smallest sum on study and an absolute increase of at least 5 mm of SoD, or unequivocal progression of existing NTLs, or the appearance of new lesion/s. Percentage of participants with DC is reported. (NCT03611556)
Timeframe: Baseline (Days -28 to -1) through 36.1 months (maximum observed duration)

InterventionPercentage of Participants (Number)
Dose-expansion, Gemcitabine + Nab-paclitaxel66.1
Dose-expansion, Oleclumab 3000 mg + Gemcitabine + Nab-paclitaxel73.7
Dose-expansion, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel75.7

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Duration of Response (DoR) According to RECIST v1.1 in Dose Expansion Phase

The DoR is defined as the time from the first documentation of an OR until the first documentation of a PD or death due to any cause, whichever occurs first. The OR is defined as best overall response of confirmed CR or PR based on RECIST v1.1 guidelines. The CR is defined as disappearance of all TLs and NTLs, any pathological lymph nodes (target and non-target) must have reduction in short axis < 10 mm, and no new lesions. The PR is defined as at least a 30% decrease in the SoD of TLs (compared to baseline) and no new lesions. Confirmation of CR and PR is required by a repeat, consecutive assessment no less than 4 weeks from the date of first documentation. The PD is defined as at least a 20% increase in SoD of TLs, taking as reference the smallest sum on study and an absolute increase of at least 5 mm of SoD, or unequivocal progression of existing NTLs, or the appearance of new lesion/s. The DoR is assessed using the Kaplan-Meier method. (NCT03611556)
Timeframe: Baseline (Days -28 to -1) through 36.1 months (maximum observed duration)

InterventionMonths (Median)
Dose-expansion, Gemcitabine + Nab-paclitaxel7.2
Dose-expansion, Oleclumab 3000 mg + Gemcitabine + Nab-paclitaxel12.9
Dose-expansion, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel9.5

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Number of Participants With Dose-limiting Toxicities (DLTs) in Dose Escalation Phase

DLT: Any study drug related Grade (G)3 or higher toxicity including: any G4 immune-mediated AEs, >=G3 colitis/pneumonitis/interstitial lung disease (ILD), >=G3 nausea/vomiting/diarrhea that does not resolve to G2 or less within 3 days of maximal supportive care (MSC), G2 pneumonitis/ILD that does not resolve within 7 days of initiation of MSC, G4 anemia, G3 anemia with clinical sequelae/requires >2 units of red blood cells transfusion, G4 thrombocytopenia/neutropenia >=7 days, G3/4 thrombocytopenia with >=G3 hemorrhage, G4 febrile neutropenia (FN), G3 FN lasting >=5 days while receiving MSC, isolated G3 liver transaminase elevation (LTE)/ isolated G3 total bilirubin (TBL) that does not downgrade to G1 or less within 14 days of onset, isolated G4 LTE or TBL, elevated aspartate aminotransferase/alanine aminotransferase >3×upper limit of normal (ULN) and concurrent TBL >2×ULN without cholestasis or alternative explanations, any other toxicity judged as a DLT by Dose Escalation Committee. (NCT03611556)
Timeframe: From Day 1 to 28 days after the first dose of study drugs

InterventionParticipants (Count of Participants)
Dose-escalation, Oleclumab 1500 mg + Durvalumab + Gemcitabine + Nab-paclitaxel0
Dose-escalation, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel0
Dose-escalation, Oleclumab 1500 mg + Durvalumab + mFOLFOX0
Dose-escalation, Oleclumab 3000 mg + Durvalumab + mFOLFOX1

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Number of Participants With Overall Survival Events by CD73 Expression at Baseline in Dose Expansion Phase

The overall survival is defined as the time from the randomization until death due to any cause. For participants who were alive at the time of data cut off, overall survival was censored on the last date when participants were known to be alive. The overall survival is assessed by CD73 expression level either low or high at baseline using the Kaplan-Meier method. The CD73 low is defined as no CD73 expression in tumor cells or <50% of tumor cells with 2+ or 3+ intensity and CD73 high is defined as CD73 expression with 2+ or 3+ intensity in >=50% of tumor cells. The number of participants with overall survival events (deaths) is reported. (NCT03611556)
Timeframe: Baseline (Days -28 to -1) through 38.7 months (maximum observed duration)

InterventionParticipants with event (Number)
Gemcitabine + Nab-paclitaxel: CD73 Level = High37
Oleclumab 3000 mg + Gemcitabine + Nab-paclitaxel: CD73 Level = High22
Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel: CD73 Level = High39
Gemcitabine + Nab-paclitaxel: CD73 Level = Low10
Oleclumab 3000 mg + Gemcitabine + Nab-paclitaxel: CD73 Level = Low10
Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel: CD73 Level = Low14

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Number of Participants With Overall Survival Events in Dose Expansion Phase

The overall survival is defined as the time from the randomization until death due to any cause. For participants who were alive at the time of data cut off, overall survival was censored on the last date when participants were known to be alive. The overall survival is assessed using the Kaplan-Meier method. The number of participants with overall survival events (deaths) is reported. (NCT03611556)
Timeframe: Baseline (Days -28 to -1) through 38.7 months (maximum observed duration)

InterventionParticipants with event (Number)
Dose-expansion, Gemcitabine + Nab-paclitaxel47
Dose-expansion, Oleclumab 3000 mg + Gemcitabine + Nab-paclitaxel32
Dose-expansion, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel53

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Number of Participants With Progression-free Survival Events According to RECIST v1.1 by CD73 Expression at Baseline in Dose Expansion Phase

PFS: Time from randomization until first documentation of PD/death due to any cause, whichever occurred first, regardless of whether participant received subsequent anticancer treatment prior to progression. PD:>=20% increase in SoD of TLs and an absolute increase of >= 5 mm of SoD/unequivocal progression of existing NTLs/appearance of new lesion. Participants who had no documented progression and were still alive at the time of analysis were censored at time of latest date of assessment from their last evaluable RECIST v1.1 assessment. PFS is assessed by CD73 expression level either low/high at baseline using Kaplan-Meier method. CD73 low: No CD73 expression in tumor cells/<50% of tumor cells with 2+/3+ intensity. CD73 high: CD73 expression with 2+/3+ intensity in >=50% of tumor cells. Number of participants with PFS events is reported. (NCT03611556)
Timeframe: Baseline (Days -28 to -1) through 36.1 months (maximum observed duration)

InterventionParticipants with event (Number)
Gemcitabine + Nab-paclitaxel: CD73 Level = High35
Oleclumab 3000 mg + Gemcitabine + Nab-paclitaxel: CD73 Level = High23
Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel: CD73 Level = High39
Gemcitabine + Nab-paclitaxel: CD73 Level = Low8
Oleclumab 3000 mg + Gemcitabine + Nab-paclitaxel: CD73 Level = Low9
Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel: CD73 Level = Low12

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Number of Participants With Progression-free Survival Events According to RECIST v1.1 in Dose Expansion Phase

