Trial Outcomes & Findings for An Efficacy and Safety Study of CNTO 148 Subcutaneous Injection Compared With Placebo in Patients With Active Rheumatoid Arthritis (NCT NCT00207714)
NCT ID: NCT00207714
Last Updated: 2012-10-18
Results Overview
ACR 20 response is a decrease of at least 20 per cent in both tender and swollen joint count and in 3 to 5 assessments (participant's assessment of pain visual analog scale \[VAS\] with 0, no pain to 10, worst pain; patient's and physician's global assessment of disease activity VAS scales: overall disease activity \[0, very well to 10, very poor and 0, no arthritis activity to 10, extremely active, respectively\]; Health Assessment Questionnaire \[HAQ\]: 20-questions on life activities \[0, no difficulty to 3, inability to perform a task\]; C-reactive protein\[CRP\]).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
172 participants
Primary outcome timeframe
Week 16
Results posted on
2012-10-18
Participant Flow
A total of 172 participants were randomly assigned to treatments at 33 sites: 16 in North America (13 in the US and 3 in Canada), 12 in Europe (3 in Belgium, 4 in the UK, 5 in Germany), and 5 in Australia. The study period extended from 01 Dec 2003 to 21 Feb 2006.
Participant milestones
| Measure |
Group I: Placebo Crossover to Infliximab
Placebo subcutaneous (SC) injections every 2 weeks (Wks) from Week (Wk) 0 thru Wk 18 plus Methotrexate (MTX) (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); after all study evaluations at Wk 20, open-label infliximab intravenous (IV) infusions: 3 milligrams per kilogram (mg/kg) at Wks 20, 22, 28 and then every 8 Wks thru Wk 44. Continue stable dose of MTX throughout the study.
|
Group II: Golimumab 50 mg Every 4 Weeks
Golimumab (CNTO148) 50 milligram (mg) SC injections every 4 Wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Wks 2, 6, 10, 14, and 18) plus MTX. Participants continued at 50 mg of golimumab at Wk 20, and then every 4 Wks thru Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study. Also referred to as Group II: golimumab 50 mg plus placebo every 4 Wks.
|
Group III: Golimumab 50 mg Every 2 or 4 Weeks
Golimumab 50 mg SC injections every 2 Wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Participants continued at 50 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study. Also referred to as GroupIII: Golimumab 50 mg every 2 or 4 Wks.
|
Group IV: Golibumab 100 mg Every 4 Weeks
Golimumab 100 mg SC injections every 4 Wks thru Wk 18 plus MTX (Wks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Wks 2, 6, 10, 14, and 18) plus MTX. Participants continued at 100 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded through the end of study. Also referred to as Group IV: golimumab 100 mg plus placebo every 4 Wks.
|
Group V: Golimumab 100 mg Every 2 or 4 Weeks
Golimumab 100 mg SC injections every 2 Wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Participants continued at 100 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study. Also referred to as Group V: Golimumab 100 mg every 2 or 4 Wks.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
35
|
35
|
34
|
34
|
34
|
|
Overall Study
COMPLETED
|
21
|
28
|
24
|
26
|
29
|
|
Overall Study
NOT COMPLETED
|
14
|
7
|
10
|
8
|
5
|
Reasons for withdrawal
| Measure |
Group I: Placebo Crossover to Infliximab
Placebo subcutaneous (SC) injections every 2 weeks (Wks) from Week (Wk) 0 thru Wk 18 plus Methotrexate (MTX) (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); after all study evaluations at Wk 20, open-label infliximab intravenous (IV) infusions: 3 milligrams per kilogram (mg/kg) at Wks 20, 22, 28 and then every 8 Wks thru Wk 44. Continue stable dose of MTX throughout the study.
|
Group II: Golimumab 50 mg Every 4 Weeks
Golimumab (CNTO148) 50 milligram (mg) SC injections every 4 Wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Wks 2, 6, 10, 14, and 18) plus MTX. Participants continued at 50 mg of golimumab at Wk 20, and then every 4 Wks thru Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study. Also referred to as Group II: golimumab 50 mg plus placebo every 4 Wks.
