Trial Outcomes & Findings for The Effects of Infliximab Versus Methotrexate in the Treatment of Moderate to Severe Psoriasis (Study P04271AM2)(COMPLETED) (NCT NCT00251641)
NCT ID: NCT00251641
Last Updated: 2017-05-10
Results Overview
PASI75 response is defined as the proportion of participants who achieved at least a 75% improvement in PASI score from Baseline.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
868 participants
Primary outcome timeframe
16 weeks
Results posted on
2017-05-10
Participant Flow
Participant milestones
| Measure |
Infliximab
The infliximab dose will be prepared according to the subject's weight (5 mg/kg). Each intravenous (IV) infusion will be administered over a period of not less than 2 hours. The infusion must be given via a separate line using the administration set with a 1.2 micron filter. Subjects will be infused at Weeks 0, 2, 6, 14, and 22.
|
Methotrexate
Methotrexate (MTX) will be supplied as 2.5 mg tablets. Subjects are to take 15 mg/week orally for the first 6 weeks of the study. Subjects will be advised to take their MTX as a single dose (weekly) on the same day of the week. If subjects randomized to MTX 15 mg/week experience a \<25% reduction in PASI score at Week 6 (Visit 4) as compared with Baseline, their MTX dose will be increased to 20 mg/week. Subjects will be treated for 22 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
653
|
215
|
|
Overall Study
COMPLETED
|
541
|
127
|
|
Overall Study
NOT COMPLETED
|
112
|
88
|
Reasons for withdrawal
| Measure |
Infliximab
The infliximab dose will be prepared according to the subject's weight (5 mg/kg). Each intravenous (IV) infusion will be administered over a period of not less than 2 hours. The infusion must be given via a separate line using the administration set with a 1.2 micron filter. Subjects will be infused at Weeks 0, 2, 6, 14, and 22.
|
Methotrexate
Methotrexate (MTX) will be supplied as 2.5 mg tablets. Subjects are to take 15 mg/week orally for the first 6 weeks of the study. Subjects will be advised to take their MTX as a single dose (weekly) on the same day of the week. If subjects randomized to MTX 15 mg/week experience a \<25% reduction in PASI score at Week 6 (Visit 4) as compared with Baseline, their MTX dose will be increased to 20 mg/week. Subjects will be treated for 22 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
80
|
8
|
|
Overall Study
Lack of Efficacy
|
2
|
1
|
|
Overall Study
Progression of Disease
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
3
|
3
|
|
Overall Study
Withdrawal by Subject
|
6
|
8
|
|
Overall Study
Protocol Violation
|
10
|
2
|
|
Overall Study
Did not Meet protocol Eligibility
|
2
|
1
|
|
Overall Study
Switched Treatment
|
9
|
63
|
Baseline Characteristics
The Effects of Infliximab Versus Methotrexate in the Treatment of Moderate to Severe Psoriasis (Study P04271AM2)(COMPLETED)
Baseline characteristics by cohort
| Measure |
Infliximab
n=653 Participants
The infliximab dose will be prepared according to the subject's weight (5 mg/kg). Each intravenous (IV) infusion will be administered over a period of not less than 2 hours. The infusion must be given via a separate line using the administration set with a 1.2 micron filter. Subjects will be infused at Weeks 0, 2, 6, 14, and 22.
|
Methotrexate
n=215 Participants
Methotrexate (MTX) will be supplied as 2.5 mg tablets. Subjects are to take 15 mg/week orally for the first 6 weeks of the study. Subjects will be advised to take their MTX as a single dose (weekly) on the same day of the week. If subjects randomized to MTX 15 mg/week experience a \<25% reduction in PASI score at Week 6 (Visit 4) as compared with Baseline, their MTX dose will be increased to 20 mg/week. Subjects will be treated for 22 weeks.
|
Total
n=868 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.1 years
n=5 Participants
|
41.9 years
n=7 Participants
|
43.6 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
215 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
282 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
438 Participants
n=5 Participants
|
148 Participants
n=7 Participants
|
586 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 16 weeksPopulation: All subjects who were randomized were included in the efficacy analysis (intent-to-treat \[ITT\]).
PASI75 response is defined as the proportion of participants who achieved at least a 75% improvement in PASI score from Baseline.
Outcome measures
| Measure |
Infliximab
n=653 Participants
The infliximab dose will be prepared according to the subject's weight (5 mg/kg). Each intravenous (IV) infusion will be administered over a period of not less than 2 hours. The infusion must be given via a separate line using the administration set with a 1.2 micron filter. Subjects will be infused at Weeks 0, 2, 6, 14, and 22.
|
Methotrexate
n=215 Participants
Methotrexate (MTX) will be supplied as 2.5 mg tablets. Subjects are to take 15 mg/week orally for the first 6 weeks of the study. Subjects will be advised to take their MTX as a single dose (weekly) on the same day of the week. If subjects randomized to MTX 15 mg/week experience a \<25% reduction in PASI score at Week 6 (Visit 4) as compared with Baseline, their MTX dose will be increased to 20 mg/week. Subjects will be treated for 22 weeks.
|
|---|---|---|
|
Psoriasis Area and Severity Index 75 (PASI75) Response at Week 16.
|
0.78 Proportion of participants
|
0.42 Proportion of participants
|
SECONDARY outcome
Timeframe: 26 weeksPopulation: Intent-to-treat
PASI75 response is defined as the proportion of participants who achieved at least a 75% improvement in PASI score from Baseline.
Outcome measures
| Measure |
Infliximab
n=653 Participants
The infliximab dose will be prepared according to the subject's weight (5 mg/kg). Each intravenous (IV) infusion will be administered over a period of not less than 2 hours. The infusion must be given via a separate line using the administration set with a 1.2 micron filter. Subjects will be infused at Weeks 0, 2, 6, 14, and 22.
|
Methotrexate
n=215 Participants
Methotrexate (MTX) will be supplied as 2.5 mg tablets. Subjects are to take 15 mg/week orally for the first 6 weeks of the study. Subjects will be advised to take their MTX as a single dose (weekly) on the same day of the week. If subjects randomized to MTX 15 mg/week experience a \<25% reduction in PASI score at Week 6 (Visit 4) as compared with Baseline, their MTX dose will be increased to 20 mg/week. Subjects will be treated for 22 weeks.
|
|---|---|---|
|
PASI75 Response at Week 26
|
0.77 Proportion of participants
|
0.31 Proportion of participants
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: ITT
PGA is assessed relative to baseline condition and is defined as: clear (100% clear; some residual pinkness or pigmentation: Wornoff's ring may be present), excellent/minimal (75-99% clearing; marked improvement: nearly normal skin texture; some erythema may be present), good (50-74% clearing; moderate improvement: plaque has cleared to point of small scattered papules with normal intervening epidermis), fair (25-49% clearing; slight improvement: decrease in scaling and softening of plaque), poor (0-24% clearing; little or no change in scaling, erythema, or plaque elevation), or worse (worse).
Outcome measures
| Measure |
Infliximab
n=653 Participants
The infliximab dose will be prepared according to the subject's weight (5 mg/kg). Each intravenous (IV) infusion will be administered over a period of not less than 2 hours. The infusion must be given via a separate line using the administration set with a 1.2 micron filter. Subjects will be infused at Weeks 0, 2, 6, 14, and 22.
|
Methotrexate
n=215 Participants
Methotrexate (MTX) will be supplied as 2.5 mg tablets. Subjects are to take 15 mg/week orally for the first 6 weeks of the study. Subjects will be advised to take their MTX as a single dose (weekly) on the same day of the week. If subjects randomized to MTX 15 mg/week experience a \<25% reduction in PASI score at Week 6 (Visit 4) as compared with Baseline, their MTX dose will be increased to 20 mg/week. Subjects will be treated for 22 weeks.
|
|---|---|---|
|
Proportion of Participants Who Achieved a Physician's Global Assessment (PGA) Score of Cleared or Minimal at Week 16
|
0.76 Proportion of participants
|
0.38 Proportion of participants
|
SECONDARY outcome
Timeframe: 26 weeksPopulation: ITT
PGA is assessed relative to baseline condition and is defined as: clear (100% clear; some residual pinkness or pigmentation: Wornoff's ring may be present), excellent/minimal (75-99% clearing; marked improvement: nearly normal skin texture; some erythema may be present), good (50-74% clearing; moderate improvement: plaque has cleared to point of small scattered papules with normal intervening epidermis), fair (25-49% clearing; slight improvement: decrease in scaling and softening of plaque), poor (0-24% clearing; little or no change in scaling, erythema, or plaque elevation), or worse (worse).
Outcome measures
| Measure |
Infliximab
n=653 Participants
The infliximab dose will be prepared according to the subject's weight (5 mg/kg). Each intravenous (IV) infusion will be administered over a period of not less than 2 hours. The infusion must be given via a separate line using the administration set with a 1.2 micron filter. Subjects will be infused at Weeks 0, 2, 6, 14, and 22.
|
Methotrexate
n=215 Participants
Methotrexate (MTX) will be supplied as 2.5 mg tablets. Subjects are to take 15 mg/week orally for the first 6 weeks of the study. Subjects will be advised to take their MTX as a single dose (weekly) on the same day of the week. If subjects randomized to MTX 15 mg/week experience a \<25% reduction in PASI score at Week 6 (Visit 4) as compared with Baseline, their MTX dose will be increased to 20 mg/week. Subjects will be treated for 22 weeks.
|
|---|---|---|
|
Proportion of Participants Who Achieved a PGA Score of Cleared or Minimal at Week 26
|
0.73 Proportion of participants
|
0.28 Proportion of participants
|
Adverse Events
Infliximab
Serious events: 44 serious events
Other events: 275 other events
Deaths: 0 deaths
Methotrexate
Serious events: 6 serious events
Other events: 95 other events
Deaths: 0 deaths
Participants Who Switched From Infliximab to Methotrexate
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Participants Who Switched From Methotrexate to Infliximab
Serious events: 3 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Infliximab
n=649 participants at risk
Adverse events reported through Week 26 for participants who did not switch treatment at Week 16 and adverse reported through Week 16 for those participants who switched treatment.
|
Methotrexate
n=211 participants at risk
Adverse events reported through Week 26 for participants who did not switch treatment at Week 16 and adverse reported through Week 16 for those participants who switched treatment.
|
Participants Who Switched From Infliximab to Methotrexate
n=9 participants at risk
Adverse events reported for participants who switched from infliximab to methotrexate at Week 16 (including only adverse events with begin dates on or after a switch in treatment).
|
Participants Who Switched From Methotrexate to Infliximab
n=63 participants at risk
Adverse events reported for participants who switched from methotrexate to infliximab at Week 16 (including only adverse events with begin dates on or after a switch in treatment).
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
0.15%
1/649 • Number of events 1
|
0.00%
0/211
|
0.00%
0/9
|
0.00%
0/63
|
|
Cardiac disorders
ANGINA PECTORIS
|
0.15%
1/649 • Number of events 1
|
0.47%
1/211 • Number of events 1
|
0.00%
0/9
|
0.00%
0/63
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.31%
2/649 • Number of events 2
|
0.00%
0/211
|
0.00%
0/9
|
0.00%
0/63
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.00%
0/649
|
0.47%
1/211 • Number of events 1
|
0.00%
0/9
|
0.00%
0/63
|
|
Cardiac disorders
PERICARDITIS
|
0.15%
1/649 • Number of events 1
|
0.00%
0/211
|
0.00%
0/9
|
0.00%
0/63
|
|
Congenital, familial and genetic disorders
PHIMOSIS
|
0.00%
0/649
|
0.47%
1/211 • Number of events 1
|
0.00%
0/9
|
0.00%
0/63
|
|
Eye disorders
IRIDOCYCLITIS
|
0.00%
0/649
|
0.47%
1/211 • Number of events 1
|
0.00%
0/9
|
0.00%
0/63
|
|
Eye disorders
MACULAR HOLE
|
0.15%
1/649 • Number of events 1
|
0.00%
0/211
|
0.00%
0/9
|
0.00%
0/63
|
|
Gastrointestinal disorders
GASTRITIS
|
0.15%
1/649 • Number of events 1
|
0.00%
0/211
|
0.00%
0/9
|
0.00%
0/63
|
|
General disorders
INFUSION RELATED REACTION
|
1.2%
8/649 • Number of events 10
|
0.00%
0/211
|
0.00%
0/9
|
0.00%
0/63
|
|
General disorders
OEDEMA PERIPHERAL
|
0.15%
1/649 • Number of events 1
|
0.00%
0/211
|
0.00%
0/9
|
0.00%
0/63
|
|
General disorders
PYREXIA
|
0.15%
1/649 • Number of events 1
|
0.00%
0/211
|
0.00%
0/9
|
0.00%
0/63
|
|
Hepatobiliary disorders
AUTOIMMUNE HEPATITIS
|
0.15%
1/649 • Number of events 1
|
0.00%
0/211
|
0.00%
0/9
|
0.00%
0/63
|
|
Hepatobiliary disorders
BILIARY COLIC
|
0.15%
1/649 • Number of events 1
|
0.00%
0/211
|
0.00%
0/9
|
0.00%
0/63
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
0.31%
2/649 • Number of events 2
|
0.00%
0/211
|
0.00%
0/9
|
0.00%
0/63
|
|
Hepatobiliary disorders
CHOLECYSTITIS ACUTE
|
0.15%
1/649 • Number of events 1
|
0.00%
0/211
|
0.00%
0/9
|
0.00%
0/63
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.15%
1/649 • Number of events 1
|
0.00%
0/211
|
0.00%
0/9
|
0.00%
0/63
|
|
Immune system disorders
HYPERSENSITIVITY
|
0.31%
2/649 • Number of events 3
|
0.00%
0/211
|
0.00%
0/9
|
0.00%
0/63
|
|
Immune system disorders
TYPE IV HYPERSENSITIVITY REACTION
|
0.15%
1/649 • Number of events 1
|
0.00%
0/211
|
0.00%
0/9
|
0.00%
0/63
|
|
Infections and infestations
ARTHRITIS BACTERIAL
|
0.00%
0/649
|
0.00%
0/211
|
0.00%
0/9
|
1.6%
1/63 • Number of events 1
|
|
Infections and infestations
FEBRILE INFECTION
|
0.00%
0/649
|
0.47%
1/211 • Number of events 1
|
0.00%
0/9
|
0.00%
0/63
|
|
Infections and infestations
LYME DISEASE
|
0.15%
1/649 • Number of events 1
|
0.00%
0/211
|
0.00%
0/9
|
0.00%
0/63
|
|
Infections and infestations
PHARYNGITIS STREPTOCOCCAL
|
0.15%
1/649 • Number of events 1
|
0.00%
0/211
|
0.00%
0/9
|
0.00%
0/63
|
|
Infections and infestations
PNEUMONIA
|
0.31%
2/649 • Number of events 2
|
0.00%
0/211
|
0.00%
0/9
|
0.00%
0/63
|
|
Infections and infestations
PULMONARY TUBERCULOSIS
|
0.15%
1/649 • Number of events 1
|
0.00%
0/211
|
0.00%
0/9
|
0.00%
0/63
|
|
Infections and infestations
STAPHYLOCOCCAL INFECTION
|
0.00%
0/649
|
0.00%
0/211
|
0.00%
0/9
|
1.6%
1/63 • Number of events 1
|
|
Infections and infestations
VIRAL INFECTION
|
0.15%
1/649 • Number of events 1
|
0.00%
0/211
|
0.00%
0/9
|
0.00%
0/63
|
|
Injury, poisoning and procedural complications
CERVICAL VERTEBRAL FRACTURE
|
0.15%
1/649 • Number of events 1
|
0.00%
0/211
|
0.00%
0/9
|
0.00%
0/63
|
|
Injury, poisoning and procedural complications
FACIAL BONES FRACTURE
|
0.15%
1/649 • Number of events 1
|
0.00%
0/211
|
0.00%
0/9
|
0.00%
0/63
|
|
Injury, poisoning and procedural complications
MENISCUS LESION
|
0.15%
1/649 • Number of events 1
|
0.00%
0/211
|
0.00%
0/9
|
0.00%
0/63
|
|
Investigations
HEPATIC ENZYME INCREASED
|
0.31%
2/649 • Number of events 2
|
0.47%
1/211 • Number of events 1
|
0.00%
0/9
|
0.00%
0/63
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS
|
0.15%
1/649 • Number of events 1
|
0.00%
0/211
|
0.00%
0/9
|
0.00%
0/63
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.46%
3/649 • Number of events 3
|
0.00%
0/211
|
0.00%
0/9
|
0.00%
0/63
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS
|
0.15%
1/649 • Number of events 1
|
0.00%
0/211
|
0.00%
0/9
|
0.00%
0/63
|
|
Musculoskeletal and connective tissue disorders
LUPUS-LIKE SYNDROME
|
0.15%
1/649 • Number of events 1
|
0.00%
0/211
|
0.00%
0/9
|
0.00%
0/63
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
0.15%
1/649 • Number of events 1
|
0.00%
0/211
|
0.00%
0/9
|
0.00%
0/63
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
0.15%
1/649 • Number of events 1
|
0.00%
0/211
|
0.00%
0/9
|
0.00%
0/63
|
|
Musculoskeletal and connective tissue disorders
PSORIATIC ARTHROPATHY
|
0.00%
0/649
|
0.00%
0/211
|
0.00%
0/9
|
1.6%
1/63 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
SPINAL COLUMN STENOSIS
|
0.00%
0/649
|
0.47%
1/211 • Number of events 1
|
0.00%
0/9
|
0.00%
0/63
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
FOCAL NODULAR HYPERPLASIA
|
0.15%
1/649 • Number of events 1
|
0.00%
0/211
|
0.00%
0/9
|
0.00%
0/63
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TESTICULAR NEOPLASM
|
0.15%
1/649 • Number of events 1
|
0.00%
0/211
|
0.00%
0/9
|
0.00%
0/63
|
|
Nervous system disorders
DYSAESTHESIA
|
0.15%
1/649 • Number of events 1
|
0.00%
0/211
|
0.00%
0/9
|
0.00%
0/63
|
|
Nervous system disorders
HYPOAESTHESIA
|
0.15%
1/649 • Number of events 1
|
0.00%
0/211
|
0.00%
0/9
|
0.00%
0/63
|
|
Nervous system disorders
NEUROPATHY PERIPHERAL
|
0.15%
1/649 • Number of events 1
|
0.00%
0/211
|
0.00%
0/9
|
0.00%
0/63
|
|
Nervous system disorders
PARAESTHESIA
|
0.00%
0/649
|
0.47%
1/211 • Number of events 1
|
0.00%
0/9
|
0.00%
0/63
|
|
Nervous system disorders
SYNCOPE
|
0.15%
1/649 • Number of events 1
|
0.00%
0/211
|
0.00%
0/9
|
0.00%
0/63
|
|
Renal and urinary disorders
NEPHROLITHIASIS
|
0.00%
0/649
|
0.47%
1/211 • Number of events 1
|
0.00%
0/9
|
0.00%
0/63
|
|
Renal and urinary disorders
NOCTURIA
|
0.15%
1/649 • Number of events 1
|
0.00%
0/211
|
0.00%
0/9
|
0.00%
0/63
|
|
Reproductive system and breast disorders
OVARIAN HAEMORRHAGE
|
0.15%
1/649 • Number of events 1
|
0.00%
0/211
|
0.00%
0/9
|
0.00%
0/63
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
0.15%
1/649 • Number of events 1
|
0.00%
0/211
|
0.00%
0/9
|
0.00%
0/63
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.15%
1/649 • Number of events 1
|
0.47%
1/211 • Number of events 1
|
0.00%
0/9
|
0.00%
0/63
|
|
Respiratory, thoracic and mediastinal disorders
INTERSTITIAL LUNG DISEASE
|
0.15%
1/649 • Number of events 1
|
0.00%
0/211
|
0.00%
0/9
|
0.00%
0/63
|
|
Respiratory, thoracic and mediastinal disorders
PLEURISY
|
0.15%
1/649 • Number of events 1
|
0.00%
0/211
|
0.00%
0/9
|
0.00%
0/63
|
|
Respiratory, thoracic and mediastinal disorders
PRODUCTIVE COUGH
|
0.15%
1/649 • Number of events 1
|
0.00%
0/211
|
0.00%
0/9
|
0.00%
0/63
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.15%
1/649 • Number of events 1
|
0.00%
0/211
|
0.00%
0/9
|
0.00%
0/63
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
0.15%
1/649 • Number of events 1
|
0.00%
0/211
|
0.00%
0/9
|
0.00%
0/63
|
|
Skin and subcutaneous tissue disorders
NIGHT SWEATS
|
0.15%
1/649 • Number of events 1
|
0.00%
0/211
|
0.00%
0/9
|
0.00%
0/63
|
|
Skin and subcutaneous tissue disorders
PSORIASIS
|
0.31%
2/649 • Number of events 2
|
0.00%
0/211
|
0.00%
0/9
|
0.00%
0/63
|
|
Vascular disorders
HYPERTENSION
|
0.00%
0/649
|
0.00%
0/211
|
0.00%
0/9
|
1.6%
1/63 • Number of events 1
|
|
Vascular disorders
THROMBOSIS
|
0.15%
1/649 • Number of events 1
|
0.00%
0/211
|
0.00%
0/9
|
0.00%
0/63
|
Other adverse events
| Measure |
Infliximab
n=649 participants at risk
Adverse events reported through Week 26 for participants who did not switch treatment at Week 16 and adverse reported through Week 16 for those participants who switched treatment.
|
Methotrexate
n=211 participants at risk
Adverse events reported through Week 26 for participants who did not switch treatment at Week 16 and adverse reported through Week 16 for those participants who switched treatment.
|
Participants Who Switched From Infliximab to Methotrexate
n=9 participants at risk
Adverse events reported for participants who switched from infliximab to methotrexate at Week 16 (including only adverse events with begin dates on or after a switch in treatment).
|
Participants Who Switched From Methotrexate to Infliximab
n=63 participants at risk
Adverse events reported for participants who switched from methotrexate to infliximab at Week 16 (including only adverse events with begin dates on or after a switch in treatment).
|
|---|---|---|---|---|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
1.1%
7/649 • Number of events 9
|
5.2%
11/211 • Number of events 27
|
0.00%
0/9
|
0.00%
0/63
|
|
Gastrointestinal disorders
DIARRHOEA
|
3.2%
21/649 • Number of events 22
|
8.1%
17/211 • Number of events 34
|
0.00%
0/9
|
1.6%
1/63 • Number of events 1
|
|
Gastrointestinal disorders
NAUSEA
|
3.2%
21/649 • Number of events 30
|
9.5%
20/211 • Number of events 77
|
0.00%
0/9
|
0.00%
0/63
|
|
General disorders
FATIGUE
|
4.0%
26/649 • Number of events 28
|
9.0%
19/211 • Number of events 39
|
0.00%
0/9
|
0.00%
0/63
|
|
General disorders
INFUSION RELATED REACTION
|
10.8%
70/649 • Number of events 139
|
0.00%
0/211
|
0.00%
0/9
|
7.9%
5/63 • Number of events 10
|
|
Infections and infestations
NASOPHARYNGITIS
|
18.3%
119/649 • Number of events 157
|
19.0%
40/211 • Number of events 46
|
0.00%
0/9
|
4.8%
3/63 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
6.3%
41/649 • Number of events 54
|
5.7%
12/211 • Number of events 15
|
0.00%
0/9
|
0.00%
0/63
|
|
Nervous system disorders
HEADACHE
|
10.2%
66/649 • Number of events 111
|
14.7%
31/211 • Number of events 74
|
0.00%
0/9
|
7.9%
5/63 • Number of events 7
|
|
Reproductive system and breast disorders
EPIDIDYMITIS
|
0.15%
1/649 • Number of events 1
|
0.00%
0/211
|
11.1%
1/9 • Number of events 1
|
0.00%
0/63
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
6.0%
39/649 • Number of events 50
|
1.9%
4/211 • Number of events 4
|
0.00%
0/9
|
1.6%
1/63 • Number of events 2
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee PI must provide sponsor w/ review copies of abstracts or manuscripts for publication that report any results of the study, 45 days before submission for publication or presentation. The sponsor shall have the right to review/comment on the material. If the parties disagree about the appropriateness of the material, PI must meet with sponsor's representatives before submission for publication, for the purpose of making good faith efforts to discuss and resolve any issues of disagreement.
- Publication restrictions are in place
Restriction type: OTHER