Progression-free survival (PFS) is defined as the time from randomization until the first documentation of a PD or death due to any cause, whichever occurred first, regardless of whether the participant received subsequent anticancer treatment prior to progression. The PD is defined as at least a 20% increase in sum of the diameters of target lesions, taking as reference the smallest sum on study and an absolute increase of at least 5 mm of sum of the diameters, or unequivocal progression of existing non-target lesions, or the appearance of new lesion/s. Participants who had no documented progression and were still alive at the time of analysis were censored at the time of the latest date of assessment from their last evaluable RECIST v1.1 assessment. The PFS is assessed using the Kaplan-Meier method. The number of participants with PFS events is reported. (NCT03611556)
Timeframe: Baseline (Days -28 to -1) through 36.1 months (maximum observed duration)

InterventionParticipants with event (Number)
Dose-expansion, Gemcitabine + Nab-paclitaxel43
Dose-expansion, Oleclumab 3000 mg + Gemcitabine + Nab-paclitaxel32
Dose-expansion, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel51

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Overall Survival by CD73 Expression at Baseline in Dose Expansion Phase

The overall survival is defined as the time from the randomization until death due to any cause. For participants who were alive at the time of data cut off, overall survival was censored on the last date when participants were known to be alive. The overall survival is assessed by CD73 expression level either low or high at baseline using the Kaplan-Meier method. The CD73 low is defined as no CD73 expression in tumor cells or <50% of tumor cells with 2+ or 3+ intensity and CD73 high is defined as CD73 expression with 2+ or 3+ intensity in >=50% of tumor cells. (NCT03611556)
Timeframe: Baseline (Days -28 to -1) through 38.7 months (maximum observed duration)

InterventionMonths (Median)
Gemcitabine + Nab-paclitaxel: CD73 Level = High9.9
Oleclumab 3000 mg + Gemcitabine + Nab-paclitaxel: CD73 Level = High7.9
Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel: CD73 Level = High12.1
Gemcitabine + Nab-paclitaxel: CD73 Level = Low22.2
Oleclumab 3000 mg + Gemcitabine + Nab-paclitaxel: CD73 Level = Low16.0
Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel: CD73 Level = Low16.1

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Overall Survival in Dose Expansion Phase

The overall survival is defined as the time from the randomization until death due to any cause. For participants who were alive at the time of data cut off, overall survival was censored on the last date when participants were known to be alive. The overall survival is assessed using the Kaplan-Meier method. (NCT03611556)
Timeframe: Baseline (Days -28 to -1) through 38.7 months (maximum observed duration)

InterventionMonths (Median)
Dose-expansion, Gemcitabine + Nab-paclitaxel10.8
Dose-expansion, Oleclumab 3000 mg + Gemcitabine + Nab-paclitaxel8.9
Dose-expansion, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel12.9

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Percentage of Participants With Disease Control (DC) According to RECIST v1.1 in Dose Escalation Phase

The DC is defined as confirmed CR, PR, or stable disease (SD) (maintained for >=8 weeks). The CR is defined as disappearance of all TLs and NTLs, any pathological lymph nodes (target and non-target) must have reduction in short axis <10 mm, and no new lesions. The PR is defined as at least a 30% decrease in the SoD of TLs (compared to baseline) and no new lesions. Confirmation of CR and PR is required by a repeat, consecutive assessment no less than 4 weeks from date of first documentation. The SD is defined as neither sufficient shrinkage of TLs to qualify for PR nor sufficient increase of TLs to qualify for progressive disease (PD), taking as reference the smallest SoD while on study, and no new lesions. The PD is defined as at least a 20% increase in SoD of TLs, taking as reference the smallest sum on study and an absolute increase of at least 5 mm of SoD, or unequivocal progression of existing NTLs, or the appearance of new lesion/s. Percentage of participants with DC is reported. (NCT03611556)
Timeframe: Baseline (Days -28 to -1) through 24.5 months (maximum observed duration)

InterventionPercentage of Participants (Number)
Dose-escalation, Oleclumab 1500 mg + Durvalumab + Gemcitabine + Nab-paclitaxel42.9
Dose-escalation, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel71.4
Dose-escalation, Oleclumab 1500 mg + Durvalumab + mFOLFOX66.7
Dose-escalation, Oleclumab 3000 mg + Durvalumab + mFOLFOX62.5

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Percentage of Participants With Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in Dose Expansion Phase

The OR is defined as best overall response of confirmed complete response (CR) or confirmed partial response (PR) based on RECIST v1.1 guidelines. The CR is defined as disappearance of all target lesions (TLs) and non-target lesions (NTLs), any pathological lymph nodes (target and non-target) must have reduction in short axis < 10 mm, and no new lesions. The PR is defined as at least a 30% decrease in the sum of the diameters (SoD) of TLs (compared to baseline) and no new lesions. Confirmation of CR and PR is required by a repeat, consecutive assessment no less than 4 weeks from the date of first documentation. Percentage of participants with OR is reported. (NCT03611556)
Timeframe: Baseline (Days -28 to -1) through 36.1 months (maximum observed duration)

InterventionPercentage of Participants (Number)
Dose-expansion, Gemcitabine + Nab-paclitaxel29.0
Dose-expansion, Oleclumab 3000 mg + Gemcitabine + Nab-paclitaxel21.1
Dose-expansion, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel32.9

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Percentage of Participants With OR According to RECIST v1.1 by CD73 Expression at Baseline in Dose Expansion Phase

The OR is defined as best overall response of confirmed CR or confirmed PR based on RECIST v1.1. The CR is defined as disappearance of all TLs and NTLs, any pathological lymph nodes (target and non-target) must have reduction in short axis <10 mm, and no new lesions. The PR is defined as at least a 30% decrease in the SoD of TLs (compared to baseline) and no new lesions. Confirmation of CR and PR is required by a repeat, consecutive assessment no less than 4 weeks from the date of first documentation. The OR is assessed by cluster of differentiation 73 (CD73) expression level either low or high at baseline. The CD73 low is defined as no CD73 expression in tumor cells or <50% of tumor cells with 2+ or 3+ intensity and CD73 high is defined as CD73 expression with 2+ or 3+ intensity in >=50% of tumor cells. (NCT03611556)
Timeframe: Baseline (Days -28 to -1) through 36.1 months (maximum observed duration)

InterventionPercentage of Participants (Number)
Gemcitabine + Nab-paclitaxel: CD73 Level = High23.9
Oleclumab 3000 mg + Gemcitabine + Nab-paclitaxel: CD73 Level = High22.2
Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel: CD73 Level = High31.4
Gemcitabine + Nab-paclitaxel: CD73 Level = Low43.8
Oleclumab 3000 mg + Gemcitabine + Nab-paclitaxel: CD73 Level = Low18.2
Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel: CD73 Level = Low36.8

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Percentage of Participants With OR According to RECIST v1.1 in Dose Escalation Phase

The OR is defined as best overall response of confirmed CR or confirmed PR based on RECIST v1.1 guidelines. The CR is defined as disappearance of all target and non-target lesions, any pathological lymph nodes (target and non-target) must have reduction in short axis < 10 mm, and no new lesions. The PR is defined as at least a 30% decrease in the sum of the diameters of target lesions (compared to baseline) and no new lesions. Confirmation of CR and PR is required by a repeat, consecutive assessment no less than 4 weeks from the date of first documentation. Percentage of participants with OR is reported. (NCT03611556)
Timeframe: Baseline (Days -28 to -1) through 24.5 months (maximum observed duration)

InterventionPercentage of Participants (Number)
Dose-escalation, Oleclumab 1500 mg + Durvalumab + Gemcitabine + Nab-paclitaxel0
Dose-escalation, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel14.3
Dose-escalation, Oleclumab 1500 mg + Durvalumab + mFOLFOX0
Dose-escalation, Oleclumab 3000 mg + Durvalumab + mFOLFOX12.5

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Progression-free Survival According to RECIST v1.1 by CD73 Expression at Baseline in Dose Expansion Phase

The PFS is defined as the time from randomization until the first documentation of a PD or death due to any cause, whichever occurred first, regardless of whether the participant receives subsequent anticancer treatment prior to progression. The PD is defined as at least a 20% increase in SoD of TLs, taking as reference the smallest sum on study and an absolute increase of at least 5 mm of SoD, or unequivocal progression of existing NTLs, or the appearance of new lesion/s. Participants who had no documented progression and were still alive at time of analysis were censored at time of latest date of assessment from their last evaluable RECIST v1.1 assessment. PFS is assessed by CD73 expression level either low/high at baseline using Kaplan-Meier method. CD73 low: No CD73 expression in tumor cells/<50% of tumor cells with 2+/3+ intensity. CD73 high: CD73 expression with 2+/3+ intensity in >=50% of tumor cells. (NCT03611556)
Timeframe: Baseline (Days -28 to -1) through 36.1 months (maximum observed duration)

InterventionMonths (Median)
Gemcitabine + Nab-paclitaxel: CD73 Level = High5.6
Oleclumab 3000 mg + Gemcitabine + Nab-paclitaxel: CD73 Level = High5.2
Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel: CD73 Level = High5.5
Gemcitabine + Nab-paclitaxel: CD73 Level = Low10.5
Oleclumab 3000 mg + Gemcitabine + Nab-paclitaxel: CD73 Level = Low7.6
Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel: CD73 Level = Low10.9

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Progression-free Survival According to RECIST v1.1 in Dose Expansion Phase

The PFS is defined as the time from randomization until the first documentation of a PD or death due to any cause, whichever occurred first, regardless of whether the participant received subsequent anticancer treatment prior to progression. The PD is defined as at least a 20% increase in sum of the diameters of target lesions, taking as reference the smallest sum on study and an absolute increase of at least 5 mm of sum of the diameters, or unequivocal progression of existing non-target lesions, or the appearance of new lesion/s. Participants who had no documented progression and were still alive at the time of analysis were censored at the time of the latest date of assessment from their last evaluable RECIST v1.1 assessment. The PFS is assessed using the Kaplan-Meier method. (NCT03611556)
Timeframe: Baseline (Days -28 to -1) through 36.1 months (maximum observed duration)

InterventionMonths (Median)
Dose-expansion, Gemcitabine + Nab-paclitaxel6.7
Dose-expansion, Oleclumab 3000 mg + Gemcitabine + Nab-paclitaxel5.6
Dose-expansion, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel7.5

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Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose Escalation Phase

Number of participants with abnormal clinical laboratory parameters reported as TEAEs are reported. (NCT03611556)
Timeframe: Day 1 through 65.7 weeks (maximum observed duration)

,,,
InterventionParticipants (Count of Participants)
AnaemiaNeutropeniaThrombocytopeniaHypothyroidismAlanine aminotransferase increasedAspartate aminotransferase increasedBlood alkaline phosphatase increasedBlood bilirubin increasedBlood creatinine increasedBlood glucose decreasedInternational normalised ratio increasedLymphocyte count decreasedNeutrophil count decreasedPlatelet count decreasedWhite blood cell count decreasedHypoalbuminaemiaHypocalcaemiaHypokalaemiaHypomagnesaemiaHyponatraemiaHypophosphataemiaProteinuriaHyperthyroidismAmylase increasedGamma-glutamyltransferase increasedLipase increased
Dose-escalation, Oleclumab 1500 mg + Durvalumab + Gemcitabine + Nab-paclitaxel32203321011001000010010000
Dose-escalation, Oleclumab 1500 mg + Durvalumab + mFOLFOX12200000000011000000000100
Dose-escalation, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel32214310300123221322100000
Dose-escalation, Oleclumab 3000 mg + Durvalumab + mFOLFOX01112311000232211212001111

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Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose Expansion Phase

Number of participants with abnormal clinical laboratory parameters reported as TEAEs are reported. (NCT03611556)
Timeframe: Day 1 through 172.1 weeks (maximum observed duration)

,,
InterventionParticipants (Count of Participants)
AnaemiaFebrile neutropeniaLeukocytosisLeukopeniaLymphopeniaNeutropeniaThrombocytopeniaThrombocytosisHyperthyroidismHypothyroidismHypertransaminasaemiaAlanine aminotransferase decreasedAlanine aminotransferase increasedAmylase increasedAspartate aminotransferase increasedBlood albumin decreasedBlood alkaline phosphatase increasedBlood bilirubin increasedBlood creatinine increasedBlood glucose increasedBlood lactate dehydrogenase increasedBlood magnesium decreasedBlood oestrogen decreasedGamma-glutamyltransferase increasedHaemoglobin decreasedInternational normalised ratio increasedLipase increasedLiver function test increasedLymphocyte count decreasedNeutrophil countNeutrophil count decreasedPlatelet count decreasedTroponin I increasedWhite blood cell count decreasedWhite blood cell count increasedHyperglycaemiaHyperkalaemiaHypoalbuminaemiaHypocalcaemiaHypoglycaemiaHypokalaemiaHypomagnesaemiaHyponatraemiaHypophosphataemiaHypovolaemiaIron deficiencyType 2 diabetes mellitusProteinuria
Dose-expansion, Gemcitabine + Nab-paclitaxel17011222620001811113320100600014019131604132044811000
Dose-expansion, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel28313216131370016115082803008112061242001006163286300101
Dose-expansion, Oleclumab 3000 mg + Gemcitabine + Nab-paclitaxel14102015700010908023020111001020890612122023000011

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Number of Participants With Abnormal ECG Parameters Reported as TEAEs in Dose Expansion Phase

Number of participants with abnormal ECG parameters reported as TEAEs are reported. (NCT03611556)
Timeframe: Day 1 through 172.1 weeks (maximum observed duration)

,,
InterventionParticipants (Count of Participants)
Supraventricular tachycardiaTachycardia
Dose-expansion, Gemcitabine + Nab-paclitaxel02
Dose-expansion, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel03
Dose-expansion, Oleclumab 3000 mg + Gemcitabine + Nab-paclitaxel13

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Number of Participants With Abnormal Electrocardiogram (ECG) Parameters Reported as TEAEs in Dose Escalation Phase

Number of participants with abnormal ECG parameters reported as TEAEs are reported. (NCT03611556)
Timeframe: Day 1 through 65.7 weeks (maximum observed duration)

,,,
InterventionParticipants (Count of Participants)
Atrial fibrillationTachycardiaAtrioventricular block
Dose-escalation, Oleclumab 1500 mg + Durvalumab + Gemcitabine + Nab-paclitaxel000
Dose-escalation, Oleclumab 1500 mg + Durvalumab + mFOLFOX000
Dose-escalation, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel110
Dose-escalation, Oleclumab 3000 mg + Durvalumab + mFOLFOX001

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Plasma Concentrations of Nab-paclitaxel

Plasma concentrations of nab-paclitaxel are reported. (NCT03611556)
Timeframe: Ten mins (± 5 mins) post EOI, approximately 30-40 mins after start of infusion on C1D1 and C4D1; and pre-dose on C4D1

,,,,
Interventionng/mL (Geometric Mean)
C1D1 (EOI)C4D1 (pre-dose)C4D1 (EOI)
Dose-escalation, Oleclumab 1500 mg + Durvalumab + Gemcitabine + Nab-paclitaxel1711NANA
Dose-escalation, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel2685NA1474
Dose-expansion, Gemcitabine + Nab-paclitaxel2381NA1825
Dose-expansion, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel2611NA1747
Dose-expansion, Oleclumab 3000 mg + Gemcitabine + Nab-paclitaxel2711NA1445

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Number of Participants With Abnormal Vital Signs Reported as TEAEs in Dose Escalation Phase

Number of participants with abnormal vital signs (temperature, blood pressure, pulse rate, and respiratory rate) reported as TEAEs are reported. (NCT03611556)
Timeframe: Day 1 through 65.7 weeks (maximum observed duration)

,,,
InterventionParticipants (Count of Participants)
PyrexiaDyspnoeaDyspnoea exertionalHypotensionTemperature intoleranceHypertension
Dose-escalation, Oleclumab 1500 mg + Durvalumab + Gemcitabine + Nab-paclitaxel310200
Dose-escalation, Oleclumab 1500 mg + Durvalumab + mFOLFOX000010
Dose-escalation, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel301100
Dose-escalation, Oleclumab 3000 mg + Durvalumab + mFOLFOX100101

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Number of Participants With Abnormal Vital Signs Reported as TEAEs in Dose Expansion Phase

Number of participants with abnormal vital signs (temperature, blood pressure, pulse rate, and respiratory rate) reported as TEAEs are reported. (NCT03611556)
Timeframe: Day 1 through 172.1 weeks (maximum observed duration)

,,
InterventionParticipants (Count of Participants)
HypothermiaPyrexiaDyspnoeaDyspnoea exertionalHypertensionHypotensionOrthostatic hypotension
Dose-expansion, Gemcitabine + Nab-paclitaxel01571231
Dose-expansion, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel121821140
Dose-expansion, Oleclumab 3000 mg + Gemcitabine + Nab-paclitaxel01261340

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Number of Participants With Positive ADA to Durvalumab

Number of participants with positive ADA to durvalumab are reported. Persistent positive is defined as positive at >= 2 post-baseline assessments (with >=16 weeks between first and last positive) or positive at last post-baseline assessment. Transient positive is defined as negative at last post-baseline assessment and positive at only one post-baseline assessment or at >= 2 post-baseline assessments (with <16 weeks between first and last positive). Treatment-boosted ADA is defined as baseline ADA positive titer that was boosted to a 4-fold or higher level following drug administration. (NCT03611556)
Timeframe: Day 1 through 128 weeks (Pre-dose on C1D1, C2D1, C3D1, Day 1 of every 3 cycles starting with C5, through 12 weeks post last dose of durvalumab)

,,,,
InterventionParticipants (Count of Participants)
ADA positive at baselineADA positive post-baselinePersistent PositiveTransient PositiveTreatment-boosted ADA
Dose-escalation, Oleclumab 1500 mg + Durvalumab + Gemcitabine + Nab-paclitaxel01100
Dose-escalation, Oleclumab 1500 mg + Durvalumab + mFOLFOX00000
Dose-escalation, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel00000
Dose-escalation, Oleclumab 3000 mg + Durvalumab + mFOLFOX02200
Dose-expansion, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel20000

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Number of Participants With Positive Anti-drug Antibodies (ADA) to Oleclumab

Number of participants with positive ADA to oleclumab are reported. Persistent positive is defined as positive at >= 2 post-baseline assessments (with >=16 weeks between first and last positive) or positive at last post-baseline assessment. Transient positive is defined as negative at last post-baseline assessment and positive at only one post-baseline assessment or at >= 2 post-baseline assessments (with <16 weeks between first and last positive). Treatment-boosted ADA is defined as baseline ADA positive titer that was boosted to a 4-fold or higher level following drug administration. (NCT03611556)
Timeframe: Day 1 through 172.1 weeks (Pre-dose on Cycle [C] 1 Day [D] 1, C2D1, C3D1, Day 1 of every 3 cycles starting with C5, through 12 weeks post last dose of oleclumab)

,,,,,
InterventionParticipants (Count of Participants)
ADA positive at baselineADA positive post-baselinePersistent PositiveTransient PositiveTreatment-boosted ADA
Dose-escalation, Oleclumab 1500 mg + Durvalumab + Gemcitabine + Nab-paclitaxel01100
Dose-escalation, Oleclumab 1500 mg + Durvalumab + mFOLFOX00000
Dose-escalation, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel00000
Dose-escalation, Oleclumab 3000 mg + Durvalumab + mFOLFOX01100
Dose-expansion, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel00000
Dose-expansion, Oleclumab 3000 mg + Gemcitabine + Nab-paclitaxel01010

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Number of Participants With TEAEs and TESAEs in Dose Expansion Phase

An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug. (NCT03611556)
Timeframe: Day 1 through 172.1 weeks (maximum observed duration)

,,
InterventionParticipants (Count of Participants)
Any TEAEsAny TESAEs
Dose-expansion, Gemcitabine + Nab-paclitaxel6234
Dose-expansion, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel7037
Dose-expansion, Oleclumab 3000 mg + Gemcitabine + Nab-paclitaxel3724

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Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) in Dose Escalation Phase

An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug. (NCT03611556)
Timeframe: Day 1 through 65.7 weeks (maximum observed duration)

,,,
InterventionParticipants (Count of Participants)
Any TEAEsAny TESAEs
Dose-escalation, Oleclumab 1500 mg + Durvalumab + Gemcitabine + Nab-paclitaxel74
Dose-escalation, Oleclumab 1500 mg + Durvalumab + mFOLFOX30
Dose-escalation, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel76
Dose-escalation, Oleclumab 3000 mg + Durvalumab + mFOLFOX84

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Plasma Concentrations of Gemcitabine and Metabolite 2',2'-Difluorodeoxyuridine (dFdU)

Plasma concentrations of gemcitabine and metabolite dFdU are reported. (NCT03611556)
Timeframe: Ten mins (± 5 mins) post EOI, approximately 30-40 mins after start of infusion on C1D1 and C4D1; and pre-dose on C4D1

,,,,
Interventionng/mL (Geometric Mean)
Gemcitabine C1D1 (EOI)Gemcitabine C4D1 (pre-dose)Gemcitabine C4D1 (EOI)dFdU C1D1 (EOI)dFdU C4D1 (pre-dose)dFdU C4D1 (EOI)
Dose-escalation, Oleclumab 1500 mg + Durvalumab + Gemcitabine + Nab-paclitaxel3194NANA33700NANA
Dose-escalation, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel4659NA353032160434.634550
Dose-expansion, Gemcitabine + Nab-paclitaxel3301NA174829510245.123900
Dose-expansion, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel4086NA299826300177.527260
Dose-expansion, Oleclumab 3000 mg + Gemcitabine + Nab-paclitaxel3315NA143132350149.921970

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Serum Concentrations of Durvalumab

Serum concentrations of durvalumab are reported. (NCT03611556)
Timeframe: Ten mins (± 5 mins) post EOI, approximately 1 hour (+ 15 mins) after start of infusion on C1D1 and C5D1; and pre-dose on C2D1 and C5D1

Interventionμg/mL (Geometric Mean)
C1D1 (EOI)C2D1 (pre-dose)
Dose-escalation, Oleclumab 1500 mg + Durvalumab + mFOLFOX309.050.52

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Percentage of Serum Uric Acid (sUA < 6 mg/dL) Overall Responders

Serum uric acid (sUA < 6 mg/dL) overall responders are defined as participants achieving and maintaining sUA < 6 mg/dL for at least 80% of the time during Month 3 and Month 6 (Weeks 10, 12, 14, 20, 22, and 24) combined. Participants with more than one sUA result in Month 3 and Month 6 are considered responders if a participant's weighted proportion of hours that sUA is < 6 mg/dL is greater than or equal to 80%. Participants with the proportion of hours less than 80% are counted as non-responders. Participants with only one value in Month 3 and Month 6 are considered overall responders if they are considered responders in both Month 3 and Month 6. (NCT03635957)
Timeframe: Month 3 and Month 6 combined (Weeks 10, 12, 14, 20, 22, and 24)

Interventionpercentage of participants (Number)
Pegloticase With Methotrexate (MTX)78.6

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Percentage of Serum Uric Acid (sUA < 5 mg/dL) Overall Responders

Serum uric acid (sUA < 5 mg/dL) overall responders are defined as participants achieving and maintaining sUA < 5 mg/dL for at least 80% of the time during Month 3 and Month 6 (Weeks 10, 12, 14, 20, 22, and 24) combined. Participants with more than one sUA result in Month 3 and Month 6 are considered responders if a participant's weighted proportion of hours that sUA is < 6 mg/dL is greater than or equal to 80%. Participants with the proportion of hours less than 80% are counted as non-responders. Participants with only one value in Month 3 and Month 6 are considered overall responders if they are considered responders in both Month 3 and Month 6. (NCT03635957)
Timeframe: Month 3 and Month 6 combined (Weeks 10, 12, 14, 20, 22, and 24)

Interventionpercentage of participants (Number)
Pegloticase With Methotrexate (MTX)78.6

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Percentage of Serum Uric Acid (sUA < 5 mg/dL) Responders During Month 3

Serum uric acid (sUA < 5 mg/dL) responders are defined as participants achieving and maintaining sUA < 5 mg/dL for at least 80% of the time during Month 3. Month 3 includes pre-infusion and post-infusion sUA assessments at Week 10, pre-infusion and post-infusion sUA assessments at Week 12, pre-infusion assessments at Week 14, and unscheduled assessments between Week 10 and Week 14 pre-infusion. (NCT03635957)
Timeframe: Month 3 (Weeks 10, 12, and 14)

Interventionpercentage of participants (Number)
Pegloticase With Methotrexate (MTX)78.6

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Percentage of Serum Uric Acid (sUA < 5 mg/dL) Responders During Month 6

Serum uric acid (sUA < 5 mg/dL) responders are defined as participants achieving and maintaining sUA < 5 mg/dL for at least 80% of the time during Month 6. Month 6 includes pre-infusion and post-infusion sUA assessments at Week 20, pre-infusion and post-infusion sUA assessments at Week 22, pre-infusion assessments at Week 24, and unscheduled sUA assessments between Week 20 and Week 24. (NCT03635957)
Timeframe: Month 6 (Weeks 20, 22, and 24)

Interventionpercentage of participants (Number)
Pegloticase With Methotrexate (MTX)78.6

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Percentage of Serum Uric Acid (sUA < 6 mg/dL) Responders During Month 3

Serum uric acid (sUA < 6 mg/dL) responders are defined as participants achieving and maintaining sUA < 6 mg/dL for at least 80% of the time during Month 3 (Weeks 10, 12, and 14). Month 3 includes pre-infusion and post-infusion sUA assessments at Week 10, pre-infusion and post-infusion sUA assessments at Week 12, pre-infusion assessments at Week 14, and unscheduled assessments between Week 10 and Week 14 pre-infusion. (NCT03635957)
Timeframe: Month 3 (Weeks 10, 12, and 14)

Interventionpercentage of participants (Number)
Pegloticase With Methotrexate (MTX)78.6

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Mean Change in sUA From Pegloticase Baseline to Weeks 14, 24, 36, 52

The mean change from baseline is based on observed values in participants remaining on treatment at given time point. For sUA values less than the lower limit of detection (up to 1.5 mg/dL), 0 is used in the analysis. (NCT03635957)
Timeframe: Baseline (defined as the last measurement taken prior to the first infusion of pegloticase in the pegloticase + IMM period), Pre- and Post-Infusion at Weeks 14, 24, 36 and Week 52

Interventionmg/dL (Mean)
Change at Week 14 - pre-infusionChange at Week 14 - post-infusionChange at Week 24 - pre-infusionChange at Week 24 - post-infusionChange at Week 36 - pre-infusionChange at Week 36 - post-infusionChange at Week 52
Pegloticase With Methotrexate (MTX)-9.27-9.31-9.27-9.48-8.13-9.41-8.15

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Percentage of Serum Uric Acid (sUA < 6 mg/dL) Responders During Month 6

Serum uric acid (sUA < 6 mg/dL) responders are defined as participants achieving and maintaining sUA < 6 mg/dL for at least 80% of the time during Month 6 (Weeks 20, 22, and 24). Month 6 includes pre-infusion and post-infusion sUA assessments at Week 20, pre-infusion and post-infusion sUA assessments at Week 22, pre-infusion assessments at Week 24, and unscheduled sUA assessments between Week 20 and Week 24. (NCT03635957)
Timeframe: Month 6 (Weeks 20, 22, and 24)

Interventionpercentage of participants (Number)
Pegloticase With Methotrexate (MTX)78.6

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Aberrant Behavior Checklist (ABC) - Parent Reported Change

"The Aberrant Behavior Checklist - parent reported version measures aberrant behavior in children and young adults. There are 58 questions.The scoring of one question can range from 0 (not a problem) to 3 (severe) points on a Likert scale. The total possible score range for the ABC is 0 - 174. Analysis will be performed for mean of total score change over time.~Scoring from 0-3~Not a problem = 0, Slightly = 1, Moderately Serious =2, Severe =3~Lower score indicates better performance." (NCT03771560)
Timeframe: Baseline to Week 12

Interventionscore on a scale (Mean)
Folinic Acid Open-label-2.4

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Pediatric Quality of Life (PedsQL) - Parent Reported Change

"Pediatric Quality of Life is reported by parent only and it assesses improvement of the child's overall quality of life through questions about physical, emotional, social and school functioning. There are 23 questions. The scoring of PedsQL questions can range from 0 (Never) to 4 (Almost Always) points on a Likert scale. Questions are reversed scored and linearly transformed to a 0 - 100 scale for data analysis as follows: 0=100, 1=75, 2=50, 3=23, 4=0. The total score = sum of all the questions over the number of items answered on. The total possible score range for the PedsQL is 0 - 100. Analysis will be performed for mean of total score change over time.~Scoring from 0 to 4~Never = 0, Almost Never = 1, Sometimes = 2, Often = 3, Almost Always =4~Higher score indicates better performance." (NCT03771560)
Timeframe: Baseline to Week 12

Interventionscore on a scale (Mean)
Folinic Acid Open-label-0.8

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Social Responsiveness Scale (SRS) - Parent Reported Change

"The Social Responsiveness Scale - parent reported version measures social ability in children and young adults. There are 65 questions. The questions on the scale with anchors 1 (Not True) - 4 (Almost Always True). The scoring of SRS questions can range from 0-3 (with possible reverse scoring) based on scoring instructions for data analysis. The total possible score range for the SRS is 0 - 195. Analysis will be performed for mean of total score change over time.~Anchors Not True = 1 Sometimes True = 2 Often True = 3 Almost Always True = 4~Lower score indicates better performance." (NCT03771560)
Timeframe: Baseline to Week 12

Interventionscore on a scale (Mean)
Folinic Acid Open-label-7.8

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Social Responsiveness Scale (SRS) - Teacher Reported Change

"The Social Responsiveness Scale - teacher reported version measures social ability in children and young adults. There are 65 questions. The questions on the scale with anchors 1 (Not True) - 4 (Almost Always True). The scoring of SRS questions can range from 0-3 (with possible reverse scoring) based on scoring instructions for data analysis. The total possible score range for the SRS is 0 - 195. Analysis will be performed for mean of total score change over time.~Anchors Not True = 1 Sometimes True = 2 Often True = 3 Almost Always True = 4~Lower score indicates better performance." (NCT03771560)
Timeframe: Baseline to Week 12

Interventionscore on a scale (Median)
Folinic Acid Open-label-0.5

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Aberrant Behavior Checklist (ABC) - Teacher Reported Change

"The Aberrant Behavior Checklist - teacher reported version measures aberrant behavior in children and young adults. There are 58 questions. The scoring of ABC questions can range from 0 (not a problem) to 3 (severe) points on a likert scale. The total possible score range for the ABC is 0 - 174. Analysis will be performed for mean of total score change over time.~Scoring from 0-3~Not a problem = 0, Slightly = 1, Moderately Serious =2, Severe =3~Lower score indicates better performance." (NCT03771560)
Timeframe: Baseline to Week 12

Interventionscore on a scale (Mean)
Folinic Acid Open-label1.2

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Percentage of Patients With at Least One Pain Flare-up During the Study

Episode of pain flare-up was defined as presence of at least 1 day with low back pain following a period without pain lasting at least 4 weeks. Therefore pain flare-ups were registered no earlier than 4 weeks after the start of treatment, i.e. starting from Visit 5 (38 days after the start of treatment). The occurrence of pain flare-up was determined by the investigator. (NCT03892707)
Timeframe: From Visit 5 (38 days after the start of treatment) to Visit 9 (End of Study Visit, 94 days after the start of treatment)

InterventionParticipants (Count of Participants)
NSAIDs Group35
NSAIDs+Milgamma+Milgamma Compositum Group10

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Number of Treatment Days With NSAIDs

Number of treatment days with NSAIDs was calculated using the data collected on the NSAIDs intake during the study irrespective of the specific drug used. Duration of each intake period was determined as Stop date - Start date +1 and, finally, all individual duration values were summed up. In case medication intake was ongoing at the End of Study Visit, stop date was imputed by the date of study completion. (NCT03892707)
Timeframe: From Baseline to Visit 9 (End of Study Visit, 94 days after the start of treatment)/ Early Discontinuation Visit

InterventionDays of treatment (Mean)
NSAIDs Group9.6
NSAIDs+Milgamma+Milgamma Compositum Group10.6

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Change of Pain Intensity Over Time

Pain intensity was measured using 0-10 point Numeric Rating Scale (NRS). NRS is 11-step scale for assessment of pain intensity at the moment of patient's examination ranging from 0 (no pain) to 10 (worst pain imaginable). Pain intensity was measured at baseline, at 5, 10, 24 and 38 days after the start of treatment. A mixed model repeated measures was used to analyze change from baseline in pain intensity over time from Baseline to Visit 5 (38 days after the start of treatment) in each group. The model included a random effect for subject and fixed effect terms for treatment, visit, treatment-by-visit interaction, baseline pain intensity. An unstructured covariance structure was used to model the within-subject errors. P-value was calculated for the difference between treatment groups. (NCT03892707)
Timeframe: From Baseline to Visit 5 (38 days after the start of treatment)

Interventionunits on a scale (Least Squares Mean)
NSAIDs Group-5.1
NSAIDs+Milgamma+Milgamma Compositum Group-4.4

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Change of Pain Intensity After 5, 24 and 38 Days of Treatment

Pain intensity was measured using 0-10 point Numeric Rating Scale (NRS). NRS is 11-step scale for assessment of pain intensity at the moment of patient's examination ranging from 0 (no pain) to 10 (worst pain imaginable). Pain intensity was measured at baseline, at 5, 24 and 38 days after the start of treatment.Changes of pain intensity from baseline to Day 5, from baseline to Day 24 and from baseline to Day 38 after the start of treatment were calculated separately. (NCT03892707)
Timeframe: Baseline; Visit 2 (5 days after the start of treatment), Visit 4 (24 days after the start of treatment); Visit 5 (38 days after the start of treatment)

,
Interventionunits on a scale (Mean)
Change of pain intensity from baseline to Day 5 after the start of treatmentChange of pain intensity from baseline to Day 24 after the start of treatmentChange of pain intensity from baseline to Day 38 after the start of treatment
NSAIDs Group-3.1-6.1-6.3
NSAIDs+Milgamma+Milgamma Compositum Group-2.4-5.3-6.0

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Patient Satisfaction With Treatment

Patient satisfaction with treatment was evaluated using a 5-point verbal rating scale (1= very dissatisfied, 2= dissatisfied, 3= neutral, 4= satisfied, 5= very satisfied) after 5, 10, 38 days and 3 months (94 days) since the start of treatment. (NCT03892707)
Timeframe: Visit 2 (5 days after the start of treatment); Visit 3 (10 days after the start of treatment); Visit 5 (38 days after the start of treatment) and Visit 9 (94 days after the start of treatment)

,
Interventionunits on a scale (Mean)
Visit 2 (5 days after the start of treatment)Visit 3 (10 days after the start of treatment)Visit 5 (38 days after the start of treatment)Visit 9 (94 days after the start of treatment)
NSAIDs Group3.84.24.54.6
NSAIDs+Milgamma+Milgamma Compositum Group3.84.14.54.7

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Percentage of Patients With 30% Low Back Pain Relief After 5, 10, 24 and 38 Days of Treatment.

Pain intensity was measured using 0-10 point Numeric Rating Scale (NRS). NRS is 11-step scale for assessment of pain intensity at the moment of patient's examination ranging from 0 (no pain) to 10 (worst pain imaginable). Relief in pain intensity was defined as 100%*(pain intensity at baseline - pain intensity at Visit 2, 3, 4 or 5)/ pain intensity at baseline. Percentage of patients showing at least 30% low back pain relief at Visit 2 (5 days after the start of treatment), at Visit 3 (10 days after the start of treatment), at Visit 4 (24 days after the start of treatment) and at Visit 5 (38 days after the start of treatment) were calculated separately. (NCT03892707)
Timeframe: Visit 2 (5 days after the start of treatment); Visit 3 (10 days after the start of treatment); Visit 4 (24 days after the start of treatment) and Visit 5 (38 days after the start of treatment)

,
InterventionParticipants (Count of Participants)
Number and percentage of patients with 30% pain relief at Day 5 after the start of treatmentNumber and percentage of patients with 30% pain relief at Day 10 after the start of treatmentNumber and percentage of patients with 30% pain relief at Day 24 after the start of treatmentNumber and percentage of patients with 30% pain relief at Day 38 after the start of treatment
NSAIDs Group194235241244
NSAIDs+Milgamma+Milgamma Compositum Group140214240241

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Percentage of Patients With at Least One Pain Flare-up Resulting in Consultancy With Physician, Resulting in Disruption of Daily Activity, and Resulting in NSAIDs Intake

"Episode of pain flare-up was defined as presence of at least 1 day with low back pain following a period without pain lasting at least 4 weeks. Therefore pain flare-ups were registered no earlier than 4 weeks after the start of treatment, i.e. starting from Visit 5 (38 days after the start of treatment). The occurrence of pain flare-up was determined by the investigator.~Percentages of patients with at least one pain flare-up resulting in consultancy with physician or professional management, resulting in disruption of daily activity, and resulting in NSAIDs intake were analyzed separately." (NCT03892707)
Timeframe: From Visit 5 (38 days after the start of treatment) to Visit 9 (End of Study Visit, 94 days after the start of treatment)

,
InterventionParticipants (Count of Participants)
Patients with at least one pain flare-up resulting in consultancy with physicianPatients with at least one pain flare-up resulting in disruption of daily activityPatients with at least one pain flare-up resulting in NSAIDs intake
NSAIDs Group42019
NSAIDs+Milgamma+Milgamma Compositum Group448

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Prescribed and Actual Number of Milgamma® Injections

Prescribed number of Milgamma® injections was reported at Baseline visit. Actual number of injections was calculated by counting the number of injections administered and reported starting from Visit 2. If the treatment was interrupted, the days patient did not receive Milgamma® injections were not contribute to the total number of injections. (NCT03892707)
Timeframe: From Baseline to Visit 9 (End of Study Visit, 94 days after the start of treatment)/ Early Discontinuation Visit

Interventionnumber of injections (Mean)
Prescribed exposure of Milgamma® injectionsActual exposure of Milgamma® injections
NSAIDs+Milgamma+Milgamma Compositum Group9.39.3

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Prescribed and Actual Number of Treatment Days With Milgamma® Compositum

Prescribed number of treatment days with Milgamma® compositum intake was reported at Baseline visit. Actual number of treatment days was calculated by summing up all the individual periods of treatment with Milgamma® compositum (in days) reported starting from Visit 2. If the treatment was interrupted, the days patient did not receive Milgamma® compositum were not contribute to the total number of treatment days with Milgamma® compositum intake. (NCT03892707)
Timeframe: From Baseline to Visit 9 (End of Study Visit, 94 days after the start of treatment)/ Early Discontinuation Visit

InterventionDays of treatment (Mean)
Prescribed exposure of Milgamma® compositumActual exposure of Milgamma® compositum
NSAIDs+Milgamma+Milgamma Compositum Group30.129.9

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Change of Pain Intensity After 10 Days of Treatment

Pain intensity was measured using 0-10 point Numeric Rating Scale (NRS). NRS is 11-step scale for assessment of pain intensity at the moment of patient's examination ranging from 0 (no pain) to 10 (worst pain imaginable). Pain intensity was measured at baseline and at 10 days after the start of treatment. (NCT03892707)
Timeframe: Baseline; Visit 3 (10 days after the start of treatment)

Interventionunits on a scale (Mean)
NSAIDs Group-5.1
NSAIDs+Milgamma+Milgamma Compositum Group-4.0

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Overall Response Rate (ORR) Per RECIST 1.1 as Assessed by Blinded Central Imaging

ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per RECIST 1.1. The percentage of participants who experienced a CR or PR is presented. (NCT03950674)
Timeframe: Through Database Cutoff Date of 20-May-2019 (Up to approximately 31.2 months)

InterventionPercentage of Participants (Number)
Pembrolizumab56.0
Control33.3

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Number of Participants Who Experienced an Adverse Event (AE)

An AE was defined as any untoward medical occurrence in a study participant administered study drug and which does not necessarily have to have a causal relationship with this study drug. The number of participants who experienced an AE is presented. (NCT03950674)
Timeframe: Through Database Cutoff Date of 20-May-2019 (Up to approximately 31.2 months)

InterventionParticipants (Count of Participants)
Pembrolizumab25
Control15

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Number of Participants Who Discontinued Any Study Drug Due to an AE

The number of participants who discontinued any randomized study drug due to an AE is presented. (NCT03950674)
Timeframe: Up to approximately 24 months

InterventionParticipants (Count of Participants)
Pembrolizumab9
Control3

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Duration of Response (DOR) Per RECIST 1.1 as Assessed by Blinded Central Imaging

For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR was defined as the time from first documented evidence of a CR or PR until PD or death. DOR for participants who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD. DOR assessments were based on blinded central imaging review with confirmation. The DOR per RECIST 1.1 for all participants who experienced a confirmed CR or PR is presented. (NCT03950674)
Timeframe: From time of first documented evidence of CR or PR through database cutoff date of 20-May-2019 (Up to approximately 31.2 months)

InterventionMonths (Median)
Pembrolizumab13.6
Control9.7

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Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Central Imaging

PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD. The PFS per RECIST 1.1 is presented. (NCT03950674)
Timeframe: Through Database Cutoff Date of 20-May-2019 (Up to approximately 31.2 months)

InterventionMonths (Median)
Pembrolizumab16.5
Control7.1

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Overall Survival (OS)

OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the analysis were censored at the date of the last follow-up. The OS is presented. (NCT03950674)
Timeframe: Through Database Cutoff Date of 20-May-2019 (Up to approximately 31.2 months)

InterventionMonths (Median)
PembrolizumabNA
Control25.9

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Percentage of sUA (sUA < 6 mg/dL) Responders During Month 12

Responders are defined as participants achieving and maintaining sUA <6 mg/dL for at least 80% of the time during Month 12 (Weeks 48, 50 and 52). Month 12 includes pre- and post-infusion sUA Weeks 48 and 50, pre-infusion sUA at Week 52, and any unscheduled sUA assessments done at unscheduled visits between Week 48 and 52. A participant must have had ≥ 2 sUA observations from different visits in order to be eligible as a responder. Participants meeting the stopping rule (those with a pre-infusion sUA >6 mg/dL at 2 consecutive scheduled trial visits beginning with the Week 2 Visit stopped pegloticase dosing) were counted as non-responders. (NCT03994731)
Timeframe: Month 12 (Weeks 48, 50 and 52)

Interventionpercentage of participants (Number)
Pegloticase + MTX60.0
Pegloticase + Placebo30.8

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Percentage of Serum Uric Acid (sUA) Responders (sUA < 6 mg/dL) During Month 6

Responders are defined as participants achieving and maintaining sUA < 6 mg/dL for at least 80% of the time during Month 6. Month 6 includes pre- and post-infusion sUA assessments at Weeks 20 and 22, non-infusion sUA at Weeks 21 and 23, pre-infusion sUA at Week 24 and any unscheduled sUA between Week 20 and Week 24. A participant must have had ≥ 2 sUA observations from different visits in order to be eligible as a responder. Participants meeting the stopping rule (those with a pre-infusion sUA >6 mg/dL at 2 consecutive scheduled trial visits beginning with the Week 2 Visit stopped pegloticase dosing) were counted as non-responders. (NCT03994731)
Timeframe: Month 6 (Weeks 20, 21, 22, 23 and 24)

Interventionpercentage of participants (Number)
Pegloticase + MTX71.0
Pegloticase + Placebo38.5

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Percentage of Participants With Complete Resolution of ≥ 1 Tophi at Week 52

Percentage of participants with complete resolution of ≥ 1 tophi (using digital photography) at Week 52 in participants with tophi at baseline. Participants with resolution of ≥ 1 tophi at a visit are participants with resolution of ≥ 1 tophi at the visit (i.e. have complete response), and no progressive disease for any other tophi. (NCT03994731)
Timeframe: Baseline, Week 52

Interventionpercentage of participants (Number)
Pegloticase + MTX53.8
Pegloticase + Placebo31.0

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Mean Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 52

HAQ-DI is a self-report functional status instrument that is filled out by the participant and measures disability over the past week via 20 questions relating to 8 domains of function: dressing, grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. The HAQ-DI ranges from 0 to 3 with higher values indicating higher disability. A change from baseline value of 0 is imputed at the first post-baseline visit for any participants without post-baseline values. (NCT03994731)
Timeframe: Baseline, Week 52

Interventionscore on a scale (Least Squares Mean)
Pegloticase + MTX-0.35
Pegloticase + Placebo-0.31

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Mean Change From Baseline in HAQ Health Score at Week 52

The HAQ health scale is a self-reported measure of overall health. Participants are asked to rate how they are doing, considering all the ways arthritis affects them, on a scale of 0 to 100, where 0 represents very well and 100 represents very poor. A change from baseline value of 0 is imputed at the first post-baseline visit for any participants without post-baseline values. (NCT03994731)
Timeframe: Baseline, Week 52

Interventionscore on a scale (Least Squares Mean)
Pegloticase + MTX-28.85
Pegloticase + Placebo-18.69

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Mean Change From Baseline HAQ Pain Score at Week 52

The HAQ-Pain score rates the participant's pain over the past week from 0 to 100 with 0 = no pain and 100 = severe pain. A change from baseline value of 0 is imputed at the first post-baseline visit for any participants without post-baseline values. (NCT03994731)
Timeframe: Baseline, Week 52

Interventionscore on a scale (Least Squares Mean)
Pegloticase + MTX-31.02
Pegloticase + Placebo-22.59

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Number of Participants With Hospitalization or Mortality

Number of participants with hospitalization or mortality (NCT04354428)
Timeframe: Day 28 after enrolment

InterventionParticipants (Count of Participants)
Ascorbic Acid and Folic Acid4
Hydroxychloroquine and Folic Acid2
Hydroxychloroquine and Azithromycin3
Lopinavir-ritonavir0
Ascorbic Acid1

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Number of Participants With Serious Adverse Events and Adverse Events Resulting in Treatment Discontinuation

Serious adverse events (including death and hospitalization) and adverse events resulting in treatment discontinuation (NCT04354428)
Timeframe: 28 days from enrolment

InterventionParticipants (Count of Participants)
Ascorbic Acid and Folic Acid6
Hydroxychloroquine and Folic Acid6
Hydroxychloroquine and Azithromycin8
Lopinavir-ritonavir9
Ascorbic Acid1

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Time to Clearance of Nasal SARS-CoV-2

Time to clearance of nasal SARS-CoV-2, defined as 2 consecutive negative swabs (NCT04354428)
Timeframe: Day 1 through Day 14 after enrolment

InterventionDays (Median)
Ascorbic Acid and Folic Acid7
Hydroxychloroquine and Folic Acid5
Hydroxychloroquine and Azithromycin6
Lopinavir-ritonavir4
Ascorbic Acid5

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Time to Resolution of COVID-19 Symptom Resolution in Days

"COVID-19 symptoms are based on the following criteria:~At least TWO of the following symptoms: Fever (≥ 38ºC), chills, rigors, myalgia, headache, sore throat, new olfactory and taste disorder(s), OR~At least ONE of the following symptoms: cough, shortness of breath or difficulty breathing, OR~Severe respiratory illness with at least 1 of the following:~Clinical or radiological evidence of pneumonia, OR~Acute respiratory distress syndrome (ARDS), OR~LRTI, defined by resting SpO2<93% sustained for 2 readings 2 hours apart AND presence of subjective dyspnea or cough Death or COVID-19-related hospitalizations will count as a failure to resolve symptoms." (NCT04354428)
Timeframe: Day 1 through Day 14 after enrolment

InterventionDays (Median)
Ascorbic Acid and Folic Acid11.5
Hydroxychloroquine and Folic Acid10.5
Hydroxychloroquine and AzithromycinNA
Lopinavir-ritonavirNA
Ascorbic AcidNA

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Number of Persons With Lower Respiratory Tract Infection (LRTI), Defined as Resting Blood Oxygen Saturation (SpO2<93%) Level Sustained for 2 Readings 2 Hours Apart and Presence of Subjective Dyspnea or Cough

Resting blood oxygen saturation (SpO2<93%) level sustained for 2 readings 2 hours apart and presence of subjective dyspnea or cough (NCT04354428)
Timeframe: 28 days from enrolment

InterventionParticipants (Count of Participants)
Ascorbic Acid and Folic Acid2
Hydroxychloroquine and Folic Acid0
Hydroxychloroquine and Azithromycin4
Lopinavir-ritonavir2
Ascorbic Acid1

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