|
Group III: Golimumab 50 mg Every 2 or 4 Weeks
Golimumab 50 mg SC injections every 2 Wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Participants continued at 50 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study. Also referred to as GroupIII: Golimumab 50 mg every 2 or 4 Wks.
|
Group IV: Golibumab 100 mg Every 4 Weeks
Golimumab 100 mg SC injections every 4 Wks thru Wk 18 plus MTX (Wks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Wks 2, 6, 10, 14, and 18) plus MTX. Participants continued at 100 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded through the end of study. Also referred to as Group IV: golimumab 100 mg plus placebo every 4 Wks.
|
Group V: Golimumab 100 mg Every 2 or 4 Weeks
Golimumab 100 mg SC injections every 2 Wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Participants continued at 100 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study. Also referred to as Group V: Golimumab 100 mg every 2 or 4 Wks.
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
6
|
2
|
4
|
3
|
1
|
|
Overall Study
Unsatisfactory therapeutic effect
|
5
|
3
|
1
|
4
|
4
|
|
Overall Study
Other
|
3
|
2
|
5
|
1
|
0
|
Baseline Characteristics
An Efficacy and Safety Study of CNTO 148 Subcutaneous Injection Compared With Placebo in Patients With Active Rheumatoid Arthritis
Baseline characteristics by cohort
| Measure |
Group I: Placebo Crossover to Infliximab
n=35 Participants
Placebo subcutaneous (SC) injections every 2 weeks (Wks) from Week (Wk) 0 thru Wk 18 plus Methotrexate (MTX) (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); after all study evaluations at Wk 20, open-label infliximab intravenous (IV) infusions: 3 milligrams per kilogram (mg/kg) at Wks 20, 22, 28 and then every 8 Wks thru Wk 44. Continue stable dose of MTX throughout the study.
|
Group II: Golimumab 50 mg Every 4 Weeks
n=35 Participants
Golimumab (CNTO148) 50 milligram (mg) SC injections every 4 Wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Wks 2, 6, 10, 14, and 18) plus MTX. Participants continued at 50 mg of golimumab at Wk 20, and then every 4 Wks thru Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study. Also referred to as Group II: golimumab 50 mg plus placebo every 4 Wks.
|
Group III: Golimumab 50 mg Every 2 or 4 Weeks
n=34 Participants
Golimumab 50 mg SC injections every 2 Wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Participants continued at 50 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study. Also referred to as GroupIII: Golimumab 50 mg every 2 or 4 Wks.
|
Group IV: Golibumab 100 mg Every 4 Weeks
n=34 Participants
Golimumab 100 mg SC injections every 4 Wks thru Wk 18 plus MTX (Wks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Wks 2, 6, 10, 14, and 18) plus MTX. Participants continued at 100 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded through the end of study. Also referred to as Group IV: golimumab 100 mg plus placebo every 4 Wks.
|
Group V: Golimumab 100 mg Every 2 or 4 Weeks
n=34 Participants
Golimumab 100 mg SC injections every 2 Wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Participants continued at 100 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study. Also referred to as Group V: Golimumab 100 mg every 2 or 4 Wks.
|
Total
n=172 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age Continuous
|
53.8 Years
STANDARD_DEVIATION 12.9 • n=5 Participants
|
56.1 Years
STANDARD_DEVIATION 10.5 • n=7 Participants
|
50.4 Years
STANDARD_DEVIATION 13.1 • n=5 Participants
|
56.3 Years
STANDARD_DEVIATION 12.1 • n=4 Participants
|
54.1 Years
STANDARD_DEVIATION 14.1 • n=21 Participants
|
54.2 Years
STANDARD_DEVIATION 12.6 • n=10 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
132 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
40 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Week 16Population: Intent to treat (ITT). Participants considered non-responder if used any pre-specified prohibited medications or discontinued subcutaneous (SC) study agent due to lack of efficacy. Missing ACR components were imputed by Last Observation Carried Forward (LOCF) unless all ACR components are missing in which case considered non-responders.
ACR 20 response is a decrease of at least 20 per cent in both tender and swollen joint count and in 3 to 5 assessments (participant's assessment of pain visual analog scale \[VAS\] with 0, no pain to 10, worst pain; patient's and physician's global assessment of disease activity VAS scales: overall disease activity \[0, very well to 10, very poor and 0, no arthritis activity to 10, extremely active, respectively\]; Health Assessment Questionnaire \[HAQ\]: 20-questions on life activities \[0, no difficulty to 3, inability to perform a task\]; C-reactive protein\[CRP\]).
Outcome measures
| Measure |
Group I: Placebo Crossover to Infliximab
n=35 Participants
Placebo SC injections every 2 weeks (Wks) from week (Wk) 0 thru Wk 18 plus Methotrexate (MTX) (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); after all study evaluations at Wk 20, open-label infliximab IV infusions: 3 mg/kg at Wks 20, 22, 28 and then every 8 Wks thru Wk 44. Continue stable dose of MTX throughout the study.
|
Group II: Golimumab 50 mg Every 4 Weeks
n=35 Participants
Golimumab (CNTO148) 50 mg SC injections every 4 Wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Wks 2, 6, 10, 14, and 18) plus MTX. Participants continued at 50 mg of golimumab at Wk 20, and then every 4 Wks thru Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study.
|
Group III: Golimumab 50 mg Every 2 or 4 Weeks
n=34 Participants
Golimumab 50 mg SC injections every 2 Wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Participants continued at 50 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study.
|
Group IV: Golibumab 100 mg Every 4 Weeks
n=34 Participants
Golimumab 100 mg SC injections every 4 Wks thru Wk 18 plus MTX (Wks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Wks 2, 6, 10, 14, and 18) plus MTX. Participants continued at 100 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded through the end of study.
|
Group V: Golimumab 100 mg Every 2 or 4 Weeks
n=34 Participants
Golimumab 100 mg SC injections every 2 Wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Participants continued at 100 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study.
|
Combined: Groups II, III, IV & V
n=137 Participants
Combines Groups II (golimumab 50 mg plus placebo), III (golimumab 50 mg every 2/4 Wks), IV (golimumab 100 mg plus placebo) \& V (golimumab 100 mg every 2/4 Wks).
|
|---|---|---|---|---|---|---|
|
Number of Participants Meeting the American College of Rheumatology 20 (ACR 20) Response at Week 16
|
13 Participants
|
21 Participants
|
17 Participants
|
19 Participants
|
27 Participants
|
84 Participants
|
SECONDARY outcome
Timeframe: Week 16Population: Intent-to-treat (ITT) and missing ACR components were imputed by LOCF unless all ACR components are missing in which case considered non-responders. The joint evaluability rules were also applied.
The ACR-N index of improvement is the minimum of the following: 1) the percent decrease from baseline in tender joint counts; 2) the percent decrease from baseline in swollen joint counts; 3) the median percent decrease from baseline for the following: a. Patient's assessment of pain as measured on a 10 cm visual assessment scale (0-10, 10 worst pain) Patient's global assessment of disease activity (VAS 0-10); c. Physician's global assessment of disease activity (VAS 0-10) d. Physical function as measured by the Health Assessment Questionnaire; e. C-Reactive Protein measurement.
Outcome measures
| Measure |
Group I: Placebo Crossover to Infliximab
n=35 Participants
Placebo SC injections every 2 weeks (Wks) from week (Wk) 0 thru Wk 18 plus Methotrexate (MTX) (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); after all study evaluations at Wk 20, open-label infliximab IV infusions: 3 mg/kg at Wks 20, 22, 28 and then every 8 Wks thru Wk 44. Continue stable dose of MTX throughout the study.
|
Group II: Golimumab 50 mg Every 4 Weeks
n=35 Participants
Golimumab (CNTO148) 50 mg SC injections every 4 Wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Wks 2, 6, 10, 14, and 18) plus MTX. Participants continued at 50 mg of golimumab at Wk 20, and then every 4 Wks thru Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study.
|
Group III: Golimumab 50 mg Every 2 or 4 Weeks
n=34 Participants
Golimumab 50 mg SC injections every 2 Wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Participants continued at 50 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study.
|
Group IV: Golibumab 100 mg Every 4 Weeks
n=34 Participants
Golimumab 100 mg SC injections every 4 Wks thru Wk 18 plus MTX (Wks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Wks 2, 6, 10, 14, and 18) plus MTX. Participants continued at 100 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded through the end of study.
|
Group V: Golimumab 100 mg Every 2 or 4 Weeks
n=34 Participants
Golimumab 100 mg SC injections every 2 Wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Participants continued at 100 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study.
|
Combined: Groups II, III, IV & V
n=137 Participants
Combines Groups II (golimumab 50 mg plus placebo), III (golimumab 50 mg every 2/4 Wks), IV (golimumab 100 mg plus placebo) \& V (golimumab 100 mg every 2/4 Wks).
|
|---|---|---|---|---|---|---|
|
Summary of ACR-N, Index of Improvement at Week 16
|
0.0 Scores on scale
Interval -12.5 to 28.6
|
37.4 Scores on scale
Interval 0.0 to 54.4
|
19.4 Scores on scale
Interval -1.0 to 49.0
|
22.3 Scores on scale
Interval 0.0 to 55.6
|
35.6 Scores on scale
Interval 20.0 to 56.6
|
33.3 Scores on scale
Interval 0.0 to 54.4
|
Adverse Events
Group I: Placebo Crossover to Infliximab
Serious events: 2 serious events
Other events: 28 other events
Deaths: 0 deaths
Group II: Golimumab 50 mg Every 4 Weeks
Serious events: 7 serious events
Other events: 34 other events
Deaths: 0 deaths
Group III: Golimumab 50 mg Every 2 or 4 Weeks
Serious events: 5 serious events
Other events: 29 other events
Deaths: 0 deaths
Group IV: Golibumab 100 mg Every 4 Weeks
Serious events: 5 serious events
Other events: 29 other events
Deaths: 0 deaths
Group V: Golimumab 100 mg Every 2 or 4 Weeks
Serious events: 5 serious events
Other events: 33 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group I: Placebo Crossover to Infliximab
n=34 participants at risk
Placebo subcutaneous (SC) injections every 2 weeks (Wks) from Week (Wk) 0 thru Wk 18 plus Methotrexate (MTX) (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); after all study evaluations at Wk 20, open-label infliximab intravenous (IV) infusions: 3 milligrams per kilogram (mg/kg) at Wks 20, 22, 28 and then every 8 Wks thru Wk 44. Continue stable dose of MTX throughout the study.
|
Group II: Golimumab 50 mg Every 4 Weeks
n=37 participants at risk
Golimumab (CNTO148) 50 milligram (mg) subcutaneous (SC) injections every 4 weeks (Wks) from Week (Wk) 0 thru Wk 18 plus methotrexate (MTX) (Wks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Wks 2, 6, 10, 14, and 18) plus MTX. Patients continued at 50 mg of golimumab at Wk 20, and then every 4 Wks thru Wk 48. Continue stable dose of MTX throughout the study. Patients remained blinded thru the end of study. Also referred to as Group II: golimumab 50 mg plus placebo every 4 Wks.
|
Group III: Golimumab 50 mg Every 2 or 4 Weeks
n=32 participants at risk
Golimumab 50 miligram (mg) subcutaneous (SC) injections every 2 weeks (Wks) from Week (Wk) 0 thru Wk 18 plus methotrexate (MTX) (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Patients continued at 50 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Patients remained blinded thru the end of study. Also referred to as GroupIII: Golimumab 50 mg every 2 or 4 Wks.
|
Group IV: Golibumab 100 mg Every 4 Weeks
n=33 participants at risk
Golimumab 100 mg subcutaneous (SC) injections every 4 weeks (Wks) thru Week (Wk) 18 plus methotrexate (MTX) (Wks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Wks 2, 6, 10, 14, and 18) plus MTX. Patients continued at 100 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Patients remained blinded through the end of study. Also referred to as Group IV: golimumab 100 mg plus placebo every 4 Wks.
