Trial Outcomes & Findings for A Study of Tocilizumab as Monotherapy and in Combination With Methotrexate Versus Methotrexate in Patients With Early Moderate to Severe Rheumatoid Arthritis (NCT NCT01007435)
NCT ID: NCT01007435
Last Updated: 2017-07-26
Results Overview
A participant has a DAS28 remission response if their DAS28 \< 2.6. 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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1162 participants
Primary outcome timeframe
Week 24
Results posted on
2017-07-26
Participant Flow
Five of 1162 randomized patients (2 placebo to tocilizumab + methotrexate, 2 tocilizumab 4 mg/kg + methotrexate, 1 tocilizumab 8 mg/kg + methotrexate) did not receive any study treatment and were excluded from all analysis populations.
Participant milestones
| Measure |
Placebo to Tocilizumab + Methotrexate
Patients received placebo tocilizumab intravenously (iv) every 4 weeks + methotrexate orally once a week for 104 weeks.
|
Tocilizumab 4 mg/kg + Methotrexate
Patients received tocilizumab 4 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
|
Tocilizumab 8 mg/kg + Methotrexate
Patients received tocilizumab 8 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
|
Tocilizumab 8 mg/kg + Placebo to Methotrexate
Patients received tocilizumab 8 mg/kg iv every 4 weeks + placebo to methotrexate orally once a week for 104 weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
289
|
290
|
291
|
292
|
|
Overall Study
COMPLETED
|
226
|
231
|
227
|
236
|
|
Overall Study
NOT COMPLETED
|
63
|
59
|
64
|
56
|
Reasons for withdrawal
| Measure |
Placebo to Tocilizumab + Methotrexate
Patients received placebo tocilizumab intravenously (iv) every 4 weeks + methotrexate orally once a week for 104 weeks.
|
Tocilizumab 4 mg/kg + Methotrexate
Patients received tocilizumab 4 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
|
Tocilizumab 8 mg/kg + Methotrexate
Patients received tocilizumab 8 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
|
Tocilizumab 8 mg/kg + Placebo to Methotrexate
Patients received tocilizumab 8 mg/kg iv every 4 weeks + placebo to methotrexate orally once a week for 104 weeks.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
16
|
25
|
47
|
31
|
|
Overall Study
Death
|
2
|
4
|
2
|
1
|
|
Overall Study
Insufficient Therapeutic Response
|
21
|
7
|
2
|
9
|
|
Overall Study
Violation of Selection Criteria at Entry
|
3
|
5
|
2
|
0
|
|
Overall Study
Other Protocol Violation
|
2
|
0
|
1
|
0
|
|
Overall Study
Refused Treatment
|
13
|
13
|
5
|
8
|
|
Overall Study
Failure to Return
|
5
|
4
|
3
|
6
|
|
Overall Study
Reason not Specified
|
1
|
1
|
2
|
1
|
Baseline Characteristics
A Study of Tocilizumab as Monotherapy and in Combination With Methotrexate Versus Methotrexate in Patients With Early Moderate to Severe Rheumatoid Arthritis
Baseline characteristics by cohort
| Measure |
Placebo to Tocilizumab + Methotrexate
n=287 Participants
Patients received placebo tocilizumab intravenously (iv) every 4 weeks + methotrexate orally once a week for 104 weeks.
|
Tocilizumab 4 mg/kg + Methotrexate
n=288 Participants
Patients received tocilizumab 4 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
|
Tocilizumab 8 mg/kg + Methotrexate
n=290 Participants
Patients received tocilizumab 8 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
|
Tocilizumab 8 mg/kg + Placebo to Methotrexate
n=292 Participants
Patients received tocilizumab 8 mg/kg iv every 4 weeks + placebo to methotrexate orally once a week for 104 weeks.
|
Total
n=1157 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
49.6 years
STANDARD_DEVIATION 13.10 • n=99 Participants
|
51.2 years
STANDARD_DEVIATION 13.84 • n=107 Participants
|
49.5 years
STANDARD_DEVIATION 13.70 • n=206 Participants
|
49.9 years
STANDARD_DEVIATION 13.22 • n=7 Participants
|
50.1 years
STANDARD_DEVIATION 13.47 • n=31 Participants
|
|
Sex: Female, Male
Female
|
229 Participants
n=99 Participants
|
228 Participants
n=107 Participants
|
228 Participants
n=206 Participants
|
219 Participants
n=7 Participants
|
904 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
58 Participants
n=99 Participants
|
60 Participants
n=107 Participants
|
62 Participants
n=206 Participants
|
73 Participants
n=7 Participants
|
253 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Week 24Population: Intent-to-treat population: All randomized participants who received at least 1 tocilizumab/placebo infusion.
A participant has a DAS28 remission response if their DAS28 \< 2.6. 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.
Outcome measures
| Measure |
Placebo to Tocilizumab + Methotrexate
n=287 Participants
Patients received placebo tocilizumab intravenously (iv) every 4 weeks + methotrexate orally once a week for 104 weeks.
|
Tocilizumab 4 mg/kg + Methotrexate
n=288 Participants
Patients received tocilizumab 4 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
|
Tocilizumab 8 mg/kg + Methotrexate
n=290 Participants
Patients received tocilizumab 8 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
|
Tocilizumab 8 mg/kg + Placebo to Methotrexate
n=292 Participants
Patients received tocilizumab 8 mg/kg iv every 4 weeks + placebo to methotrexate orally once a week for 104 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants With a Disease Activity Score 28 (DAS28) Remission Response at Week 24
|
15.0 Percentage of participants
Interval 10.9 to 19.1
|
31.9 Percentage of participants
Interval 26.6 to 37.3
|
44.8 Percentage of participants
Interval 39.1 to 50.6
|
38.7 Percentage of participants
Interval 33.1 to 44.3
|
SECONDARY outcome
Timeframe: Week 52Population: Intent-to-treat population: All randomized participants who received at least 1 tocilizumab/placebo infusion.
Outcome measures
| Measure |
Placebo to Tocilizumab + Methotrexate
n=287 Participants
Patients received placebo tocilizumab intravenously (iv) every 4 weeks + methotrexate orally once a week for 104 weeks.
|
Tocilizumab 4 mg/kg + Methotrexate
n=288 Participants
Patients received tocilizumab 4 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
|
Tocilizumab 8 mg/kg + Methotrexate
n=290 Participants
Patients received tocilizumab 8 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
|
Tocilizumab 8 mg/kg + Placebo to Methotrexate
n=292 Participants
Patients received tocilizumab 8 mg/kg iv every 4 weeks + placebo to methotrexate orally once a week for 104 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants With a Disease Activity Score 28 (DAS28) Remission Response at Week 52
|
19.5 Percentage of participants
|
34.0 Percentage of participants
|
49.0 Percentage of participants
|
39.4 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Weeks 24 and 52Population: Intent-to-treat population: All randomized participants who received at least 1 tocilizumab/placebo infusion.
Improvement must be seen in tender (68) and swollen (66) joint counts. Joints were assessed and classified as swollen/not swollen and tender/not tender by pressure and joint manipulation. Improvement must also be seen 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 extreme left end of the line "no disease activity" \[symptom-free and no arthritis symptoms\] and the extreme right end "maximum disease activity"; patient assessment of pain in previous the 24 hours on a VAS (extreme left end of the line "no pain" and the extreme right end "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 C-reactive protein (CRP), or erythrocyte sedimentation rate if CRP was missing.
Outcome measures
| Measure |
Placebo to Tocilizumab + Methotrexate
n=287 Participants
Patients received placebo tocilizumab intravenously (iv) every 4 weeks + methotrexate orally once a week for 104 weeks.
|
Tocilizumab 4 mg/kg + Methotrexate
n=288 Participants
Patients received tocilizumab 4 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
|
Tocilizumab 8 mg/kg + Methotrexate
n=290 Participants
Patients received tocilizumab 8 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
|
Tocilizumab 8 mg/kg + Placebo to Methotrexate
n=292 Participants
Patients received tocilizumab 8 mg/kg iv every 4 weeks + placebo to methotrexate orally once a week for 104 weeks.
|
|---|---|---|---|---|
|
Percentage of Patients With an Improvement ≥ 20%, 50%, or 70% in American College of Rheumatology (ACR) Score (ACR20/50/70) From Baseline to Weeks 24 and 52
Week 24: ACR 20
|
65.2 Percentage of participants
|
73.6 Percentage of participants
|
74.5 Percentage of participants
|
70.2 Percentage of participants
|
|
Percentage of Patients With an Improvement ≥ 20%, 50%, or 70% in American College of Rheumatology (ACR) Score (ACR20/50/70) From Baseline to Weeks 24 and 52
Week 24: ACR 50
|
43.2 Percentage of participants
|
47.9 Percentage of participants
|
56.9 Percentage of participants
|
47.6 Percentage of participants
|
|
Percentage of Patients With an Improvement ≥ 20%, 50%, or 70% in American College of Rheumatology (ACR) Score (ACR20/50/70) From Baseline to Weeks 24 and 52
Week 24: ACR 70
|
25.4 Percentage of participants
|
34.7 Percentage of participants
|
38.6 Percentage of participants
|
30.1 Percentage of participants
|
|
Percentage of Patients With an Improvement ≥ 20%, 50%, or 70% in American College of Rheumatology (ACR) Score (ACR20/50/70) From Baseline to Weeks 24 and 52
Week 52: ACR 20
|
57.1 Percentage of participants
|
62.8 Percentage of participants
|
67.2 Percentage of participants
|
63.0 Percentage of participants
|
|
Percentage of Patients With an Improvement ≥ 20%, 50%, or 70% in American College of Rheumatology (ACR) Score (ACR20/50/70) From Baseline to Weeks 24 and 52
Week 52: ACR 50
|
40.8 Percentage of participants
|
52.4 Percentage of participants
|
55.9 Percentage of participants
|
49.3 Percentage of participants
|
|
Percentage of Patients With an Improvement ≥ 20%, 50%, or 70% in American College of Rheumatology (ACR) Score (ACR20/50/70) From Baseline to Weeks 24 and 52
Week 52: ACR 70
|
28.9 Percentage of participants
|
37.2 Percentage of participants
|
43.1 Percentage of participants
|
36.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 52Population: Intent-to-treat population: All randomized participants who received at least 1 tocilizumab/placebo infusion.
The mTSS is a measure of joint damage and includes measures of joint erosion (JE) and joint space narrowing (JSN). The JE score, using the van der Heijde modification, measures erosion severity in 32 hand joints and 12 foot joints. Each hand joint is scored from 0 to 5 and each foot joint is scored from 0 to 10; the total score ranges from 0 to 280. Each joint is scored according to the surface area involved. A score of 10 indicates extensive loss of bone from more than one-half of the articulating bone; a score of 0 indicates no erosion. The JSN score measures the severity of JSN in 30 hand joints (15 per hand) and 12 foot joints (6 per foot). Each joint, including subluxation, is scored from 0 to 4; the total score ranges from 0 to 168. A higher score indicates more joint space narrowing. The mTSS ranges from 0 to 448 (280+168). A higher mTSS score indicates greater damage. A negative change score indicates improvement.
Outcome measures
| Measure |
Placebo to Tocilizumab + Methotrexate
n=267 Participants
Patients received placebo tocilizumab intravenously (iv) every 4 weeks + methotrexate orally once a week for 104 weeks.
|
Tocilizumab 4 mg/kg + Methotrexate
n=267 Participants
Patients received tocilizumab 4 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
|
Tocilizumab 8 mg/kg + Methotrexate
n=273 Participants
Patients received tocilizumab 8 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
|
Tocilizumab 8 mg/kg + Placebo to Methotrexate
n=275 Participants
Patients received tocilizumab 8 mg/kg iv every 4 weeks + placebo to methotrexate orally once a week for 104 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Modified Total Sharp Score (mTSS) at Week 52
|
1.14 Units on a scale
Standard Deviation 4.297
|
0.42 Units on a scale
Standard Deviation 2.929
|
0.08 Units on a scale
Standard Deviation 2.090
|
0.26 Units on a scale
Standard Deviation 1.876
|
SECONDARY outcome
Timeframe: Baseline to Week 52Population: Intent-to-treat population: All randomized participants who received at least 1 tocilizumab/placebo infusion.
Outcome measures
| Measure |
Placebo to Tocilizumab + Methotrexate
n=267 Participants
Patients received placebo tocilizumab intravenously (iv) every 4 weeks + methotrexate orally once a week for 104 weeks.
|
Tocilizumab 4 mg/kg + Methotrexate
n=267 Participants
Patients received tocilizumab 4 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
|
Tocilizumab 8 mg/kg + Methotrexate
n=273 Participants
Patients received tocilizumab 8 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
|
Tocilizumab 8 mg/kg + Placebo to Methotrexate
n=275 Participants
Patients received tocilizumab 8 mg/kg iv every 4 weeks + placebo to methotrexate orally once a week for 104 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Modified Sharp Erosion Score at Week 52
|
0.63 Units on a scale
Standard Deviation 2.556
|
0.25 Units on a scale
Standard Deviation 1.686
|
0.05 Units on a scale
Standard Deviation 1.736
|
0.15 Units on a scale
Standard Deviation 1.544
|
SECONDARY outcome
Timeframe: Baseline to Week 52Population: Intent-to-treat population: All randomized participants who received at least 1 tocilizumab/placebo infusion.
Outcome measures
| Measure |
Placebo to Tocilizumab + Methotrexate
n=267 Participants
Patients received placebo tocilizumab intravenously (iv) every 4 weeks + methotrexate orally once a week for 104 weeks.
|
Tocilizumab 4 mg/kg + Methotrexate
n=268 Participants
Patients received tocilizumab 4 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
|
Tocilizumab 8 mg/kg + Methotrexate
n=273 Participants
Patients received tocilizumab 8 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
|
Tocilizumab 8 mg/kg + Placebo to Methotrexate
n=275 Participants
Patients received tocilizumab 8 mg/kg iv every 4 weeks + placebo to methotrexate orally once a week for 104 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Sharp Joint Space Narrowing Score at Week 52
|
0.51 Units on a scale
Standard Deviation 2.362
|
0.17 Units on a scale
Standard Deviation 1.645
|
0.03 Units on a scale
Standard Deviation 0.751
|
0.11 Units on a scale
Standard Deviation 1.046
|
SECONDARY outcome
Timeframe: Baseline to Week 52Population: Intent-to-treat population: All randomized participants who received at least 1 tocilizumab/placebo infusion.
A major clinical response is defined as an ACR70 response that is maintained for 6 consecutive months (24 weeks) for any 24-week period between Week 2 and Week 52.
Outcome measures
| Measure |
Placebo to Tocilizumab + Methotrexate
n=287 Participants
Patients received placebo tocilizumab intravenously (iv) every 4 weeks + methotrexate orally once a week for 104 weeks.
|
Tocilizumab 4 mg/kg + Methotrexate
n=288 Participants
Patients received tocilizumab 4 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
|
Tocilizumab 8 mg/kg + Methotrexate
n=290 Participants
Patients received tocilizumab 8 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
|
Tocilizumab 8 mg/kg + Placebo to Methotrexate
n=292 Participants
Patients received tocilizumab 8 mg/kg iv every 4 weeks + placebo to methotrexate orally once a week for 104 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants With a Major Clinical Response at Week 52
|
16 Percentage of participants
|
22 Percentage of participants
|
31 Percentage of participants
|
22 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Weeks 24 and 52Population: Intent-to-treat population: All randomized participants who received at least 1 tocilizumab/placebo infusion.
The Stanford HAQ-DI is a patient completed questionnaire specific for rheumatoid arthritis. The HAQ-DI assesses how well the patient is able to perform 8 activities: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. The patient answers 20 questions with 1 of 4 responses with the past week as the time frame: 0=without difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. The highest score for any question in a category determines the category score. The total score ranges from 0 (no disability) to 3 (completely disabled). A negative change score indicates improvement.
Outcome measures
| Measure |
Placebo to Tocilizumab + Methotrexate
n=287 Participants
Patients received placebo tocilizumab intravenously (iv) every 4 weeks + methotrexate orally once a week for 104 weeks.
|
Tocilizumab 4 mg/kg + Methotrexate
n=288 Participants
Patients received tocilizumab 4 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
|
Tocilizumab 8 mg/kg + Methotrexate
n=290 Participants
Patients received tocilizumab 8 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
|
Tocilizumab 8 mg/kg + Placebo to Methotrexate
n=292 Participants
Patients received tocilizumab 8 mg/kg iv every 4 weeks + placebo to methotrexate orally once a week for 104 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Weeks 24 and 52
Week 24 (n=246, 255, 250, 265)
|
-0.71 Units on a scale
Standard Deviation 0.718
|
-0.92 Units on a scale
Standard Deviation 0.736
|
-0.91 Units on a scale
Standard Deviation 0.695
|
-0.82 Units on a scale
Standard Deviation 0.739
|
|
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Weeks 24 and 52
Week 52 (n=214, 227, 228, 230)
|
-0.76 Units on a scale
Standard Deviation 0.800
|
-1.00 Units on a scale
Standard Deviation 0.795
|
-0.97 Units on a scale
Standard Deviation 0.700
|
-0.87 Units on a scale
Standard Deviation 0.776
|
SECONDARY outcome
Timeframe: Baseline to Weeks 24 and 52Population: Intent-to-treat population: All randomized participants who received at least 1 tocilizumab/placebo infusion.
The SF-36 Health Survey (Version 2) is a standardized questionnaire consisting of 36 questions that measures patient-reported symptoms on 8 dimensions; it is used 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. A positive change score indicates better HRQoL.
Outcome measures
| Measure |
Placebo to Tocilizumab + Methotrexate
n=287 Participants
Patients received placebo tocilizumab intravenously (iv) every 4 weeks + methotrexate orally once a week for 104 weeks.
|
Tocilizumab 4 mg/kg + Methotrexate
n=288 Participants
Patients received tocilizumab 4 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
|
Tocilizumab 8 mg/kg + Methotrexate
n=290 Participants
Patients received tocilizumab 8 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
|
Tocilizumab 8 mg/kg + Placebo to Methotrexate
n=292 Participants
Patients received tocilizumab 8 mg/kg iv every 4 weeks + placebo to methotrexate orally once a week for 104 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Short Form 36 (SF-36) Physical Component Summary (PCS) Scores at Weeks 24 and 52
Week 24 (n=237, 247, 246, 255)
|
9.35 Units on a scale
Standard Deviation 9.763
|
11.33 Units on a scale
Standard Deviation 9.282
|
12.13 Units on a scale
Standard Deviation 9.263
|
10.75 Units on a scale
Standard Deviation 10.055
|
|
Change From Baseline in Short Form 36 (SF-36) Physical Component Summary (PCS) Scores at Weeks 24 and 52
Week 52 (n=204, 225, 221, 224)
|
10.72 Units on a scale
Standard Deviation 10.389
|
12.27 Units on a scale
Standard Deviation 10.509
|
13.52 Units on a scale
Standard Deviation 9.848
|
11.73 Units on a scale
Standard Deviation 10.691
|
Adverse Events
Placebo to Tocilizumab + Methotrexate
Serious events: 24 serious events
Other events: 177 other events
Deaths: 0 deaths
Tocilizumab 4 mg/kg + Methotrexate
Serious events: 29 serious events
Other events: 182 other events
Deaths: 0 deaths
Tocilizumab 8 mg/kg + Methotrexate
Serious events: 31 serious events
Other events: 201 other events
Deaths: 0 deaths
Tocilizumab 8 mg/kg + Placebo to Methotrexate
Serious events: 25 serious events
Other events: 163 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo to Tocilizumab + Methotrexate
n=282 participants at risk
Patients received placebo tocilizumab intravenously (iv) every 4 weeks + methotrexate orally once a week for 104 weeks.
|
Tocilizumab 4 mg/kg + Methotrexate
n=289 participants at risk
Patients received tocilizumab 4 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
|
Tocilizumab 8 mg/kg + Methotrexate
n=290 participants at risk
Patients received tocilizumab 8 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
|
Tocilizumab 8 mg/kg + Placebo to Methotrexate
n=292 participants at risk
Patients received tocilizumab 8 mg/kg iv every 4 weeks + placebo to methotrexate orally once a week for 104 weeks.
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Oteoarthritis
|
0.00%
0/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.34%
1/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Infections and infestations
Pneumonia
|
0.35%
1/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
1.4%
4/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.34%
1/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.34%
1/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.35%
1/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.34%
1/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.68%
2/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
1.0%
3/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Infections and infestations
Bronchopneumonia
|
0.35%
1/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.35%
1/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.34%
1/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.35%
1/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.34%
1/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Infections and infestations
Appendicitis perforated
|
0.35%
1/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.34%
1/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.35%
1/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.34%
1/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.34%
1/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.35%
1/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Infections and infestations
Lung infection
|
0.00%
0/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.35%
1/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Infections and infestations
Lyme disease
|
0.00%
0/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.34%
1/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Infections and infestations
Pneumococcal infection
|
0.00%
0/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.34%
1/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.35%
1/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Infections and infestations
Pneumonia influenzal
|
0.35%
1/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Infections and infestations
Sepsis
|
0.35%
1/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.34%
1/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Infections and infestations
Tuberculosis
|
0.00%
0/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.34%
1/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.35%
1/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Infections and infestations
Viral infection
|
0.00%
0/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.34%
1/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.35%
1/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.34%
1/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.35%
1/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.00%
0/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.35%
1/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer stage I
|
0.00%
0/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.34%
1/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant
|
0.00%
0/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.35%
1/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.00%
0/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.34%
1/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic bronchial carcinoma
|
0.00%
0/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.35%
1/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian germ cell teratoma benign
|
0.00%
0/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.34%
1/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer stage II
|
0.00%
0/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.35%
1/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.35%
1/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.34%
1/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.68%
2/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.69%
2/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.35%
1/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.34%
1/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.35%
1/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.35%
1/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.35%
1/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.34%
1/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.34%
1/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.34%
1/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.35%
1/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.34%
1/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.34%
1/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.34%
1/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.34%
1/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.34%
1/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.34%
1/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.35%
1/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.35%
1/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.34%
1/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.34%
1/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.35%
1/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.35%
1/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.35%
1/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.34%
1/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Nervous system disorders
Hypoglycaemic coma
|
0.00%
0/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.34%
1/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Nervous system disorders
Peroneal nerve palsy
|
0.35%
1/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Nervous system disorders
Syncope
|
0.00%
0/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.34%
1/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.35%
1/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Nervous system disorders
VIth nerve paralysis
|
0.00%
0/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.34%
1/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.35%
1/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.34%
1/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.35%
1/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.34%
1/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Cardiac disorders
Angina pectoris
|
0.35%
1/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Cardiac disorders
Myocardial fibrosis
|
0.00%
0/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.34%
1/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Cardiac disorders
Sick sinus syndrome
|
0.00%
0/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.35%
1/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Cardiac disorders
Silent myocardial infarction
|
0.00%
0/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.35%
1/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.71%
2/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.34%
1/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.00%
0/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.35%
1/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion osteoarthritis
|
0.00%
0/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.34%
1/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.34%
1/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.35%
1/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.34%
1/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.35%
1/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.34%
1/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.34%
1/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.35%
1/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.00%
0/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.69%
2/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
1.4%
4/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.35%
1/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.34%
1/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.35%
1/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Vascular disorders
Hypertension
|
0.00%
0/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.34%
1/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Vascular disorders
Peripheral ischaemia
|
0.35%
1/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.00%
0/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.35%
1/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.35%
1/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.35%
1/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.34%
1/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Hepatobiliary disorders
Biliary dyskinesia
|
0.35%
1/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.35%
1/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.35%
1/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.35%
1/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.00%
0/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.34%
1/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Reproductive system and breast disorders
Epididymal cyst
|
0.00%
0/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.35%
1/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.35%
1/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.35%
1/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.35%
1/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.35%
1/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Investigations
Transaminases increased
|
0.00%
0/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.34%
1/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.35%
1/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Renal and urinary disorders
Renal failure acute
|
0.35%
1/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.35%
1/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Ear and labyrinth disorders
Neurosensory hypoacusis
|
0.00%
0/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.35%
1/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.35%
1/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.00%
0/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
0.34%
1/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
Other adverse events
| Measure |
Placebo to Tocilizumab + Methotrexate
n=282 participants at risk
Patients received placebo tocilizumab intravenously (iv) every 4 weeks + methotrexate orally once a week for 104 weeks.
|
Tocilizumab 4 mg/kg + Methotrexate
n=289 participants at risk
Patients received tocilizumab 4 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
|
Tocilizumab 8 mg/kg + Methotrexate
n=290 participants at risk
Patients received tocilizumab 8 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
|
Tocilizumab 8 mg/kg + Placebo to Methotrexate
n=292 participants at risk
Patients received tocilizumab 8 mg/kg iv every 4 weeks + placebo to methotrexate orally once a week for 104 weeks.
|
|---|---|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
14.2%
40/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
12.8%
37/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
10.3%
30/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
13.4%
39/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Infections and infestations
Nasopharyngitis
|
13.5%
38/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
13.8%
40/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
9.7%
28/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
9.2%
27/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Infections and infestations
Urinary tract infection
|
4.6%
13/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
6.2%
18/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
4.8%
14/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
3.4%
10/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Infections and infestations
Bronchitis
|
2.1%
6/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
6.2%
18/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
6.9%
20/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
2.7%
8/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Investigations
Alanine aminotransferase increased
|
10.3%
29/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
13.5%
39/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
19.0%
55/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
7.5%
22/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Investigations
Transaminases increased
|
8.2%
23/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
12.1%
35/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
13.8%
40/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
7.5%
22/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Investigations
Aspartate aminotransferase increased
|
2.8%
8/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
2.8%
8/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
5.9%
17/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
3.8%
11/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Gastrointestinal disorders
Nausea
|
16.3%
46/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
14.2%
41/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
14.8%
43/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
6.5%
19/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.4%
18/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
5.5%
16/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
6.6%
19/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
6.2%
18/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.7%
16/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
5.9%
17/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
3.8%
11/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
4.8%
14/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
7.4%
21/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
3.1%
9/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
5.5%
16/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
3.4%
10/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.5%
7/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
3.5%
10/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
2.8%
8/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
6.5%
19/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Vascular disorders
Hypertension
|
7.4%
21/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
5.5%
16/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
7.9%
23/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
8.6%
25/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Nervous system disorders
Headache
|
4.3%
12/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
6.9%
20/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
6.2%
18/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
6.8%
20/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.1%
3/282 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
6.2%
18/289 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
4.1%
12/290 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
2.7%
8/292 • Adverse events were reported from Baseline through Week 52.
Safety population: All patients who received at least 1 tocilizumab/placebo infusion and had at least 1 post-dose safety assessment. 7 patients were excluded from the safety population (no treatment received or no post-baseline safety data). The total safety population included 1153 patients.
|
Additional Information
Medical Communications
Hoffmann-La Roche
Phone: 800 821-8590
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