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Trial record 24 of 31 for:    Developmental Disabilities | ( Map: Alabama, United States )

A Study of CNTO 136 (Sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Patients With Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy (SIRROUND-T)

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ClinicalTrials.gov Identifier: NCT01606761
Recruitment Status : Completed
First Posted : May 28, 2012
Results First Posted : February 5, 2018
Last Update Posted : March 23, 2018
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Arthritis, Rheumatoid
Interventions Drug: Placebo
Drug: Sirukumab
Enrollment 878
Recruitment Details  
Pre-assignment Details A total of 878 participants (placebo [n=294], sirukumab 50 mg every 4 week (q4w) [n=292], and sirukumab 100 milligram (mg) every 2 week (q2w) [n=292]) were randomized and included in the study.
Arm/Group Title Placebo Sirukumab 50 mg q4w Sirukumab 100 mg q2w Placebo to 50 mg q4w Due to EE or CO Placebo to 100 mg q2w Due to EE or CO
Hide Arm/Group Description Participants received matching placebo every 2 week (q2w) until either early escape (EE) at Week 18, or crossed over (CO) at Week 24. Participants who met EE criteria at Week 18 or crossover (CO) at Week 24 re-randomized and received subcutaneous (SC) sirukumab 50 mg dose regimen q4w up to Week 52. Participants who discontinued or completed study agent administration before and up to Week 52 entered the safety follow-up period as well as those who completed through Week 52 were followed up for safety. All participants received Sirukumab 50 mg SC at Week 0, 4 and q4w up to Week 52. Participants who discontinued or completed study agent administration up to Week 52 and decided to enter the safety follow-up period were followed up for safety from Week 52 to Week 68. All participants received Sirukumab 100 mg SC at Week 0, 2 and q2w up to Week 24. Participants who received matching placebo in the placebo controlled period and met EE criteria at Week 18 or crossover (CO) at Week 24 re-randomized and received subcutaneous (SC) sirukumab 100 mg dose regimen q2w up to Week 52. Participants who discontinued or completed study agent administration up to Week 52 and decided to enter the safety follow-up period were followed up for safety from Week 52 to Week 68. Participants who received matching placebo in the placebo controlled period were re-randomized (due to early escape [EE] at Week 18 or crossed over [CO] at Week 24) to receive subcutaneous (SC) sirukumab 50 mg dose regimen q4w up to Week 52. Participants who discontinued or completed study agent administration up to Week 52 and decided to enter the safety follow-up period were followed up for safety from Week 52 to Week 68. Participants who received matching placebo in the placebo controlled period were re-randomized (due to EE at Week 18 or CO at Week 24) to receive subcutaneous (SC) sirukumab 100 mg dose regimen q2w up to Week 52. Participants who discontinued or completed study agent administration up to Week 52 and decided to enter the safety follow-up period were followed up for safety from Week 52 to Week 68.
Period Title: Prior to Week 24
Started 294 292 292 0 0
Participants Re-randomized at Week 18 94 [1] 0 0 0 0
Completed 252 237 245 0 0
Not Completed 42 55 47 0 0
Reason Not Completed
Lost to Follow-up             0             3             2             0             0
Withdrawal by Subject             12             10             9             0             0
Adverse Event             11             18             22             0             0
Lack of Efficacy             15             14             8             0             0
Physician Decision             0             3             1             0             0
Other             4             7             5             0             0
[1]
Out of 94, 46 were re-randomized to sirukumab 50 mg and 48 were re-randomized to 100 mg group.
Period Title: Week 24 to Week 52
Started 0 237 245 126 [1] 126 [2]
Treated 0 237 245 124 126
Completed 0 204 212 109 106
Not Completed 0 33 33 17 20
Reason Not Completed
Lost to Follow-up             0             1             1             1             0
Withdrawal by Subject             0             6             3             0             0
Adverse Event             0             11             14             3             15
Death             0             0             2             1             0
Lack of Efficacy             0             13             7             10             3
Physician Decision             0             1             1             0             0
Other             0             1             5             2             2
[1]
Participants re-randomized at Week 18 (46) and Week 24 (80) were included.
[2]
Participants re-randomized at Week 18 (48) and Week 24 (78) were included.
Period Title: Safety Follow-up Period (Week 52-68)
Started 28 65 62 9 19
Safety Population 28 65 62 7 19
Completed 24 55 45 7 11
Not Completed 4 10 17 2 8
Reason Not Completed
Lost to Follow-up             0             1             2             0             1
Withdrawal by Subject             4             6             6             1             3
Death             0             0             0             0             1
Other             0             3             9             1             3
Arm/Group Title Placebo Sirukumab 50 mg q4w Sirukumab 100 mg q2w Total
Hide Arm/Group Description Participants received matching placebo every 2 week (q2w) until either early escape (EE) at Week 18, or crossed over (CO) at Week 24. Participants who met EE criteria at Week 18 or crossover (CO) at Week 24 re-randomized and received subcutaneous (SC) sirukumab 50 mg dose regimen q4w up to Week 52. Participants who discontinued or completed study agent administration before and up to Week 52 entered the safety follow-up period as well as those who completed through Week 52 were followed up for safety. All participants received Sirukumab 50 mg SC at Week 0, 4 and q4w up to Week 52. Participants who discontinued or completed study agent administration up to Week 52 and decided to enter the safety follow-up period were followed up for safety from Week 52 to Week 68. All participants received Sirukumab 100 mg SC at Week 0, 2 and q2w up to Week 24. Participants who received matching placebo in the placebo controlled period and met EE criteria at Week 18 or crossover (CO) at Week 24 re-randomized and received subcutaneous (SC) sirukumab 100 mg dose regimen q2w up to Week 52. Participants who discontinued or completed study agent administration up to Week 52 and decided to enter the safety follow-up period were followed up for safety from Week 52 to Week 68. Total of all reporting groups
Overall Number of Baseline Participants 294 292 292 878
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 294 participants 292 participants 292 participants 878 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
228
  77.6%
225
  77.1%
230
  78.8%
683
  77.8%
>=65 years
66
  22.4%
67
  22.9%
62
  21.2%
195
  22.2%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 294 participants 292 participants 292 participants 878 participants
55.4  (12.19) 55.8  (11.89) 55  (12.28) 55.4  (12.11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 294 participants 292 participants 292 participants 878 participants
Female
240
  81.6%
232
  79.5%
240
  82.2%
712
  81.1%
Male
54
  18.4%
60
  20.5%
52
  17.8%
166
  18.9%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 294 participants 292 participants 292 participants 878 participants
Argentina
10
   3.4%
6
   2.1%
3
   1.0%
19
   2.2%
Australia
1
   0.3%
2
   0.7%
0
   0.0%
3
   0.3%
Austria
2
   0.7%
0
   0.0%
0
   0.0%
2
   0.2%
Belgium
1
   0.3%
0
   0.0%
0
   0.0%
1
   0.1%
Canada
2
   0.7%
7
   2.4%
1
   0.3%
10
   1.1%
France
0
   0.0%
1
   0.3%
0
   0.0%
1
   0.1%
Germany
7
   2.4%
13
   4.5%
7
   2.4%
27
   3.1%
Italy
5
   1.7%
0
   0.0%
4
   1.4%
9
   1.0%
Japan
37
  12.6%
35
  12.0%
44
  15.1%
116
  13.2%
Lithuania
4
   1.4%
7
   2.4%
5
   1.7%
16
   1.8%
Mexico
7
   2.4%
4
   1.4%
6
   2.1%
17
   1.9%
Netherlands
4
   1.4%
1
   0.3%
1
   0.3%
6
   0.7%
Poland
21
   7.1%
29
   9.9%
26
   8.9%
76
   8.7%
Portugal
3
   1.0%
4
   1.4%
4
   1.4%
11
   1.3%
Puerto Rico
1
   0.3%
6
   2.1%
1
   0.3%
8
   0.9%
Republic of Korea
5
   1.7%
7
   2.4%
5
   1.7%
17
   1.9%
Russian Federation
18
   6.1%
11
   3.8%
21
   7.2%
50
   5.7%
Spain
8
   2.7%
8
   2.7%
7
   2.4%
23
   2.6%
Taiwan, Province of China
8
   2.7%
2
   0.7%
2
   0.7%
12
   1.4%
United Kingdom
2
   0.7%
4
   1.4%
3
   1.0%
9
   1.0%
United States
148
  50.3%
145
  49.7%
152
  52.1%
445
  50.7%
1.Primary Outcome
Title Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response at Week 16
Hide Description The ACR 20 Response is defined as greater than or equal to (>=) 20 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=20 percent improvement in 3 of following 5 assessments: patient's assessment of pain using Visual Analog Scale (VAS; 0-10 scale, 0 =no pain and 10 =worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 to 10, [0 =no pain to 10 =worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and serum C-Reactive Protein (CRP).
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy full analysis set included all participants who were randomized into the study.
Arm/Group Title Placebo Sirukumab 50 mg Sirukumab 100 mg
Hide Arm/Group Description:
Participants received matching placebo every 2 week (q2w) until either early escape (EE) at Week 18, or crossed over (CO) at Week 24. Participants who met EE criteria at Week 18 or crossover (CO) at Week 24 re-randomized and received subcutaneous (SC) sirukumab 50 mg dose regimen q4w up to Week 52.
Participants received Sirukumab 50 mg SC at Week 0, 4 and q4w up to Week 52.
Participants received Sirukumab 100 mg SC at Week 0, 2 and q2w up to Week 24. Participants who received matching placebo in the placebo controlled period and met EE criteria at Week 18 or crossover (CO) at Week 24 re-randomized and received subcutaneous (SC) sirukumab 100 mg dose regimen q2w up to Week 52.
Overall Number of Participants Analyzed 294 292 292
Measure Type: Number
Unit of Measure: Percentage of Participants
24.1 40.1 45.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Sirukumab 50 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage Difference
Estimated Value 15.9
Confidence Interval (2-Sided) 95%
8.5 to 23.2
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Sirukumab 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage Difference
Estimated Value 21.0
Confidence Interval (2-Sided) 95%
13.6 to 28.5
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Week 24
Hide Description The HAQ-DI is a 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping and activities of daily living). Responses in each functional area are scored from 0 to 3 (0=no difficulty and 3=inability to perform a task in that area). Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy full analysis set included all participants who were randomized into the study. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this endpoint.
Arm/Group Title Placebo Sirukumab 50 mg Sirukumab 100 mg
Hide Arm/Group Description:
Participants received matching placebo every 2 week (q2w) until either early escape (EE) at Week 18, or crossed over (CO) at Week 24. Participants who met EE criteria at Week 18 or crossover (CO) at Week 24 re-randomized and received subcutaneous (SC) sirukumab 50 mg dose regimen q4w up to Week 52.
Participants received Sirukumab 50 mg SC at Week 0, 4 and q4w up to Week 52.
Participants received Sirukumab 100 mg SC at Week 0, 2 and q2w up to Week 24. Participants who received matching placebo in the placebo controlled period and met EE criteria at Week 18 or crossover (CO) at Week 24 re-randomized and received subcutaneous (SC) sirukumab 100 mg dose regimen q2w up to Week 52.
Overall Number of Participants Analyzed 294 291 292
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 1.5663  (0.65223) 1.6499  (0.59743) 1.6122  (0.61320)
Change at Week 24 -0.12  (0.491) -0.31  (0.543) -0.33  (0.526)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Sirukumab 50 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Square (LS) mean difference
Estimated Value -0.17
Confidence Interval (2-Sided) 95%
-0.251 to -0.088
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Sirukumab 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.194
Confidence Interval (2-Sided) 95%
-0.275 to -0.112
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants Achieving American College of Rheumatology (ACR) 50 Response at Week 24
Hide Description The ACR 50 Response is defined as >= 50 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=50 percent improvement in 3 of following 5 assessments: patient's assessment of pain using VAS ( 0-10 scale, 0 =no pain and 10 =worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 to 10, [0 =no pain to 10 =worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by HAQ-DI (defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and serum C-Reactive Protein (CRP).
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy full analysis set included all participants who were randomized into the study.
Arm/Group Title Placebo Sirukumab 50 mg Sirukumab 100 mg
Hide Arm/Group Description:
Participants received matching placebo every 2 week (q2w) until either early escape (EE) at Week 18, or crossed over (CO) at Week 24. Participants who met EE criteria at Week 18 or crossover (CO) at Week 24 re-randomized and received subcutaneous (SC) sirukumab 50 mg dose regimen q4w up to Week 52.
Participants received Sirukumab 50 mg SC at Week 0, 4 and q4w up to Week 52.
Participants received Sirukumab 100 mg SC at Week 0, 2 and q2w up to Week 24. Participants who received matching placebo in the placebo controlled period and met EE criteria at Week 18 or crossover (CO) at Week 24 re-randomized and received subcutaneous (SC) sirukumab 100 mg dose regimen q2w up to Week 52.
Overall Number of Participants Analyzed 294 292 292
Measure Type: Number
Unit of Measure: Percentage of Participants
8.8 20.9 21.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Sirukumab 50 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage Difference
Estimated Value 12.0
Confidence Interval (2-Sided) 95%
6.4 to 17.7
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Sirukumab 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage Difference
Estimated Value 12.7
Confidence Interval (2-Sided) 95%
7.0 to 18.4
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission at Week 24
Hide Description The Disease Activity Index Score 28 (DAS28) based on C-Reactive Protein (CRP) is a statistically derived index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst. DAS28 (CRP) remission is defined as a DAS28 (CRP) value of less than (<) 2.6 at any study visit.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy full analysis set included all participants who were randomized into the study.
Arm/Group Title Placebo Sirukumab 50 mg Sirukumab 100 mg
Hide Arm/Group Description:
Participants received matching placebo every 2 week (q2w) until either early escape (EE) at Week 18, or crossed over (CO) at Week 24. Participants who met EE criteria at Week 18 or crossover (CO) at Week 24 re-randomized and received subcutaneous (SC) sirukumab 50 mg dose regimen q4w up to Week 52.
Participants received Sirukumab 50 mg SC at Week 0, 4 and q4w up to Week 52.
Participants received Sirukumab 100 mg SC at Week 0, 2 and q2w up to Week 24. Participants who received matching placebo in the placebo controlled period and met EE criteria at Week 18 or crossover (CO) at Week 24 re-randomized and received subcutaneous (SC) sirukumab 100 mg dose regimen q2w up to Week 52.
Overall Number of Participants Analyzed 294 292 292
Measure Type: Number
Unit of Measure: Percentage of Participants
8.2 19.2 21.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Sirukumab 50 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage Difference
Estimated Value 11.0
Confidence Interval (2-Sided) 95%
5.5 to 16.5
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Sirukumab 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage Difference
Estimated Value 13.4
Confidence Interval (2-Sided) 95%
7.8 to 19.1
Estimation Comments [Not Specified]
Time Frame Up to Week 68
Adverse Event Reporting Description For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
 
Arm/Group Title Week (W) 24-Placebo W24 to W52-Placebo to 50 mg q4w Due to EE or CO W52-Sirukumab 50 mg q4w W24 to W52-Placebo to 100 mg q2w Due to EE or CO W52-Sirukumab 100 mg q2w W52 to W68-Placebo W52 to W68-Placebo to 50 mg q4w Due to EE or CO W52 to W68-Sirukumab 50 mg q4w W52 to W68-Placebo to 100 mg q2w Due to EE or CO W52 to W68-Sirukumab 100 mg q2w
Hide Arm/Group Description Participants received matching placebo every 2 week (q2w) until either early escape (EE) at Week 18, or crossover (CO) at Week 24. Participants who received matching placebo in the placebo controlled period and were re-randomized (due to early escape [EE] at Week 18 or crossed over [CO] at Week 24) to receive subcutaneous (SC) sirukumab 50 mg q4w dose regimen up to Week 52. Participants received Sirukumab 50 mg SC at Week 0, 4 and q4w up to Week 52. Participants who received matching placebo in the placebo controlled period and were re-randomized (due to early escape [EE] at Week 18 or crossed over [CO] at Week 24) to receive subcutaneous (SC) sirukumab 100 mg q4w dose regimen up to Week 52. Participants received sirukumab 100 mg SC at Week 0, 2 and q2w up to Week 52. Participants who discontinued or completed study agent administration up to Week 52 and decided to enter the safety follow-up period were followed up for safety from Week 52 to Week 68. Participants who discontinued or completed sirukumab 50 mg q4w due to EE or CO administration up to Week 52 and decided to enter the safety follow-up period were followed up for safety from Week 52 to Week 68. Participants who discontinued or completed sirukumab 50 mg q4w administration up to Week 52 and decided to enter the safety follow-up period were followed up for safety from Week 52 to Week 68. Participants who discontinued or completed sirukumab 100 mg q2w due to EE or CO administration up to Week 52 and decided to enter the safety follow-up period were followed up for safety from Week 52 to Week 68. Participants who discontinued or completed sirukumab 100 mg q2w administration up to Week 52 and decided to enter the safety follow-up period were followed up for safety from Week 52 to Week 68.
All-Cause Mortality
Week (W) 24-Placebo W24 to W52-Placebo to 50 mg q4w Due to EE or CO W52-Sirukumab 50 mg q4w W24 to W52-Placebo to 100 mg q2w Due to EE or CO W52-Sirukumab 100 mg q2w W52 to W68-Placebo W52 to W68-Placebo to 50 mg q4w Due to EE or CO W52 to W68-Sirukumab 50 mg q4w W52 to W68-Placebo to 100 mg q2w Due to EE or CO W52 to W68-Sirukumab 100 mg q2w
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Week (W) 24-Placebo W24 to W52-Placebo to 50 mg q4w Due to EE or CO W52-Sirukumab 50 mg q4w W24 to W52-Placebo to 100 mg q2w Due to EE or CO W52-Sirukumab 100 mg q2w W52 to W68-Placebo W52 to W68-Placebo to 50 mg q4w Due to EE or CO W52 to W68-Sirukumab 50 mg q4w W52 to W68-Placebo to 100 mg q2w Due to EE or CO W52 to W68-Sirukumab 100 mg q2w
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   15/294 (5.10%)   8/124 (6.45%)   51/292 (17.47%)   18/126 (14.29%)   37/292 (12.67%)   0/28 (0.00%)   0/7 (0.00%)   1/65 (1.54%)   2/19 (10.53%)   0/62 (0.00%) 
Blood and lymphatic system disorders                     
Anaemia * 1  1/294 (0.34%)  0/124 (0.00%)  0/292 (0.00%)  0/126 (0.00%)  0/292 (0.00%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Normochromic Normocytic Anaemia * 1  1/294 (0.34%)  0/124 (0.00%)  0/292 (0.00%)  0/126 (0.00%)  0/292 (0.00%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Pancytopenia * 1  0/294 (0.00%)  0/124 (0.00%)  1/292 (0.34%)  0/126 (0.00%)  0/292 (0.00%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Thrombocytopenia * 1  0/294 (0.00%)  0/124 (0.00%)  0/292 (0.00%)  1/126 (0.79%)  0/292 (0.00%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Cardiac disorders                     
Acute Coronary Syndrome * 1  0/294 (0.00%)  0/124 (0.00%)  1/292 (0.34%)  0/126 (0.00%)  0/292 (0.00%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Angina Unstable * 1  0/294 (0.00%)  0/124 (0.00%)  3/292 (1.03%)  0/126 (0.00%)  0/292 (0.00%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Atrial Fibrillation * 1  0/294 (0.00%)  0/124 (0.00%)  1/292 (0.34%)  0/126 (0.00%)  1/292 (0.34%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Atrial Flutter * 1  0/294 (0.00%)  0/124 (0.00%)  1/292 (0.34%)  0/126 (0.00%)  0/292 (0.00%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Coronary Artery Disease * 1  1/294 (0.34%)  0/124 (0.00%)  0/292 (0.00%)  0/126 (0.00%)  1/292 (0.34%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Coronary Artery Stenosis * 1  1/294 (0.34%)  0/124 (0.00%)  0/292 (0.00%)  0/126 (0.00%)  0/292 (0.00%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Myocardial Infarction * 1  1/294 (0.34%)  0/124 (0.00%)  1/292 (0.34%)  1/126 (0.79%)  0/292 (0.00%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Endocrine disorders                     
Goitre * 1  0/294 (0.00%)  1/124 (0.81%)  0/292 (0.00%)  0/126 (0.00%)  0/292 (0.00%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Eye disorders                     
Diplopia * 1  0/294 (0.00%)  0/124 (0.00%)  0/292 (0.00%)  1/126 (0.79%)  0/292 (0.00%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Gastrointestinal disorders                     
Anal Fissure * 1  0/294 (0.00%)  1/124 (0.81%)  0/292 (0.00%)  0/126 (0.00%)  0/292 (0.00%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Diverticular Perforation * 1  0/294 (0.00%)  0/124 (0.00%)  1/292 (0.34%)  0/126 (0.00%)  1/292 (0.34%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  1/19 (5.26%)  0/62 (0.00%) 
Diverticulum Intestinal * 1  0/294 (0.00%)  0/124 (0.00%)  0/292 (0.00%)  0/126 (0.00%)  1/292 (0.34%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Duodenal Ulcer * 1  1/294 (0.34%)  0/124 (0.00%)  0/292 (0.00%)  0/126 (0.00%)  0/292 (0.00%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Duodenal Ulcer Perforation * 1  0/294 (0.00%)  0/124 (0.00%)  0/292 (0.00%)  0/126 (0.00%)  1/292 (0.34%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Faecal Incontinence * 1  1/294 (0.34%)  0/124 (0.00%)  0/292 (0.00%)  0/126 (0.00%)  0/292 (0.00%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Gastric Ulcer * 1  0/294 (0.00%)  0/124 (0.00%)  0/292 (0.00%)  1/126 (0.79%)  0/292 (0.00%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Gastric Ulcer Perforation * 1  0/294 (0.00%)  0/124 (0.00%)  1/292 (0.34%)  0/126 (0.00%)  1/292 (0.34%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Gastritis Erosive * 1  0/294 (0.00%)  0/124 (0.00%)  0/292 (0.00%)  0/126 (0.00%)  1/292 (0.34%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Gastrooesophageal Reflux Disease * 1  0/294 (0.00%)  0/124 (0.00%)  1/292 (0.34%)  0/126 (0.00%)  0/292 (0.00%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Intestinal Obstruction * 1  0/294 (0.00%)  0/124 (0.00%)  1/292 (0.34%)  0/126 (0.00%)  0/292 (0.00%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Large Intestine Polyp * 1  0/294 (0.00%)  0/124 (0.00%)  0/292 (0.00%)  0/126 (0.00%)  1/292 (0.34%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Lower Gastrointestinal Haemorrhage * 1  0/294 (0.00%)  0/124 (0.00%)  1/292 (0.34%)  0/126 (0.00%)  0/292 (0.00%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Pancreatic Pseudocyst * 1  0/294 (0.00%)  0/124 (0.00%)  0/292 (0.00%)  0/126 (0.00%)  1/292 (0.34%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Pancreatitis Acute * 1  0/294 (0.00%)  0/124 (0.00%)  0/292 (0.00%)  0/126 (0.00%)  1/292 (0.34%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Tongue Ulceration * 1  0/294 (0.00%)  0/124 (0.00%)  0/292 (0.00%)  1/126 (0.79%)  0/292 (0.00%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
General disorders                     
Chest Pain * 1  1/294 (0.34%)  1/124 (0.81%)  1/292 (0.34%)  0/126 (0.00%)  2/292 (0.68%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Device Dislocation * 1  0/294 (0.00%)  0/124 (0.00%)  2/292 (0.68%)  0/126 (0.00%)  1/292 (0.34%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Impaired Healing * 1  0/294 (0.00%)  0/124 (0.00%)  1/292 (0.34%)  0/126 (0.00%)  0/292 (0.00%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Non-Cardiac Chest Pain * 1  0/294 (0.00%)  0/124 (0.00%)  1/292 (0.34%)  0/126 (0.00%)  0/292 (0.00%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Sudden Death * 1  0/294 (0.00%)  0/124 (0.00%)  0/292 (0.00%)  0/126 (0.00%)  1/292 (0.34%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Hepatobiliary disorders                     
Cholecystitis Acute * 1  0/294 (0.00%)  0/124 (0.00%)  0/292 (0.00%)  0/126 (0.00%)  1/292 (0.34%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Cholelithiasis * 1  0/294 (0.00%)  0/124 (0.00%)  1/292 (0.34%)  0/126 (0.00%)  0/292 (0.00%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Immune system disorders                     
Drug Hypersensitivity * 1  0/294 (0.00%)  0/124 (0.00%)  0/292 (0.00%)  1/126 (0.79%)  0/292 (0.00%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Food Allergy * 1  0/294 (0.00%)  0/124 (0.00%)  1/292 (0.34%)  0/126 (0.00%)  0/292 (0.00%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Infections and infestations                     
Abdominal Abscess * 1  0/294 (0.00%)  0/124 (0.00%)  0/292 (0.00%)  1/126 (0.79%)  0/292 (0.00%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Abscess Jaw * 1  0/294 (0.00%)  0/124 (0.00%)  1/292 (0.34%)  0/126 (0.00%)  0/292 (0.00%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Alpha Haemolytic Streptococcal Infection * 1  0/294 (0.00%)  0/124 (0.00%)  0/292 (0.00%)  0/126 (0.00%)  1/292 (0.34%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Appendicitis * 1  0/294 (0.00%)  0/124 (0.00%)  1/292 (0.34%)  0/126 (0.00%)  0/292 (0.00%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Arthritis Infective * 1  0/294 (0.00%)  0/124 (0.00%)  1/292 (0.34%)  0/126 (0.00%)  0/292 (0.00%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Bacteraemia * 1  0/294 (0.00%)  0/124 (0.00%)  0/292 (0.00%)  0/126 (0.00%)  1/292 (0.34%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Cellulitis * 1  0/294 (0.00%)  0/124 (0.00%)  3/292 (1.03%)  2/126 (1.59%)  2/292 (0.68%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Clostridium Difficile Colitis * 1  0/294 (0.00%)  0/124 (0.00%)  0/292 (0.00%)  0/126 (0.00%)  1/292 (0.34%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Colonic Abscess * 1  0/294 (0.00%)  0/124 (0.00%)  0/292 (0.00%)  0/126 (0.00%)  1/292 (0.34%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Cystitis * 1  0/294 (0.00%)  0/124 (0.00%)  1/292 (0.34%)  0/126 (0.00%)  1/292 (0.34%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Device Related Infection * 1  0/294 (0.00%)  0/124 (0.00%)  0/292 (0.00%)  0/126 (0.00%)  1/292 (0.34%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Diverticulitis * 1  1/294 (0.34%)  0/124 (0.00%)  0/292 (0.00%)  1/126 (0.79%)  2/292 (0.68%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Empyema * 1  0/294 (0.00%)  0/124 (0.00%)  1/292 (0.34%)  0/126 (0.00%)  0/292 (0.00%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Erysipelas * 1  0/294 (0.00%)  0/124 (0.00%)  0/292 (0.00%)  2/126 (1.59%)  0/292 (0.00%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  1/19 (5.26%)  0/62 (0.00%) 
Escherichia Sepsis * 1  0/294 (0.00%)  0/124 (0.00%)  1/292 (0.34%)  0/126 (0.00%)  0/292 (0.00%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Gastroenteritis * 1  1/294 (0.34%)  0/124 (0.00%)  0/292 (0.00%)  1/126 (0.79%)  0/292 (0.00%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Herpes Zoster * 1  0/294 (0.00%)  0/124 (0.00%)  1/292 (0.34%)  0/126 (0.00%)  0/292 (0.00%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Infectious Pleural Effusion * 1  0/294 (0.00%)  0/124 (0.00%)  1/292 (0.34%)  0/126 (0.00%)  0/292 (0.00%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Influenza * 1  1/294 (0.34%)  0/124 (0.00%)  0/292 (0.00%)  1/126 (0.79%)  0/292 (0.00%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Necrotising Fasciitis * 1  0/294 (0.00%)  0/124 (0.00%)  1/292 (0.34%)  0/126 (0.00%)  0/292 (0.00%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Osteomyelitis * 1  0/294 (0.00%)  0/124 (0.00%)  1/292 (0.34%)  0/126 (0.00%)  2/292 (0.68%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Peritonitis * 1  0/294 (0.00%)  0/124 (0.00%)  0/292 (0.00%)  0/126 (0.00%)  1/292 (0.34%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Pneumonia * 1  1/294 (0.34%)  0/124 (0.00%)  5/292 (1.71%)  0/126 (0.00%)  5/292 (1.71%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Sepsis * 1  0/294 (0.00%)  0/124 (0.00%)  0/292 (0.00%)  1/126 (0.79%)  1/292 (0.34%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Urinary Tract Infection * 1  1/294 (0.34%)  0/124 (0.00%)  0/292 (0.00%)  0/126 (0.00%)  0/292 (0.00%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Urosepsis * 1  0/294 (0.00%)  0/124 (0.00%)  1/292 (0.34%)  0/126 (0.00%)  0/292 (0.00%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Wound Infection Pseudomonas * 1  0/294 (0.00%)  0/124 (0.00%)  0/292 (0.00%)  0/126 (0.00%)  1/292 (0.34%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Injury, poisoning and procedural complications                     
Femur Fracture * 1  0/294 (0.00%)  0/124 (0.00%)  0/292 (0.00%)  1/126 (0.79%)  2/292 (0.68%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Periprosthetic Fracture * 1  0/294 (0.00%)  0/124 (0.00%)  0/292 (0.00%)  0/126 (0.00%)  1/292 (0.34%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Tendon Rupture * 1  0/294 (0.00%)  0/124 (0.00%)  2/292 (0.68%)  0/126 (0.00%)  0/292 (0.00%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Investigations                     
Aspartate Aminotransferase Increased * 1  0/294 (0.00%)  0/124 (0.00%)  1/292 (0.34%)  0/126 (0.00%)  0/292 (0.00%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Hepatic Enzyme Abnormal * 1  0/294 (0.00%)  0/124 (0.00%)  0/292 (0.00%)  1/126 (0.79%)  0/292 (0.00%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Hepatic Enzyme Increased * 1  0/294 (0.00%)  0/124 (0.00%)  1/292 (0.34%)  0/126 (0.00%)  0/292 (0.00%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Liver Function Test Abnormal * 1  0/294 (0.00%)  0/124 (0.00%)  1/292 (0.34%)  1/126 (0.79%)  0/292 (0.00%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Morganella Test Positive * 1  0/294 (0.00%)  0/124 (0.00%)  0/292 (0.00%)  0/126 (0.00%)  1/292 (0.34%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Metabolism and nutrition disorders                     
Hypoglycaemia * 1  0/294 (0.00%)  0/124 (0.00%)  0/292 (0.00%)  1/126 (0.79%)  0/292 (0.00%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Hypokalaemia * 1  0/294 (0.00%)  0/124 (0.00%)  0/292 (0.00%)  1/126 (0.79%)  0/292 (0.00%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Musculoskeletal and connective tissue disorders                     
Arthralgia * 1  0/294 (0.00%)  0/124 (0.00%)  0/292 (0.00%)  0/126 (0.00%)  1/292 (0.34%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Arthropathy * 1  0/294 (0.00%)  0/124 (0.00%)  1/292 (0.34%)  0/126 (0.00%)  0/292 (0.00%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Back Pain * 1  1/294 (0.34%)  0/124 (0.00%)  0/292 (0.00%)  0/126 (0.00%)  0/292 (0.00%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Foot Deformity * 1  0/294 (0.00%)  0/124 (0.00%)  0/292 (0.00%)  0/126 (0.00%)  2/292 (0.68%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Haemarthrosis * 1  0/294 (0.00%)  0/124 (0.00%)  0/292 (0.00%)  1/126 (0.79%)  0/292 (0.00%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Intervertebral Disc Protrusion * 1  0/294 (0.00%)  0/124 (0.00%)  1/292 (0.34%)  0/126 (0.00%)  0/292 (0.00%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Musculoskeletal Chest Pain * 1  0/294 (0.00%)  0/124 (0.00%)  1/292 (0.34%)  0/126 (0.00%)  0/292 (0.00%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Osteoarthritis * 1  0/294 (0.00%)  1/124 (0.81%)  3/292 (1.03%)  1/126 (0.79%)  1/292 (0.34%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Osteochondrosis * 1  1/294 (0.34%)  0/124 (0.00%)  0/292 (0.00%)  0/126 (0.00%)  0/292 (0.00%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Osteonecrosis * 1  0/294 (0.00%)  0/124 (0.00%)  0/292 (0.00%)  0/126 (0.00%)  1/292 (0.34%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Rheumatoid Arthritis * 1  2/294 (0.68%)  2/124 (1.61%)  3/292 (1.03%)  0/126 (0.00%)  1/292 (0.34%)  0/28 (0.00%)  0/7 (0.00%)  1/65 (1.54%)  0/19 (0.00%)  0/62 (0.00%) 
Soft Tissue Necrosis * 1  0/294 (0.00%)  0/124 (0.00%)  0/292 (0.00%)  0/126 (0.00%)  1/292 (0.34%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Spondylolisthesis * 1  0/294 (0.00%)  0/124 (0.00%)  0/292 (0.00%)  0/126 (0.00%)  1/292 (0.34%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                     
Breast Cancer Metastatic * 1  0/294 (0.00%)  0/124 (0.00%)  1/292 (0.34%)  0/126 (0.00%)  0/292 (0.00%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Chondroma * 1  0/294 (0.00%)  0/124 (0.00%)  0/292 (0.00%)  0/126 (0.00%)  1/292 (0.34%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Invasive Ductal Breast Carcinoma * 1  0/294 (0.00%)  0/124 (0.00%)  1/292 (0.34%)  0/126 (0.00%)  0/292 (0.00%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Lung Adenocarcinoma * 1  0/294 (0.00%)  0/124 (0.00%)  0/292 (0.00%)  0/126 (0.00%)  1/292 (0.34%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Lymphoproliferative Disorder * 1  0/294 (0.00%)  0/124 (0.00%)  0/292 (0.00%)  0/126 (0.00%)  1/292 (0.34%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Oropharyngeal Squamous Cell Carcinoma * 1  0/294 (0.00%)  1/124 (0.81%)  0/292 (0.00%)  0/126 (0.00%)  0/292 (0.00%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Rectal Adenocarcinoma * 1  0/294 (0.00%)  0/124 (0.00%)  1/292 (0.34%)  0/126 (0.00%)  0/292 (0.00%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Nervous system disorders                     
Carotid Artery Stenosis * 1  1/294 (0.34%)  0/124 (0.00%)  0/292 (0.00%)  0/126 (0.00%)  0/292 (0.00%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Cerebrovascular Accident * 1  0/294 (0.00%)  1/124 (0.81%)  2/292 (0.68%)  0/126 (0.00%)  0/292 (0.00%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Diabetic Neuropathy * 1  0/294 (0.00%)  0/124 (0.00%)  0/292 (0.00%)  1/126 (0.79%)  0/292 (0.00%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Lumbar Radiculopathy * 1  0/294 (0.00%)  0/124 (0.00%)  1/292 (0.34%)  0/126 (0.00%)  0/292 (0.00%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Transient Ischaemic Attack * 1  1/294 (0.34%)  0/124 (0.00%)  0/292 (0.00%)  0/126 (0.00%)  0/292 (0.00%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Pregnancy, puerperium and perinatal conditions                     
Abortion Missed * 1  0/294 (0.00%)  0/124 (0.00%)  0/292 (0.00%)  0/126 (0.00%)  1/292 (0.34%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Psychiatric disorders                     
Anxiety * 1  0/294 (0.00%)  0/124 (0.00%)  1/292 (0.34%)  0/126 (0.00%)  0/292 (0.00%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Mental Status Changes * 1  0/294 (0.00%)  0/124 (0.00%)  1/292 (0.34%)  0/126 (0.00%)  0/292 (0.00%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Renal and urinary disorders                     
Acute Kidney Injury * 1  0/294 (0.00%)  0/124 (0.00%)  0/292 (0.00%)  1/126 (0.79%)  0/292 (0.00%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Calculus Ureteric * 1  1/294 (0.34%)  0/124 (0.00%)  1/292 (0.34%)  0/126 (0.00%)  0/292 (0.00%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Calculus Urinary * 1  0/294 (0.00%)  0/124 (0.00%)  1/292 (0.34%)  0/126 (0.00%)  0/292 (0.00%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Nephrolithiasis * 1  0/294 (0.00%)  0/124 (0.00%)  1/292 (0.34%)  0/126 (0.00%)  0/292 (0.00%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Nephrotic Syndrome * 1  0/294 (0.00%)  0/124 (0.00%)  0/292 (0.00%)  0/126 (0.00%)  1/292 (0.34%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Renal Colic * 1  0/294 (0.00%)  0/124 (0.00%)  1/292 (0.34%)  0/126 (0.00%)  0/292 (0.00%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Reproductive system and breast disorders                     
Cervical Dysplasia * 1  0/294 (0.00%)  0/124 (0.00%)  1/292 (0.34%)  0/126 (0.00%)  0/292 (0.00%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Respiratory, thoracic and mediastinal disorders                     
Acute Respiratory Failure * 1  1/294 (0.34%)  0/124 (0.00%)  0/292 (0.00%)  0/126 (0.00%)  0/292 (0.00%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Interstitial Lung Disease * 1  0/294 (0.00%)  0/124 (0.00%)  0/292 (0.00%)  1/126 (0.79%)  0/292 (0.00%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Laryngeal Oedema * 1  0/294 (0.00%)  0/124 (0.00%)  0/292 (0.00%)  1/126 (0.79%)  0/292 (0.00%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Oropharyngeal Discomfort * 1  0/294 (0.00%)  0/124 (0.00%)  0/292 (0.00%)  1/126 (0.79%)  0/292 (0.00%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Pleural Effusion * 1  0/294 (0.00%)  0/124 (0.00%)  1/292 (0.34%)  0/126 (0.00%)  1/292 (0.34%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Pulmonary Embolism * 1  0/294 (0.00%)  0/124 (0.00%)  0/292 (0.00%)  0/126 (0.00%)  1/292 (0.34%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Skin and subcutaneous tissue disorders                     
Dermatitis * 1  0/294 (0.00%)  0/124 (0.00%)  0/292 (0.00%)  0/126 (0.00%)  1/292 (0.34%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Drug Eruption * 1  0/294 (0.00%)  0/124 (0.00%)  0/292 (0.00%)  0/126 (0.00%)  1/292 (0.34%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Skin Ulcer * 1  1/294 (0.34%)  0/124 (0.00%)  0/292 (0.00%)  0/126 (0.00%)  1/292 (0.34%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Vascular disorders                     
Hypertension * 1  0/294 (0.00%)  0/124 (0.00%)  1/292 (0.34%)  1/126 (0.79%)  0/292 (0.00%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Intermittent Claudication * 1  0/294 (0.00%)  0/124 (0.00%)  0/292 (0.00%)  1/126 (0.79%)  0/292 (0.00%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Phlebitis * 1  0/294 (0.00%)  0/124 (0.00%)  0/292 (0.00%)  0/126 (0.00%)  1/292 (0.34%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Thrombosed Varicose Vein * 1  0/294 (0.00%)  1/124 (0.81%)  0/292 (0.00%)  0/126 (0.00%)  0/292 (0.00%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 17.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Week (W) 24-Placebo W24 to W52-Placebo to 50 mg q4w Due to EE or CO W52-Sirukumab 50 mg q4w W24 to W52-Placebo to 100 mg q2w Due to EE or CO W52-Sirukumab 100 mg q2w W52 to W68-Placebo W52 to W68-Placebo to 50 mg q4w Due to EE or CO W52 to W68-Sirukumab 50 mg q4w W52 to W68-Placebo to 100 mg q2w Due to EE or CO W52 to W68-Sirukumab 100 mg q2w
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   106/294 (36.05%)   50/124 (40.32%)   152/292 (52.05%)   63/126 (50.00%)   169/292 (57.88%)   0/28 (0.00%)   1/7 (14.29%)   2/65 (3.08%)   3/19 (15.79%)   4/62 (6.45%) 
Eye disorders                     
Blepharitis * 1  1/294 (0.34%)  1/124 (0.81%)  0/292 (0.00%)  1/126 (0.79%)  0/292 (0.00%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  1/19 (5.26%)  0/62 (0.00%) 
Gastrointestinal disorders                     
Chronic Gastritis * 1  0/294 (0.00%)  0/124 (0.00%)  0/292 (0.00%)  0/126 (0.00%)  0/292 (0.00%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  1/19 (5.26%)  0/62 (0.00%) 
Nausea * 1  4/294 (1.36%)  2/124 (1.61%)  10/292 (3.42%)  1/126 (0.79%)  13/292 (4.45%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  1/19 (5.26%)  0/62 (0.00%) 
General disorders                     
Injection Site Erythema * 1  4/294 (1.36%)  5/124 (4.03%)  28/292 (9.59%)  19/126 (15.08%)  47/292 (16.10%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Injection Site Pruritus * 1  2/294 (0.68%)  4/124 (3.23%)  8/292 (2.74%)  10/126 (7.94%)  31/292 (10.62%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Injection Site Swelling * 1  0/294 (0.00%)  2/124 (1.61%)  4/292 (1.37%)  7/126 (5.56%)  24/292 (8.22%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Hepatobiliary disorders                     
Drug-Induced Liver Injury * 1  0/294 (0.00%)  0/124 (0.00%)  0/292 (0.00%)  0/126 (0.00%)  0/292 (0.00%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  1/19 (5.26%)  0/62 (0.00%) 
Infections and infestations                     
Bronchitis * 1  5/294 (1.70%)  7/124 (5.65%)  13/292 (4.45%)  4/126 (3.17%)  22/292 (7.53%)  0/28 (0.00%)  1/7 (14.29%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Conjunctivitis Bacterial * 1  0/294 (0.00%)  0/124 (0.00%)  0/292 (0.00%)  1/126 (0.79%)  0/292 (0.00%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  1/19 (5.26%)  0/62 (0.00%) 
Nasopharyngitis * 1  11/294 (3.74%)  2/124 (1.61%)  34/292 (11.64%)  7/126 (5.56%)  26/292 (8.90%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Pneumonia * 1  0/294 (0.00%)  1/124 (0.81%)  3/292 (1.03%)  2/126 (1.59%)  5/292 (1.71%)  0/28 (0.00%)  1/7 (14.29%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Sinusitis * 1  8/294 (2.72%)  5/124 (4.03%)  14/292 (4.79%)  3/126 (2.38%)  15/292 (5.14%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Upper Respiratory Tract Infection * 1  19/294 (6.46%)  6/124 (4.84%)  24/292 (8.22%)  9/126 (7.14%)  26/292 (8.90%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Urinary Tract Infection * 1  11/294 (3.74%)  2/124 (1.61%)  13/292 (4.45%)  6/126 (4.76%)  19/292 (6.51%)  0/28 (0.00%)  0/7 (0.00%)  1/65 (1.54%)  0/19 (0.00%)  0/62 (0.00%) 
Investigations                     
Alanine Aminotransferase Increased * 1  6/294 (2.04%)  12/124 (9.68%)  27/292 (9.25%)  8/126 (6.35%)  23/292 (7.88%)  0/28 (0.00%)  0/7 (0.00%)  1/65 (1.54%)  1/19 (5.26%)  1/62 (1.61%) 
Aspartate Aminotransferase Increased * 1  4/294 (1.36%)  6/124 (4.84%)  18/292 (6.16%)  5/126 (3.97%)  15/292 (5.14%)  0/28 (0.00%)  0/7 (0.00%)  1/65 (1.54%)  1/19 (5.26%)  1/62 (1.61%) 
Hepatitis B Dna Assay Positive * 1  0/294 (0.00%)  0/124 (0.00%)  1/292 (0.34%)  1/126 (0.79%)  0/292 (0.00%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  1/19 (5.26%)  0/62 (0.00%) 
Lymphocyte Count Increased * 1  0/294 (0.00%)  0/124 (0.00%)  0/292 (0.00%)  0/126 (0.00%)  0/292 (0.00%)  0/28 (0.00%)  1/7 (14.29%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Neutrophil Count Increased * 1  2/294 (0.68%)  1/124 (0.81%)  0/292 (0.00%)  0/126 (0.00%)  0/292 (0.00%)  0/28 (0.00%)  1/7 (14.29%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
White Blood Cell Count Increased * 1  2/294 (0.68%)  1/124 (0.81%)  0/292 (0.00%)  0/126 (0.00%)  0/292 (0.00%)  0/28 (0.00%)  1/7 (14.29%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
X-Ray with Contrast Upper Gastrointestinal Tract Abnormal * 1  0/294 (0.00%)  0/124 (0.00%)  0/292 (0.00%)  0/126 (0.00%)  0/292 (0.00%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  1/19 (5.26%)  0/62 (0.00%) 
Metabolism and nutrition disorders                     
Hyperglycaemia * 1  3/294 (1.02%)  2/124 (1.61%)  3/292 (1.03%)  0/126 (0.00%)  1/292 (0.34%)  0/28 (0.00%)  1/7 (14.29%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Musculoskeletal and connective tissue disorders                     
Back Pain * 1  2/294 (0.68%)  0/124 (0.00%)  7/292 (2.40%)  1/126 (0.79%)  9/292 (3.08%)  0/28 (0.00%)  1/7 (14.29%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Muscle Spasms * 1  2/294 (0.68%)  2/124 (1.61%)  5/292 (1.71%)  1/126 (0.79%)  7/292 (2.40%)  0/28 (0.00%)  1/7 (14.29%)  0/65 (0.00%)  0/19 (0.00%)  1/62 (1.61%) 
Rheumatoid Arthritis * 1  28/294 (9.52%)  13/124 (10.48%)  30/292 (10.27%)  4/126 (3.17%)  30/292 (10.27%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  1/62 (1.61%) 
Respiratory, thoracic and mediastinal disorders                     
Cough * 1  2/294 (0.68%)  4/124 (3.23%)  13/292 (4.45%)  4/126 (3.17%)  22/292 (7.53%)  0/28 (0.00%)  1/7 (14.29%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Nasal Pruritus * 1  0/294 (0.00%)  0/124 (0.00%)  0/292 (0.00%)  0/126 (0.00%)  0/292 (0.00%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  1/19 (5.26%)  0/62 (0.00%) 
Skin and subcutaneous tissue disorders                     
Eczema Asteatotic * 1  0/294 (0.00%)  0/124 (0.00%)  0/292 (0.00%)  0/126 (0.00%)  1/292 (0.34%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  1/19 (5.26%)  0/62 (0.00%) 
Rash * 1  3/294 (1.02%)  2/124 (1.61%)  9/292 (3.08%)  0/126 (0.00%)  15/292 (5.14%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Vascular disorders                     
Hypertension * 1  7/294 (2.38%)  3/124 (2.42%)  17/292 (5.82%)  3/126 (2.38%)  15/292 (5.14%)  0/28 (0.00%)  0/7 (0.00%)  0/65 (0.00%)  0/19 (0.00%)  1/62 (1.61%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 17.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
Results Point of Contact
Name/Title: Associate Director
Organization: Janssen Research & Development, LLC
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01606761     History of Changes
Other Study ID Numbers: CR100864
CNTO136ARA3003 ( Other Identifier: Janssen Research & Development, LLC )
2010-022243-38 ( EudraCT Number )
U1111-1135-6365 ( Other Identifier: Universal Trial Number )
First Submitted: May 24, 2012
First Posted: May 28, 2012
Results First Submitted: November 24, 2017
Results First Posted: February 5, 2018
Last Update Posted: March 23, 2018