|
Group V: Golimumab 100 mg Every 2 or 4 Weeks
n=35 participants at risk
Golimumab 100 milligrams (mg) subcutaneous (SC) injections every 2 weeks (Wks) from Week (Wk) 0 thru Wk 18 plus methotrexate (MTX) (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Patients continued at 100 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Patients remained blinded thru the end of study. Also referred to as Group V: Golimumab 100 mg every 2 or 4 Wks.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Angina unstable
|
0.00%
0/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
3.1%
1/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
5.9%
2/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
2.7%
1/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
3.1%
1/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
3.0%
1/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
2.9%
1/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Musculoskeletal and connective tissue disorders
Fracture delayed union
|
0.00%
0/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
2.7%
1/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
2.7%
1/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
2.9%
1/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
2.7%
1/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
2.7%
1/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
3.1%
1/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Infections and infestations
Pneumonia legionella
|
0.00%
0/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
3.0%
1/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Infections and infestations
Septic shock
|
0.00%
0/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
3.1%
1/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
3.1%
1/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Infections and infestations
Listeria sepsis
|
0.00%
0/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Infections and infestations
Lower respiratory tract infection
|
2.9%
1/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
2.9%
1/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Injury, poisoning and procedural complications
Fractured coccyx
|
0.00%
0/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
2.9%
1/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Injury, poisoning and procedural complications
Medical device complication
|
0.00%
0/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
2.7%
1/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
3.0%
1/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
3.1%
1/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
3.1%
1/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
2.9%
1/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
General disorders
Chest pain
|
0.00%
0/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
3.0%
1/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
2.7%
1/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
2.9%
1/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive airways disease exacerbated
|
0.00%
0/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
3.0%
1/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
2.9%
1/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Nervous system disorders
Nerve root compression
|
0.00%
0/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
Other adverse events
| Measure |
Group I: Placebo Crossover to Infliximab
n=34 participants at risk
Placebo subcutaneous (SC) injections every 2 weeks (Wks) from Week (Wk) 0 thru Wk 18 plus Methotrexate (MTX) (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); after all study evaluations at Wk 20, open-label infliximab intravenous (IV) infusions: 3 milligrams per kilogram (mg/kg) at Wks 20, 22, 28 and then every 8 Wks thru Wk 44. Continue stable dose of MTX throughout the study.
|
Group II: Golimumab 50 mg Every 4 Weeks
n=37 participants at risk
Golimumab (CNTO148) 50 milligram (mg) subcutaneous (SC) injections every 4 weeks (Wks) from Week (Wk) 0 thru Wk 18 plus methotrexate (MTX) (Wks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Wks 2, 6, 10, 14, and 18) plus MTX. Patients continued at 50 mg of golimumab at Wk 20, and then every 4 Wks thru Wk 48. Continue stable dose of MTX throughout the study. Patients remained blinded thru the end of study. Also referred to as Group II: golimumab 50 mg plus placebo every 4 Wks.
|
Group III: Golimumab 50 mg Every 2 or 4 Weeks
n=32 participants at risk
Golimumab 50 miligram (mg) subcutaneous (SC) injections every 2 weeks (Wks) from Week (Wk) 0 thru Wk 18 plus methotrexate (MTX) (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Patients continued at 50 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Patients remained blinded thru the end of study. Also referred to as GroupIII: Golimumab 50 mg every 2 or 4 Wks.
|
Group IV: Golibumab 100 mg Every 4 Weeks
n=33 participants at risk
Golimumab 100 mg subcutaneous (SC) injections every 4 weeks (Wks) thru Week (Wk) 18 plus methotrexate (MTX) (Wks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Wks 2, 6, 10, 14, and 18) plus MTX. Patients continued at 100 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Patients remained blinded through the end of study. Also referred to as Group IV: golimumab 100 mg plus placebo every 4 Wks.
|
Group V: Golimumab 100 mg Every 2 or 4 Weeks
n=35 participants at risk
Golimumab 100 milligrams (mg) subcutaneous (SC) injections every 2 weeks (Wks) from Week (Wk) 0 thru Wk 18 plus methotrexate (MTX) (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Patients continued at 100 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Patients remained blinded thru the end of study. Also referred to as Group V: Golimumab 100 mg every 2 or 4 Wks.
|
|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
8.8%
3/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
21.6%
8/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
9.4%
3/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
6.1%
2/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
22.9%
8/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Infections and infestations
Upper respiratory tract infection
|
20.6%
7/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
16.2%
6/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
18.8%
6/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
15.2%
5/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
11.4%
4/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Infections and infestations
Influenza
|
0.00%
0/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
10.8%
4/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
6.2%
2/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
6.1%
2/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
2.9%
1/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Infections and infestations
Sinusitis
|
5.9%
2/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
8.1%
3/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
9.4%
3/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
6.1%
2/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
2.9%
1/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Infections and infestations
Bronchitis
|
2.9%
1/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
8.1%
3/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
14.3%
5/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Infections and infestations
Herpes simplex
|
2.9%
1/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
8.1%
3/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
6.2%
2/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
3.0%
1/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
2.9%
1/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Infections and infestations
Urinary tract infection
|
5.9%
2/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
5.4%
2/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
9.1%
3/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
2.9%
1/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Infections and infestations
Gastroenteritis viral
|
2.9%
1/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
2.7%
1/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
3.1%
1/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
6.1%
2/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
2.9%
1/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Infections and infestations
Lower respiratory tract infection
|
8.8%
3/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
2.7%
1/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
9.1%
3/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
2.9%
1/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Infections and infestations
Respiratory tract infection
|
2.9%
1/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
8.1%
3/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
3.1%
1/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
3.0%
1/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Infections and infestations
Viral infection
|
0.00%
0/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
5.4%
2/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
3.1%
1/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
3.0%
1/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
2.9%
1/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
5.4%
2/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
3.0%
1/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
2.9%
1/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
3.1%
1/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
8.6%
3/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Infections and infestations
Nail infection
|
0.00%
0/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
6.2%
2/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
3.0%
1/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Infections and infestations
Ear infection
|
0.00%
0/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
6.1%
2/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Infections and infestations
Fungal rash
|
0.00%
0/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
6.2%
2/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Infections and infestations
Gingival infection
|
0.00%
0/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
6.2%
2/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
14.7%
5/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
21.6%
8/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
21.9%
7/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
12.1%
4/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
20.0%
7/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
8.1%
3/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
15.6%
5/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
6.1%
2/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
14.3%
5/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.9%
1/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
8.1%
3/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
9.4%
3/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
6.1%
2/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
5.7%
2/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.9%
1/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
8.1%
3/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
6.2%
2/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
3.0%
1/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
5.7%
2/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.9%
2/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
2.7%
1/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
9.4%
3/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
3.0%
1/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
8.6%
3/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
8.1%
3/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
5.7%
2/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
5.4%
2/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
3.1%
1/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
2.9%
1/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
2.7%
1/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
6.2%
2/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
2.9%
1/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
2.7%
1/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
5.7%
2/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
5.4%
2/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
3.1%
1/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
9.4%
3/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
0.00%
0/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
3.1%
1/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
5.7%
2/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
General disorders
Injection site erythema
|
11.8%
4/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
13.5%
5/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
15.6%
5/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
12.1%
4/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
28.6%
10/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
General disorders
Fatigue
|
0.00%
0/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
5.4%
2/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
12.5%
4/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
6.1%
2/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
8.6%
3/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
General disorders
Pyrexia
|
2.9%
1/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
8.1%
3/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
3.1%
1/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
12.1%
4/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
5.7%
2/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
General disorders
Injection site pain
|
0.00%
0/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
2.7%
1/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
6.2%
2/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
9.1%
3/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
5.7%
2/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
General disorders
Oedema peripheral
|
0.00%
0/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
8.1%
3/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
9.4%
3/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
3.0%
1/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
2.9%
1/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
General disorders
Chest pain
|
0.00%
0/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
6.2%
2/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
3.0%
1/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
8.6%
3/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
General disorders
Injection site pruritus
|
0.00%
0/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
2.7%
1/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
3.0%
1/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
8.6%
3/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
General disorders
Chills
|
5.9%
2/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
3.1%
1/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
6.1%
2/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
2.9%
1/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
General disorders
Injection site induration
|
0.00%
0/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
2.7%
1/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
3.1%
1/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
5.7%
2/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
General disorders
Malaise
|
0.00%
0/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
5.4%
2/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
3.0%
1/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
2.9%
1/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
General disorders
Injection site haemorrhage
|
2.9%
1/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
6.2%
2/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
3.0%
1/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Gastrointestinal disorders
Nausea
|
5.9%
2/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
13.5%
5/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
25.0%
8/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
21.2%
7/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
22.9%
8/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Gastrointestinal disorders
Diarrhoea
|
11.8%
4/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
13.5%
5/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
9.4%
3/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
9.1%
3/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
17.1%
6/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Gastrointestinal disorders
Vomiting
|
5.9%
2/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
13.5%
5/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
6.1%
2/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
14.3%
5/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
11.8%
4/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
5.4%
2/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
6.2%
2/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
9.1%
3/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
2.9%
1/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
3.1%
1/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
6.1%
2/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
2.9%
1/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Gastrointestinal disorders
Constipation
|
2.9%
1/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
5.4%
2/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
3.1%
1/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
2.9%
1/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
10.8%
4/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
5.4%
2/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
2.9%
1/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
5.4%
2/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
6.2%
2/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Nervous system disorders
Headache
|
20.6%
7/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
21.6%
8/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
18.8%
6/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
27.3%
9/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
8.6%
3/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Nervous system disorders
Dizziness
|
17.6%
6/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
2.7%
1/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
9.4%
3/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
12.1%
4/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
8.6%
3/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
8.1%
3/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
6.2%
2/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
3.0%
1/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
2.7%
1/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
3.1%
1/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
3.0%
1/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
5.7%
2/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
8.1%
3/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
3.0%
1/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
5.7%
2/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.9%
1/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
8.1%
3/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
15.6%
5/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
12.1%
4/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
11.4%
4/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
5.4%
2/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
6.2%
2/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
9.1%
3/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
5.7%
2/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
5.9%
2/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
5.4%
2/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
9.4%
3/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
6.1%
2/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
2.9%
1/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
5.4%
2/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
3.1%
1/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis seasonal
|
0.00%
0/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
5.7%
2/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.8%
3/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
5.4%
2/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
3.0%
1/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
8.6%
3/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.8%
3/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
5.4%
2/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
3.1%
1/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
3.0%
1/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
5.7%
2/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
8.1%
3/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
3.1%
1/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
2.7%
1/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
6.2%
2/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
3.0%
1/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.9%
1/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
9.4%
3/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
2.9%
1/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
5.4%
2/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
3.1%
1/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Skin and subcutaneous tissue disorders
Increased tendency to bruise
|
0.00%
0/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
5.7%
2/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
5.4%
2/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
6.2%
2/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
6.1%
2/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
5.7%
2/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
6.2%
2/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
3.0%
1/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
5.7%
2/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Injury, poisoning and procedural complications
Excoriation
|
2.9%
1/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
2.7%
1/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
6.1%
2/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
6.1%
2/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
2.7%
1/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
12.5%
4/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
9.1%
3/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
2.9%
1/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
2.7%
1/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
9.4%
3/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
9.1%
3/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
2.9%
1/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
3.0%
1/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
5.7%
2/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Investigations
Blood pressure increased
|
0.00%
0/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
6.1%
2/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Investigations
Liver function test abnormal
|
0.00%
0/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
6.1%
2/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Vascular disorders
Hypertension
|
2.9%
1/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
10.8%
4/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
9.4%
3/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
3.0%
1/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
5.7%
2/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Vascular disorders
Hot flush
|
5.9%
2/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
2.7%
1/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
6.2%
2/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
3.0%
1/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Ear and labyrinth disorders
Vertigo
|
2.9%
1/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
6.2%
2/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
3.0%
1/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
5.7%
2/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
2.7%
1/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
6.1%
2/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Eye disorders
Dry eye
|
2.9%
1/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
6.1%
2/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
2.9%
1/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Eye disorders
Conjunctivitis
|
2.9%
1/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
5.4%
2/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
6.2%
2/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
6.2%
2/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign breast neoplasm
|
0.00%
0/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
6.1%
2/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
5.9%
2/34 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/37 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/32 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
3.0%
1/33 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
0.00%
0/35 • Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
|
Additional Information
Director Clinical Research
Centocor Research & Development, Inc.
Phone: 1-800-457-6399
Results disclosure agreements
- Principal investigator is a sponsor employee Generally, the only disclosure restriction on the Principal Investigator is that the sponsor has 60 days to review results communications prior to public release and can embargo communications regarding trial results for a period that does not exceed 180 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER