Trial Outcomes & Findings for Long-term Safety and Efficacy of Sirukumab in Participants With RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003 (NCT NCT01856309)

NCT ID: NCT01856309

Last Updated: 2019-05-06

Results Overview

An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 1820 participants
• Primary outcome timeframe: From baseline of this LTE study up to 4.3 years
• Results posted on: 2019-05-06

Participant Flow

Participants who completed participation in studies CNTO136ARA3002 (NCT01604343) and CNTO136ARA3003 (NCT01606761) and consented to participate in extension study were enrolled in this study.

Data in the participant flow section is reported for treatment discontinuation.

Participant milestones

Measure	Placebo to 50 mg q4w Due to EE/LE/CO Participants initially randomized to placebo, then at early escape (EE), late escape (LE), or cross over (CO) randomized to sirukumab 50 milligram (mg) every 4 weeks (q4w) during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen (sirukumab 50 mg q4w) upon entering this long-term extension (LTE) study.	Placebo to 100 mg q2w Due to EE/LE/CO Participants initially randomized to placebo, then at EE, LE, or CO randomized to sirukumab 100 mg every two weeks (q2w) during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.	Sirukumab 50 mg q4w Participants initially randomized to sirukumab 50 mg q4w during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.	Sirukumab 100 mg q2w Participants initially randomized to sirukumab 100 mg q2w during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.
Overall Study STARTED	305	291	606	618
Overall Study Participants From Study CNTO136ARA3002	197	187	405	412
Overall Study Participants From Study CNTO136ARA3003	108	104	201	206
Overall Study Treated Partcipants	305	290	605	618
Overall Study COMPLETED	6	3	11	9
Overall Study NOT COMPLETED	299	288	595	609

Reasons for withdrawal

Measure	Placebo to 50 mg q4w Due to EE/LE/CO Participants initially randomized to placebo, then at early escape (EE), late escape (LE), or cross over (CO) randomized to sirukumab 50 milligram (mg) every 4 weeks (q4w) during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen (sirukumab 50 mg q4w) upon entering this long-term extension (LTE) study.	Placebo to 100 mg q2w Due to EE/LE/CO Participants initially randomized to placebo, then at EE, LE, or CO randomized to sirukumab 100 mg every two weeks (q2w) during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.	Sirukumab 50 mg q4w Participants initially randomized to sirukumab 50 mg q4w during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.	Sirukumab 100 mg q2w Participants initially randomized to sirukumab 100 mg q2w during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.
Overall Study Death	4	6	11	6
Overall Study Lost to Follow-up	6	2	4	8
Overall Study Withdrawal by Subject	11	13	28	26
Overall Study Other	227	225	447	469
Overall Study Lack of Efficacy	14	9	40	25
Overall Study Adverse Event	31	31	55	65
Overall Study Pregnancy	0	0	0	1
Overall Study Physician Decision	6	1	6	8
Overall Study Noncompliance With Study Drug	0	1	4	1

Baseline Characteristics

Long-term Safety and Efficacy of Sirukumab in Participants With RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003

Baseline characteristics by cohort

Measure	Placebo to 50 mg q4w Due to EE/LE/CO n=305 Participants Participants initially randomized to placebo, then at early escape (EE), late escape (LE), or cross over (CO) randomized to sirukumab 50 mg every 4 weeks (q4w) during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen (sirukumab 50 mg q4w) upon entering this long-term extension (LTE) study.	Placebo to 100 mg q2w Due to EE/LE/CO n=291 Participants Participants initially randomized to placebo, then at EE, LE, or CO randomized to sirukumab 100 mg every two weeks (q2w) during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.	Sirukumab 50 mg q4w n=606 Participants Participants initially randomized to sirukumab 50 mg q4w during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.	Sirukumab 100 mg q2w n=618 Participants Participants initially randomized to sirukumab 100 mg q2w during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.	Total n=1820 Participants Total of all reporting groups
Age, Continuous	54 years STANDARD_DEVIATION 11.92 • n=5 Participants	53.1 years STANDARD_DEVIATION 11.75 • n=7 Participants	53.1 years STANDARD_DEVIATION 11.43 • n=5 Participants	53.4 years STANDARD_DEVIATION 11.29 • n=4 Participants	53.4 years STANDARD_DEVIATION 11.51 • n=21 Participants
Sex: Female, Male Female	241 Participants n=5 Participants	231 Participants n=7 Participants	479 Participants n=5 Participants	503 Participants n=4 Participants	1454 Participants n=21 Participants
Sex: Female, Male Male	64 Participants n=5 Participants	60 Participants n=7 Participants	127 Participants n=5 Participants	115 Participants n=4 Participants	366 Participants n=21 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	5 Participants n=4 Participants	11 Participants n=21 Participants
Race/Ethnicity, Customized Asian	50 Participants n=5 Participants	47 Participants n=7 Participants	102 Participants n=5 Participants	110 Participants n=4 Participants	309 Participants n=21 Participants
Race/Ethnicity, Customized Black or African American	10 Participants n=5 Participants	15 Participants n=7 Participants	21 Participants n=5 Participants	23 Participants n=4 Participants	69 Participants n=21 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race/Ethnicity, Customized White	231 Participants n=5 Participants	211 Participants n=7 Participants	433 Participants n=5 Participants	443 Participants n=4 Participants	1318 Participants n=21 Participants
Race/Ethnicity, Customized Other	11 Participants n=5 Participants	15 Participants n=7 Participants	40 Participants n=5 Participants	31 Participants n=4 Participants	97 Participants n=21 Participants
Race/Ethnicity, Customized Multiple	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized Not reported	1 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants	4 Participants n=4 Participants	12 Participants n=21 Participants
Race/Ethnicity, Customized Unknown	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants
Region of Enrollment Argentina	4 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	2 Participants n=4 Participants	15 Participants n=21 Participants
Region of Enrollment Australia	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Region of Enrollment Austria	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Region of Enrollment Belgium	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Region of Enrollment Bulgaria	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	9 Participants n=21 Participants
Region of Enrollment Canada	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	7 Participants n=21 Participants
Region of Enrollment Chile	11 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants	18 Participants n=4 Participants	50 Participants n=21 Participants
Region of Enrollment Colombia	2 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants	11 Participants n=4 Participants	29 Participants n=21 Participants
Region of Enrollment Croatia	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	8 Participants n=21 Participants
Region of Enrollment France	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Region of Enrollment Germany	2 Participants n=5 Participants	3 Participants n=7 Participants	10 Participants n=5 Participants	5 Participants n=4 Participants	20 Participants n=21 Participants
Region of Enrollment Italy	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants
Region of Enrollment Japan	36 Participants n=5 Participants	36 Participants n=7 Participants	74 Participants n=5 Participants	78 Participants n=4 Participants	224 Participants n=21 Participants
Region of Enrollment Lithuania	13 Participants n=5 Participants	10 Participants n=7 Participants	26 Participants n=5 Participants	32 Participants n=4 Participants	81 Participants n=21 Participants
Region of Enrollment Malaysia	3 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	5 Participants n=21 Participants
Region of Enrollment Mexico	17 Participants n=5 Participants	16 Participants n=7 Participants	39 Participants n=5 Participants	40 Participants n=4 Participants	112 Participants n=21 Participants
Region of Enrollment Netherlands	1 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	5 Participants n=21 Participants
Region of Enrollment Poland	36 Participants n=5 Participants	31 Participants n=7 Participants	67 Participants n=5 Participants	62 Participants n=4 Participants	196 Participants n=21 Participants
Region of Enrollment Portugal	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	4 Participants n=4 Participants	10 Participants n=21 Participants
Region of Enrollment Puerto Rico	1 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	0 Participants n=4 Participants	4 Participants n=21 Participants
Region of Enrollment Romania	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants	8 Participants n=21 Participants
Region of Enrollment Russia	34 Participants n=5 Participants	29 Participants n=7 Participants	63 Participants n=5 Participants	72 Participants n=4 Participants	198 Participants n=21 Participants
Region of Enrollment Serbia	21 Participants n=5 Participants	23 Participants n=7 Participants	38 Participants n=5 Participants	36 Participants n=4 Participants	118 Participants n=21 Participants
Region of Enrollment South Africa	13 Participants n=5 Participants	16 Participants n=7 Participants	22 Participants n=5 Participants	20 Participants n=4 Participants	71 Participants n=21 Participants
Region of Enrollment Korea, Republic Of	6 Participants n=5 Participants	5 Participants n=7 Participants	14 Participants n=5 Participants	23 Participants n=4 Participants	48 Participants n=21 Participants
Region of Enrollment Spain	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants	4 Participants n=4 Participants	14 Participants n=21 Participants
Region of Enrollment Taiwan, Province Of China	5 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants	4 Participants n=4 Participants	27 Participants n=21 Participants
Region of Enrollment Ukraine	16 Participants n=5 Participants	13 Participants n=7 Participants	31 Participants n=5 Participants	41 Participants n=4 Participants	101 Participants n=21 Participants
Region of Enrollment United Kingdom	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants
Region of Enrollment United States	71 Participants n=5 Participants	73 Participants n=7 Participants	156 Participants n=5 Participants	149 Participants n=4 Participants	449 Participants n=21 Participants

PRIMARY outcome

Timeframe: From baseline of this LTE study up to 4.3 years

Population: Population included all participants who were enrolled in this study. One participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses.

An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

Outcome measures

Measure	Placebo to 50 mg q4w Due to EE/LE/CO n=305 Participants Participants initially randomized to placebo, then at early escape (EE), late escape (LE), or cross over (CO) randomized to sirukumab 50 mg every 4 weeks (q4w) during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen (sirukumab 50 mg q4w) upon entering this long-term extension (LTE) study.	Placebo to 100 mg q2w Due to EE/LE/CO n=291 Participants Participants initially randomized to placebo, then at EE, LE, or CO randomized to sirukumab 100 mg every two weeks (q2w) during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.	Sirukumab 50 mg q4w n=605 Participants Participants initially randomized to sirukumab 50 mg q4w during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.	Sirukumab 100 mg q2w n=619 Participants Participants initially randomized to sirukumab 100 mg q2w during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.
Percentage of Participants With Serious Adverse Events (SAEs)	21.3 Percentage of participants	27.8 Percentage of participants	26.4 Percentage of participants	23.1 Percentage of participants

PRIMARY outcome

Timeframe: From baseline of this LTE study up to 4.3 years

Population: Population included all participants who were enrolled in this study. One participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses.

MACE was defined as a composite of Myocardial Infarction (MI), stroke, death, hospitalization for unstable angina, and hospitalization for Transient Ischemic Attack (TIA). Adjudication of these events by the Endpoint Adjudication Committee (EAC) was performed in a blinded fashion.

Outcome measures

Measure	Placebo to 50 mg q4w Due to EE/LE/CO n=305 Participants Participants initially randomized to placebo, then at early escape (EE), late escape (LE), or cross over (CO) randomized to sirukumab 50 mg every 4 weeks (q4w) during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen (sirukumab 50 mg q4w) upon entering this long-term extension (LTE) study.	Placebo to 100 mg q2w Due to EE/LE/CO n=291 Participants Participants initially randomized to placebo, then at EE, LE, or CO randomized to sirukumab 100 mg every two weeks (q2w) during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.	Sirukumab 50 mg q4w n=605 Participants Participants initially randomized to sirukumab 50 mg q4w during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.	Sirukumab 100 mg q2w n=619 Participants Participants initially randomized to sirukumab 100 mg q2w during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.
Percentage of Participants With Major Adverse Cardiovascular Events (MACE)	2.0 Percentage of participants	0.7 Percentage of participants	2.3 Percentage of participants	1.1 Percentage of participants

PRIMARY outcome

Timeframe: From baseline of this LTE study up to 4.3 years

Population: Population included all participants who were enrolled in this study. One participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses.

Percentage of participants with one or more malignancy was reported.

Outcome measures

Measure	Placebo to 50 mg q4w Due to EE/LE/CO n=305 Participants Participants initially randomized to placebo, then at early escape (EE), late escape (LE), or cross over (CO) randomized to sirukumab 50 mg every 4 weeks (q4w) during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen (sirukumab 50 mg q4w) upon entering this long-term extension (LTE) study.	Placebo to 100 mg q2w Due to EE/LE/CO n=291 Participants Participants initially randomized to placebo, then at EE, LE, or CO randomized to sirukumab 100 mg every two weeks (q2w) during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.	Sirukumab 50 mg q4w n=605 Participants Participants initially randomized to sirukumab 50 mg q4w during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.	Sirukumab 100 mg q2w n=619 Participants Participants initially randomized to sirukumab 100 mg q2w during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.
Percentage of Participants With Malignancies	1.0 Percentage of participants	3.4 Percentage of participants	1.5 Percentage of participants	1.8 Percentage of participants

PRIMARY outcome

Timeframe: From baseline of this LTE study up to 4.3 years

Population: Population included all participants who were enrolled in this study. One participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses.

Percentage of participants with one or more serious infections was reported.

Outcome measures

Measure	Placebo to 50 mg q4w Due to EE/LE/CO n=305 Participants Participants initially randomized to placebo, then at early escape (EE), late escape (LE), or cross over (CO) randomized to sirukumab 50 mg every 4 weeks (q4w) during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen (sirukumab 50 mg q4w) upon entering this long-term extension (LTE) study.	Placebo to 100 mg q2w Due to EE/LE/CO n=291 Participants Participants initially randomized to placebo, then at EE, LE, or CO randomized to sirukumab 100 mg every two weeks (q2w) during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.	Sirukumab 50 mg q4w n=605 Participants Participants initially randomized to sirukumab 50 mg q4w during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.	Sirukumab 100 mg q2w n=619 Participants Participants initially randomized to sirukumab 100 mg q2w during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.
Percentage of Participants With Serious Infections	7.9 Percentage of participants	12.0 Percentage of participants	10.4 Percentage of participants	10.7 Percentage of participants

PRIMARY outcome

Timeframe: From baseline of this LTE study up to 4.3 years

Population: Population included all participants who were enrolled in this study. One participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses.

Percentage of participants with one or more GI perforations was reported. GI perforation is a hole that develops through the entire wall of the stomach, small intestine, large bowel, or gallbladder.

Outcome measures

Measure	Placebo to 50 mg q4w Due to EE/LE/CO n=305 Participants Participants initially randomized to placebo, then at early escape (EE), late escape (LE), or cross over (CO) randomized to sirukumab 50 mg every 4 weeks (q4w) during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen (sirukumab 50 mg q4w) upon entering this long-term extension (LTE) study.	Placebo to 100 mg q2w Due to EE/LE/CO n=291 Participants Participants initially randomized to placebo, then at EE, LE, or CO randomized to sirukumab 100 mg every two weeks (q2w) during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.	Sirukumab 50 mg q4w n=605 Participants Participants initially randomized to sirukumab 50 mg q4w during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.	Sirukumab 100 mg q2w n=619 Participants Participants initially randomized to sirukumab 100 mg q2w during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.
Percentage of Participants With Gastrointestinal (GI) Perforations	0.7 Percentage of participants	1.4 Percentage of participants	0.7 Percentage of participants	0.5 Percentage of participants

PRIMARY outcome

Timeframe: From baseline of this LTE study up to 4.3 years

Population: Population included all participants who were enrolled in this study. One participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses.

Percentage of participants with hepatobiliary abnormalities was reported.

Outcome measures

Measure	Placebo to 50 mg q4w Due to EE/LE/CO n=305 Participants Participants initially randomized to placebo, then at early escape (EE), late escape (LE), or cross over (CO) randomized to sirukumab 50 mg every 4 weeks (q4w) during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen (sirukumab 50 mg q4w) upon entering this long-term extension (LTE) study.	Placebo to 100 mg q2w Due to EE/LE/CO n=291 Participants Participants initially randomized to placebo, then at EE, LE, or CO randomized to sirukumab 100 mg every two weeks (q2w) during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.	Sirukumab 50 mg q4w n=605 Participants Participants initially randomized to sirukumab 50 mg q4w during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.	Sirukumab 100 mg q2w n=619 Participants Participants initially randomized to sirukumab 100 mg q2w during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.
Percentage of Participants With Hepatobiliary Abnormalities	0 Percentage of participants	0.3 Percentage of participants	0.2 Percentage of participants	0.2 Percentage of participants

PRIMARY outcome

Timeframe: From baseline of this LTE study up to 4.3 years

Population: Population included all participants who were enrolled in this study. One participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses.

Percentage of participants with serious or moderate/severe systemic hypersensitivity reactions, or serum sickness adverse events (AEs) was reported.

Outcome measures

Measure	Placebo to 50 mg q4w Due to EE/LE/CO n=305 Participants Participants initially randomized to placebo, then at early escape (EE), late escape (LE), or cross over (CO) randomized to sirukumab 50 mg every 4 weeks (q4w) during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen (sirukumab 50 mg q4w) upon entering this long-term extension (LTE) study.	Placebo to 100 mg q2w Due to EE/LE/CO n=291 Participants Participants initially randomized to placebo, then at EE, LE, or CO randomized to sirukumab 100 mg every two weeks (q2w) during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.	Sirukumab 50 mg q4w n=605 Participants Participants initially randomized to sirukumab 50 mg q4w during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.	Sirukumab 100 mg q2w n=619 Participants Participants initially randomized to sirukumab 100 mg q2w during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.
Percentage of Participants With Serious or Moderate/Severe Systemic Hypersensitivity Reactions, or Serum Sickness Adverse Events	0.3 Percentage of participants	0.7 Percentage of participants	0.2 Percentage of participants	0.3 Percentage of participants

SECONDARY outcome

Timeframe: From baseline of primary studies through end of this LTE study (Approximately 5.3 years)

Population: Population included all participants who were enrolled in this study. One participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses.

Percentage of participants with toxicity grade 4 decrease in neutrophils was reported. As per National Cancer Institute's Common Terminology Criteria for Adverse Events, toxicity grade 4 was defined as decrease in neutrophils less than (<) 500 per Cubic Millimeter (mm^3) or < 0.5 * 10^9 per liter.

Outcome measures

Measure	Placebo to 50 mg q4w Due to EE/LE/CO n=305 Participants Participants initially randomized to placebo, then at early escape (EE), late escape (LE), or cross over (CO) randomized to sirukumab 50 mg every 4 weeks (q4w) during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen (sirukumab 50 mg q4w) upon entering this long-term extension (LTE) study.	Placebo to 100 mg q2w Due to EE/LE/CO n=291 Participants Participants initially randomized to placebo, then at EE, LE, or CO randomized to sirukumab 100 mg every two weeks (q2w) during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.	Sirukumab 50 mg q4w n=605 Participants Participants initially randomized to sirukumab 50 mg q4w during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.	Sirukumab 100 mg q2w n=619 Participants Participants initially randomized to sirukumab 100 mg q2w during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.
Percentage of Participants With Toxicity Grade 4 Decrease in Neutrophils	1.3 Percentage of participants	0 Percentage of participants	0.5 Percentage of participants	0 Percentage of participants

SECONDARY outcome

Timeframe: From baseline of primary studies through end of this LTE study (Approximately 5.3 years)

Population: Population included all participants who were enrolled in this study. One participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses.

Percentage of participants with toxicity grade 4 decrease in platelets was reported. As per National Cancer Institute's Common Terminology Criteria for Adverse Events, toxicity grade 4 was defined as decreased in platelets <25000/mm^3 or < 25.0 * 10^9 per liter.

Outcome measures

Measure	Placebo to 50 mg q4w Due to EE/LE/CO n=305 Participants Participants initially randomized to placebo, then at early escape (EE), late escape (LE), or cross over (CO) randomized to sirukumab 50 mg every 4 weeks (q4w) during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen (sirukumab 50 mg q4w) upon entering this long-term extension (LTE) study.	Placebo to 100 mg q2w Due to EE/LE/CO n=291 Participants Participants initially randomized to placebo, then at EE, LE, or CO randomized to sirukumab 100 mg every two weeks (q2w) during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.	Sirukumab 50 mg q4w n=605 Participants Participants initially randomized to sirukumab 50 mg q4w during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.	Sirukumab 100 mg q2w n=619 Participants Participants initially randomized to sirukumab 100 mg q2w during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.
Percentage of Participants With Toxicity Grade 4 Decrease in Platelets	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants

SECONDARY outcome

Timeframe: From baseline of primary studies through end of this LTE study (Approximately 5.3 years)

Population: Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses.

Percentage of participants with Alanine Aminotranserase (ALT) >= 3*Upper Limit of Normal (ULN), ALT >= 5*ULN or ALT >= 8*ULN was reported.

Outcome measures

Measure	Placebo to 50 mg q4w Due to EE/LE/CO n=305 Participants Participants initially randomized to placebo, then at early escape (EE), late escape (LE), or cross over (CO) randomized to sirukumab 50 mg every 4 weeks (q4w) during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen (sirukumab 50 mg q4w) upon entering this long-term extension (LTE) study.	Placebo to 100 mg q2w Due to EE/LE/CO n=291 Participants Participants initially randomized to placebo, then at EE, LE, or CO randomized to sirukumab 100 mg every two weeks (q2w) during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.	Sirukumab 50 mg q4w n=605 Participants Participants initially randomized to sirukumab 50 mg q4w during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.	Sirukumab 100 mg q2w n=619 Participants Participants initially randomized to sirukumab 100 mg q2w during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.
Percentage of Participants With ALT >= 3*ULN, ALT >= 5*ULN and ALT >= 8*ULN ALT >= 3 * ULN	14.1 Percentage of participants	14.4 Percentage of participants	15.9 Percentage of participants	17.1 Percentage of participants
Percentage of Participants With ALT >= 3*ULN, ALT >= 5*ULN and ALT >= 8*ULN ALT >= 5 * ULN	2.0 Percentage of participants	2.4 Percentage of participants	2.5 Percentage of participants	3.9 Percentage of participants
Percentage of Participants With ALT >= 3*ULN, ALT >= 5*ULN and ALT >= 8*ULN ALT >= 8 * ULN	0 Percentage of participants	0.7 Percentage of participants	0.2 Percentage of participants	0.2 Percentage of participants

SECONDARY outcome

Timeframe: From baseline of primary studies through end of this LTE study (Approximately 5.3 years)

Population: Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses.

Percentage of participants with Aspartate Aminotransferase (AST) >= 3*ULN, AST >= 5*ULN and AST >= 8*ULN was reported.

Outcome measures

Measure	Placebo to 50 mg q4w Due to EE/LE/CO n=305 Participants Participants initially randomized to placebo, then at early escape (EE), late escape (LE), or cross over (CO) randomized to sirukumab 50 mg every 4 weeks (q4w) during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen (sirukumab 50 mg q4w) upon entering this long-term extension (LTE) study.	Placebo to 100 mg q2w Due to EE/LE/CO n=291 Participants Participants initially randomized to placebo, then at EE, LE, or CO randomized to sirukumab 100 mg every two weeks (q2w) during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.	Sirukumab 50 mg q4w n=605 Participants Participants initially randomized to sirukumab 50 mg q4w during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.	Sirukumab 100 mg q2w n=619 Participants Participants initially randomized to sirukumab 100 mg q2w during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.
Percentage of Participants With AST >= 3*ULN, AST >= 5*ULN and AST >= 8*ULN AST >= 3 * ULN	3.9 Percentage of participants	6.2 Percentage of participants	4.5 Percentage of participants	7.8 Percentage of participants
Percentage of Participants With AST >= 3*ULN, AST >= 5*ULN and AST >= 8*ULN AST >= 5 * ULN	0.3 Percentage of participants	1.7 Percentage of participants	0.5 Percentage of participants	1.1 Percentage of participants
Percentage of Participants With AST >= 3*ULN, AST >= 5*ULN and AST >= 8*ULN AST >= 8 * ULN	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0.3 Percentage of participants

SECONDARY outcome

Timeframe: From baseline of primary studies through end of this LTE study (Approximately 5.3 years)

Population: Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses.

Percentage of participants with either ALT >= 3*ULN or AST >= 3*ULN and total bilirubin >= 2*ULN was reported.

Outcome measures

Measure	Placebo to 50 mg q4w Due to EE/LE/CO n=305 Participants Participants initially randomized to placebo, then at early escape (EE), late escape (LE), or cross over (CO) randomized to sirukumab 50 mg every 4 weeks (q4w) during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen (sirukumab 50 mg q4w) upon entering this long-term extension (LTE) study.	Placebo to 100 mg q2w Due to EE/LE/CO n=291 Participants Participants initially randomized to placebo, then at EE, LE, or CO randomized to sirukumab 100 mg every two weeks (q2w) during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.	Sirukumab 50 mg q4w n=605 Participants Participants initially randomized to sirukumab 50 mg q4w during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.	Sirukumab 100 mg q2w n=619 Participants Participants initially randomized to sirukumab 100 mg q2w during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.
Percentage of Participants With Either ALT >= 3*ULN or AST >= 3*ULN, and Total Bilirubin >= 2*ULN	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0.2 Percentage of participants

SECONDARY outcome

Timeframe: From baseline of primary studies through end of this LTE study (Approximately 5.3 years)

Population: Population included all participants who were enrolled in this study and had total cholesterol baseline value within normal range.

Percentage of participants with normal total cholesterol value at baseline and at least 1 abnormal value post-baseline was reported. Abnormal total cholesterol value was defined as total cholesterol value more than (>) 200 milligrams per deciliter (mg/dL).

Outcome measures

Measure	Placebo to 50 mg q4w Due to EE/LE/CO n=177 Participants Participants initially randomized to placebo, then at early escape (EE), late escape (LE), or cross over (CO) randomized to sirukumab 50 mg every 4 weeks (q4w) during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen (sirukumab 50 mg q4w) upon entering this long-term extension (LTE) study.	Placebo to 100 mg q2w Due to EE/LE/CO n=163 Participants Participants initially randomized to placebo, then at EE, LE, or CO randomized to sirukumab 100 mg every two weeks (q2w) during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.	Sirukumab 50 mg q4w n=354 Participants Participants initially randomized to sirukumab 50 mg q4w during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.	Sirukumab 100 mg q2w n=345 Participants Participants initially randomized to sirukumab 100 mg q2w during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.
Percentage of Participants With Normal Total Cholesterol Value at Baseline and at Least 1 Abnormal Value Post-Baseline	86.4 Percentage of participants	81.6 Percentage of participants	82.5 Percentage of participants	87.2 Percentage of participants

SECONDARY outcome

Timeframe: From baseline of primary studies through end of this LTE study (Approximately 5.3 years)

Population: Population included all participants who were enrolled in this study and had LDL baseline value within normal range.

Percentage of participants with normal LDL value at baseline and at least 1 abnormal value post-baseline was reported. Abnormal LDL value was defined as LDL value > 130 mg/dL.

Outcome measures

Measure	Placebo to 50 mg q4w Due to EE/LE/CO n=225 Participants Participants initially randomized to placebo, then at early escape (EE), late escape (LE), or cross over (CO) randomized to sirukumab 50 mg every 4 weeks (q4w) during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen (sirukumab 50 mg q4w) upon entering this long-term extension (LTE) study.	Placebo to 100 mg q2w Due to EE/LE/CO n=209 Participants Participants initially randomized to placebo, then at EE, LE, or CO randomized to sirukumab 100 mg every two weeks (q2w) during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.	Sirukumab 50 mg q4w n=459 Participants Participants initially randomized to sirukumab 50 mg q4w during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.	Sirukumab 100 mg q2w n=449 Participants Participants initially randomized to sirukumab 100 mg q2w during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.
Percentage of Participants With Normal Low-Density Lipoprotein (LDL) Value at Baseline and at Least 1 Abnormal Value Post-Baseline	70.2 Percentage of participants	67.9 Percentage of participants	69.7 Percentage of participants	70.8 Percentage of participants

SECONDARY outcome

Timeframe: From baseline of primary studies through end of this LTE study (Approximately 5.3 years)

Population: Population included all participants who were enrolled in this study and had HDL baseline value within normal range.

Percentage of participants with normal HDL value at baseline and at least 1 abnormal value post-baseline was reported. Abnormal HDL value was defined as HDL value < 40 mg/dL.

Outcome measures

Measure	Placebo to 50 mg q4w Due to EE/LE/CO n=277 Participants Participants initially randomized to placebo, then at early escape (EE), late escape (LE), or cross over (CO) randomized to sirukumab 50 mg every 4 weeks (q4w) during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen (sirukumab 50 mg q4w) upon entering this long-term extension (LTE) study.	Placebo to 100 mg q2w Due to EE/LE/CO n=273 Participants Participants initially randomized to placebo, then at EE, LE, or CO randomized to sirukumab 100 mg every two weeks (q2w) during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.	Sirukumab 50 mg q4w n=533 Participants Participants initially randomized to sirukumab 50 mg q4w during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.	Sirukumab 100 mg q2w n=569 Participants Participants initially randomized to sirukumab 100 mg q2w during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.
Percentage of Participants With Normal High-Density Lipoprotein (HDL) Value at Baseline and at Least 1 Abnormal Value Post-Baseline	16.2 Percentage of participants	14.7 Percentage of participants	16.1 Percentage of participants	16.0 Percentage of participants

SECONDARY outcome

Timeframe: From baseline of primary studies through end of this LTE study (Approximately 5.3 years)

Population: Population included all participants who were enrolled in this study and had triglyceride baseline value within normal range.

Percentage of participants with normal triglyceride value at baseline and at least 1 abnormal value post-baseline was reported. Abnormal triglyceride value was defined as triglyceride value > 250 mg/dL.

Outcome measures

Measure	Placebo to 50 mg q4w Due to EE/LE/CO n=279 Participants Participants initially randomized to placebo, then at early escape (EE), late escape (LE), or cross over (CO) randomized to sirukumab 50 mg every 4 weeks (q4w) during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen (sirukumab 50 mg q4w) upon entering this long-term extension (LTE) study.	Placebo to 100 mg q2w Due to EE/LE/CO n=268 Participants Participants initially randomized to placebo, then at EE, LE, or CO randomized to sirukumab 100 mg every two weeks (q2w) during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.	Sirukumab 50 mg q4w n=554 Participants Participants initially randomized to sirukumab 50 mg q4w during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.	Sirukumab 100 mg q2w n=564 Participants Participants initially randomized to sirukumab 100 mg q2w during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.
Percentage of Participants With Normal Triglyceride Value at Baseline and at Least 1 Abnormal Value Post-Baseline	32.6 Percentage of participants	35.1 Percentage of participants	36.1 Percentage of participants	34.4 Percentage of participants

SECONDARY outcome

Timeframe: Week 2, 4, 6, 8, 12, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52, 76, 80, 104, 128, 132, 156, 180, 208, 232 and 260

Population: Population included all participants who were enrolled in this study. For "Placebo to 50mg" and "Placebo to 100mg" groups, only efficacy data collected after escape or CO (after Week 18) to sirukumab was planned to be reported, with exception of baseline data. Here 'n' signifies the number of participants analyzed at the specified time point.

ACR 50 response is greater than or equal to (>=) 50 percent (%) improvement in both tender joint count (68) and swollen joint count (66) and >= 50% improvement in 3 of following 5 assessments:Participant's assessment of pain using visual analog scale (VAS) (0-10 scale, 0=no pain and 10=worst possible pain),Participant's global assessment of disease activity by using VAS (scale ranges from 0 to 10, [0 = very well to 10 = very poor]), Physician's global assessment of disease activity using VAS (scale ranges from 0 to 10, [0=no arthritis activity to 10=extremely active arthritis]), Participant's assessment of physical function as measured by Health Assessment Questionnaire-Disability Index (HAQ-DI) (scale ranges from 0= no difficulty to 3= inability to perform a task in that area), and Serum C-reactive protein (CRP). Participants were analyzed for efficacy according to assigned treatment groups from the primary studies, regardless of treatments actually received.

Outcome measures

Measure	Placebo to 50 mg q4w Due to EE/LE/CO n=305 Participants Participants initially randomized to placebo, then at early escape (EE), late escape (LE), or cross over (CO) randomized to sirukumab 50 mg every 4 weeks (q4w) during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen (sirukumab 50 mg q4w) upon entering this long-term extension (LTE) study.	Placebo to 100 mg q2w Due to EE/LE/CO n=291 Participants Participants initially randomized to placebo, then at EE, LE, or CO randomized to sirukumab 100 mg every two weeks (q2w) during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.	Sirukumab 50 mg q4w n=606 Participants Participants initially randomized to sirukumab 50 mg q4w during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.	Sirukumab 100 mg q2w n=618 Participants Participants initially randomized to sirukumab 100 mg q2w during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.
Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 At Week 2	—	—	2.5 Percentage of participants	2.4 Percentage of participants
Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 At Week 4	—	—	9.1 Percentage of participants	9.7 Percentage of participants
Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 At Week 6	—	—	16.2 Percentage of participants	14.6 Percentage of participants
Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 At Week 8	—	—	21.4 Percentage of participants	20.0 Percentage of participants
Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 At Week 12	—	—	27.7 Percentage of participants	29.6 Percentage of participants
Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 At Week 16	—	—	31.8 Percentage of participants	29.2 Percentage of participants
Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 At Week 18	—	—	33.7 Percentage of participants	32.0 Percentage of participants
Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 At Week 20	4.5 Percentage of participants	3.8 Percentage of participants	36.9 Percentage of participants	38.1 Percentage of participants
Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 At Week 24	17.9 Percentage of participants	10.4 Percentage of participants	35.1 Percentage of participants	37.9 Percentage of participants
Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 At Week 28	24.4 Percentage of participants	23.1 Percentage of participants	40.0 Percentage of participants	39.2 Percentage of participants
Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 At Week 32	30.0 Percentage of participants	30.2 Percentage of participants	40.9 Percentage of participants	42.2 Percentage of participants
Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 At Week 36	29.2 Percentage of participants	33.9 Percentage of participants	42.3 Percentage of participants	43.0 Percentage of participants
Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 At Week 40	38.3 Percentage of participants	34.7 Percentage of participants	42.0 Percentage of participants	42.2 Percentage of participants
Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 At Week 44	40.1 Percentage of participants	33.5 Percentage of participants	43.3 Percentage of participants	44.3 Percentage of participants
Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 At Week 48	43.3 Percentage of participants	27.9 Percentage of participants	44.6 Percentage of participants	44.1 Percentage of participants
Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 At Week 52	41.9 Percentage of participants	34.1 Percentage of participants	43.0 Percentage of participants	44.9 Percentage of participants
Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 At Week 76	56.6 Percentage of participants	49.7 Percentage of participants	52.4 Percentage of participants	56.1 Percentage of participants
Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 At Week 80	38.9 Percentage of participants	26.4 Percentage of participants	38.2 Percentage of participants	44.9 Percentage of participants
Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 At Week 104	48.8 Percentage of participants	46.1 Percentage of participants	50.3 Percentage of participants	53.0 Percentage of participants
Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 At Week 128	35.5 Percentage of participants	43.8 Percentage of participants	42.7 Percentage of participants	46.5 Percentage of participants
Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 At Week 132	51.1 Percentage of participants	46.7 Percentage of participants	50.0 Percentage of participants	53.4 Percentage of participants
Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 At Week 156	48.3 Percentage of participants	56.4 Percentage of participants	50.3 Percentage of participants	52.6 Percentage of participants
Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 At Week 180	53.3 Percentage of participants	54.9 Percentage of participants	54.6 Percentage of participants	56.4 Percentage of participants
Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 At Week 208	50.9 Percentage of participants	50.5 Percentage of participants	50.8 Percentage of participants	59.6 Percentage of participants
Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 At Week 232	48.5 Percentage of participants	57.1 Percentage of participants	51.5 Percentage of participants	57.1 Percentage of participants
Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 At Week 260	66.7 Percentage of participants	50.0 Percentage of participants	60.0 Percentage of participants	25.0 Percentage of participants

SECONDARY outcome

Timeframe: Week 2, 4, 6, 8, 12, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52, 76, 80, 104, 128, 132, 156, 180, 208, 232 and 260

Population: Population included all participants who were enrolled in this study. For "Placebo to 50mg" and "Placebo to 100mg" groups, only efficacy data collected after escape or CO (after Week 18) to sirukumab was planned to be reported, with exception of baseline data. Here 'n' signifies the number of participants analyzed at the specified time point.

Boolean based ACR/EULAR remission is achieved if all of the following 4 criteria at that visit are met: tender joint count (68 joints) <=1; swollen joint count (66 joints) <=1; CRP <=1 milligram per deciliter (mg/dL); and patient's global assessment of disease activity on visual analog scale (VAS) <=1 on a 0 (very well ) to 10 (extremely bad) scale. Higher scores indicates worst health condition. Participants were analyzed for efficacy according to the assigned treatment groups from the primary studies, regardless of the treatments they actually received.

Outcome measures

Measure	Placebo to 50 mg q4w Due to EE/LE/CO n=305 Participants Participants initially randomized to placebo, then at early escape (EE), late escape (LE), or cross over (CO) randomized to sirukumab 50 mg every 4 weeks (q4w) during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen (sirukumab 50 mg q4w) upon entering this long-term extension (LTE) study.	Placebo to 100 mg q2w Due to EE/LE/CO n=291 Participants Participants initially randomized to placebo, then at EE, LE, or CO randomized to sirukumab 100 mg every two weeks (q2w) during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.	Sirukumab 50 mg q4w n=606 Participants Participants initially randomized to sirukumab 50 mg q4w during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.	Sirukumab 100 mg q2w n=618 Participants Participants initially randomized to sirukumab 100 mg q2w during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.
Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 At Week 2	—	—	0.2 Percentage of participants	0.2 Percentage of participants
Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 At Week 4	—	—	0.5 Percentage of participants	0.6 Percentage of participants
Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 At Week 6	—	—	0.8 Percentage of participants	1.5 Percentage of participants
Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 At Week 8	—	—	1.2 Percentage of participants	2.5 Percentage of participants
Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 At Week 12	—	—	3.2 Percentage of participants	4.9 Percentage of participants
Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 At Week 16	—	—	3.3 Percentage of participants	5.7 Percentage of participants
Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 At Week 18	—	—	4.3 Percentage of participants	5.4 Percentage of participants
Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 At Week 20	0 Percentage of participants	0 Percentage of participants	4.5 Percentage of participants	5.9 Percentage of participants
Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 At Week 24	0.9 Percentage of participants	0.9 Percentage of participants	5.3 Percentage of participants	8.1 Percentage of participants
Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 At Week 28	2.8 Percentage of participants	2.9 Percentage of participants	6.0 Percentage of participants	6.2 Percentage of participants
Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 At Week 32	2.2 Percentage of participants	4.1 Percentage of participants	4.8 Percentage of participants	7.7 Percentage of participants
Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 At Week 36	2.8 Percentage of participants	4.0 Percentage of participants	7.8 Percentage of participants	9.7 Percentage of participants
Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 At Week 40	4.0 Percentage of participants	6.4 Percentage of participants	7.2 Percentage of participants	9.0 Percentage of participants
Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 At Week 44	4.3 Percentage of participants	6.1 Percentage of participants	7.4 Percentage of participants	9.7 Percentage of participants
Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 At Week 48	4.3 Percentage of participants	7.3 Percentage of participants	9.8 Percentage of participants	9.0 Percentage of participants
Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 At Week 52	6.8 Percentage of participants	6.6 Percentage of participants	9.3 Percentage of participants	7.1 Percentage of participants
Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 At Week 76	9.7 Percentage of participants	7.1 Percentage of participants	10.7 Percentage of participants	9.2 Percentage of participants
Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 At Week 80	6.6 Percentage of participants	8.0 Percentage of participants	7.8 Percentage of participants	6.3 Percentage of participants
Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 At Week 104	10.6 Percentage of participants	11.1 Percentage of participants	12.6 Percentage of participants	10.2 Percentage of participants
Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 At Week 128	2.6 Percentage of participants	8.1 Percentage of participants	10.8 Percentage of participants	8.9 Percentage of participants
Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 At Week 132	12.4 Percentage of participants	11.3 Percentage of participants	10.8 Percentage of participants	10.2 Percentage of participants
Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 At Week 156	9.4 Percentage of participants	8.7 Percentage of participants	10.9 Percentage of participants	11.8 Percentage of participants
Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 At Week 180	11.8 Percentage of participants	10.7 Percentage of participants	14.2 Percentage of participants	13.9 Percentage of participants
Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 At Week 208	12.6 Percentage of participants	13.7 Percentage of participants	11.4 Percentage of participants	19.2 Percentage of participants
Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 At Week 232	11.8 Percentage of participants	17.9 Percentage of participants	18.2 Percentage of participants	9.1 Percentage of participants
Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 At Week 260	0 Percentage of participants	0 Percentage of participants	18.2 Percentage of participants	0 Percentage of participants

SECONDARY outcome

Timeframe: Week 2, 4, 6, 8, 12, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52, 76, 80, 104, 128, 132, 156, 180, 208, 232 and 260

Population: Population included all participants who were enrolled in this study. For "Placebo to 50mg" and "Placebo to 100mg" groups, only efficacy data collected after escape or CO (after Week 18) to sirukumab was planned to be reported, with exception of baseline data. Here 'n' signifies the number of participants analyzed at the specified time point.

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. Participants were analyzed for efficacy according to the assigned treatment groups from the primary studies, regardless of the treatments they actually received.

Outcome measures

Measure	Placebo to 50 mg q4w Due to EE/LE/CO n=305 Participants Participants initially randomized to placebo, then at early escape (EE), late escape (LE), or cross over (CO) randomized to sirukumab 50 mg every 4 weeks (q4w) during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen (sirukumab 50 mg q4w) upon entering this long-term extension (LTE) study.	Placebo to 100 mg q2w Due to EE/LE/CO n=291 Participants Participants initially randomized to placebo, then at EE, LE, or CO randomized to sirukumab 100 mg every two weeks (q2w) during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.	Sirukumab 50 mg q4w n=606 Participants Participants initially randomized to sirukumab 50 mg q4w during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.	Sirukumab 100 mg q2w n=618 Participants Participants initially randomized to sirukumab 100 mg q2w during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.
Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 At Week 2	—	—	2.7 Percentage of participants	2.6 Percentage of participants
Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 At Week 4	—	—	7.5 Percentage of participants	9.0 Percentage of participants
Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 At Week 6	—	—	10.2 Percentage of participants	13.4 Percentage of participants
Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 At Week 8	—	—	15.0 Percentage of participants	18.8 Percentage of participants
Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 At Week 12	—	—	20.4 Percentage of participants	23.5 Percentage of participants
Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 At Week 16	—	—	23.8 Percentage of participants	24.0 Percentage of participants
Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 At Week 18	—	—	25.6 Percentage of participants	25.4 Percentage of participants
Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 At Week 20	1.8 Percentage of participants	0 Percentage of participants	29.8 Percentage of participants	30.1 Percentage of participants
Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 At Week 24	7.2 Percentage of participants	7.5 Percentage of participants	30.8 Percentage of participants	32.1 Percentage of participants
Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 At Week 28	17.8 Percentage of participants	20.8 Percentage of participants	33.8 Percentage of participants	32.7 Percentage of participants
Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 At Week 32	24.9 Percentage of participants	24.7 Percentage of participants	35.3 Percentage of participants	36.9 Percentage of participants
Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 At Week 36	21.3 Percentage of participants	30.5 Percentage of participants	35.1 Percentage of participants	35.4 Percentage of participants
Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 At Week 40	29.9 Percentage of participants	32.0 Percentage of participants	34.5 Percentage of participants	34.9 Percentage of participants
Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 At Week 44	34.2 Percentage of participants	30.9 Percentage of participants	36.0 Percentage of participants	35.4 Percentage of participants
Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 At Week 48	33.2 Percentage of participants	31.3 Percentage of participants	38.7 Percentage of participants	38.3 Percentage of participants
Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 At Week 52	30.7 Percentage of participants	32.6 Percentage of participants	38.8 Percentage of participants	37.4 Percentage of participants
Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 At Week 76	44.6 Percentage of participants	44.3 Percentage of participants	47.6 Percentage of participants	45.8 Percentage of participants
Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 At Week 80	38.9 Percentage of participants	39.3 Percentage of participants	38.3 Percentage of participants	38.6 Percentage of participants
Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 At Week 104	44.8 Percentage of participants	47.4 Percentage of participants	42.6 Percentage of participants	46.6 Percentage of participants
Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 At Week 128	43.8 Percentage of participants	43.1 Percentage of participants	45.5 Percentage of participants	43.5 Percentage of participants
Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 At Week 132	41.4 Percentage of participants	47.3 Percentage of participants	48.0 Percentage of participants	49.0 Percentage of participants
Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 At Week 156	43.0 Percentage of participants	47.1 Percentage of participants	46.5 Percentage of participants	49.6 Percentage of participants
Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 At Week 180	48.9 Percentage of participants	48.8 Percentage of participants	50.5 Percentage of participants	53.9 Percentage of participants
Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 At Week 208	55.0 Percentage of participants	54.8 Percentage of participants	54.3 Percentage of participants	60.1 Percentage of participants
Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 At Week 232	59.3 Percentage of participants	52.0 Percentage of participants	57.1 Percentage of participants	59.6 Percentage of participants
Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 At Week 260	66.7 Percentage of participants	100.0 Percentage of participants	77.8 Percentage of participants	25.0 Percentage of participants

SECONDARY outcome

Timeframe: Baseline (Week 0 of primary studies), Week 2, 4, 6, 8, 12, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52, 76, 80, 104, 128, 132, 156, 180, 208, 232 and 260

Population: Population included all participants who were enrolled in this study. For "Placebo to 50mg" and "Placebo to 100mg" groups, only efficacy data collected after escape or CO (after Week 18) to sirukumab was planned to be reported, with exception of baseline data. Here 'n' signifies the number of participants analyzed at specified time point.

The CDAI score is a derived score of 4 components: tender joints (28 joints), swollen joints (28 joints), patient's global assessment of disease activity, and physician's global assessments of disease activity. The total score ranges from 0 to 76 with a lower score indicating less disease activity. A negative change in CDAI score indicates an improvement in disease activity and a positive change in score indicates a worsening of disease activity. Participants were analyzed for efficacy according to the assigned treatment groups from the primary studies, regardless of the treatments they actually received.

Outcome measures

Measure	Placebo to 50 mg q4w Due to EE/LE/CO n=305 Participants Participants initially randomized to placebo, then at early escape (EE), late escape (LE), or cross over (CO) randomized to sirukumab 50 mg every 4 weeks (q4w) during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen (sirukumab 50 mg q4w) upon entering this long-term extension (LTE) study.	Placebo to 100 mg q2w Due to EE/LE/CO n=291 Participants Participants initially randomized to placebo, then at EE, LE, or CO randomized to sirukumab 100 mg every two weeks (q2w) during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.	Sirukumab 50 mg q4w n=606 Participants Participants initially randomized to sirukumab 50 mg q4w during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.	Sirukumab 100 mg q2w n=618 Participants Participants initially randomized to sirukumab 100 mg q2w during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.
Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 Change at Week 260	-34.70 Units on a scale Standard Deviation 4.776	-26.60 Units on a scale Standard Deviation 20.789	-20.73 Units on a scale Standard Deviation 11.983	-19.03 Units on a scale Standard Deviation 18.823
Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 Change at Week 2	—	—	-6.54 Units on a scale Standard Deviation 9.464	-6.10 Units on a scale Standard Deviation 9.295
Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 Change at Week 4	—	—	-11.09 Units on a scale Standard Deviation 11.257	-10.73 Units on a scale Standard Deviation 11.469
Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 Change at Week 6	—	—	-13.79 Units on a scale Standard Deviation 12.198	-14.05 Units on a scale Standard Deviation 11.613
Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 Change at Week 8	—	—	-15.56 Units on a scale Standard Deviation 12.736	-15.74 Units on a scale Standard Deviation 12.333
Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 Change at Week 12	—	—	-17.79 Units on a scale Standard Deviation 13.955	-17.89 Units on a scale Standard Deviation 13.636
Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 Change at Week 16	—	—	-18.50 Units on a scale Standard Deviation 13.956	-18.65 Units on a scale Standard Deviation 13.584
Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 Change at Week 18	—	—	-18.93 Units on a scale Standard Deviation 14.459	-18.40 Units on a scale Standard Deviation 13.524
Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 Change at Week 20	-7.19 Units on a scale Standard Deviation 12.051	-7.01 Units on a scale Standard Deviation 11.666	-20.72 Units on a scale Standard Deviation 14.077	-19.96 Units on a scale Standard Deviation 13.678
Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 Change at Week 24	-15.08 Units on a scale Standard Deviation 11.697	-12.78 Units on a scale Standard Deviation 11.654	-21.20 Units on a scale Standard Deviation 13.625	-21.06 Units on a scale Standard Deviation 13.888
Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 Change at Week 28	-19.69 Units on a scale Standard Deviation 13.518	-19.58 Units on a scale Standard Deviation 12.578	-21.85 Units on a scale Standard Deviation 14.000	-21.33 Units on a scale Standard Deviation 13.655
Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 Change at Week 32	-20.36 Units on a scale Standard Deviation 14.238	-20.69 Units on a scale Standard Deviation 12.754	-22.37 Units on a scale Standard Deviation 13.935	-22.17 Units on a scale Standard Deviation 13.462
Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 Change at Week 36	-21.49 Units on a scale Standard Deviation 12.343	-22.53 Units on a scale Standard Deviation 12.609	-22.64 Units on a scale Standard Deviation 13.750	-22.79 Units on a scale Standard Deviation 13.220
Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 Change at Week 40	-22.67 Units on a scale Standard Deviation 13.374	-22.36 Units on a scale Standard Deviation 13.208	-23.09 Units on a scale Standard Deviation 13.890	-22.49 Units on a scale Standard Deviation 14.268
Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 Change at Week 44	-22.80 Units on a scale Standard Deviation 14.390	-22.31 Units on a scale Standard Deviation 13.062	-23.19 Units on a scale Standard Deviation 14.214	23.04 Units on a scale Standard Deviation 13.484
Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 Change at Week 48	-23.74 Units on a scale Standard Deviation 13.685	-22.56 Units on a scale Standard Deviation 13.229	-23.22 Units on a scale Standard Deviation 14.281	-23.20 Units on a scale Standard Deviation 13.008
Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 Change at Week 52	-24.09 Units on a scale Standard Deviation 13.629	-23.17 Units on a scale Standard Deviation 13.280	-24.05 Units on a scale Standard Deviation 13.930	-23.61 Units on a scale Standard Deviation 13.376
Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 Change at Week 76	-27.49 Units on a scale Standard Deviation 12.763	-25.91 Units on a scale Standard Deviation 13.537	-25.98 Units on a scale Standard Deviation 14.077	-24.83 Units on a scale Standard Deviation 12.664
Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 Change at Week 80	-23.31 Units on a scale Standard Deviation 14.840	-22.67 Units on a scale Standard Deviation 12.546	-23.27 Units on a scale Standard Deviation 15.372	-23.70 Units on a scale Standard Deviation 14.755
Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 Change at Week 104	-26.85 Units on a scale Standard Deviation 13.261	-26.08 Units on a scale Standard Deviation 12.872	-25.75 Units on a scale Standard Deviation 13.931	-25.60 Units on a scale Standard Deviation 13.596
Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 Change at Week 128	-24.55 Units on a scale Standard Deviation 13.797	-25.12 Units on a scale Standard Deviation 12.102	-25.06 Units on a scale Standard Deviation 15.496	-26.14 Units on a scale Standard Deviation 14.810
Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 Change at Week 132	-27.24 Units on a scale Standard Deviation 12.671	-26.62 Units on a scale Standard Deviation 13.994	-26.06 Units on a scale Standard Deviation 13.661	-24.61 Units on a scale Standard Deviation 13.391
Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 Change at Week 156	-26.53 Units on a scale Standard Deviation 14.998	-26.85 Units on a scale Standard Deviation 13.999	-25.59 Units on a scale Standard Deviation 14.641	-25.60 Units on a scale Standard Deviation 13.196
Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 Change at Week 180	-27.21 Units on a scale Standard Deviation 14.370	-27.07 Units on a scale Standard Deviation 13.969	-26.95 Units on a scale Standard Deviation 13.671	-25.88 Units on a scale Standard Deviation 13.910
Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 Change at Week 208	-27.54 Units on a scale Standard Deviation 12.054	-27.06 Units on a scale Standard Deviation 15.579	-27.01 Units on a scale Standard Deviation 12.968	-27.12 Units on a scale Standard Deviation 13.008
Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 Change at Week 232	-26.61 Units on a scale Standard Deviation 13.420	-26.25 Units on a scale Standard Deviation 17.509	-26.06 Units on a scale Standard Deviation 16.858	-27.23 Units on a scale Standard Deviation 14.636

SECONDARY outcome

Timeframe: Week 2, 4, 6, 8, 12, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52, 76, 80, 104, 128, 132, 156, 180, 208, 232 and 260

Population: Population included all participants who were enrolled in this study. For "Placebo to 50mg" and "Placebo to 100mg" groups, only efficacy data collected after escape or CO (after Week 18) to sirukumab was planned to be reported, with exception of baseline data. Here 'n' signifies the number of participants analyzed at the specified time point.

Participant having SDAI-based ACR/EULAR remission at a visit if SDAI score is of <= 3.3. SDAI derived by combining 5 disease assessments: tender joint (28), swollen joint (28) counts, participants global assessment of disease activity using VAS (scale ranges from 0 to 10 [0 =very well to 10 = very poor]), physicians global assessment of disease activity using VAS (scale ranges from 0 to 10 [0=no arthritis to 10=extremely active arthritis]) and CRP. 28 joints evaluated for swelling and tenderness are same set of 28 joints used in DAS28 includes shoulder, elbow, wrist, MCP1, MCP2, MCP3, MCP4, MCP5, PIP1, PIP2, PIP3, PIP4, PIP5 joints of upper right and left extremities and knee joints of lower right and left extremities. Participants were analyzed for efficacy according to assigned treatment groups from the primary studies, regardless of treatments actually received.

Outcome measures

Measure	Placebo to 50 mg q4w Due to EE/LE/CO n=305 Participants Participants initially randomized to placebo, then at early escape (EE), late escape (LE), or cross over (CO) randomized to sirukumab 50 mg every 4 weeks (q4w) during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen (sirukumab 50 mg q4w) upon entering this long-term extension (LTE) study.	Placebo to 100 mg q2w Due to EE/LE/CO n=291 Participants Participants initially randomized to placebo, then at EE, LE, or CO randomized to sirukumab 100 mg every two weeks (q2w) during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.	Sirukumab 50 mg q4w n=606 Participants Participants initially randomized to sirukumab 50 mg q4w during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.	Sirukumab 100 mg q2w n=618 Participants Participants initially randomized to sirukumab 100 mg q2w during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.
Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 At Week 2	—	—	0.2 Percentage of participants	0.2 Percentage of participants
Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 At Week 4	—	—	0.8 Percentage of participants	1.1 Percentage of participants
Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 At Week 6	—	—	1.2 Percentage of participants	2.9 Percentage of participants
Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 At Week 8	—	—	2.8 Percentage of participants	3.9 Percentage of participants
Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 At Week 12	—	—	4.5 Percentage of participants	6.4 Percentage of participants
Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 At Week 16	—	—	5.2 Percentage of participants	8.0 Percentage of participants
Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 At Week 18	—	—	7.5 Percentage of participants	7.1 Percentage of participants
Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 At Week 20	0 Percentage of participants	0 Percentage of participants	8.0 Percentage of participants	9.3 Percentage of participants
Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 At Week 24	1.8 Percentage of participants	1.9 Percentage of participants	9.8 Percentage of participants	10.7 Percentage of participants
Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 At Week 28	3.9 Percentage of participants	6.4 Percentage of participants	10.4 Percentage of participants	9.2 Percentage of participants
Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 At Week 32	4.0 Percentage of participants	7.1 Percentage of participants	9.9 Percentage of participants	12.4 Percentage of participants
Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 At Week 36	4.5 Percentage of participants	7.5 Percentage of participants	11.7 Percentage of participants	13.0 Percentage of participants
Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 At Week 40	7.5 Percentage of participants	11.0 Percentage of participants	13.7 Percentage of participants	13.7 Percentage of participants
Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 At Week 44	8.7 Percentage of participants	10.2 Percentage of participants	11.8 Percentage of participants	13.5 Percentage of participants
Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 At Week 48	8.2 Percentage of participants	12.3 Percentage of participants	14.9 Percentage of participants	12.8 Percentage of participants
Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 At Week 52	905 Percentage of participants	8.8 Percentage of participants	15.0 Percentage of participants	12.5 Percentage of participants
Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 At Week 76	16.9 Percentage of participants	13.7 Percentage of participants	16.8 Percentage of participants	14.2 Percentage of participants
Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 At Week 80	9.3 Percentage of participants	10.8 Percentage of participants	12.6 Percentage of participants	11.1 Percentage of participants
Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 At Week 104	14.3 Percentage of participants	18.2 Percentage of participants	17.8 Percentage of participants	19.8 Percentage of participants
Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 At Week 128	8.2 Percentage of participants	15.3 Percentage of participants	16.1 Percentage of participants	13.6 Percentage of participants
Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 At Week 132	18.3 Percentage of participants	15.8 Percentage of participants	20.5 Percentage of participants	19.0 Percentage of participants
Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 At Week 156	17.9 Percentage of participants	14.8 Percentage of participants	17.8 Percentage of participants	19.4 Percentage of participants
Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 At Week 180	18.3 Percentage of participants	20.4 Percentage of participants	22.5 Percentage of participants	24.0 Percentage of participants
Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 At Week 208	21.3 Percentage of participants	20.7 Percentage of participants	22.4 Percentage of participants	30.3 Percentage of participants
Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 At Week 232	25.39 Percentage of participants	20.2 Percentage of participants	27.3 Percentage of participants	29.8 Percentage of participants
Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 At Week 260	33.3 Percentage of participants	50.0 Percentage of participants	55.6 Percentage of participants	0 Percentage of participants

SECONDARY outcome

Timeframe: Baseline (Week 0 of primary studies), Week 2, 4, 6, 8, 12, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52, 76, 80, 104, 128, 132, 156, 180, 208, 232 and 260

Population: Population included all participants who were enrolled in this study. For "Placebo to 50mg" and "Placebo to 100mg" groups, only efficacy data collected after the escape or CO (after Week 18) to sirukumab was planned to be reported, with exception of baseline data. Here 'n' signifies number of participants analyzed at specified time point.

The Health Assessment Questionnaire-Disability Index (HAQ-DI) score is an evaluation of the functional status for a participant. The 20-question instrument 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, indicating no difficulty, to 3, indicating 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. Participants were analyzed for efficacy according to assigned treatment groups from the primary studies, regardless of treatments actually received.

Outcome measures

Measure	Placebo to 50 mg q4w Due to EE/LE/CO n=305 Participants Participants initially randomized to placebo, then at early escape (EE), late escape (LE), or cross over (CO) randomized to sirukumab 50 mg every 4 weeks (q4w) during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen (sirukumab 50 mg q4w) upon entering this long-term extension (LTE) study.	Placebo to 100 mg q2w Due to EE/LE/CO n=291 Participants Participants initially randomized to placebo, then at EE, LE, or CO randomized to sirukumab 100 mg every two weeks (q2w) during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.	Sirukumab 50 mg q4w n=606 Participants Participants initially randomized to sirukumab 50 mg q4w during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.	Sirukumab 100 mg q2w n=618 Participants Participants initially randomized to sirukumab 100 mg q2w during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 Change at Week 2	—	—	-0.1136 Units on Scale Standard Deviation 0.3455	-0.1230 Units on Scale Standard Deviation 0.3741
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 Change at Week 4	—	—	-0.2307 Units on Scale Standard Deviation 0.4173	-0.2417 Units on Scale Standard Deviation 0.4034
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 Change at Week 6	—	—	-0.3112 Units on Scale Standard Deviation 0.4944	-0.3683 Units on Scale Standard Deviation 0.4823
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 Change at Week 8	—	—	-0.3499 Units on Scale Standard Deviation 0.5077	-0.3914 Units on Scale Standard Deviation 0.5022
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 Change at Week 12	—	—	-0.3866 Units on Scale Standard Deviation 0.5421	-0.4121 Units on Scale Standard Deviation 0.5270
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 Change at Week 16	—	—	-0.3991 Units on Scale Standard Deviation 0.5611	-0.4414 Units on Scale Standard Deviation 0.5430
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 Change at Week 18	—	—	-0.4365 Units on Scale Standard Deviation 0.5476	-0.4621 Units on Scale Standard Deviation 0.5325
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 Change at Week 20	-0.1363 Units on Scale Standard Deviation 0.4947	-0.2005 Units on Scale Standard Deviation 0.4987	-0.4425 Units on Scale Standard Deviation 0.5826	-0.4920 Units on Scale Standard Deviation 0.5582
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 Change at Week 24	-0.3192 Units on Scale Standard Deviation 0.5279	-0.3267 Units on Scale Standard Deviation 0.4739	-0.4506 Units on Scale Standard Deviation 0.5665	-0.4876 Units on Scale Standard Deviation 0.5622
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 Change at Week 28	-0.3722 Units on Scale Standard Deviation 0.5683	-0.3836 Units on Scale Standard Deviation 0.4741	-0.4736 Units on Scale Standard Deviation 0.5696	-0.4912 Units on Scale Standard Deviation 0.5626
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 Change at Week 32	-0.3847 Units on Scale Standard Deviation 0.5651	-0.4015 Units on Scale Standard Deviation 0.5532	-0.4769 Units on Scale Standard Deviation 0.5880	-0.5307 Units on Scale Standard Deviation 0.5740
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 Change at Week 36	-0.3862 Units on Scale Standard Deviation 0.5474	-0.4339 Units on Scale Standard Deviation 0.5432	-0.4850 Units on Scale Standard Deviation 0.5764	-0.5176 Units on Scale Standard Deviation 0.5688
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 Change at Week 40	-0.4138 Units on Scale Standard Deviation 0.5778	-0.4509 Units on Scale Standard Deviation 0.4988	-0.4850 Units on Scale Standard Deviation 0.5894	-0.5039 Units on Scale Standard Deviation 0.5735
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 Change at Week 44	-0.4231 Units on Scale Standard Deviation 0.5809	-0.4461 Units on Scale Standard Deviation 0.5206	-0.4906 Units on Scale Standard Deviation 0.6088	-0.5297 Units on Scale Standard Deviation 0.5777
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 Change at Week 48	-0.4392 Units on Scale Standard Deviation 0.5911	-0.4567 Units on Scale Standard Deviation 0.5254	-0.4890 Units on Scale Standard Deviation 0.6242	-0.5470 Units on Scale Standard Deviation 0.5942
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 Change at Week 52	-0.4228 Units on Scale Standard Deviation 0.5752	-0.4609 Units on Scale Standard Deviation 0.5455	-0.4946 Units on Scale Standard Deviation 0.6021	-0.5374 Units on Scale Standard Deviation 0.5881
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 Change at Week 76	-0.5816 Units on Scale Standard Deviation 0.6313	-0.5351 Units on Scale Standard Deviation 0.5605	-0.5628 Units on Scale Standard Deviation 0.6089	-0.6128 Units on Scale Standard Deviation 0.5992
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 Change at Week 80	-0.2074 Units on Scale Standard Deviation 0.5333	-0.3980 Units on Scale Standard Deviation 0.5579	-0.3834 Units on Scale Standard Deviation 0.5685	-0.4211 Units on Scale Standard Deviation 0.5626
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 Change at Week 104	-0.4778 Units on Scale Standard Deviation 0.6569	-0.5107 Units on Scale Standard Deviation 0.5958	-0.5153 Units on Scale Standard Deviation 0.6094	-0.5579 Units on Scale Standard Deviation 0.5913
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 Change at Week 128	-0.2664 Units on Scale Standard Deviation 0.5963	-0.4476 Units on Scale Standard Deviation 0.5263	-0.3615 Units on Scale Standard Deviation 0.6227	-0.4506 Units on Scale Standard Deviation 0.5527
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 Change at Week 132	-0.4831 Units on Scale Standard Deviation 0.6979	-0.4815 Units on Scale Standard Deviation 0.6656	-0.5045 Units on Scale Standard Deviation 0.6542	-0.5310 Units on Scale Standard Deviation 0.6240
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 Change at Week 156	-0.4614 Units on Scale Standard Deviation 0.6610	-0.4984 Units on Scale Standard Deviation 0.6520	-0.4719 Units on Scale Standard Deviation 0.6604	-0.4998 Units on Scale Standard Deviation 0.6109
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 Change at Week 180	-0.4505 Units on Scale Standard Deviation 0.7024	-0.4957 Units on Scale Standard Deviation 0.5969	-0.5072 Units on Scale Standard Deviation 0.6492	-0.5258 Units on Scale Standard Deviation 0.6167
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 Change at Week 208	-0.4622 Units on Scale Standard Deviation 0.6898	-0.4973 Units on Scale Standard Deviation 0.6032	-0.5031 Units on Scale Standard Deviation 0.6701	-0.5588 Units on Scale Standard Deviation 0.6023
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 Change at Week 232	-0.4191 Units on Scale Standard Deviation 0.7410	-0.4655 Units on Scale Standard Deviation 0.6477	-0.5877 Units on Scale Standard Deviation 0.8312	-0.6069 Units on Scale Standard Deviation 0.6262
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 Change at Week 260	-0.5417 Units on Scale Standard Deviation 0.8323	-0.3750 Units on Scale Standard Deviation 1.0607	-0.2083 Units on Scale Standard Deviation 0.6702	-0.5000 Units on Scale Standard Deviation 0.4507

SECONDARY outcome

Timeframe: Week 2, 4, 6, 8, 12, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52, 76, 80, 104, 128, 132, 156, 180, 208, 232 and 260

Population: Population included all participants who were enrolled in this study. For "Placebo to 50mg" and "Placebo to 100mg" groups, only efficacy data collected after escape or CO (after Week 18) to sirukumab was planned to be reported, with exception of baseline data. Here 'n' signifies the number of participants analyzed at the specified time point.

HAQ-DI response was defined as change of less than -0.22 from baseline in HAQ-DI score. The HAQ-DI score is an evaluation of the functional status for a participant. The 20-question instrument 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, indicating no difficulty, to 3, indicating 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. Participants were analyzed for efficacy according to assigned treatment groups from the primary studies, regardless of treatments actually received.

Outcome measures

Measure	Placebo to 50 mg q4w Due to EE/LE/CO n=305 Participants Participants initially randomized to placebo, then at early escape (EE), late escape (LE), or cross over (CO) randomized to sirukumab 50 mg every 4 weeks (q4w) during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen (sirukumab 50 mg q4w) upon entering this long-term extension (LTE) study.	Placebo to 100 mg q2w Due to EE/LE/CO n=291 Participants Participants initially randomized to placebo, then at EE, LE, or CO randomized to sirukumab 100 mg every two weeks (q2w) during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.	Sirukumab 50 mg q4w n=606 Participants Participants initially randomized to sirukumab 50 mg q4w during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.	Sirukumab 100 mg q2w n=618 Participants Participants initially randomized to sirukumab 100 mg q2w during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.
Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 At Week 2	—	—	36.3 Percentage of participants	36.4 Percentage of participants
Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 At Week 4	—	—	48.3 Percentage of participants	51.3 Percentage of participants
Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 At Week 6	—	—	56.4 Percentage of participants	57.6 Percentage of participants
Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 At Week 8	—	—	58.0 Percentage of participants	62.5 Percentage of participants
Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 At Week 12	—	—	60.4 Percentage of participants	62.3 Percentage of participants
Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 At Week 16	—	—	62.0 Percentage of participants	63.2 Percentage of participants
Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 At Week 18	—	—	63.0 Percentage of participants	66.0 Percentage of participants
Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 At Week 20	40.5 Percentage of participants	45.3 Percentage of participants	64.0 Percentage of participants	67.1 Percentage of participants
Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 At Week 24	54.5 Percentage of participants	54.7 Percentage of participants	64.3 Percentage of participants	67.0 Percentage of participants
Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 At Week 28	58.3 Percentage of participants	61.5 Percentage of participants	66.7 Percentage of participants	66.8 Percentage of participants
Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 At Week 32	59.4 Percentage of participants	59.4 Percentage of participants	65.2 Percentage of participants	68.1 Percentage of participants
Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 At Week 36	61.2 Percentage of participants	64.9 Percentage of participants	67.1 Percentage of participants	67.9 Percentage of participants
Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 At Week 40	61.0 Percentage of participants	67.1 Percentage of participants	65.4 Percentage of participants	66.6 Percentage of participants
Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 At Week 44	62.6 Percentage of participants	65.2 Percentage of participants	65.8 Percentage of participants	67.9 Percentage of participants
Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 At Week 48	61.5 Percentage of participants	65.9 Percentage of participants	65.6 Percentage of participants	70.1 Percentage of participants
Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 At Week 52	60.7 Percentage of participants	65.9 Percentage of participants	65.6 Percentage of participants	68.9 Percentage of participants
Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 At Week 76	70.4 Percentage of participants	69.2 Percentage of participants	68.4 Percentage of participants	73.7 Percentage of participants
Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 At Week 80	40.7 Percentage of participants	58.6 Percentage of participants	58.1 Percentage of participants	62.0 Percentage of participants
Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 At Week 104	64.2 Percentage of participants	68.4 Percentage of participants	66.1 Percentage of participants	68.0 Percentage of participants
Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 At Week 128	51.3 Percentage of participants	64.9 Percentage of participants	54.8 Percentage of participants	61.1 Percentage of participants
Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 At Week 132	65.2 Percentage of participants	63.3 Percentage of participants	66.3 Percentage of participants	69.9 Percentage of participants
Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 At Week 156	62.6 Percentage of participants	64.5 Percentage of participants	65.0 Percentage of participants	66.9 Percentage of participants
Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 At Week 180	61.0 Percentage of participants	69.3 Percentage of participants	66.4 Percentage of participants	72.3 Percentage of participants
Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 At Week 208	65.1 Percentage of participants	69.1 Percentage of participants	71.1 Percentage of participants	72.4 Percentage of participants
Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 At Week 232	67.6 Percentage of participants	69.0 Percentage of participants	65.7 Percentage of participants	72.5 Percentage of participants
Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 At Week 260	66.7 Percentage of participants	50.0 Percentage of participants	44.4 Percentage of participants	66.7 Percentage of participants

Adverse Events

Placebo to 50 mg q4w Due to EE/LE/CO

Serious events: 65 serious events

Other events: 139 other events

Deaths: 5 deaths

Placebo to 100 mg q2w Due to EE/LE/CO

Serious events: 81 serious events

Other events: 135 other events

Deaths: 7 deaths

Sirukumab 50 mg q4w

Serious events: 160 serious events

Other events: 268 other events

Deaths: 13 deaths

Sirukumab 100 mg q2w

Serious events: 143 serious events

Other events: 281 other events

Deaths: 8 deaths

Serious adverse events

Measure	Placebo to 50 mg q4w Due to EE/LE/CO n=305 participants at risk Participants initially randomized to placebo, then at early escape (EE), late escape (LE), or cross over (CO) randomized to sirukumab 50 mg every 4 weeks (q4w) during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen (sirukumab 50 mg q4w) upon entering this long-term extension (LTE) study.	Placebo to 100 mg q2w Due to EE/LE/CO n=291 participants at risk Participants initially randomized to placebo, then at EE, LE, or CO randomized to sirukumab 100 mg every two weeks (q2w) during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.	Sirukumab 50 mg q4w n=605 participants at risk Participants initially randomized to sirukumab 50 mg q4w during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.	Sirukumab 100 mg q2w n=619 participants at risk Participants initially randomized to sirukumab 100 mg q2w during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.
Blood and lymphatic system disorders Anaemia	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Blood and lymphatic system disorders Bone marrow failure	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.34% 1/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Blood and lymphatic system disorders Haemorrhagic anaemia	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Blood and lymphatic system disorders Hypochromic anaemia	0.33% 1/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Blood and lymphatic system disorders Leukopenia	0.33% 1/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Blood and lymphatic system disorders Lymphadenitis	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.32% 2/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Blood and lymphatic system disorders Neutropenia	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.50% 3/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Cardiac disorders Acute left ventricular failure	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Cardiac disorders Acute myocardial infarction	0.33% 1/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.50% 3/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.48% 3/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Cardiac disorders Angina pectoris	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.33% 2/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Cardiac disorders Angina unstable	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.50% 3/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Cardiac disorders Atrial fibrillation	0.33% 1/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.33% 2/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.97% 6/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Cardiac disorders Atrial flutter	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Cardiac disorders Bradycardia	0.33% 1/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Cardiac disorders Cardiac arrest	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Cardiac disorders Cardiac failure	0.33% 1/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Cardiac disorders Cardiac failure congestive	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.34% 1/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Cardiac disorders Cardiac tamponade	0.33% 1/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Cardiac disorders Cardio-respiratory arrest	0.33% 1/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Cardiac disorders Cardiomyopathy	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Cardiac disorders Coronary artery disease	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Cardiac disorders Coronary artery insufficiency	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Cardiac disorders Hypertensive heart disease	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Cardiac disorders Mitral valve incompetence	0.33% 1/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Cardiac disorders Myocardial infarction	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Cardiac disorders Myocardial ischaemia	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.34% 1/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Cardiac disorders Pericarditis	0.33% 1/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Cardiac disorders Sinus node dysfunction	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.34% 1/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Cardiac disorders Sinus tachycardia	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.34% 1/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Congenital, familial and genetic disorders Hydrocele	0.33% 1/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Ear and labyrinth disorders Inner ear disorder	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Ear and labyrinth disorders Meniere's disease	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Endocrine disorders Hypothyroidism	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Eye disorders Blindness	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Eye disorders Cataract	0.33% 1/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.34% 1/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.50% 3/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Eye disorders Corneal perforation	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Eye disorders Keratitis	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Eye disorders Retinal detachment	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Eye disorders Scleritis	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Eye disorders Ulcerative keratitis	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.34% 1/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Gastrointestinal disorders Abdominal hernia	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Gastrointestinal disorders Anal fissure	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.34% 1/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Gastrointestinal disorders Colitis	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.69% 2/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Gastrointestinal disorders Colitis ischaemic	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Gastrointestinal disorders Diverticular perforation	0.33% 1/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.34% 1/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.48% 3/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Gastrointestinal disorders Diverticulum intestinal haemorrhagic	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Gastrointestinal disorders Duodenal ulcer	0.33% 1/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Gastrointestinal disorders Enterocolitis	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Gastrointestinal disorders Gastric volvulus	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Gastrointestinal disorders Gastritis	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.34% 1/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Gastrointestinal disorders Gastrointestinal angiodysplasia haemorrhagic	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.34% 1/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Gastrointestinal disorders Haematemesis	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.34% 1/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.32% 2/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Gastrointestinal disorders Haemorrhoids thrombosed	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Gastrointestinal disorders Inguinal hernia	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.34% 1/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Gastrointestinal disorders Intestinal ischaemia	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Gastrointestinal disorders Large intestine perforation	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.69% 2/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Gastrointestinal disorders Mesenteric vein thrombosis	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Gastrointestinal disorders Pancreatic cyst	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.34% 1/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Gastrointestinal disorders Pancreatitis	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Gastrointestinal disorders Pancreatitis acute	0.33% 1/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.34% 1/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
General disorders Chest pain	0.33% 1/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.34% 1/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
General disorders Death	0.33% 1/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
General disorders Implant site haematoma	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
General disorders Multiple organ dysfunction syndrome	0.33% 1/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
General disorders Non-cardiac chest pain	0.33% 1/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
General disorders Peripheral swelling	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
General disorders Soft tissue inflammation	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.34% 1/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
General disorders Sudden cardiac death	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Hepatobiliary disorders Biliary colic	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.34% 1/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.33% 2/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Hepatobiliary disorders Cholelithiasis	0.33% 1/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.69% 2/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Hepatobiliary disorders Sphincter of Oddi dysfunction	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Infections and infestations Abscess	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Infections and infestations Abscess intestinal	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Infections and infestations Pyomyositis	0.33% 1/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Infections and infestations Abscess limb	0.66% 2/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.34% 1/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Infections and infestations Anal abscess	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Infections and infestations Appendicitis	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.34% 1/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.33% 2/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Infections and infestations Arthritis bacterial	0.33% 1/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.34% 1/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.33% 2/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Infections and infestations Bacteraemia	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Infections and infestations Bacterial pyelonephritis	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.34% 1/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Infections and infestations Beta haemolytic streptococcal infection	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Infections and infestations Breast abscess	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Infections and infestations Breast cellulitis	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.34% 1/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Infections and infestations Bronchitis	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Infections and infestations Bursitis infective staphylococcal	0.33% 1/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.32% 2/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Infections and infestations Cellulitis	0.98% 3/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	1.4% 4/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	2.0% 12/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	1.6% 10/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Infections and infestations Colonic abscess	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Infections and infestations Cystitis	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.33% 2/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Infections and infestations Dermatitis infected	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Infections and infestations Device related infection	0.33% 1/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.34% 1/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Infections and infestations Diverticulitis	0.66% 2/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.34% 1/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.32% 2/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Infections and infestations Erysipelas	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.66% 4/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.81% 5/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Infections and infestations Extradural abscess	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Infections and infestations Gangrene	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Infections and infestations Gastroenteritis	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Infections and infestations Gastroenteritis salmonella	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.34% 1/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Infections and infestations Gastroenteritis viral	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Infections and infestations Haematoma infection	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.34% 1/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Infections and infestations Hepatitis E	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Infections and infestations Herpes zoster	0.33% 1/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.34% 1/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Infections and infestations Herpes zoster disseminated	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Infections and infestations Infected seroma	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Infections and infestations Infected skin ulcer	0.33% 1/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Infections and infestations Infectious pleural effusion	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Infections and infestations Infective tenosynovitis	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Infections and infestations Intervertebral discitis	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Infections and infestations Klebsiella infection	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.34% 1/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Infections and infestations Localised infection	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.34% 1/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Infections and infestations Lower respiratory tract infection	0.66% 2/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Infections and infestations Mastitis	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Infections and infestations Medical device site joint infection	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Infections and infestations Meningitis pneumococcal	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Infections and infestations Necrotising fasciitis	0.33% 1/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.33% 2/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Infections and infestations Ophthalmic herpes zoster	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Infections and infestations Osteomyelitis	0.66% 2/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.34% 1/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.33% 2/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.48% 3/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Infections and infestations Peritonitis	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.34% 1/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Infections and infestations Pilonidal cyst	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Infections and infestations Pneumococcal sepsis	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.34% 1/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Infections and infestations Pneumonia	1.3% 4/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	2.7% 8/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	1.5% 9/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	3.1% 19/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Infections and infestations Pneumonia bacterial	0.33% 1/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Infections and infestations Pneumonia pneumococcal	0.33% 1/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.34% 1/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Infections and infestations Pneumonia viral	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.34% 1/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Infections and infestations Post procedural infection	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Infections and infestations Postoperative wound infection	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.34% 1/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Infections and infestations Psoas abscess	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Infections and infestations Pyelonephritis	0.33% 1/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.34% 1/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Infections and infestations Pyelonephritis acute	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.33% 2/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Infections and infestations Respiratory tract infection	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Infections and infestations Sepsis	0.33% 1/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	2.1% 6/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.50% 3/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.81% 5/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Infections and infestations Septic shock	0.33% 1/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	1.0% 3/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.32% 2/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Infections and infestations Soft tissue infection	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Infections and infestations Spinal cord infection	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Infections and infestations Staphylococcal abscess	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.32% 2/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Infections and infestations Staphylococcal infection	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.34% 1/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Infections and infestations Staphylococcal sepsis	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Infections and infestations Staphylococcal skin infection	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Infections and infestations Streptococcal abscess	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Infections and infestations Streptococcal endocarditis	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Infections and infestations Tooth abscess	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Infections and infestations Tuberculosis	0.33% 1/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Infections and infestations Urinary tract infection	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.33% 2/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.32% 2/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Infections and infestations Urosepsis	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Infections and infestations Vulval abscess	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Infections and infestations Wound infection	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Injury, poisoning and procedural complications Acetabulum fracture	0.33% 1/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Injury, poisoning and procedural complications Comminuted fracture	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.34% 1/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Injury, poisoning and procedural complications Dislocation of vertebra	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.34% 1/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Injury, poisoning and procedural complications Femoral neck fracture	0.66% 2/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.34% 1/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.33% 2/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Injury, poisoning and procedural complications Femur fracture	0.66% 2/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Injury, poisoning and procedural complications Fractured sacrum	0.33% 1/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Injury, poisoning and procedural complications Hand fracture	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.34% 1/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Injury, poisoning and procedural complications Hip fracture	0.33% 1/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Injury, poisoning and procedural complications Joint dislocation	0.33% 1/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.69% 2/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.33% 2/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Injury, poisoning and procedural complications Joint injury	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.34% 1/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Injury, poisoning and procedural complications Ligament rupture	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Injury, poisoning and procedural complications Limb injury	0.33% 1/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Injury, poisoning and procedural complications Lower limb fracture	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.33% 2/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Injury, poisoning and procedural complications Multiple injuries	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Injury, poisoning and procedural complications Muscle injury	0.33% 1/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoproliferative disorder	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.33% 2/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Injury, poisoning and procedural complications Muscle rupture	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Injury, poisoning and procedural complications Overdose	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Injury, poisoning and procedural complications Patella fracture	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Injury, poisoning and procedural complications Pelvic fracture	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.34% 1/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Injury, poisoning and procedural complications Periprosthetic fracture	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Injury, poisoning and procedural complications Pneumothorax traumatic	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Injury, poisoning and procedural complications Post procedural fistula	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Injury, poisoning and procedural complications Postoperative thrombosis	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.34% 1/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Injury, poisoning and procedural complications Radius fracture	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Injury, poisoning and procedural complications Skin injury	0.33% 1/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.34% 1/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.33% 2/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Injury, poisoning and procedural complications Splenic rupture	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.34% 1/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Injury, poisoning and procedural complications Subarachnoid haemorrhage	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Injury, poisoning and procedural complications Synovial rupture	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Injury, poisoning and procedural complications Tendon rupture	0.66% 2/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.69% 2/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Injury, poisoning and procedural complications Ulna fracture	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Injury, poisoning and procedural complications Upper limb fracture	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.34% 1/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Injury, poisoning and procedural complications Vascular pseudoaneurysm	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.34% 1/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Injury, poisoning and procedural complications Wound necrosis	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Injury, poisoning and procedural complications Wrist fracture	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Investigations Alanine aminotransferase increased	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Investigations Aspartate aminotransferase increased	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Investigations Transaminases increased	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Metabolism and nutrition disorders Dehydration	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.69% 2/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Metabolism and nutrition disorders Diabetes mellitus	0.33% 1/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Metabolism and nutrition disorders Hyperlipidaemia	0.33% 1/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Metabolism and nutrition disorders Hypokalaemia	0.33% 1/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Metabolism and nutrition disorders Hypoproteinaemia	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Musculoskeletal and connective tissue disorders Arthralgia	0.66% 2/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.32% 2/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.69% 2/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Musculoskeletal and connective tissue disorders Atlantoaxial instability	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Musculoskeletal and connective tissue disorders Back pain	0.33% 1/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.34% 1/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Musculoskeletal and connective tissue disorders Bursitis	0.66% 2/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Musculoskeletal and connective tissue disorders Finger deformity	0.33% 1/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Musculoskeletal and connective tissue disorders Foot deformity	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.34% 1/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Musculoskeletal and connective tissue disorders Intervertebral disc disorder	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.69% 2/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.34% 1/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.50% 3/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Musculoskeletal and connective tissue disorders Mixed connective tissue disease	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.34% 1/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.34% 1/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.34% 1/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.66% 2/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	3.1% 9/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.50% 3/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	1.5% 9/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Musculoskeletal and connective tissue disorders Osteochondrosis	0.33% 1/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.33% 1/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Musculoskeletal and connective tissue disorders Pathological fracture	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Musculoskeletal and connective tissue disorders Pseudarthrosis	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.69% 2/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.99% 6/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.81% 5/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.34% 1/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Musculoskeletal and connective tissue disorders Synovitis	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute promyelocytic leukaemia	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.34% 1/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign ovarian tumour	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.34% 1/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.34% 1/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.48% 3/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Central nervous system lymphoma	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.34% 1/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon adenoma	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diffuse large B-cell lymphoma	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Inflammatory pseudotumour	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraductal proliferative breast lesion	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Psychiatric disorders Acute psychosis	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Monoclonal gammopathy	0.33% 1/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelofibrosis	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkin's lymphoma	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.34% 1/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary thyroid cancer	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.34% 1/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer stage III	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.34% 1/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Schwannoma	0.33% 1/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of lung	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.34% 1/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of pharynx	0.33% 1/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tonsil cancer	0.33% 1/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine cancer	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.34% 1/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Vaginal cancer	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Nervous system disorders Amnesia	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Nervous system disorders Carpal tunnel syndrome	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Nervous system disorders Cerebellar infarction	0.33% 1/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Nervous system disorders Cerebral artery embolism	0.33% 1/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Nervous system disorders Cerebral haematoma	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Nervous system disorders Cerebral haemorrhage	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.34% 1/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Nervous system disorders Cerebral infarction	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.66% 4/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Nervous system disorders Cerebrovascular accident	0.33% 1/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.34% 1/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.48% 3/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Nervous system disorders Cubital tunnel syndrome	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Nervous system disorders Dizziness postural	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Nervous system disorders Epilepsy	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Nervous system disorders Facial paresis	0.33% 1/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Nervous system disorders Hemiparesis	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Nervous system disorders Hypertensive encephalopathy	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Nervous system disorders IIIrd nerve paralysis	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Nervous system disorders Intracranial mass	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.34% 1/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Nervous system disorders Ischaemic stroke	0.33% 1/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Nervous system disorders Lumbar radiculopathy	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Nervous system disorders Mononeuropathy multiplex	0.33% 1/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Nervous system disorders Myxoedema coma	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Nervous system disorders Spondylitic myelopathy	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Nervous system disorders Syncope	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.69% 2/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Nervous system disorders Transient ischaemic attack	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.34% 1/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Nervous system disorders Ulnar tunnel syndrome	0.33% 1/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Product Issues Device dislocation	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.34% 1/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.33% 2/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Product Issues Device loosening	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Psychiatric disorders Alcohol abuse	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.34% 1/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Psychiatric disorders Conversion disorder	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Psychiatric disorders Depression	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.50% 3/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Psychiatric disorders Depression suicidal	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Psychiatric disorders Disorientation	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.34% 1/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Psychiatric disorders Mental status changes	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Psychiatric disorders Persistent depressive disorder	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Psychiatric disorders Suicidal ideation	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Psychiatric disorders Suicide attempt	0.33% 1/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Renal and urinary disorders Acute kidney injury	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.33% 2/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.81% 5/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Renal and urinary disorders Calculus urethral	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Renal and urinary disorders Calculus urinary	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.34% 1/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Renal and urinary disorders Cystitis interstitial	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Renal and urinary disorders Glomerulonephritis	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Renal and urinary disorders Hydronephrosis	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.33% 2/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Renal and urinary disorders IgA nephropathy	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Renal and urinary disorders Incontinence	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Renal and urinary disorders Lupus nephritis	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Renal and urinary disorders Nephrolithiasis	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.34% 1/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.50% 3/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.32% 2/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Renal and urinary disorders Renal failure	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Renal and urinary disorders Renal haematoma	0.33% 1/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Renal and urinary disorders Stag horn calculus	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Renal and urinary disorders Ureterolithiasis	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.34% 1/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.50% 3/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Reproductive system and breast disorders Cervical polyp	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Reproductive system and breast disorders Endometriosis	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Reproductive system and breast disorders Genital haemorrhage	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Reproductive system and breast disorders Metrorrhagia	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.34% 1/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Reproductive system and breast disorders Ovarian cyst	0.33% 1/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Reproductive system and breast disorders Ovarian cyst ruptured	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Reproductive system and breast disorders Pelvic prolapse	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Reproductive system and breast disorders Uterine polyp	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.32% 2/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.32% 2/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.34% 1/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.48% 3/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.34% 1/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.33% 2/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.32% 2/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Respiratory, thoracic and mediastinal disorders Diaphragmatic disorder	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.33% 1/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.48% 3/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.34% 1/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.33% 1/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.69% 2/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.32% 2/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.33% 1/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.33% 1/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Skin and subcutaneous tissue disorders Cutaneous vasculitis	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Skin and subcutaneous tissue disorders Dermatitis bullous	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.34% 1/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Skin and subcutaneous tissue disorders Diabetic foot	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Skin and subcutaneous tissue disorders Hypersensitivity vasculitis	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Skin and subcutaneous tissue disorders Skin necrosis	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.34% 1/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.34% 1/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.83% 5/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Skin and subcutaneous tissue disorders Subcutaneous emphysema	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Vascular disorders Aortic aneurysm	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Vascular disorders Aortic dissection	0.33% 1/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.34% 1/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Vascular disorders Aortic stenosis	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Vascular disorders Deep vein thrombosis	0.33% 1/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.34% 1/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.33% 2/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.32% 2/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Vascular disorders Hypertension	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.34% 1/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Vascular disorders Hypertensive crisis	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.50% 3/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Vascular disorders Malignant hypertension	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Vascular disorders Penetrating aortic ulcer	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.17% 1/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Vascular disorders Peripheral vascular disorder	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.34% 1/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Vascular disorders Thrombophlebitis	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.34% 1/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Vascular disorders Varicose vein	0.33% 1/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Vascular disorders Vasculitis	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Vascular disorders Vasculitis necrotising	0.00% 0/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.00% 0/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	0.16% 1/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.

Other adverse events

Measure	Placebo to 50 mg q4w Due to EE/LE/CO n=305 participants at risk Participants initially randomized to placebo, then at early escape (EE), late escape (LE), or cross over (CO) randomized to sirukumab 50 mg every 4 weeks (q4w) during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen (sirukumab 50 mg q4w) upon entering this long-term extension (LTE) study.	Placebo to 100 mg q2w Due to EE/LE/CO n=291 participants at risk Participants initially randomized to placebo, then at EE, LE, or CO randomized to sirukumab 100 mg every two weeks (q2w) during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.	Sirukumab 50 mg q4w n=605 participants at risk Participants initially randomized to sirukumab 50 mg q4w during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.	Sirukumab 100 mg q2w n=619 participants at risk Participants initially randomized to sirukumab 100 mg q2w during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study.
Blood and lymphatic system disorders Leukopenia	1.6% 5/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	4.8% 14/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	3.8% 23/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	5.3% 33/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
General disorders Injection site erythema	3.3% 10/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	5.8% 17/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	2.6% 16/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	4.2% 26/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Infections and infestations Bronchitis	9.5% 29/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	6.9% 20/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	5.3% 32/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	6.6% 41/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Infections and infestations Upper respiratory tract infection	9.8% 30/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	12.0% 35/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	8.6% 52/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	10.0% 62/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Infections and infestations Urinary tract infection	3.6% 11/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	5.2% 15/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	4.0% 24/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	2.7% 17/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Infections and infestations Viral upper respiratory tract infection	12.1% 37/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	12.4% 36/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	12.1% 73/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	12.9% 80/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Investigations Alanine aminotransferase increased	8.9% 27/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	10.0% 29/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	5.8% 35/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	7.6% 47/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Investigations Aspartate aminotransferase increased	5.2% 16/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	6.2% 18/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	3.6% 22/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	5.7% 35/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	11.5% 35/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	10.3% 30/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	13.2% 80/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	10.5% 65/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.
Vascular disorders Hypertension	4.6% 14/305 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	4.8% 14/291 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	5.1% 31/605 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.	5.0% 31/619 • Baseline of this LTE study through up to 4.3 years Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses. In treatment group 'Placebo to 100 mg q2w Due to EE/LE/CO', 6 deaths happened during the CNTO136ARA3004 study. One additional death was reported in this group after the participant was discontinued from the study.

Additional Information

Associate Director, Clinical Development

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Phone: 844-434-4210

Email: ClinicalTrialDisclosure@its.jnj.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER