Trial Outcomes & Findings for An Extension Study of Tocilizumab (Myeloma Receptor Antibody [MRA]) in Patients Completing Treatment in Tocilizumab Core Studies (NCT NCT00720798)

NCT ID: NCT00720798

Last Updated: 2014-09-30

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

2067 participants

Primary outcome timeframe

Baseline to the end of the study (up to 7 years, 7 months)

Results posted on

2014-09-30

Participant Flow

Participant milestones

Participant milestones
Measure	Tocilizumab Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
Overall Study STARTED	2067
Overall Study COMPLETED	1311
Overall Study NOT COMPLETED	756

Reasons for withdrawal

Reasons for withdrawal
Measure	Tocilizumab Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
Overall Study Adverse Event	304
Overall Study Death	39
Overall Study Insufficient Therapeutic Response	129
Overall Study Protocol Violation	4
Overall Study Refused Treatment	151
Overall Study Failure to Return	46
Overall Study Reason not Specified	83

Baseline Characteristics

An Extension Study of Tocilizumab (Myeloma Receptor Antibody [MRA]) in Patients Completing Treatment in Tocilizumab Core Studies

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tocilizumab n=2067 Participants Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
Age, Continuous	52.2 years STANDARD_DEVIATION 12.60 • n=5 Participants
Sex: Female, Male Female	1689 Participants n=5 Participants
Sex: Female, Male Male	378 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to the end of the study (up to 7 years, 7 months)

Population: All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.

Outcome measures

Outcome measures
Measure	Tocilizumab n=2067 Participants Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
Percentage of Participants With ≥ 1 Adverse Event	96.3 Percentage of participants

SECONDARY outcome

Timeframe: Baseline to the end of the study (up to 7 years, 7 months)

Population: All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.

Outcome measures

Outcome measures
Measure	Tocilizumab n=2067 Participants Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
Percentage of Participants Who Withdrew From Treatment	36.6 Percentage of participants

SECONDARY outcome

Timeframe: Baseline to the end of the study (up to 7 years, 7 months)

Population: All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.

Concomitant therapy with oral corticosteroids (up 5 to 10 mg daily prednisone or equivalent) was permitted in the study. Reduction of oral corticosteroids was permitted, but not required, if a patient achieved at least a 50% improvement from baseline in both tender joint count and swollen joint count. The data are reported for each 6-month period of the study where a month = 28 days. The last 6-month period is for months 96 through 101. The actually study duration in 28-day months was 98.85 months.

Outcome measures

Outcome measures
Measure	Tocilizumab n=2067 Participants Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
Percentage of Participants With Concomitant Oral Corticosteroid Therapy 72 - 78 Months, n = 788	48.7 Percentage of participants
Percentage of Participants With Concomitant Oral Corticosteroid Therapy 78 - 84 Months, n = 62	72.6 Percentage of participants
Percentage of Participants With Concomitant Oral Corticosteroid Therapy 84 - 90 Months, n = 34	79.4 Percentage of participants
Percentage of Participants With Concomitant Oral Corticosteroid Therapy 90 - 96 Months, n = 10	70.0 Percentage of participants
Percentage of Participants With Concomitant Oral Corticosteroid Therapy 0 - 6 Months, n = 2067	55.8 Percentage of participants
Percentage of Participants With Concomitant Oral Corticosteroid Therapy 6 - 12 Months, n = 2041	55.3 Percentage of participants
Percentage of Participants With Concomitant Oral Corticosteroid Therapy 12 - 18 Months, n = 1944	54.6 Percentage of participants
Percentage of Participants With Concomitant Oral Corticosteroid Therapy 18 - 24 Months, n = 1832	54.3 Percentage of participants
Percentage of Participants With Concomitant Oral Corticosteroid Therapy 24 - 30 Months, n = 1753	53.2 Percentage of participants
Percentage of Participants With Concomitant Oral Corticosteroid Therapy 30 - 36 Months, n = 1677	52.9 Percentage of participants
Percentage of Participants With Concomitant Oral Corticosteroid Therapy 36 - 42 Months, n = 1620	51.3 Percentage of participants
Percentage of Participants With Concomitant Oral Corticosteroid Therapy 42 - 48 Months, n = 1568	50.4 Percentage of participants
Percentage of Participants With Concomitant Oral Corticosteroid Therapy 48 - 54 Months, n = 1516	50.6 Percentage of participants
Percentage of Participants With Concomitant Oral Corticosteroid Therapy 54 - 60 Months, n = 1475	50.1 Percentage of participants
Percentage of Participants With Concomitant Oral Corticosteroid Therapy 60 - 66 Months, n = 1423	49.2 Percentage of participants
Percentage of Participants With Concomitant Oral Corticosteroid Therapy 66 - 72 Months, n = 1342	48.4 Percentage of participants
Percentage of Participants With Concomitant Oral Corticosteroid Therapy 96 - 102 Months, n = 2	0.0 Percentage of participants

SECONDARY outcome

Timeframe: Baseline to Week 296

Population: All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants from the core study WA17824 are included in the analysis.

Participants who entered this study from study WA17824 on tocilizumab monotherapy, who did not achieve a 50% reduction in tender and swollen joint counts from Baseline of study WA17824, could add methotrexate or another allowable disease-modifying anti-rheumatic drug, according to the investigator's practice and as tolerated by the patient, at any time during this study.

Outcome measures

Outcome measures
Measure	Tocilizumab n=243 Participants Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
Percentage of Participants Who Changed From Monotherapy to Combination Therapy Week 8	1.2 Percentage of participants
Percentage of Participants Who Changed From Monotherapy to Combination Therapy Week 12	0.4 Percentage of participants
Percentage of Participants Who Changed From Monotherapy to Combination Therapy Week 24	15.6 Percentage of participants
Percentage of Participants Who Changed From Monotherapy to Combination Therapy Week 28	7.0 Percentage of participants
Percentage of Participants Who Changed From Monotherapy to Combination Therapy Week 32	2.5 Percentage of participants
Percentage of Participants Who Changed From Monotherapy to Combination Therapy Week 36	1.6 Percentage of participants
Percentage of Participants Who Changed From Monotherapy to Combination Therapy Week 40	0.4 Percentage of participants
Percentage of Participants Who Changed From Monotherapy to Combination Therapy Week 44	0.4 Percentage of participants
Percentage of Participants Who Changed From Monotherapy to Combination Therapy Week 48	1.6 Percentage of participants
Percentage of Participants Who Changed From Monotherapy to Combination Therapy Week 52	0.8 Percentage of participants
Percentage of Participants Who Changed From Monotherapy to Combination Therapy Week 54	0.8 Percentage of participants
Percentage of Participants Who Changed From Monotherapy to Combination Therapy Week 64	1.2 Percentage of participants
Percentage of Participants Who Changed From Monotherapy to Combination Therapy Week 68	0.8 Percentage of participants
Percentage of Participants Who Changed From Monotherapy to Combination Therapy Week 72	0.8 Percentage of participants
Percentage of Participants Who Changed From Monotherapy to Combination Therapy Week 76	0.4 Percentage of participants
Percentage of Participants Who Changed From Monotherapy to Combination Therapy Week 88	0.8 Percentage of participants
Percentage of Participants Who Changed From Monotherapy to Combination Therapy Week 96	1.2 Percentage of participants
Percentage of Participants Who Changed From Monotherapy to Combination Therapy Week 100	0.8 Percentage of participants
Percentage of Participants Who Changed From Monotherapy to Combination Therapy Week 104	0.4 Percentage of participants
Percentage of Participants Who Changed From Monotherapy to Combination Therapy Week 108	0.4 Percentage of participants
Percentage of Participants Who Changed From Monotherapy to Combination Therapy Week 112	0.4 Percentage of participants
Percentage of Participants Who Changed From Monotherapy to Combination Therapy Week 116	0.4 Percentage of participants
Percentage of Participants Who Changed From Monotherapy to Combination Therapy Week 120	0.4 Percentage of participants
Percentage of Participants Who Changed From Monotherapy to Combination Therapy Week 140	0.4 Percentage of participants
Percentage of Participants Who Changed From Monotherapy to Combination Therapy Week 152	0.8 Percentage of participants
Percentage of Participants Who Changed From Monotherapy to Combination Therapy Week 184	0.4 Percentage of participants
Percentage of Participants Who Changed From Monotherapy to Combination Therapy Week 196	0.4 Percentage of participants
Percentage of Participants Who Changed From Monotherapy to Combination Therapy Week 200	0.8 Percentage of participants
Percentage of Participants Who Changed From Monotherapy to Combination Therapy Week 292	0.4 Percentage of participants
Percentage of Participants Who Changed From Monotherapy to Combination Therapy Week 296	0.8 Percentage of participants

SECONDARY outcome

Timeframe: Baseline to Week 264

Improvement must be seen in tender (68 assessed joints) and swollen joint counts (66 assessed joints) and in at least 3 of the following 5 parameters: Separate patient and physician assessments of patient disease activity in the previous 24 hours on a visual analog scale (VAS, the left end of the scale "no disease activity" \[symptom-free and no arthritis symptoms\], right end of the scale "maximum disease activity"); patient assessment of pain in the previous 24 hours on a VAS (left end of the scale "no pain", right end of the scale "unbearable pain"); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and erythrocyte sedimentation rate.

Outcome measures

Outcome measures
Measure	Tocilizumab n=2067 Participants Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
Percentage of Participants With an Improvement of at Least 20%, 50%, 70%, or 90% in the American College of Rheumatology (ACR) Score (ACR20/50/70/90) From Baseline at Weeks 24, 48, 108, 156, 204, and 264 ACR20 Week 24 (n=1966)	59.5 Percentage of participants
Percentage of Participants With an Improvement of at Least 20%, 50%, 70%, or 90% in the American College of Rheumatology (ACR) Score (ACR20/50/70/90) From Baseline at Weeks 24, 48, 108, 156, 204, and 264 ACR20 Week 48 (n=1825)	66.7 Percentage of participants
Percentage of Participants With an Improvement of at Least 20%, 50%, 70%, or 90% in the American College of Rheumatology (ACR) Score (ACR20/50/70/90) From Baseline at Weeks 24, 48, 108, 156, 204, and 264 ACR20 Week 108 (n=1607)	74.1 Percentage of participants
Percentage of Participants With an Improvement of at Least 20%, 50%, 70%, or 90% in the American College of Rheumatology (ACR) Score (ACR20/50/70/90) From Baseline at Weeks 24, 48, 108, 156, 204, and 264 ACR20 Week 156 (n=1512)	74.3 Percentage of participants
Percentage of Participants With an Improvement of at Least 20%, 50%, 70%, or 90% in the American College of Rheumatology (ACR) Score (ACR20/50/70/90) From Baseline at Weeks 24, 48, 108, 156, 204, and 264 ACR20 Week 204 (n=1415)	77.5 Percentage of participants
Percentage of Participants With an Improvement of at Least 20%, 50%, 70%, or 90% in the American College of Rheumatology (ACR) Score (ACR20/50/70/90) From Baseline at Weeks 24, 48, 108, 156, 204, and 264 ACR20 Week 264 (n = 1319)	78.7 Percentage of participants
Percentage of Participants With an Improvement of at Least 20%, 50%, 70%, or 90% in the American College of Rheumatology (ACR) Score (ACR20/50/70/90) From Baseline at Weeks 24, 48, 108, 156, 204, and 264 ACR50 Week 24 (n=1966)	34.9 Percentage of participants
Percentage of Participants With an Improvement of at Least 20%, 50%, 70%, or 90% in the American College of Rheumatology (ACR) Score (ACR20/50/70/90) From Baseline at Weeks 24, 48, 108, 156, 204, and 264 ACR50 Week 48 (n=1825)	44.4 Percentage of participants
Percentage of Participants With an Improvement of at Least 20%, 50%, 70%, or 90% in the American College of Rheumatology (ACR) Score (ACR20/50/70/90) From Baseline at Weeks 24, 48, 108, 156, 204, and 264 ACR50 Week 108 (n=1607)	52.8 Percentage of participants
Percentage of Participants With an Improvement of at Least 20%, 50%, 70%, or 90% in the American College of Rheumatology (ACR) Score (ACR20/50/70/90) From Baseline at Weeks 24, 48, 108, 156, 204, and 264 ACR50 Week 156 (n=1512)	54.7 Percentage of participants
Percentage of Participants With an Improvement of at Least 20%, 50%, 70%, or 90% in the American College of Rheumatology (ACR) Score (ACR20/50/70/90) From Baseline at Weeks 24, 48, 108, 156, 204, and 264 ACR50 Week 204 (n=1415)	56.5 Percentage of participants
Percentage of Participants With an Improvement of at Least 20%, 50%, 70%, or 90% in the American College of Rheumatology (ACR) Score (ACR20/50/70/90) From Baseline at Weeks 24, 48, 108, 156, 204, and 264 ACR50 Week 264 (n= 1319)	58.8 Percentage of participants
Percentage of Participants With an Improvement of at Least 20%, 50%, 70%, or 90% in the American College of Rheumatology (ACR) Score (ACR20/50/70/90) From Baseline at Weeks 24, 48, 108, 156, 204, and 264 ACR70 Week 24 (n=1966)	17.8 Percentage of participants
Percentage of Participants With an Improvement of at Least 20%, 50%, 70%, or 90% in the American College of Rheumatology (ACR) Score (ACR20/50/70/90) From Baseline at Weeks 24, 48, 108, 156, 204, and 264 ACR70 Week 48 (n=1825)	25.5 Percentage of participants
Percentage of Participants With an Improvement of at Least 20%, 50%, 70%, or 90% in the American College of Rheumatology (ACR) Score (ACR20/50/70/90) From Baseline at Weeks 24, 48, 108, 156, 204, and 264 ACR70 Week 108 (n=1607)	33.2 Percentage of participants
Percentage of Participants With an Improvement of at Least 20%, 50%, 70%, or 90% in the American College of Rheumatology (ACR) Score (ACR20/50/70/90) From Baseline at Weeks 24, 48, 108, 156, 204, and 264 ACR70 Week 156 (n=1512)	35.7 Percentage of participants
Percentage of Participants With an Improvement of at Least 20%, 50%, 70%, or 90% in the American College of Rheumatology (ACR) Score (ACR20/50/70/90) From Baseline at Weeks 24, 48, 108, 156, 204, and 264 ACR70 Week 204 (n =1415)	38.6 Percentage of participants
Percentage of Participants With an Improvement of at Least 20%, 50%, 70%, or 90% in the American College of Rheumatology (ACR) Score (ACR20/50/70/90) From Baseline at Weeks 24, 48, 108, 156, 204, and 264 ACR70 Week 264 (n=1319)	40.5 Percentage of participants
Percentage of Participants With an Improvement of at Least 20%, 50%, 70%, or 90% in the American College of Rheumatology (ACR) Score (ACR20/50/70/90) From Baseline at Weeks 24, 48, 108, 156, 204, and 264 ACR90 Week 24 (n=1966)	4.3 Percentage of participants
Percentage of Participants With an Improvement of at Least 20%, 50%, 70%, or 90% in the American College of Rheumatology (ACR) Score (ACR20/50/70/90) From Baseline at Weeks 24, 48, 108, 156, 204, and 264 ACR90 Week 48 (n=1825	7.9 Percentage of participants
Percentage of Participants With an Improvement of at Least 20%, 50%, 70%, or 90% in the American College of Rheumatology (ACR) Score (ACR20/50/70/90) From Baseline at Weeks 24, 48, 108, 156, 204, and 264 ACR90 Week 108 (n=1607)	12.1 Percentage of participants
Percentage of Participants With an Improvement of at Least 20%, 50%, 70%, or 90% in the American College of Rheumatology (ACR) Score (ACR20/50/70/90) From Baseline at Weeks 24, 48, 108, 156, 204, and 264 ACR90 Week 156 (n=1512)	14.7 Percentage of participants
Percentage of Participants With an Improvement of at Least 20%, 50%, 70%, or 90% in the American College of Rheumatology (ACR) Score (ACR20/50/70/90) From Baseline at Weeks 24, 48, 108, 156, 204, and 264 ACR90 Week 204 (n=1415)	17.7 Percentage of participants
Percentage of Participants With an Improvement of at Least 20%, 50%, 70%, or 90% in the American College of Rheumatology (ACR) Score (ACR20/50/70/90) From Baseline at Weeks 24, 48, 108, 156, 204, and 264 ACR90 Week 264 (n=1319)	18.1 Percentage of participants

SECONDARY outcome

Timeframe: Baseline to Week 264

A major clinical response was defined as maintenance of an improvement of at least 70% in the American College of Rheumatology (ACR) score (ACR70) for at least 24 weeks. Improvement must be seen in tender (68 assessed joints) and swollen joint counts (66 assessed joints) and in at least 3 of the following 5 parameters: Separate patient and physician assessments of patient disease activity in the previous 24 hours on a visual analog scale (VAS, the left end of the scale "no disease activity" \[symptom-free and no arthritis symptoms\], right end of the scale "maximum disease activity"); patient assessment of pain in the previous 24 hours on a VAS (left end of the scale "no pain", right end of the scale "unbearable pain"); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and erythrocyte sedimentation rate.

Outcome measures

Outcome measures
Measure	Tocilizumab n=2067 Participants Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
Percentage of Participants Who Achieved a Major Clinical Response at Weeks 48, 96, 144, 192, and 264 Week 48 (n = 1937)	8.5 Percentage of participants
Percentage of Participants Who Achieved a Major Clinical Response at Weeks 48, 96, 144, 192, and 264 Week 96 (n = 1745)	16.2 Percentage of participants
Percentage of Participants Who Achieved a Major Clinical Response at Weeks 48, 96, 144, 192, and 264 Week 144 (n = 1615)	20.9 Percentage of participants
Percentage of Participants Who Achieved a Major Clinical Response at Weeks 48, 96, 144, 192, and 264 Week 192 (n = 1514)	22.9 Percentage of participants
Percentage of Participants Who Achieved a Major Clinical Response at Weeks 48, 96, 144, 192, and 264 Week 264 (n = 1358)	24.9 Percentage of participants

SECONDARY outcome

Timeframe: Baseline to Week 264

Outcome measures

Outcome measures
Measure	Tocilizumab n=2067 Participants Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
Percentage of Participants Who Maintained an Improvement of at Least 20%, 50%, or 70% in the American College of Rheumatology (ACR) Score (ACR20/50/70) Consecutively for 24, 48, 96, and 264 Weeks at Weeks 48, 96, 144, 192, and 264 ACR70 Week 96: Maintained 48 weeks (n=1745)	11.2 Percentage of participants
Percentage of Participants Who Maintained an Improvement of at Least 20%, 50%, or 70% in the American College of Rheumatology (ACR) Score (ACR20/50/70) Consecutively for 24, 48, 96, and 264 Weeks at Weeks 48, 96, 144, 192, and 264 ACR70 Week 144: Maintained 4 weeks (n=1615)	20.9 Percentage of participants
Percentage of Participants Who Maintained an Improvement of at Least 20%, 50%, or 70% in the American College of Rheumatology (ACR) Score (ACR20/50/70) Consecutively for 24, 48, 96, and 264 Weeks at Weeks 48, 96, 144, 192, and 264 ACR70 Week 144: Maintained 48 weeks (n=1615)	15.0 Percentage of participants
Percentage of Participants Who Maintained an Improvement of at Least 20%, 50%, or 70% in the American College of Rheumatology (ACR) Score (ACR20/50/70) Consecutively for 24, 48, 96, and 264 Weeks at Weeks 48, 96, 144, 192, and 264 ACR70 Week 144: Maintained 96 weeks (n=1615)	8.7 Percentage of participants
Percentage of Participants Who Maintained an Improvement of at Least 20%, 50%, or 70% in the American College of Rheumatology (ACR) Score (ACR20/50/70) Consecutively for 24, 48, 96, and 264 Weeks at Weeks 48, 96, 144, 192, and 264 ACR70 Week 192: Maintained 24 weeks (n=1514)	22.9 Percentage of participants
Percentage of Participants Who Maintained an Improvement of at Least 20%, 50%, or 70% in the American College of Rheumatology (ACR) Score (ACR20/50/70) Consecutively for 24, 48, 96, and 264 Weeks at Weeks 48, 96, 144, 192, and 264 ACR70 Week 192: Maintained 48 weeks (n=1514)	17.6 Percentage of participants
Percentage of Participants Who Maintained an Improvement of at Least 20%, 50%, or 70% in the American College of Rheumatology (ACR) Score (ACR20/50/70) Consecutively for 24, 48, 96, and 264 Weeks at Weeks 48, 96, 144, 192, and 264 ACR70 Week 192: Maintained 96 weeks (n=1514)	11.4 Percentage of participants
Percentage of Participants Who Maintained an Improvement of at Least 20%, 50%, or 70% in the American College of Rheumatology (ACR) Score (ACR20/50/70) Consecutively for 24, 48, 96, and 264 Weeks at Weeks 48, 96, 144, 192, and 264 ACR70 Week 192: Maintained 144 weeks (n=1514)	7.3 Percentage of participants
Percentage of Participants Who Maintained an Improvement of at Least 20%, 50%, or 70% in the American College of Rheumatology (ACR) Score (ACR20/50/70) Consecutively for 24, 48, 96, and 264 Weeks at Weeks 48, 96, 144, 192, and 264 ACR70 Week 264: Maintained 24 weeks (n=1358)	24.9 Percentage of participants
Percentage of Participants Who Maintained an Improvement of at Least 20%, 50%, or 70% in the American College of Rheumatology (ACR) Score (ACR20/50/70) Consecutively for 24, 48, 96, and 264 Weeks at Weeks 48, 96, 144, 192, and 264 ACR70 Week 264: Maintained 48 weeks (n=1358)	19.7 Percentage of participants
Percentage of Participants Who Maintained an Improvement of at Least 20%, 50%, or 70% in the American College of Rheumatology (ACR) Score (ACR20/50/70) Consecutively for 24, 48, 96, and 264 Weeks at Weeks 48, 96, 144, 192, and 264 ACR70 Week 264: Maintained 96 weeks (n=1358)	14.4 Percentage of participants
Percentage of Participants Who Maintained an Improvement of at Least 20%, 50%, or 70% in the American College of Rheumatology (ACR) Score (ACR20/50/70) Consecutively for 24, 48, 96, and 264 Weeks at Weeks 48, 96, 144, 192, and 264 ACR70 Week 264: Maintained 144 weeks (n=1358)	11.0 Percentage of participants
Percentage of Participants Who Maintained an Improvement of at Least 20%, 50%, or 70% in the American College of Rheumatology (ACR) Score (ACR20/50/70) Consecutively for 24, 48, 96, and 264 Weeks at Weeks 48, 96, 144, 192, and 264 ACR70 Week 264: Maintained 192 weeks (n=1358)	7.7 Percentage of participants
Percentage of Participants Who Maintained an Improvement of at Least 20%, 50%, or 70% in the American College of Rheumatology (ACR) Score (ACR20/50/70) Consecutively for 24, 48, 96, and 264 Weeks at Weeks 48, 96, 144, 192, and 264 ACR20 Week 48: Maintained 24 weeks (n=1937)	41.2 Percentage of participants
Percentage of Participants Who Maintained an Improvement of at Least 20%, 50%, or 70% in the American College of Rheumatology (ACR) Score (ACR20/50/70) Consecutively for 24, 48, 96, and 264 Weeks at Weeks 48, 96, 144, 192, and 264 ACR20 Week 96: Maintained 24 weeks (n=1745)	53.0 Percentage of participants
Percentage of Participants Who Maintained an Improvement of at Least 20%, 50%, or 70% in the American College of Rheumatology (ACR) Score (ACR20/50/70) Consecutively for 24, 48, 96, and 264 Weeks at Weeks 48, 96, 144, 192, and 264 ACR20 Week 96: Maintained 48 weeks (n=1745)	43.0 Percentage of participants
Percentage of Participants Who Maintained an Improvement of at Least 20%, 50%, or 70% in the American College of Rheumatology (ACR) Score (ACR20/50/70) Consecutively for 24, 48, 96, and 264 Weeks at Weeks 48, 96, 144, 192, and 264 ACR20 Week 144: Maintained 24 weeks (n=1615)	56.3 Percentage of participants
Percentage of Participants Who Maintained an Improvement of at Least 20%, 50%, or 70% in the American College of Rheumatology (ACR) Score (ACR20/50/70) Consecutively for 24, 48, 96, and 264 Weeks at Weeks 48, 96, 144, 192, and 264 ACR20 Week 144: Maintained 48 weeks (n=1615)	48.7 Percentage of participants
Percentage of Participants Who Maintained an Improvement of at Least 20%, 50%, or 70% in the American College of Rheumatology (ACR) Score (ACR20/50/70) Consecutively for 24, 48, 96, and 264 Weeks at Weeks 48, 96, 144, 192, and 264 ACR20 Week 144: Maintained 96 weeks (n=1615)	35.6 Percentage of participants
Percentage of Participants Who Maintained an Improvement of at Least 20%, 50%, or 70% in the American College of Rheumatology (ACR) Score (ACR20/50/70) Consecutively for 24, 48, 96, and 264 Weeks at Weeks 48, 96, 144, 192, and 264 ACR20 Week 192: Maintained 24 weeks (n=1514)	60.0 Percentage of participants
Percentage of Participants Who Maintained an Improvement of at Least 20%, 50%, or 70% in the American College of Rheumatology (ACR) Score (ACR20/50/70) Consecutively for 24, 48, 96, and 264 Weeks at Weeks 48, 96, 144, 192, and 264 ACR20 Week 192: Maintained 48 weeks (n=1514)	52.3 Percentage of participants
Percentage of Participants Who Maintained an Improvement of at Least 20%, 50%, or 70% in the American College of Rheumatology (ACR) Score (ACR20/50/70) Consecutively for 24, 48, 96, and 264 Weeks at Weeks 48, 96, 144, 192, and 264 ACR20 Week 192: Maintained 96 weeks (n=1514)	41.3 Percentage of participants
Percentage of Participants Who Maintained an Improvement of at Least 20%, 50%, or 70% in the American College of Rheumatology (ACR) Score (ACR20/50/70) Consecutively for 24, 48, 96, and 264 Weeks at Weeks 48, 96, 144, 192, and 264 ACR20 Week 192: Maintained 144 weeks (n=1514)	31.8 Percentage of participants
Percentage of Participants Who Maintained an Improvement of at Least 20%, 50%, or 70% in the American College of Rheumatology (ACR) Score (ACR20/50/70) Consecutively for 24, 48, 96, and 264 Weeks at Weeks 48, 96, 144, 192, and 264 ACR20 Week 264: Maintained 24 weeks (n=1358)	63.0 Percentage of participants
Percentage of Participants Who Maintained an Improvement of at Least 20%, 50%, or 70% in the American College of Rheumatology (ACR) Score (ACR20/50/70) Consecutively for 24, 48, 96, and 264 Weeks at Weeks 48, 96, 144, 192, and 264 ACR20 Week 264: Maintained 48 weeks (n=1358)	54.7 Percentage of participants
Percentage of Participants Who Maintained an Improvement of at Least 20%, 50%, or 70% in the American College of Rheumatology (ACR) Score (ACR20/50/70) Consecutively for 24, 48, 96, and 264 Weeks at Weeks 48, 96, 144, 192, and 264 ACR20 Week 264: Maintained 96 weeks (n=1358)	46.2 Percentage of participants
Percentage of Participants Who Maintained an Improvement of at Least 20%, 50%, or 70% in the American College of Rheumatology (ACR) Score (ACR20/50/70) Consecutively for 24, 48, 96, and 264 Weeks at Weeks 48, 96, 144, 192, and 264 ACR20 Week 264: Maintained 144 weeks (n=1358)	38.7 Percentage of participants
Percentage of Participants Who Maintained an Improvement of at Least 20%, 50%, or 70% in the American College of Rheumatology (ACR) Score (ACR20/50/70) Consecutively for 24, 48, 96, and 264 Weeks at Weeks 48, 96, 144, 192, and 264 ACR20 Week 264: Maintained 192 weeks (n=1358)	32.6 Percentage of participants
Percentage of Participants Who Maintained an Improvement of at Least 20%, 50%, or 70% in the American College of Rheumatology (ACR) Score (ACR20/50/70) Consecutively for 24, 48, 96, and 264 Weeks at Weeks 48, 96, 144, 192, and 264 ACR50 Week 48: Maintained 24 weeks (n=1937)	20.7 Percentage of participants
Percentage of Participants Who Maintained an Improvement of at Least 20%, 50%, or 70% in the American College of Rheumatology (ACR) Score (ACR20/50/70) Consecutively for 24, 48, 96, and 264 Weeks at Weeks 48, 96, 144, 192, and 264 ACR50 Week 96: Maintained 24 weeks (n=1745)	32.0 Percentage of participants
Percentage of Participants Who Maintained an Improvement of at Least 20%, 50%, or 70% in the American College of Rheumatology (ACR) Score (ACR20/50/70) Consecutively for 24, 48, 96, and 264 Weeks at Weeks 48, 96, 144, 192, and 264 ACR50 Week 96: Maintained 48 weeks (n=1745)	22.8 Percentage of participants
Percentage of Participants Who Maintained an Improvement of at Least 20%, 50%, or 70% in the American College of Rheumatology (ACR) Score (ACR20/50/70) Consecutively for 24, 48, 96, and 264 Weeks at Weeks 48, 96, 144, 192, and 264 ACR50 Week 144: Maintained 24 weeks (n=1615)	36.9 Percentage of participants
Percentage of Participants Who Maintained an Improvement of at Least 20%, 50%, or 70% in the American College of Rheumatology (ACR) Score (ACR20/50/70) Consecutively for 24, 48, 96, and 264 Weeks at Weeks 48, 96, 144, 192, and 264 ACR50 Week 144: Maintained 48 weeks (n=1615)	28.4 Percentage of participants
Percentage of Participants Who Maintained an Improvement of at Least 20%, 50%, or 70% in the American College of Rheumatology (ACR) Score (ACR20/50/70) Consecutively for 24, 48, 96, and 264 Weeks at Weeks 48, 96, 144, 192, and 264 ACR50 Week 144: Maintained 96 weeks (n=1615)	18.1 Percentage of participants
Percentage of Participants Who Maintained an Improvement of at Least 20%, 50%, or 70% in the American College of Rheumatology (ACR) Score (ACR20/50/70) Consecutively for 24, 48, 96, and 264 Weeks at Weeks 48, 96, 144, 192, and 264 ACR50 Week 192: Maintained 24 weeks (n=1514)	39.8 Percentage of participants
Percentage of Participants Who Maintained an Improvement of at Least 20%, 50%, or 70% in the American College of Rheumatology (ACR) Score (ACR20/50/70) Consecutively for 24, 48, 96, and 264 Weeks at Weeks 48, 96, 144, 192, and 264 ACR50 Week 192: Maintained 48 weeks (n=1514)	33.0 Percentage of participants
Percentage of Participants Who Maintained an Improvement of at Least 20%, 50%, or 70% in the American College of Rheumatology (ACR) Score (ACR20/50/70) Consecutively for 24, 48, 96, and 264 Weeks at Weeks 48, 96, 144, 192, and 264 ACR50 Week 192: Maintained 96 weeks (n=1514)	22.7 Percentage of participants
Percentage of Participants Who Maintained an Improvement of at Least 20%, 50%, or 70% in the American College of Rheumatology (ACR) Score (ACR20/50/70) Consecutively for 24, 48, 96, and 264 Weeks at Weeks 48, 96, 144, 192, and 264 ACR50 Week 192: Maintained 144 weeks (n=1514)	15.9 Percentage of participants
Percentage of Participants Who Maintained an Improvement of at Least 20%, 50%, or 70% in the American College of Rheumatology (ACR) Score (ACR20/50/70) Consecutively for 24, 48, 96, and 264 Weeks at Weeks 48, 96, 144, 192, and 264 ACR50 Week 264: Maintained 24 weeks (n=1358)	42.3 Percentage of participants
Percentage of Participants Who Maintained an Improvement of at Least 20%, 50%, or 70% in the American College of Rheumatology (ACR) Score (ACR20/50/70) Consecutively for 24, 48, 96, and 264 Weeks at Weeks 48, 96, 144, 192, and 264 ACR50 Week 264: Maintained 48 weeks (n=1358)	34.7 Percentage of participants
Percentage of Participants Who Maintained an Improvement of at Least 20%, 50%, or 70% in the American College of Rheumatology (ACR) Score (ACR20/50/70) Consecutively for 24, 48, 96, and 264 Weeks at Weeks 48, 96, 144, 192, and 264 ACR50 Week 264: Maintained 96 weeks (n=1358)	27.6 Percentage of participants
Percentage of Participants Who Maintained an Improvement of at Least 20%, 50%, or 70% in the American College of Rheumatology (ACR) Score (ACR20/50/70) Consecutively for 24, 48, 96, and 264 Weeks at Weeks 48, 96, 144, 192, and 264 ACR50 Week 264: Maintained 144 weeks (n=1358)	21.7 Percentage of participants
Percentage of Participants Who Maintained an Improvement of at Least 20%, 50%, or 70% in the American College of Rheumatology (ACR) Score (ACR20/50/70) Consecutively for 24, 48, 96, and 264 Weeks at Weeks 48, 96, 144, 192, and 264 ACR50 Week 264: Maintained 192 weeks (n=1358)	16.6 Percentage of participants
Percentage of Participants Who Maintained an Improvement of at Least 20%, 50%, or 70% in the American College of Rheumatology (ACR) Score (ACR20/50/70) Consecutively for 24, 48, 96, and 264 Weeks at Weeks 48, 96, 144, 192, and 264 ACR70 Week 48: Maintained 24 weeks (n=1937)	8.5 Percentage of participants
Percentage of Participants Who Maintained an Improvement of at Least 20%, 50%, or 70% in the American College of Rheumatology (ACR) Score (ACR20/50/70) Consecutively for 24, 48, 96, and 264 Weeks at Weeks 48, 96, 144, 192, and 264 ACR70 Week 96: Maintained 24 weeks (n=1745)	16.2 Percentage of participants

SECONDARY outcome

Timeframe: Baseline to Week 264

The number of swollen (66 assessed joints) and tender (68 assessed joints) joints was assessed. Joints were physically examined and classified as swollen/not swollen and tender/not tender by pressure and joint manipulation.

Outcome measures

Outcome measures
Measure	Tocilizumab n=2067 Participants Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
Swollen and Tender Joint Count (SJC/TJC) at Baseline and Weeks 24, 48, 108, 156, 204, and 264 Baseline SJC (n = 2047)	17.4 Joints Standard Deviation 11.96
Swollen and Tender Joint Count (SJC/TJC) at Baseline and Weeks 24, 48, 108, 156, 204, and 264 Week 24 SJC (n = 2010)	8.2 Joints Standard Deviation 9.43
Swollen and Tender Joint Count (SJC/TJC) at Baseline and Weeks 24, 48, 108, 156, 204, and 264 Week 48 SJC (n = 1924)	6.4 Joints Standard Deviation 8.75
Swollen and Tender Joint Count (SJC/TJC) at Baseline and Weeks 24, 48, 108, 156, 204, and 264 Week 108 SJC (n = 1692)	4.2 Joints Standard Deviation 6.69
Swollen and Tender Joint Count (SJC/TJC) at Baseline and Weeks 24, 48, 108, 156, 204, and 264 Week 156 SJC (n = 1580)	4.0 Joints Standard Deviation 7.09
Swollen and Tender Joint Count (SJC/TJC) at Baseline and Weeks 24, 48, 108, 156, 204, and 264 Week 204 SJC (n = 1482)	3.2 Joints Standard Deviation 5.96
Swollen and Tender Joint Count (SJC/TJC) at Baseline and Weeks 24, 48, 108, 156, 204, and 264 Week 264 SJC (n = 1352)	2.9 Joints Standard Deviation 5.85
Swollen and Tender Joint Count (SJC/TJC) at Baseline and Weeks 24, 48, 108, 156, 204, and 264 Baseline TJC (n = 2047)	27.3 Joints Standard Deviation 16.97
Swollen and Tender Joint Count (SJC/TJC) at Baseline and Weeks 24, 48, 108, 156, 204, and 264 Week 24 TJC (n = 2010)	12.8 Joints Standard Deviation 14.10
Swollen and Tender Joint Count (SJC/TJC) at Baseline and Weeks 24, 48, 108, 156, 204, and 264 Week 48 TJC (n = 1924)	10.3 Joints Standard Deviation 12.99
Swollen and Tender Joint Count (SJC/TJC) at Baseline and Weeks 24, 48, 108, 156, 204, and 264 Week 108 TJC (n = 1692)	7.8 Joints Standard Deviation 11.04
Swollen and Tender Joint Count (SJC/TJC) at Baseline and Weeks 24, 48, 108, 156, 204, and 264 Week 156 TJC (n = 1580)	7.2 Joints Standard Deviation 11.03
Swollen and Tender Joint Count (SJC/TJC) at Baseline and Weeks 24, 48, 108, 156, 204, and 264 Week 204 TJC (n = 1482)	6.1 Joints Standard Deviation 9.83
Swollen and Tender Joint Count (SJC/TJC) at Baseline and Weeks 24, 48, 108, 156, 204, and 264 Week 264 TJC (n = 1352)	5.6 Joints Standard Deviation 9.48

SECONDARY outcome

Timeframe: Baseline to Week 264

Participant's made a global assessment of their current disease activity on a 100 mm horizontal visual analogue scale (VAS). The left end of the scale indicated "no disease activity" (symptom-free and no arthritis symptoms, score = 0) and the right end indicated "maximum disease activity" (maximum arthritis disease activity, score = 100). The participant's treating physician made a global assessment of the participant's current disease activity on a 100 mm horizontal VAS. The left end of the scale indicated "no disease activity" (symptom-free and no arthritis symptoms, score = 0) and the right end indicated "maximum disease activity" (maximum arthritis disease activity, score = 100). Participant's made an assessment of their current level of pain on a 100 mm horizontal VAS. The left end of the scale indicated "no pain" (score = 0) and the right end of the scale indicated "unbearable pain" (score = 100).

Outcome measures

Outcome measures
Measure	Tocilizumab n=2067 Participants Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
Disease Activity and Pain at Baseline and Weeks 24, 48, 108, 156, 204, and 264 Participant Disease Activity - Baseline (n=2039)	60.5 mm Standard Deviation 25.52
Disease Activity and Pain at Baseline and Weeks 24, 48, 108, 156, 204, and 264 Participant Disease Activity - Week 24 (n=1989)	34.4 mm Standard Deviation 26.03
Disease Activity and Pain at Baseline and Weeks 24, 48, 108, 156, 204, and 264 Participant Disease Activity - Week 48 (n=1840)	31.7 mm Standard Deviation 25.25
Disease Activity and Pain at Baseline and Weeks 24, 48, 108, 156, 204, and 264 Participant Disease Activity - Week 108 (n=1621)	29.2 mm Standard Deviation 24.75
Disease Activity and Pain at Baseline and Weeks 24, 48, 108, 156, 204, and 264 Participant Disease Activity - Week 156 (n=1515)	28.5 mm Standard Deviation 25.16
Disease Activity and Pain at Baseline and Weeks 24, 48, 108, 156, 204, and 264 Participant Disease Activity - Week 204 (n=1427)	27.4 mm Standard Deviation 24.72
Disease Activity and Pain at Baseline and Weeks 24, 48, 108, 156, 204, and 264 Participant Disease Activity - Week 264 (n=1328)	27.4 mm Standard Deviation 25.50
Disease Activity and Pain at Baseline and Weeks 24, 48, 108, 156, 204, and 264 Physician Disease Activity - Baseline (n=2043)	57.3 mm Standard Deviation 22.04
Disease Activity and Pain at Baseline and Weeks 24, 48, 108, 156, 204, and 264 Physician Disease Activity - Week 24 (n=1990)	26.8 mm Standard Deviation 20.22
Disease Activity and Pain at Baseline and Weeks 24, 48, 108, 156, 204, and 264 Physician Disease Activity - Week 48 (n=1830)	22.3 mm Standard Deviation 18.93
Disease Activity and Pain at Baseline and Weeks 24, 48, 108, 156, 204, and 264 Physician Disease Activity - Week 108 (n=1619)	18.6 mm Standard Deviation 17.59
Disease Activity and Pain at Baseline and Weeks 24, 48, 108, 156, 204, and 264 Physician Disease Activity - Week 156 (n=1516)	17.4 mm Standard Deviation 17.21
Disease Activity and Pain at Baseline and Weeks 24, 48, 108, 156, 204, and 264 Physician Disease Activity - Week 204 (n=1413)	15.6 mm Standard Deviation 16.49
Disease Activity and Pain at Baseline and Weeks 24, 48, 108, 156, 204, and 264 Physician Disease Activity - Week 264 (n=1330)	15.1 mm Standard Deviation 16.51
Disease Activity and Pain at Baseline and Weeks 24, 48, 108, 156, 204, and 264 Participant Pain - Baseline (n=2041)	54.9 mm Standard Deviation 25.00
Disease Activity and Pain at Baseline and Weeks 24, 48, 108, 156, 204, and 264 Participant Pain - Week 24 (n=1991)	31.0 mm Standard Deviation 24.56
Disease Activity and Pain at Baseline and Weeks 24, 48, 108, 156, 204, and 264 Participant Pain - Week 48 (n=1842)	28.0 mm Standard Deviation 23.76
Disease Activity and Pain at Baseline and Weeks 24, 48, 108, 156, 204, and 264 Participant Pain - Week 108 (n=1622)	26.6 mm Standard Deviation 23.52
Disease Activity and Pain at Baseline and Weeks 24, 48, 108, 156, 204, and 264 Participant Pain - Week 156 (n=1517)	26.2 mm Standard Deviation 23.90
Disease Activity and Pain at Baseline and Weeks 24, 48, 108, 156, 204, and 264 Participant Pain - Week 204 (n=1428)	25.3 mm Standard Deviation 23.05
Disease Activity and Pain at Baseline and Weeks 24, 48, 108, 156, 204, and 264 Participant Pain - Week 264 (n=1329)	25.1 mm Standard Deviation 23.72

SECONDARY outcome

Timeframe: Baseline to Week 264

The Health Assessment Questionnaire-Disability Index (HAQ-DI), as a measure of functional ability, consists of 30 questions in 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. There are 4 possible responses to each question (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do). A domain score is the highest score in that domain. To calculate the overall score, the patient must have a domain score in at least 6 of the 8 domains. The HAQ-DI score is the sum of the domain scores divided by the number of domains that have a non-missing score and ranges from 0 (best) to 3 (worst). A higher score indicates less ability.

Outcome measures

Outcome measures
Measure	Tocilizumab n=2067 Participants Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
Health Assessment Questionnaire-Disability Index Score at Baseline and Weeks 24, 48, 108, 156, 204, and 264 Baseline (n = 2037)	1.46 Units on a scale Standard Deviation 0.660
Health Assessment Questionnaire-Disability Index Score at Baseline and Weeks 24, 48, 108, 156, 204, and 264 Week 24 (n = 2008)	1.04 Units on a scale Standard Deviation 0.692
Health Assessment Questionnaire-Disability Index Score at Baseline and Weeks 24, 48, 108, 156, 204, and 264 Week 48 (n = 1853)	0.97 Units on a scale Standard Deviation 0.693
Health Assessment Questionnaire-Disability Index Score at Baseline and Weeks 24, 48, 108, 156, 204, and 264 Week 108 (n = 1635)	0.89 Units on a scale Standard Deviation 0.694
Health Assessment Questionnaire-Disability Index Score at Baseline and Weeks 24, 48, 108, 156, 204, and 264 Week 156 (n = 1529)	0.87 Units on a scale Standard Deviation 0.689
Health Assessment Questionnaire-Disability Index Score at Baseline and Weeks 24, 48, 108, 156, 204, and 264 Week 204 (n = 1438)	0.84 Units on a scale Standard Deviation 0.684
Health Assessment Questionnaire-Disability Index Score at Baseline and Weeks 24, 48, 108, 156, 204, and 264 Week 264 (n = 1334)	0.86 Units on a scale Standard Deviation 0.696

SECONDARY outcome

Timeframe: Baseline to Week 264

Erythrocyte sedimentation rate (ESR) was determined locally.

Outcome measures

Outcome measures
Measure	Tocilizumab n=2067 Participants Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
Erythrocyte Sedimentation Rate at Baseline and Weeks 24, 48, 108, 156, 204, and 264 Baseline (n = 2047)	46.2 mm/h Standard Deviation 27.45
Erythrocyte Sedimentation Rate at Baseline and Weeks 24, 48, 108, 156, 204, and 264 Week 24 (n = 1992)	11.3 mm/h Standard Deviation 14.97
Erythrocyte Sedimentation Rate at Baseline and Weeks 24, 48, 108, 156, 204, and 264 Week 48 (n = 1830)	10.2 mm/h Standard Deviation 13.94
Erythrocyte Sedimentation Rate at Baseline and Weeks 24, 48, 108, 156, 204, and 264 Week 108 (n = 1606)	9.0 mm/h Standard Deviation 12.79
Erythrocyte Sedimentation Rate at Baseline and Weeks 24, 48, 108, 156, 204, and 264 Week 156 (n = 1509)	8.9 mm/h Standard Deviation 12.44
Erythrocyte Sedimentation Rate at Baseline and Weeks 24, 48, 108, 156, 204, and 264 Week 204 (n = 1412)	8.9 mm/h Standard Deviation 12.01
Erythrocyte Sedimentation Rate at Baseline and Weeks 24, 48, 108, 156, 204, and 264 Week 264 (n = 1329)	9.7 mm/h Standard Deviation 13.51

SECONDARY outcome

Timeframe: Baseline to Week 264

The DAS28 is a combined index for measuring disease activity in rheumatic arthritis (RA) and includes swollen and tender joint counts, erythrocyte sedimentation rate (ESR), and general health (GH) status. The index is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(ESR)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints. GH = a patient's global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity \[symptom-free and no arthritis symptoms\], right end = maximum disease activity \[maximum arthritis disease activity\]). When ESR equaled 0 mm/hr, it was set to 1 mm/hr. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A negative change score indicates improvement.

Outcome measures

Outcome measures
Measure	Tocilizumab n=2067 Participants Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
Change in the Disease Activity Score 28 (DAS-28) From Baseline to Weeks 24, 48, 96, and 264 Week 24 (n = 1920)	-2.82 Units on a scale Standard Deviation 1.559
Change in the Disease Activity Score 28 (DAS-28) From Baseline to Weeks 24, 48, 96, and 264 Week 48 (n = 1753)	-3.20 Units on a scale Standard Deviation 1.644
Change in the Disease Activity Score 28 (DAS-28) From Baseline to Weeks 24, 48, 96, and 264 Week 96 (n = 1596)	-3.46 Units on a scale Standard Deviation 1.715
Change in the Disease Activity Score 28 (DAS-28) From Baseline to Weeks 24, 48, 96, and 264 Week 264 (n = 1278)	-3.73 Units on a scale Standard Deviation 1.742

SECONDARY outcome

Timeframe: Baseline to Week 264

A DAS-28 responder was defined as someone who met the European League Against Rheumatism \[EULAR\] criteria of a good or moderate response. A change of the DAS-28 score from Baseline was used to determine EULAR responses of good, moderate, or no response. For a post-baseline score ≤ 3.2, a change from baseline of \< -1.2 was a good response, \< -0.6 to ≥ -1.2 was a moderate response, and ≥ -0.6 was no response. For a post-baseline score \> 3.2 to ≤ 5.1, a change from baseline of \< -0.6 was a moderate response and ≥ -0.6 was no response. For a post-baseline score \> 5.1, a change from baseline \< -1.2 was a moderate response and ≥ -1.2 was no response. A good response could not be achieved for post-baseline scores \> 3.2.

Outcome measures

Outcome measures
Measure	Tocilizumab n=2067 Participants Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
Percentage of Participants Who Were Disease Activity Score 28 (DAS-28) Responders at Weeks 24, 48, 108, 156, 204, and 264 Week 24 Good (n = 1920)	43.3 Percentage of participants
Percentage of Participants Who Were Disease Activity Score 28 (DAS-28) Responders at Weeks 24, 48, 108, 156, 204, and 264 Week 48 Good (n = 1753)	51.9 Percentage of participants
Percentage of Participants Who Were Disease Activity Score 28 (DAS-28) Responders at Weeks 24, 48, 108, 156, 204, and 264 Week 108 Good (n = 1525)	61.1 Percentage of participants
Percentage of Participants Who Were Disease Activity Score 28 (DAS-28) Responders at Weeks 24, 48, 108, 156, 204, and 264 Week 156 Good (n = 1441)	64.7 Percentage of participants
Percentage of Participants Who Were Disease Activity Score 28 (DAS-28) Responders at Weeks 24, 48, 108, 156, 204, and 264 Week 204 Good (n = 1358)	67.8 Percentage of participants
Percentage of Participants Who Were Disease Activity Score 28 (DAS-28) Responders at Weeks 24, 48, 108, 156, 204, and 264 Week 264 Good (n = 1278)	68.8 Percentage of participants
Percentage of Participants Who Were Disease Activity Score 28 (DAS-28) Responders at Weeks 24, 48, 108, 156, 204, and 264 Week 24 Moderate (n = 1920)	45.1 Percentage of participants
Percentage of Participants Who Were Disease Activity Score 28 (DAS-28) Responders at Weeks 24, 48, 108, 156, 204, and 264 Week 48 Moderate (n = 1753)	40.0 Percentage of participants
Percentage of Participants Who Were Disease Activity Score 28 (DAS-28) Responders at Weeks 24, 48, 108, 156, 204, and 264 Week 108 Moderate (n = 1525)	33.2 Percentage of participants
Percentage of Participants Who Were Disease Activity Score 28 (DAS-28) Responders at Weeks 24, 48, 108, 156, 204, and 264 Week 156 Moderate (n = 1441)	28.7 Percentage of participants
Percentage of Participants Who Were Disease Activity Score 28 (DAS-28) Responders at Weeks 24, 48, 108, 156, 204, and 264 Week 204 Moderate (n = 1358)	26.4 Percentage of participants
Percentage of Participants Who Were Disease Activity Score 28 (DAS-28) Responders at Weeks 24, 48, 108, 156, 204, and 264 Week 264 Moderate (n = 1278)	26.1 Percentage of participants

SECONDARY outcome

Timeframe: Baseline to Week 264

Outcome measures

Outcome measures
Measure	Tocilizumab n=2067 Participants Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
Percentage of Participants Who Maintained a Disease Activity Score 28 (DAS-28) Response for 24, 48, 96, 144, and 192 Weeks at Weeks 48, 96, 144, 192, and 264 Week 48: Maintained response 24 weeks (n=1937)	67.6 Percentage of participants
Percentage of Participants Who Maintained a Disease Activity Score 28 (DAS-28) Response for 24, 48, 96, 144, and 192 Weeks at Weeks 48, 96, 144, 192, and 264 Week 96: Maintained response 24 weeks (n=1745)	72.7 Percentage of participants
Percentage of Participants Who Maintained a Disease Activity Score 28 (DAS-28) Response for 24, 48, 96, 144, and 192 Weeks at Weeks 48, 96, 144, 192, and 264 Week 96: Maintained response 48 weeks (n=1745)	63.4 Percentage of participants
Percentage of Participants Who Maintained a Disease Activity Score 28 (DAS-28) Response for 24, 48, 96, 144, and 192 Weeks at Weeks 48, 96, 144, 192, and 264 Week 144: Maintained response 24 weeks (n=1615)	73.1 Percentage of participants
Percentage of Participants Who Maintained a Disease Activity Score 28 (DAS-28) Response for 24, 48, 96, 144, and 192 Weeks at Weeks 48, 96, 144, 192, and 264 Week 144: Maintained response 48 weeks (n=1615)	64.1 Percentage of participants
Percentage of Participants Who Maintained a Disease Activity Score 28 (DAS-28) Response for 24, 48, 96, 144, and 192 Weeks at Weeks 48, 96, 144, 192, and 264 Week 144: Maintained response 96 weeks (n=1615)	52.9 Percentage of participants
Percentage of Participants Who Maintained a Disease Activity Score 28 (DAS-28) Response for 24, 48, 96, 144, and 192 Weeks at Weeks 48, 96, 144, 192, and 264 Week 192: Maintained response 24 weeks (n=1514)	73.3 Percentage of participants
Percentage of Participants Who Maintained a Disease Activity Score 28 (DAS-28) Response for 24, 48, 96, 144, and 192 Weeks at Weeks 48, 96, 144, 192, and 264 Week 192: Maintained response 48 weeks (n=1514)	64.7 Percentage of participants
Percentage of Participants Who Maintained a Disease Activity Score 28 (DAS-28) Response for 24, 48, 96, 144, and 192 Weeks at Weeks 48, 96, 144, 192, and 264 Week 192: Maintained response 96 weeks (n=1514)	53.6 Percentage of participants
Percentage of Participants Who Maintained a Disease Activity Score 28 (DAS-28) Response for 24, 48, 96, 144, and 192 Weeks at Weeks 48, 96, 144, 192, and 264 Week 192: Maintained response 144 weeks (n=1514)	45.5 Percentage of participants
Percentage of Participants Who Maintained a Disease Activity Score 28 (DAS-28) Response for 24, 48, 96, 144, and 192 Weeks at Weeks 48, 96, 144, 192, and 264 Week 264: Maintained response 24 weeks (n = 1358)	76.7 Percentage of participants
Percentage of Participants Who Maintained a Disease Activity Score 28 (DAS-28) Response for 24, 48, 96, 144, and 192 Weeks at Weeks 48, 96, 144, 192, and 264 Week 264: Maintained response 48 weeks (n = 1358)	68.6 Percentage of participants
Percentage of Participants Who Maintained a Disease Activity Score 28 (DAS-28) Response for 24, 48, 96, 144, and 192 Weeks at Weeks 48, 96, 144, 192, and 264 Week 264: Maintained response 96 weeks (n = 1358)	56.4 Percentage of participants
Percentage of Participants Who Maintained a Disease Activity Score 28 (DAS-28) Response for 24, 48, 96, 144, and 192 Weeks at Weeks 48, 96, 144, 192, and 264 Week 264: Maintained response 144 weeks (n = 1358)	48.7 Percentage of participants
Percentage of Participants Who Maintained a Disease Activity Score 28 (DAS-28) Response for 24, 48, 96, 144, and 192 Weeks at Weeks 48, 96, 144, 192, and 264 Week 264: Maintained response 192 weeks (n = 1358)	42.1 Percentage of participants

SECONDARY outcome

Timeframe: Baseline to Week 264

The FACIT-F is a 13-item participant self-report questionnaire that assesses fatigue over the previous 7 days by scoring each item on a 5-point scale (0=Not at all, 1=A little bit, 2=Somewhat, 3=Quite a bit, 4=Very much). An overall FACIT-F score was obtained by summing the scores of all 13 items. The overall score ranged from 0 to 52. A lower score indicates less fatigue. A clinically relevant improvement in the FACIT-F score was defined as a ≥ 5-point increase from Baseline.

Outcome measures

Outcome measures
Measure	Tocilizumab n=2067 Participants Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
Percentage of Participants With a Clinically Relevant Improvement in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score at Weeks 24, 36, 48, 108, 156, 204, and 264 Week 24 (n = 1984)	59.5 Percentage of participants
Percentage of Participants With a Clinically Relevant Improvement in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score at Weeks 24, 36, 48, 108, 156, 204, and 264 Week 36 (n = 1839)	52.5 Percentage of participants
Percentage of Participants With a Clinically Relevant Improvement in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score at Weeks 24, 36, 48, 108, 156, 204, and 264 Week 48 (n = 1803)	56.0 Percentage of participants
Percentage of Participants With a Clinically Relevant Improvement in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score at Weeks 24, 36, 48, 108, 156, 204, and 264 Week 108 (n = 1616)	56.8 Percentage of participants
Percentage of Participants With a Clinically Relevant Improvement in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score at Weeks 24, 36, 48, 108, 156, 204, and 264 Week 156 (n = 1513)	56.3 Percentage of participants
Percentage of Participants With a Clinically Relevant Improvement in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score at Weeks 24, 36, 48, 108, 156, 204, and 264 Week 204 (n = 1422)	56.4 Percentage of participants
Percentage of Participants With a Clinically Relevant Improvement in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score at Weeks 24, 36, 48, 108, 156, 204, and 264 Week 264 (n = 1320)	61.9 Percentage of participants

SECONDARY outcome

Timeframe: Baseline to Week 264

The SF-36 Health Survey uses participant-reported symptoms on 8 subscales to assess health-related quality of life (HRQoL). The Physical Component Summary (PCS) score summarizes the subscales Physical Functioning, Role-Physical, Bodily Pain, and General Health. The Mental Component Summary (MCS) score summarizes the subscales Vitality, Social Functioning, Role-Emotional, and Mental Health. Each score was scaled from 0 to 100 with a higher score indicating better HRQoL. A clinically relevant improvement in the Physical and Mental Component Scores of the SF-36 was defined as a ≥ 5-point increase from Baseline.

Outcome measures

Outcome measures
Measure	Tocilizumab n=2067 Participants Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
Percentage of Participants With a Clinically Relevant Improvement in the Physical and Mental Component Scores of the Short Form 36 (SF-36) Health Survey at Weeks 24, 48, 108, 156, 204, and 264 Week 24 Mental Score (n = 1850)	42.4 Percentage of participants
Percentage of Participants With a Clinically Relevant Improvement in the Physical and Mental Component Scores of the Short Form 36 (SF-36) Health Survey at Weeks 24, 48, 108, 156, 204, and 264 Week 48 Mental Score (n = 1789)	44.4 Percentage of participants
Percentage of Participants With a Clinically Relevant Improvement in the Physical and Mental Component Scores of the Short Form 36 (SF-36) Health Survey at Weeks 24, 48, 108, 156, 204, and 264 Week 108 Mental Score (n = 1551)	45.3 Percentage of participants
Percentage of Participants With a Clinically Relevant Improvement in the Physical and Mental Component Scores of the Short Form 36 (SF-36) Health Survey at Weeks 24, 48, 108, 156, 204, and 264 Week 156 Mental Score (n = 1468)	46.1 Percentage of participants
Percentage of Participants With a Clinically Relevant Improvement in the Physical and Mental Component Scores of the Short Form 36 (SF-36) Health Survey at Weeks 24, 48, 108, 156, 204, and 264 Week 204 Mental Score (n = 1377)	47.1 Percentage of participants
Percentage of Participants With a Clinically Relevant Improvement in the Physical and Mental Component Scores of the Short Form 36 (SF-36) Health Survey at Weeks 24, 48, 108, 156, 204, and 264 Week 264 Mental Score (n = 1302)	44.9 Percentage of participants
Percentage of Participants With a Clinically Relevant Improvement in the Physical and Mental Component Scores of the Short Form 36 (SF-36) Health Survey at Weeks 24, 48, 108, 156, 204, and 264 Week 24 Physical Score (n = 1850)	56.2 Percentage of participants
Percentage of Participants With a Clinically Relevant Improvement in the Physical and Mental Component Scores of the Short Form 36 (SF-36) Health Survey at Weeks 24, 48, 108, 156, 204, and 264 Week 48 Physical Score (n = 1789)	61.4 Percentage of participants
Percentage of Participants With a Clinically Relevant Improvement in the Physical and Mental Component Scores of the Short Form 36 (SF-36) Health Survey at Weeks 24, 48, 108, 156, 204, and 264 Week 108 Physical Score (n = 1551)	63.2 Percentage of participants
Percentage of Participants With a Clinically Relevant Improvement in the Physical and Mental Component Scores of the Short Form 36 (SF-36) Health Survey at Weeks 24, 48, 108, 156, 204, and 264 Week 156 Physical Score (n = 1468)	62.5 Percentage of participants
Percentage of Participants With a Clinically Relevant Improvement in the Physical and Mental Component Scores of the Short Form 36 (SF-36) Health Survey at Weeks 24, 48, 108, 156, 204, and 264 Week 204 Physical Score (n = 1377)	64.1 Percentage of participants
Percentage of Participants With a Clinically Relevant Improvement in the Physical and Mental Component Scores of the Short Form 36 (SF-36) Health Survey at Weeks 24, 48, 108, 156, 204, and 264 Week 264 Physical Score (n = 1302)	63.7 Percentage of participants

Adverse Events

Tocilizumab

Serious events: 727 serious events

Other events: 1836 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Tocilizumab n=2067 participants at risk Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
Infections and infestations Pneumonia	3.4% 70/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Cellulitis	2.8% 57/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Appendicitis	0.53% 11/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Diverticulitis	0.48% 10/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Gastroenteritis	0.48% 10/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Sepsis	0.48% 10/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Urinary tract infection	0.48% 10/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Arthritis bacterial	0.39% 8/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Bronchitis	0.34% 7/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Herpes zoster	0.34% 7/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Abscess limb	0.29% 6/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Erysipelas	0.29% 6/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Septic shock	0.29% 6/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Bronchopneumonia	0.24% 5/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Postoperative wound infection	0.24% 5/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Pyelonephritis	0.24% 5/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Infectious pleural effusion	0.19% 4/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Peritonitis	0.19% 4/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Pulmonary tuberculosis	0.19% 4/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Staphylococcal infection	0.19% 4/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Wound infection	0.19% 4/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Abdominal abscess	0.15% 3/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Bursitis infective	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Staphylococcal Clostridium difficile colitis	0.15% 3/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Empyema	0.15% 3/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Infective exacerbation of chronic obstructive airways disease	0.15% 3/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Lung infection	0.15% 3/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Necrotising fasciitis	0.15% 3/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Osteomyelitis	0.15% 3/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Pneumonia pneumococcal	0.15% 3/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Pneumonia staphylococcal	0.15% 3/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Post procedural infection	0.15% 3/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Septic arthritis	0.15% 3/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Staphylococcal sinusitis	0.15% 3/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Subcutaneous abscess	0.15% 3/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Wound infection staphylococcal	0.15% 3/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Abdominal wall abscess	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Gastroenteritis viral	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Infective tenosynovitis	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Influenza	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Liver abscess	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Localised infection	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Lower respiratory tract infection	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Pelvic inflammatory disease	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Pericolic abscess	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Peritonitis bacterial	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Pneumonia haemophilus	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Pneumonia streptococcal	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Pulmonary sepsis	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Respiratory tract infection	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Salmonellosis	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Septic arthritis streptococcal	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Sinusitis fungal	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Soft tissue infection	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Staphylococcal abscess	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Tooth infection	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Tuberculous pleurisy	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Upper respiratory tract infection	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Urosepsis	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Viral infection	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Abscess	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Abscess oral	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Abscess soft tissue	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Acquired immunodeficiency syndrome	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Alcaligenes infection	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Anal abscess	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Appendiceal abscess	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Arthritis infective	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Bacteraemia	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Bacterial sepsis	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Biliary sepsis	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Breast abscess	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Bronchitis bacterial	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Bronchitis viral	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Campylobacter gastroenteritis	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Cellulitis gangrenous	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Cellulitis staphylococcal	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Central nervous system infection	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Chronic tonsillitis	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Encephalitis viral	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Endocarditis bacterial	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Endocarditis enterococcal	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Enterocolitis infectious	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Escherichia infection	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Escherichia sepsis	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Escherichia urinary tract infection	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Extradural abscess	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Fallopian tube abscess	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Furuncle	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Gingival infection	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Haematoma infection	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Hepatitis B	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Hepatitis E	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Herpes zoster ophthalmic	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Incision site cellulitis	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Incision site infection	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Infected bites	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Infected skin ulcer	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Infection	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Keratitis herpetic	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Klebsiella sepsis	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Lobar pneumonia	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Meningitis aseptic	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Mycobacterium avium complex infection	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Nasal abscess	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Neutropenic sepsis	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Osteomyelitis chronic	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Paronychia	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Parotitis	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Perineal infection	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Periorbital cellulitis	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Peritoneal abscess	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Peritonsillar abscess	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Pharyngitis streptococcal	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Pneumococcal sepsis	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Pneumonia bacterial	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Pneumonia blastomyces	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Pneumonia viral	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Post procedural cellulitis	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Prostatic abscess	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Proteus infection	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Pseudomonal bacteraemia	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Pseudomonas infection	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Psoas abscess	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Pyelonephritis acute	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Rectal abscess	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Renal abscess	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Sialoadenitis	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Skin infection	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Staphylococcal sepsis	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Streptococcal sepsis	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Systemic candida	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Tongue abscess	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Tracheitis	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Tuberculosis	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Varicella	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Viral diarrhoea	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Wound infection bacterial	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Injury, poisoning and procedural complications Ankle fracture	0.39% 8/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Injury, poisoning and procedural complications Humerus fracture	0.34% 7/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Injury, poisoning and procedural complications Femur fracture	0.24% 5/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Injury, poisoning and procedural complications Pelvic fracture	0.24% 5/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Injury, poisoning and procedural complications Femoral neck fracture	0.19% 4/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Injury, poisoning and procedural complications Joint dislocation	0.19% 4/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Injury, poisoning and procedural complications Upper limb fracture	0.19% 4/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Injury, poisoning and procedural complications Wound dehiscence	0.19% 4/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Injury, poisoning and procedural complications Laceration	0.15% 3/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Injury, poisoning and procedural complications Lower limb fracture	0.15% 3/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Injury, poisoning and procedural complications Spinal compression fracture	0.15% 3/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Injury, poisoning and procedural complications Comminuted fracture	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Injury, poisoning and procedural complications Foot fracture	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Injury, poisoning and procedural complications Incisional hernia	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Injury, poisoning and procedural complications Intentional overdose	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Injury, poisoning and procedural complications Meniscus injury	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Injury, poisoning and procedural complications Overdose	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Injury, poisoning and procedural complications Postoperative ileus	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Injury, poisoning and procedural complications Postoperative wound complication	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Injury, poisoning and procedural complications Procedural pain	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Injury, poisoning and procedural complications Radius fracture	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Injury, poisoning and procedural complications Seroma	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Injury, poisoning and procedural complications Tibia fracture	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Injury, poisoning and procedural complications Ulna fracture	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Injury, poisoning and procedural complications Accidental overdose	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Injury, poisoning and procedural complications Bone fragmentation	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Injury, poisoning and procedural complications Burns second degree	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Injury, poisoning and procedural complications Carotid artery restenosis	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Injury, poisoning and procedural complications Cervical vertebral fracture	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Injury, poisoning and procedural complications Hip fracture	0.48% 10/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Injury, poisoning and procedural complications Contusion	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Injury, poisoning and procedural complications Face injury	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Injury, poisoning and procedural complications Fall	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Injury, poisoning and procedural complications Fracture displacement	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Injury, poisoning and procedural complications Head injury	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Injury, poisoning and procedural complications Infusion related reaction	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Injury, poisoning and procedural complications Joint injury	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Injury, poisoning and procedural complications Multiple fractures	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Injury, poisoning and procedural complications Multiple injuries	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Injury, poisoning and procedural complications Patella fracture	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Injury, poisoning and procedural complications Periprosthetic fracture	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Injury, poisoning and procedural complications Post procedural haematoma	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Injury, poisoning and procedural complications Post-traumatic pain	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Injury, poisoning and procedural complications Pubis fracture	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Injury, poisoning and procedural complications Rib fracture	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Injury, poisoning and procedural complications Road traffic accident	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Injury, poisoning and procedural complications Skull fracture	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Injury, poisoning and procedural complications Spinal column injury	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Injury, poisoning and procedural complications Spinal cord injury	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Injury, poisoning and procedural complications Subcutaneous haematoma	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Injury, poisoning and procedural complications Subdural haematoma	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Injury, poisoning and procedural complications Synovial rupture	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Injury, poisoning and procedural complications Tendon rupture	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Injury, poisoning and procedural complications Tracheal haemorrhage	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Injury, poisoning and procedural complications Tracheostomy malfunction	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Injury, poisoning and procedural complications Wound	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.24% 5/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	0.24% 5/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.24% 5/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.19% 4/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.15% 3/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian adenoma	0.15% 3/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.15% 3/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer metastatic	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Carcinoid tumour of the gastrointestinal tract	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix carcinoma stage 0	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diffuse large b-cell lymphoma	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma stage II	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma stage III	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung squamous cell carcinoma stage III	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma metastatic	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer metastatic	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma gastric	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Astrocytoma malignant	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basosquamous carcinoma of skin	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign breast neoplasm	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign neoplasm of thyroid gland	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign renal neoplasm	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma stage 0	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bowen's disease	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer stage III	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic lymphocytic leukaemia	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon adenoma	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer stage I	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer stage II	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Dermatofibrosarcoma protuberans	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial adenocarcinoma	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Fibrosarcoma	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal cancer metastatic	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioblastoma	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic neoplasm	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraductal papillary mucinous neoplasm	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraductal proliferative breast lesion	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Large intestine benign neoplasm	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma metastatic	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma stage I	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung squamous cell carcinoma metastatic	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung squamous cell carcinoma stage I	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant anorectal neoplasm	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma in situ	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm of unknown primary site	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma benign	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Nasal cavity cancer	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-hodgkin's lymphoma	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ocular cancer metastatic	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal carcinoma	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian epithelial cancer stage III	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian germ cell teratoma benign	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Post transplant lymphoproliferative disorder	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer metastatic	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer stage I	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer stage II	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer stage III	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Sarcoma uterus	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Spindle cell sarcoma	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of lung	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of pharynx	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of the cervix	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of the tongue	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine cancer	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Gastrointestinal disorders Diverticular perforation	0.53% 11/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Gastrointestinal disorders Abdominal pain	0.29% 6/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Gastrointestinal disorders Gastritis	0.24% 5/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Gastrointestinal disorders Pancreatitis	0.24% 5/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Gastrointestinal disorders Vomiting	0.19% 4/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Gastrointestinal disorders Colitis	0.15% 3/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Gastrointestinal disorders Crohn's disease	0.15% 3/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Gastrointestinal disorders Diarrhoea	0.15% 3/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.15% 3/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Gastrointestinal disorders Irritable bowel syndrome	0.15% 3/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Gastrointestinal disorders Large intestine perforation	0.15% 3/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Gastrointestinal disorders Small intestinal obstruction	0.15% 3/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Gastrointestinal disorders Abdominal pain upper	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Gastrointestinal disorders Colitis ischaemic	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Gastrointestinal disorders Diverticulum intestinal haemorrhagic	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Gastrointestinal disorders Gastric ulcer	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Gastrointestinal disorders Gastric ulcer haemorrhage	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Gastrointestinal disorders Gastritis erosive	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Gastrointestinal disorders Haemorrhoids	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Gastrointestinal disorders Ileus	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Gastrointestinal disorders Mallory-weiss syndrome	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Gastrointestinal disorders Abdominal adhesions	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Gastrointestinal disorders Abdominal distension	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Gastrointestinal disorders Abdominal wall haematoma	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Gastrointestinal disorders Anal fissure	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Gastrointestinal disorders Ascites	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Gastrointestinal disorders Colitis ulcerative	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Gastrointestinal disorders Diverticulum	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Gastrointestinal disorders Diverticulum intestinal	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Gastrointestinal disorders Duodenal ulcer	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Gastrointestinal disorders Dyspepsia	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Gastrointestinal disorders Enterocutaneous fistula	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Gastrointestinal disorders Erosive duodenitis	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Gastrointestinal disorders Food poisoning	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Gastrointestinal disorders Gastric disorder	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Gastrointestinal disorders Gastric perforation	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Gastrointestinal disorders Gastrointestinal erosion	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Gastrointestinal disorders Gastrointestinal necrosis	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Gastrointestinal disorders Ileal perforation	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Gastrointestinal disorders Inguinal hernia	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Gastrointestinal disorders Intestinal ischaemia	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Gastrointestinal disorders Intestinal perforation	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Gastrointestinal disorders Intussusception	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Gastrointestinal disorders Large intestinal ulcer	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Gastrointestinal disorders Nausea	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Gastrointestinal disorders Oedematous pancreatitis	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Gastrointestinal disorders Oesophagitis	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Gastrointestinal disorders Pancreatitis acute	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Gastrointestinal disorders Peptic ulcer perforation	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Gastrointestinal disorders Poor dental condition	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Gastrointestinal disorders Rectal haemorrhage	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Gastrointestinal disorders Small intestinal perforation	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Gastrointestinal disorders Stomatitis haemorrhagic	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Gastrointestinal disorders Umbilical hernia	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Musculoskeletal and connective tissue disorders Osteoarthritis	1.2% 25/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.34% 7/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Musculoskeletal and connective tissue disorders Foot deformity	0.24% 5/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Musculoskeletal and connective tissue disorders Back pain	0.19% 4/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.19% 4/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.19% 4/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Musculoskeletal and connective tissue disorders Bursitis	0.15% 3/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	0.15% 3/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.15% 3/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Musculoskeletal and connective tissue disorders Osteoporotic fracture	0.15% 3/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Musculoskeletal and connective tissue disorders Spinal column stenosis	0.15% 3/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.15% 3/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Musculoskeletal and connective tissue disorders Arthralgia	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Musculoskeletal and connective tissue disorders Haemarthrosis	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Musculoskeletal and connective tissue disorders Synovitis	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Musculoskeletal and connective tissue disorders Acquired claw toe	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Musculoskeletal and connective tissue disorders Arthritis	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Musculoskeletal and connective tissue disorders Arthrofibrosis	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Musculoskeletal and connective tissue disorders Arthropathy	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Musculoskeletal and connective tissue disorders Cervical spinal stenosis	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Musculoskeletal and connective tissue disorders Chondrocalcinosis pyrophosphate	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Musculoskeletal and connective tissue disorders Dupuytren's contracture	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Musculoskeletal and connective tissue disorders Fistula	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Musculoskeletal and connective tissue disorders Fracture malunion	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Musculoskeletal and connective tissue disorders Joint contracture	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Musculoskeletal and connective tissue disorders Joint instability	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Musculoskeletal and connective tissue disorders Muscular weakness	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Musculoskeletal and connective tissue disorders Osteitis	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Musculoskeletal and connective tissue disorders Patellofemoral pain syndrome	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Musculoskeletal and connective tissue disorders Pathological fracture	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Musculoskeletal and connective tissue disorders Periarthritis	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Musculoskeletal and connective tissue disorders Pseudarthrosis	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Musculoskeletal and connective tissue disorders Scoliosis	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Musculoskeletal and connective tissue disorders Spinal disorder	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Musculoskeletal and connective tissue disorders Tendonitis	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Cardiac disorders Myocardial infarction	0.77% 16/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Cardiac disorders Atrial fibrillation	0.63% 13/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Cardiac disorders Angina pectoris	0.44% 9/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Cardiac disorders Acute myocardial infarction	0.39% 8/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Cardiac disorders Cardiac failure congestive	0.29% 6/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Cardiac disorders Myocardial ischaemia	0.29% 6/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Cardiac disorders Cardiac failure	0.24% 5/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Cardiac disorders Coronary artery disease	0.19% 4/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Cardiac disorders Arrhythmia	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Cardiac disorders Atrioventricular block complete	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Cardiac disorders Coronary artery occlusion	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Cardiac disorders Coronary artery stenosis	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Cardiac disorders Tachycardia	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Cardiac disorders Angina unstable	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Cardiac disorders Arteriosclerosis coronary artery	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Cardiac disorders Atrial tachycardia	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Cardiac disorders Atrioventricular block second degree	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Cardiac disorders Bradycardia	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Cardiac disorders Cardiac arrest	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Cardiac disorders Cardiac failure chronic	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Cardiac disorders Congestive cardiomyopathy	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Cardiac disorders Diastolic dysfunction	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Cardiac disorders Mitral valve incompetence	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Cardiac disorders Palpitations	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Cardiac disorders Pericardial effusion	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Cardiac disorders Sinus bradycardia	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Cardiac disorders Stress cardiomyopathy	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Cardiac disorders Supraventricular tachycardia	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Cardiac disorders Ventricular extrasystoles	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Cardiac disorders Ventricular tachycardia	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Nervous system disorders Transient ischaemic attack	0.44% 9/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Nervous system disorders Syncope	0.29% 6/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Nervous system disorders Cerebrovascular accident	0.24% 5/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Nervous system disorders Carotid artery stenosis	0.19% 4/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Nervous system disorders Sciatica	0.15% 3/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Nervous system disorders Cerebral infarction	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Nervous system disorders Cerebral ischaemia	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Nervous system disorders Headache	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Nervous system disorders Intracranial aneurysm	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Nervous system disorders Ischaemic stroke	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Nervous system disorders Transient global amnesia	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Nervous system disorders Viith nerve paralysis	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Nervous system disorders Aphasia	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Nervous system disorders Balance disorder	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Nervous system disorders Carotid artery occlusion	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Nervous system disorders Cerebral haemorrhage	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Nervous system disorders Convulsion	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Nervous system disorders Dementia	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Nervous system disorders Dizziness	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Nervous system disorders Dysarthria	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Nervous system disorders Facial neuralgia	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Nervous system disorders Grand mal convulsion	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Nervous system disorders Haemorrhagic stroke	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Nervous system disorders Hypoglycaemic coma	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Nervous system disorders Hypoxic-ischaemic encephalopathy	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Nervous system disorders Intercostal neuralgia	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Nervous system disorders Ischaemic cerebral infarction	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Nervous system disorders Lacunar infarction	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Nervous system disorders Lumbar radiculopathy	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Nervous system disorders Meralgia paraesthetica	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Nervous system disorders Migraine	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Nervous system disorders Migraine with aura	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Nervous system disorders Monoparesis	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Nervous system disorders Multiple sclerosis relapse	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Nervous system disorders Neuropathy peripheral	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Nervous system disorders Normal pressure hydrocephalus	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Nervous system disorders Parkinson's disease	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Nervous system disorders Perineurial cyst	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Nervous system disorders Presyncope	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Nervous system disorders Ruptured cerebral aneurysm	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Nervous system disorders Spinal claudication	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Nervous system disorders Subarachnoid haemorrhage	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Nervous system disorders Thalamus haemorrhage	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.73% 15/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.34% 7/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.34% 7/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.24% 5/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.24% 5/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.15% 3/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Respiratory, thoracic and mediastinal disorders Asthma	0.15% 3/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Respiratory, thoracic and mediastinal disorders Rheumatoid lung	0.15% 3/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Respiratory, thoracic and mediastinal disorders Acute interstitial pneumonitis	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Respiratory, thoracic and mediastinal disorders Alveolitis	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Respiratory, thoracic and mediastinal disorders Bronchiectasis	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Respiratory, thoracic and mediastinal disorders Bronchopleural fistula	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Respiratory, thoracic and mediastinal disorders Bronchopneumopathy	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Respiratory, thoracic and mediastinal disorders Haemothorax	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Vascular disorders Deep vein thrombosis	0.68% 14/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Vascular disorders Hypertension	0.39% 8/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Vascular disorders Aortic aneurysm	0.19% 4/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Vascular disorders Haematoma	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Vascular disorders Hypertensive crisis	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Vascular disorders Orthostatic hypotension	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Vascular disorders Phlebitis	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Vascular disorders Aortic stenosis	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Vascular disorders Arteriosclerosis	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Vascular disorders Arteritis	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Vascular disorders Essential hypertension	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Vascular disorders Hypovolaemic shock	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Vascular disorders Peripheral vascular disorder	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Vascular disorders Post thrombotic syndrome	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Vascular disorders Thrombosed varicose vein	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Vascular disorders Thrombosis	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Vascular disorders Vascular rupture	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
General disorders Non-cardiac chest pain	0.53% 11/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
General disorders Device dislocation	0.29% 6/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
General disorders Chest pain	0.15% 3/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
General disorders Multi-organ failure	0.15% 3/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
General disorders Surgical failure	0.15% 3/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
General disorders Death	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
General disorders Impaired healing	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
General disorders Cyst	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
General disorders Drug withdrawal syndrome	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
General disorders Effusion	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
General disorders Oedema peripheral	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
General disorders Sudden death	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
General disorders Systemic inflammatory response syndrome	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Renal and urinary disorders Nephrolithiasis	0.58% 12/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Renal and urinary disorders Renal failure acute	0.34% 7/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Renal and urinary disorders Calculus ureteric	0.19% 4/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Renal and urinary disorders Renal failure	0.15% 3/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Renal and urinary disorders Calculus urinary	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Renal and urinary disorders Hydronephrosis	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Renal and urinary disorders Incontinence	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Renal and urinary disorders Mesangioproliferative glomerulonephritis	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Renal and urinary disorders Obstructive uropathy	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Renal and urinary disorders Postrenal failure	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Renal and urinary disorders Renal mass	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Reproductive system and breast disorders Ovarian cyst	0.19% 4/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Reproductive system and breast disorders Uterine prolapse	0.19% 4/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Reproductive system and breast disorders Menorrhagia	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Reproductive system and breast disorders Adnexa uteri cyst	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Reproductive system and breast disorders Adnexa uteri mass	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Reproductive system and breast disorders Cervical dysplasia	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Reproductive system and breast disorders Cervical polyp	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Reproductive system and breast disorders Endometrial hyperplasia	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Reproductive system and breast disorders Endometriosis	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Reproductive system and breast disorders Fibrocystic breast disease	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Reproductive system and breast disorders Postmenopausal haemorrhage 1	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Reproductive system and breast disorders Prostatitis	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Reproductive system and breast disorders Uterine fibrosis	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Reproductive system and breast disorders Uterine polyp	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Hepatobiliary disorders Cholelithiasis	0.48% 10/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Hepatobiliary disorders Cholecystitis	0.19% 4/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Hepatobiliary disorders Biliary colic	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Hepatobiliary disorders Cholecystitis acute	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Hepatobiliary disorders Bile duct stone	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Hepatobiliary disorders Cholestasis	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Hepatobiliary disorders Hepatic steatosis	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Hepatobiliary disorders Ischaemic hepatitis	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Psychiatric disorders Depression	0.19% 4/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Psychiatric disorders Completed suicide	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Psychiatric disorders Mental status changes	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Psychiatric disorders Suicide attempt	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Psychiatric disorders Abnormal behaviour	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Psychiatric disorders Alcohol abuse	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Psychiatric disorders Anxiety	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Psychiatric disorders Bipolar disorder	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Psychiatric disorders Bipolar I disorder	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Psychiatric disorders Conversion disorder	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Psychiatric disorders Drug dependence	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Psychiatric disorders Schizophrenia, paranoid type	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Psychiatric disorders Somatoform disorder neurologic	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Blood and lymphatic system disorders Anaemia	0.39% 8/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Blood and lymphatic system disorders Leukopenia	0.19% 4/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Blood and lymphatic system disorders Thrombocytopenia	0.15% 3/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Blood and lymphatic system disorders Neutropenia	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Blood and lymphatic system disorders Pancytopenia	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Blood and lymphatic system disorders Anaemia megaloblastic	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Skin and subcutaneous tissue disorders Acute febrile neutrophilic dermatosis	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Skin and subcutaneous tissue disorders Leukocytoclastic vasculitis	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Skin and subcutaneous tissue disorders Skin ulcer	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Skin and subcutaneous tissue disorders Dry gangrene	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Skin and subcutaneous tissue disorders Mucocutaneous rash	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Metabolism and nutrition disorders Dehydration	0.15% 3/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Metabolism and nutrition disorders Hypokalaemia	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Metabolism and nutrition disorders Type 1 diabetes mellitus	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Eye disorders Cataract	0.15% 3/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Eye disorders Angle closure glaucoma	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Eye disorders Corneal perforation	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Eye disorders Retinal artery occlusion	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.19% 4/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Pregnancy, puerperium and perinatal conditions Pregnancy	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Immune system disorders Anaphylactic reaction	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Immune system disorders Allergy to arthropod sting	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Immune system disorders Anaphylactic shock	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Ear and labyrinth disorders Hypoacusis	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Ear and labyrinth disorders Sudden hearing loss	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Ear and labyrinth disorders Vertigo	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Endocrine disorders Goitre	0.10% 2/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Endocrine disorders Thyroid cyst	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Congenital, familial and genetic disorders Arnold-chiari malformation	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Congenital, familial and genetic disorders Choledochal cyst	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Investigations Hepatic enzyme increased	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Surgical and medical procedures Removal of internal fixation 1	0.05% 1/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.

Other adverse events

Other adverse events
Measure	Tocilizumab n=2067 participants at risk Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
Infections and infestations Upper respiratory tract infection	29.8% 616/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Nasopharyngitis	23.9% 495/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Urinary tract infection	20.3% 420/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Bronchitis	19.6% 405/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Sinusitis	15.8% 326/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Influenza	11.2% 231/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Gastroenteritis	10.3% 213/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Pharyngitis	8.7% 180/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Herpes zoster	6.2% 129/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Cellulitis	6.1% 127/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Infections and infestations Gastroenteritis viral	5.9% 122/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Gastrointestinal disorders Diarrhoea	17.3% 358/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Gastrointestinal disorders Nausea	12.6% 261/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Gastrointestinal disorders Dyspepsia	9.1% 189/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Gastrointestinal disorders Abdominal pain upper	7.3% 151/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Gastrointestinal disorders Gastritis	7.2% 149/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Gastrointestinal disorders Abdominal pain	5.8% 120/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Gastrointestinal disorders Vomiting	5.5% 114/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Gastrointestinal disorders Gastrooesophageal reflux disease	5.5% 113/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Gastrointestinal disorders Constipation	5.2% 107/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	15.6% 322/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Musculoskeletal and connective tissue disorders Back pain	14.2% 294/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Musculoskeletal and connective tissue disorders Arthralgia	9.7% 201/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Musculoskeletal and connective tissue disorders Osteoarthritis	6.3% 131/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Musculoskeletal and connective tissue disorders Pain in extremity	6.3% 131/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Musculoskeletal and connective tissue disorders Bursitis	5.7% 117/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	5.5% 113/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Vascular disorders Hypertension	19.9% 411/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Nervous system disorders Headache	14.0% 289/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Nervous system disorders Dizziness	7.8% 161/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Respiratory, thoracic and mediastinal disorders Cough	9.6% 199/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	5.6% 115/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
General disorders Oedema peripheral	8.9% 183/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
General disorders Fatigue	6.2% 128/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Psychiatric disorders Insomnia	6.6% 136/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Psychiatric disorders Depression	5.9% 122/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Investigations Transaminases increased	6.6% 136/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Investigations Alanine aminotransferase increased	5.4% 111/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Skin and subcutaneous tissue disorders Rash	8.8% 181/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Metabolism and nutrition disorders Hypercholesterolaemia	8.2% 170/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Injury, poisoning and procedural complications Contusion	7.2% 149/2067 All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800 821-8590

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER