Trial Outcomes & Findings for A Study to Compare Subcutaneous Versus Intravenous Administration of RoActemra/Actemra (Tocilizumab) in Participants With Moderate to Severe Active Rheumatoid Arthritis (NCT NCT01194414)
NCT ID: NCT01194414
Last Updated: 2016-06-20
Results Overview
ACR20 response is defined as a ≥ 20% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the five additional ACR core set variables: Patient's Assessment of Pain over the previous 24 hours using a Visual Analog Scale (VAS) where left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions in 8 areas (dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities) answered on a scale of 0=without difficulty to 3=unable to do; and acute-phase reactant (either C-reactive protein \[CRP\] or Erythrocyte Sedimentation Rate \[ESR\]).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1262 participants
Primary outcome timeframe
Baseline, 24 weeks
Results posted on
2016-06-20
Participant Flow
A total of 1262 participants at 209 centers in 25 countries were randomized into the study.
Participant milestones
| Measure |
Tocilizumab SC
Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study.
|
Tocilizumab IV
Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study.
|
Tocilizumab SC Then Tocilizumab IV
Participants who received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab IV infusion every 4 weeks for 24 weeks in double blind treatment period switched to tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study.
|
Tocilizumab IV Then Tocilizumab SC
Participants who received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection once a week in double blind treatment period switched to tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose will be continued throughout the study.
|
|---|---|---|---|---|
|
24 Weeks Double Blind Period
STARTED
|
631
|
631
|
0
|
0
|
|
24 Weeks Double Blind Period
Per Protocol Population
|
558
|
537
|
0
|
0
|
|
24 Weeks Double Blind Period
COMPLETED
|
572
|
564
|
0
|
0
|
|
24 Weeks Double Blind Period
NOT COMPLETED
|
59
|
67
|
0
|
0
|
|
72 Weeks Open Label Extension
STARTED
|
524
|
377
|
48
|
186
|
|
72 Weeks Open Label Extension
COMPLETED
|
445
|
311
|
40
|
160
|
|
72 Weeks Open Label Extension
NOT COMPLETED
|
79
|
66
|
8
|
26
|
Reasons for withdrawal
| Measure |
Tocilizumab SC
Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study.
|
Tocilizumab IV
Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study.
|
Tocilizumab SC Then Tocilizumab IV
Participants who received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab IV infusion every 4 weeks for 24 weeks in double blind treatment period switched to tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study.
|
Tocilizumab IV Then Tocilizumab SC
Participants who received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection once a week in double blind treatment period switched to tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose will be continued throughout the study.
|
|---|---|---|---|---|
|
24 Weeks Double Blind Period
Insufficient Therapeutic Response
|
11
|
8
|
0
|
0
|
|
24 Weeks Double Blind Period
Subject/legal Guardian Decision
|
9
|
5
|
0
|
0
|
|
24 Weeks Double Blind Period
Protocol Violation
|
5
|
3
|
0
|
0
|
|
24 Weeks Double Blind Period
Physician Decision to Withdraw Subject
|
0
|
5
|
0
|
0
|
|
24 Weeks Double Blind Period
Pregnancy
|
2
|
2
|
0
|
0
|
|
24 Weeks Double Blind Period
Lost to Follow-up
|
2
|
1
|
0
|
0
|
|
24 Weeks Double Blind Period
Other
|
0
|
1
|
0
|
0
|
|
24 Weeks Double Blind Period
Adverse Event
|
28
|
40
|
0
|
0
|
|
24 Weeks Double Blind Period
Anaphylaxis or Hypersensitivity Reaction
|
2
|
1
|
0
|
0
|
|
24 Weeks Double Blind Period
Death
|
0
|
1
|
0
|
0
|
|
72 Weeks Open Label Extension
Randomized but not Treated
|
3
|
5
|
0
|
0
|
|
72 Weeks Open Label Extension
Subject/legal Guardian Decision
|
20
|
14
|
1
|
6
|
|
72 Weeks Open Label Extension
Insufficient Therapeutic Response
|
9
|
11
|
2
|
3
|
|
72 Weeks Open Label Extension
Lost to Follow-up
|
4
|
3
|
2
|
1
|
|
72 Weeks Open Label Extension
Physician Decision to Withdraw Subject
|
3
|
5
|
0
|
0
|
|
72 Weeks Open Label Extension
Pregnancy
|
1
|
3
|
1
|
1
|
|
72 Weeks Open Label Extension
Other
|
2
|
1
|
0
|
0
|
|
72 Weeks Open Label Extension
Protocol Violation
|
0
|
0
|
0
|
1
|
|
72 Weeks Open Label Extension
Adverse Event
|
35
|
21
|
2
|
12
|
|
72 Weeks Open Label Extension
Anaphylaxis or Hypersensitivity Reaction
|
1
|
1
|
0
|
0
|
|
72 Weeks Open Label Extension
Death
|
1
|
2
|
0
|
2
|
Baseline Characteristics
A Study to Compare Subcutaneous Versus Intravenous Administration of RoActemra/Actemra (Tocilizumab) in Participants With Moderate to Severe Active Rheumatoid Arthritis
Baseline characteristics by cohort
| Measure |
Tocilizumab SC
n=631 Participants
Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study.
|
Tocilizumab IV
n=631 Participants
Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study.
|
Total
n=1262 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.7 years
STANDARD_DEVIATION 12.35 • n=39 Participants
|
52.8 years
STANDARD_DEVIATION 12.53 • n=41 Participants
|
52.7 years
STANDARD_DEVIATION 12.44 • n=35 Participants
|
|
Sex: Female, Male
Female
|
520 Participants
n=39 Participants
|
521 Participants
n=41 Participants
|
1041 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
111 Participants
n=39 Participants
|
110 Participants
n=41 Participants
|
221 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Baseline, 24 weeksPopulation: Per Protocol Population included all randomized participants who received study drug and had no major protocol violations. Last Observation Carried Forward was used for missing joint counts, no imputation for other ACR components. CRP will be used primarily for calculation of the ACR response. If missing, the ESR will be used for that participant.
ACR20 response is defined as a ≥ 20% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the five additional ACR core set variables: Patient's Assessment of Pain over the previous 24 hours using a Visual Analog Scale (VAS) where left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions in 8 areas (dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities) answered on a scale of 0=without difficulty to 3=unable to do; and acute-phase reactant (either C-reactive protein \[CRP\] or Erythrocyte Sedimentation Rate \[ESR\]).
Outcome measures
| Measure |
Tocilizumab SC
n=558 Participants
Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study.
|
Tocilizumab IV
n=537 Participants
Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study.
|
Tocilizumab SC Then Tocilizumab IV
Participants who received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab IV infusion every 4 weeks for 24 weeks in double blind treatment period switched to tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study.
|
Tocilizumab IV Then Tocilizumab SC
Participants who received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection once a week in double blind treatment period switched to tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose will be continued throughout the study.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving an American College of Rheumatology Criteria (ACR20) Response at Week 24
|
69.4 Percentage of participants
Interval 65.5 to 73.2
|
73.4 Percentage of participants
Interval 69.6 to 77.1
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)Population: The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
Outcome measures
| Measure |
Tocilizumab SC
n=631 Participants
Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study.
|
Tocilizumab IV
n=631 Participants
Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study.
|
Tocilizumab SC Then Tocilizumab IV
n=48 Participants
Participants who received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab IV infusion every 4 weeks for 24 weeks in double blind treatment period switched to tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study.
|
Tocilizumab IV Then Tocilizumab SC
n=186 Participants
Participants who received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection once a week in double blind treatment period switched to tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose will be continued throughout the study.
|
|---|---|---|---|---|
|
Percentage of Participants With Adverse Events, Serious Adverse Events and Clinically Significant Laboratory Assessments
Adverse Events (AEs)
|
91.6 percentage of participants
|
87.8 percentage of participants
|
81.3 percentage of participants
|
86.6 percentage of participants
|
|
Percentage of Participants With Adverse Events, Serious Adverse Events and Clinically Significant Laboratory Assessments
Serious Adverse Events (SAEs)
|
13.9 percentage of participants
|
12.7 percentage of participants
|
12.5 percentage of participants
|
11.3 percentage of participants
|
|
Percentage of Participants With Adverse Events, Serious Adverse Events and Clinically Significant Laboratory Assessments
Clinically Significant Laboratory Assessments
|
37.7 percentage of participants
|
28.2 percentage of participants
|
25.0 percentage of participants
|
19.4 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, 24 weeksPopulation: Per Protocol Population included all randomized participants who received study drug and had no major protocol violations. Last Observation Carried Forward was used for missing joint counts, no imputation for other ACR components. CRP will be used primarily for calculation of the ACR response. If missing, the ESR will be used for that participant.
ACR50 response is defined as a ≥ 50% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the five additional ACR core set variables: Patient's Assessment of Pain over the previous 24 hours using a Visual Analog Scale (VAS) where left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions in 8 areas (dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities) answered on a scale of 0=without difficulty to 3=unable to do; and acute-phase reactant (either C-reactive protein or Erythrocyte Sedimentation Rate).
Outcome measures
| Measure |
Tocilizumab SC
n=558 Participants
Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study.
|
Tocilizumab IV
n=537 Participants
Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study.
|
Tocilizumab SC Then Tocilizumab IV
Participants who received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab IV infusion every 4 weeks for 24 weeks in double blind treatment period switched to tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study.
|
Tocilizumab IV Then Tocilizumab SC
Participants who received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection once a week in double blind treatment period switched to tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose will be continued throughout the study.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving an American College of Rheumatology Criteria (ACR50) Response at Week 24
|
47.0 Percentage of participants
|
48.6 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 24 weeksPopulation: Per Protocol Population included all randomized participants who received study drug and had no major protocol violations. Last Observation Carried Forward was used for missing joint counts, no imputation for other ACR components. CRP will be used primarily for calculation of the ACR response. If missing, the ESR will be used for that participant.
ACR70 response is defined as a ≥ 70% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the five additional ACR core set variables: Patient's Assessment of Pain over the previous 24 hours using a Visual Analog Scale (VAS) where left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions in 8 areas (dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities) answered on a scale of 0=without difficulty to 3=unable to do; and acute-phase reactant (either C-reactive protein or Erythrocyte Sedimentation Rate).
Outcome measures
| Measure |
Tocilizumab SC
n=558 Participants
Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study.
|
Tocilizumab IV
n=537 Participants
Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study.
|
Tocilizumab SC Then Tocilizumab IV
Participants who received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab IV infusion every 4 weeks for 24 weeks in double blind treatment period switched to tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study.
|
Tocilizumab IV Then Tocilizumab SC
Participants who received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection once a week in double blind treatment period switched to tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose will be continued throughout the study.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving an American College of Rheumatology Criteria (ACR70) Response at Week 24
|
24.0 Percentage of participants
|
27.9 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 24Population: Participants from the Per Protocol Population (randomized participants who received study drug and had no major protocol violations) with data available for analysis. Missing SJC and TJC will be imputed using the last post-baseline value for the patient (LOCF). No imputation for missing ESR or patient's global assessment of disease activity.
The DAS28 (ESR) score is a measure of the subject's disease activity. It is calculated using the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity VAS where left side of the line 0=no disease activity to right side of the line 100=extreme disease activity and ESR. DAS28-(ESR) total scores range from 0 - 10. Remission is defined as achieving a DAS28-ESR score of less than 2.6.
Outcome measures
| Measure |
Tocilizumab SC
n=516 Participants
Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study.
|
Tocilizumab IV
n=498 Participants
Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study.
|
Tocilizumab SC Then Tocilizumab IV
Participants who received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab IV infusion every 4 weeks for 24 weeks in double blind treatment period switched to tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study.
|
Tocilizumab IV Then Tocilizumab SC
Participants who received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection once a week in double blind treatment period switched to tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose will be continued throughout the study.
|
|---|---|---|---|---|
|
Percentage of Participants With Disease Activity Score 28 (DAS28) Remission at Week 24
|
38.4 Percentage of participants
|
36.9 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 24 WeeksPopulation: Participants from the Per Protocol Population (all randomized participants who received study drug and had no major protocol violations) with data available for analysis. No imputation of missing scores will be made other than for missing baseline scores, for which last score prior to defined protocol baseline time window will be carried forward.
The Stanford Health Assessment Questionnaire disability index (HAQ-DI) is a participant completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Each domain has at least two component questions. There are four possible responses for each component ranging from 0(without any difficulty) to 4 (unable to do).HAQ-DI=sum of worst scores in each domain divided by the number of domains answered. A decrease indicates improvement.
Outcome measures
| Measure |
Tocilizumab SC
n=515 Participants
Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study.
|
Tocilizumab IV
n=500 Participants
Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study.
|
Tocilizumab SC Then Tocilizumab IV
Participants who received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab IV infusion every 4 weeks for 24 weeks in double blind treatment period switched to tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study.
|
Tocilizumab IV Then Tocilizumab SC
Participants who received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection once a week in double blind treatment period switched to tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose will be continued throughout the study.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving a Decrease of ≥ 0.3 in the Health Assessment Questionnaire-Disability Index (HAQ-DI) From Baseline to Week 24
|
65.2 Percentage of participants
|
67.4 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 24 WeeksPopulation: Per Protocol Population included all randomized participants who received study drug and had no major protocol violations.
The percentage of participants who withdrew from the study because they were not responding to treatment with the study drug.
Outcome measures
| Measure |
Tocilizumab SC
n=558 Participants
Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study.
|
Tocilizumab IV
n=537 Participants
Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study.
|
Tocilizumab SC Then Tocilizumab IV
Participants who received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab IV infusion every 4 weeks for 24 weeks in double blind treatment period switched to tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study.
|
Tocilizumab IV Then Tocilizumab SC
Participants who received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection once a week in double blind treatment period switched to tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose will be continued throughout the study.
|
|---|---|---|---|---|
|
Percentage of Participants Who Withdrew Because of Lack of Therapeutic Response at Week 24
|
1.8 Percentage of participants
|
0.9 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 97Population: Re-Randomized Intent-to-Treat Population (ITT Population) included all participants who completed double blind period and were re-randomized at Week 24, received at least 1 dose of study drug. Here, number of participants analyzed is the participants for whom parameter was collected.
ACR20, ACR50 and ACR70: ≥20%, ≥50% and ≥70% reduction from baseline for both TJC68 and SJC66, as well as for 3 of 5 additional ACR variables: Patient's Assessment of Pain in last 24 hours using a Visual Analog Scale (VAS) (0=no pain and 100=unbearable pain); Patient's and Physician's Global Assessment of Disease Activity in last 24 hours using a VAS (0=no disease activity and100=maximum disease activity); Health Assessment Questionnaire: 20 questions in 8 areas (dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities) answered on a scale of 0=without difficulty to 3=unable to do; and acute-phase reactant (either CRP or ESR). CRP was used for calculation of ACR. If missing, ESR was used. LOCF was used for missing joint counts, no imputation for other ACR components.
Outcome measures
| Measure |
Tocilizumab SC
n=451 Participants
Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study.
|
Tocilizumab IV
n=317 Participants
Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study.
|
Tocilizumab SC Then Tocilizumab IV
n=40 Participants
Participants who received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab IV infusion every 4 weeks for 24 weeks in double blind treatment period switched to tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study.
|
Tocilizumab IV Then Tocilizumab SC
n=165 Participants
Participants who received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection once a week in double blind treatment period switched to tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose will be continued throughout the study.
|
|---|---|---|---|---|
|
Percentage of Participants With American College of Rheumatology Criteria (ACR20, ACR50, ACR70) at Week 97
ACR20
|
83.6 percentage of participants
|
83.3 percentage of participants
|
82.5 percentage of participants
|
88.5 percentage of participants
|
|
Percentage of Participants With American College of Rheumatology Criteria (ACR20, ACR50, ACR70) at Week 97
ACR50
|
65.4 percentage of participants
|
62.5 percentage of participants
|
57.5 percentage of participants
|
67.3 percentage of participants
|
|
Percentage of Participants With American College of Rheumatology Criteria (ACR20, ACR50, ACR70) at Week 97
ACR70
|
44.8 percentage of participants
|
42.0 percentage of participants
|
37.5 percentage of participants
|
47.3 percentage of participants
|
SECONDARY outcome
Timeframe: Week 97Population: ITT Population included all participants who completed double blind period and were re-randomized at Week 24 and received at least one dose of study drug. If ESR=0 then ESR=1 is substituted into the DAS28 calculation to enable a non-missing DAS28 score. Here, number of participants analyzed is the participants for whom parameter was collected.
The DAS28 (ESR) score is a measure of the subject's disease activity. It is calculated using the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity VAS where left side of the line 0=no disease activity to right side of the line 100=extreme disease activity and ESR. DAS28-(ESR) total scores range from 0 - 10. Remission is defined as achieving a DAS28-ESR score of less than 2.6. LOCF used for tender and swollen joint counts, no imputation used for ESR and Patient's Global Assessment of Disease Activity VAS.
Outcome measures
| Measure |
Tocilizumab SC
n=446 Participants
Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study.
|
Tocilizumab IV
n=306 Participants
Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study.
|
Tocilizumab SC Then Tocilizumab IV
n=40 Participants
Participants who received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab IV infusion every 4 weeks for 24 weeks in double blind treatment period switched to tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study.
|
Tocilizumab IV Then Tocilizumab SC
n=162 Participants
Participants who received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection once a week in double blind treatment period switched to tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose will be continued throughout the study.
|
|---|---|---|---|---|
|
Percentage of Participants With Disease Activity Score 28 (DAS28) Remission at Week 97
|
53.4 percentage of participants
|
46.4 percentage of participants
|
50.0 percentage of participants
|
55.6 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 97Population: ITT Population included all participants who completed double blind period and were re-randomized at Week 24 and received at least one dose of study drug. Here, number of participants analyzed is the participants for whom parameter was collected.
The Stanford Health Assessment Questionnaire disability index (HAQ-DI) is a patient completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Each domain has at least two component questions. There are four possible responses for each component ranging from 0(without any difficulty) to 4 (unable to do).HAQ-DI=sum of worst scores in each domain divided by the number of domains answered. A decrease indicates improvement. No imputation of missing scores was made other than for missing baseline scores, for which last score prior to baseline will be carried forward. For participants who prematurely withdrew, data collected at withdrawal visit was used and data thereafter is missing.
Outcome measures
| Measure |
Tocilizumab SC
n=445 Participants
Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study.
|
Tocilizumab IV
n=317 Participants
Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study.
|
Tocilizumab SC Then Tocilizumab IV
n=39 Participants
Participants who received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab IV infusion every 4 weeks for 24 weeks in double blind treatment period switched to tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study.
|
Tocilizumab IV Then Tocilizumab SC
n=162 Participants
Participants who received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection once a week in double blind treatment period switched to tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose will be continued throughout the study.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving a Decrease of ≥0.3 in the Health Assessment Questionnaire-Disability Index (HAQ-DI) From Baseline to Week 97
|
72.4 percentage of participants
|
69.1 percentage of participants
|
56.4 percentage of participants
|
71.0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 97Population: ITT Population included all participants who completed double blind period and were re-randomized at Week 24 and received at least one dose of study drug.
The percentage of participants who withdrew from the study because they were not responding to treatment with the study drug.
Outcome measures
| Measure |
Tocilizumab SC
n=521 Participants
Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study.
|
Tocilizumab IV
n=372 Participants
Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study.
|
Tocilizumab SC Then Tocilizumab IV
n=48 Participants
Participants who received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab IV infusion every 4 weeks for 24 weeks in double blind treatment period switched to tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study.
|
Tocilizumab IV Then Tocilizumab SC
n=186 Participants
Participants who received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection once a week in double blind treatment period switched to tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose will be continued throughout the study.
|
|---|---|---|---|---|
|
Percentage of Participants Who Withdrew Because of Lack of Therapeutic Response at Week 97
|
1.7 percentage of participants
|
3.0 percentage of participants
|
4.2 percentage of participants
|
1.6 percentage of participants
|
SECONDARY outcome
Timeframe: Week 0: at 6 hours (hr), 24 hr, 48 hr, 96 hr, 120 hr and 168 hr after first dosePopulation: Pharmacokinetic-Evaluable Population included all participants who provided at least one evaluable PK sample were included in the pharmacokinetic analysis (PK) analysis. Here, number of participants analyzed who were evaluable for this outcome measure.
Outcome measures
| Measure |
Tocilizumab SC
n=17 Participants
Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study.
|
Tocilizumab IV
n=16 Participants
Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study.
|
Tocilizumab SC Then Tocilizumab IV
Participants who received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab IV infusion every 4 weeks for 24 weeks in double blind treatment period switched to tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study.
|
Tocilizumab IV Then Tocilizumab SC
Participants who received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection once a week in double blind treatment period switched to tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose will be continued throughout the study.
|
|---|---|---|---|---|
|
Area Under the Serum Concentration Curve of Tocilizumab After First SC Injection or IV Infusion
|
1444 microgram*hour/milliliter (mcg*hr/mL)
Standard Deviation 839
|
30988 microgram*hour/milliliter (mcg*hr/mL)
Standard Deviation 9114
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 20: at 6 hours (hr), 24 hr, 48 hr, 96 hr, 120 hr and 168 hr after dose.Population: Pharmacokinetic-Evaluable Population included all participants who provided at least one evaluable PK sample were included in the pharmacokinetic analysis (PK) analysis. Here, number of participants analyzed who were evaluable for this outcome measure.
Outcome measures
| Measure |
Tocilizumab SC
n=13 Participants
Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study.
|
Tocilizumab IV
n=13 Participants
Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study.
|
Tocilizumab SC Then Tocilizumab IV
Participants who received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab IV infusion every 4 weeks for 24 weeks in double blind treatment period switched to tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study.
|
Tocilizumab IV Then Tocilizumab SC
Participants who received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection once a week in double blind treatment period switched to tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose will be continued throughout the study.
|
|---|---|---|---|---|
|
Area Under the Serum Concentration Curve of Tocilizumab at Steady State for SC and IV Treatment
|
7542 μg*hr/mL
Standard Deviation 3989
|
41304 μg*hr/mL
Standard Deviation 15104
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 20: at 6 hours (hr), 24 hr, 48 hr, 96 hr, 120 hr and 168 hr after dosePopulation: Pharmacokinetic-Evaluable Population included all participants who provided at least one evaluable PK sample were included in the PK analysis. Here, number of participants analyzed who were evaluable for this outcome measure and 'n' indicates number of participants who were evaluated at specified time point.
Outcome measures
| Measure |
Tocilizumab SC
n=17 Participants
Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study.
|
Tocilizumab IV
n=16 Participants
Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study.
|
Tocilizumab SC Then Tocilizumab IV
Participants who received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab IV infusion every 4 weeks for 24 weeks in double blind treatment period switched to tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study.
|
Tocilizumab IV Then Tocilizumab SC
Participants who received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection once a week in double blind treatment period switched to tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose will be continued throughout the study.
|
|---|---|---|---|---|
|
Minimum Serum Concentration (Cmin) of Tocilizumab
Week 0 (after first dose) (n=17, 16)
|
7.48 micrgram/milliliter (mcg/mL)
Standard Deviation 4.91
|
6.65 micrgram/milliliter (mcg/mL)
Standard Deviation 6.05
|
—
|
—
|
|
Minimum Serum Concentration (Cmin) of Tocilizumab
Week 20 (n=13, 13)
|
35.7 micrgram/milliliter (mcg/mL)
Standard Deviation 16.2
|
16.0 micrgram/milliliter (mcg/mL)
Standard Deviation 10.3
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 20: at 6 hours (hr), 24 hr, 48 hr, 96 hr, 120 hr and 168 hr after dosePopulation: Pharmacokinetic-Evaluable Population included all participants who provided at least one evaluable PK sample were included in the PK analysis. Here, number of participants analyzed who were evaluable for this outcome measure and 'n' indicates number of participants who were evaluated at specified time point.
Outcome measures
| Measure |
Tocilizumab SC
n=17 Participants
Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study.
|
Tocilizumab IV
n=16 Participants
Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study.
|
Tocilizumab SC Then Tocilizumab IV
Participants who received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab IV infusion every 4 weeks for 24 weeks in double blind treatment period switched to tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study.
|
Tocilizumab IV Then Tocilizumab SC
Participants who received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection once a week in double blind treatment period switched to tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose will be continued throughout the study.
|
|---|---|---|---|---|
|
Maximum Serum Concentration (Cmax) of Tocilizumab
Week 0 (after first dose) (n=17, 16)
|
14.7 mcg/mL
Standard Deviation 8.74
|
180 mcg/mL
Standard Deviation 40.1
|
—
|
—
|
|
Maximum Serum Concentration (Cmax) of Tocilizumab
Week 20 (n=13, 13)
|
52.7 mcg/mL
Standard Deviation 27.3
|
233 mcg/mL
Standard Deviation 117
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 20: at 6 hours (hr), 24 hr, 48 hr, 96 hr, 120 hr and 168 hr after dosePopulation: Pharmacokinetic-Evaluable Population included all participants who provided at least one evaluable PK sample were included in the PK analysis. Here, number of participants analyzed who were evaluable for this outcome measure and 'n' indicates number of participants who were evaluated at specified time point.
Outcome measures
| Measure |
Tocilizumab SC
n=17 Participants
Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study.
|
Tocilizumab IV
n=16 Participants
Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study.
|
Tocilizumab SC Then Tocilizumab IV
Participants who received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab IV infusion every 4 weeks for 24 weeks in double blind treatment period switched to tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study.
|
Tocilizumab IV Then Tocilizumab SC
Participants who received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection once a week in double blind treatment period switched to tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose will be continued throughout the study.
|
|---|---|---|---|---|
|
Time to Maximum Serum Concentration (Tmax) of Tocilizumab
Week 0 (after first dose) (n=17, 16)
|
74 hour (hr)
Interval 24.0 to 121.0
|
6 hour (hr)
Interval 3.0 to 7.0
|
—
|
—
|
|
Time to Maximum Serum Concentration (Tmax) of Tocilizumab
Week 20 (n=13, 13)
|
70 hour (hr)
Interval 0.0 to 122.0
|
6 hour (hr)
Interval 4.0 to 46.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 25Population: The ITT-PK population includes all participants who were eligible for the ITT population and provided at least 1 evaluable PK sample in the double blind or open label periods. Here, number of participants analyzed who were evaluable for this outcome measure and 'n' indicates number of participants who were evaluated at specified time point.
Outcome measures
| Measure |
Tocilizumab SC
n=493 Participants
Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study.
|
Tocilizumab IV
n=359 Participants
Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study.
|
Tocilizumab SC Then Tocilizumab IV
n=46 Participants
Participants who received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab IV infusion every 4 weeks for 24 weeks in double blind treatment period switched to tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study.
|
Tocilizumab IV Then Tocilizumab SC
n=186 Participants
Participants who received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection once a week in double blind treatment period switched to tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose will be continued throughout the study.
|
|---|---|---|---|---|
|
Change From Baseline in Serum Interleukin-6 (IL-6) Concentration at Week 25
Baseline (n=493, 359, 46, 186)
|
39.04 picogram/milliliter (pg/mL)
Standard Deviation 55.456
|
52.48 picogram/milliliter (pg/mL)
Standard Deviation 240.964
|
62.18 picogram/milliliter (pg/mL)
Standard Deviation 125.081
|
50.07 picogram/milliliter (pg/mL)
Standard Deviation 161.045
|
|
Change From Baseline in Serum Interleukin-6 (IL-6) Concentration at Week 25
Change at Week 25 (n=385, 280, 33, 149)
|
34.42 picogram/milliliter (pg/mL)
Standard Deviation 110.842
|
52.61 picogram/milliliter (pg/mL)
Standard Deviation 507.157
|
37.54 picogram/milliliter (pg/mL)
Standard Deviation 93.464
|
44.12 picogram/milliliter (pg/mL)
Standard Deviation 136.955
|
SECONDARY outcome
Timeframe: Baseline, Week 97Population: The ITT-PK population includes all participants who were eligible for the ITT population and provided at least 1 evaluable PK sample in the double blind or open label periods. Here, number of participants analyzed who were evaluable for this outcome measure and 'n' indicates number of participants who were evaluated at specified time point.
Outcome measures
| Measure |
Tocilizumab SC
n=504 Participants
Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study.
|
Tocilizumab IV
n=366 Participants
Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study.
|
Tocilizumab SC Then Tocilizumab IV
n=46 Participants
Participants who received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab IV infusion every 4 weeks for 24 weeks in double blind treatment period switched to tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study.
|
Tocilizumab IV Then Tocilizumab SC
n=186 Participants
Participants who received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection once a week in double blind treatment period switched to tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose will be continued throughout the study.
|
|---|---|---|---|---|
|
Change From Baseline in Serum Soluble Interleukin-6 Receptor (sIL-6R) Concentration at Week 97
Baseline (n=504, 366, 46, 186)
|
44.53 nanogram/milliliter (ng/mL)
Standard Deviation 35.470
|
45.72 nanogram/milliliter (ng/mL)
Standard Deviation 40.219
|
44.71 nanogram/milliliter (ng/mL)
Standard Deviation 13.068
|
43.28 nanogram/milliliter (ng/mL)
Standard Deviation 16.197
|
|
Change From Baseline in Serum Soluble Interleukin-6 Receptor (sIL-6R) Concentration at Week 97
Change at Week 97 (n=416, 296, 37,157)
|
601.52 nanogram/milliliter (ng/mL)
Standard Deviation 222.141
|
575.75 nanogram/milliliter (ng/mL)
Standard Deviation 244.398
|
569.60 nanogram/milliliter (ng/mL)
Standard Deviation 213.588
|
586.50 nanogram/milliliter (ng/mL)
Standard Deviation 226.915
|
SECONDARY outcome
Timeframe: Week 97Population: The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Here, 'n' indicates number of subjects in the safety population tested by screening assay at any time point.
Outcome measures
| Measure |
Tocilizumab SC
n=629 Participants
Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study.
|
Tocilizumab IV
n=629 Participants
Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study.
|
Tocilizumab SC Then Tocilizumab IV
n=46 Participants
Participants who received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab IV infusion every 4 weeks for 24 weeks in double blind treatment period switched to tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study.
|
Tocilizumab IV Then Tocilizumab SC
n=184 Participants
Participants who received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection once a week in double blind treatment period switched to tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose will be continued throughout the study.
|
|---|---|---|---|---|
|
Percentage of Participants Who Developed Antibodies To Tocilizumab at Week 97
|
1.3 percentage of participants
|
1.0 percentage of participants
|
0.0 percentage of participants
|
0.5 percentage of participants
|
Adverse Events
Tocilizumab SC
Serious events: 88 serious events
Other events: 488 other events
Deaths: 0 deaths
Tocilizumab IV
Serious events: 80 serious events
Other events: 430 other events
Deaths: 0 deaths
Tocilizumab SC Then Tocilizumab IV
Serious events: 6 serious events
Other events: 29 other events
Deaths: 0 deaths
Tocilizumab IV Then Tocilizumab SC
Serious events: 21 serious events
Other events: 118 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tocilizumab SC
n=631 participants at risk
Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study.
|
Tocilizumab IV
n=631 participants at risk
Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study.
|
Tocilizumab SC Then Tocilizumab IV
n=48 participants at risk
Participants who received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for 24 weeks in double blind treatment period switched to tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study.
|
Tocilizumab IV Then Tocilizumab SC
n=186 participants at risk
Participants who received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly in double blind treatment period switched to tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose will be continued throughout the study.
|
|---|---|---|---|---|
|
Infections and infestations
Pneumonia
|
0.63%
4/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.95%
6/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
2.2%
4/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Infections and infestations
Cellulitis
|
1.3%
8/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
1.1%
2/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Infections and infestations
Gastroenteritis
|
0.32%
2/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.32%
2/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Infections and infestations
Septic Shock
|
0.48%
3/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Infections and infestations
Urinary tract infection
|
0.48%
3/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Infections and infestations
Peritonitis
|
0.32%
2/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.54%
1/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Infections and infestations
Wound infection
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.48%
3/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.32%
2/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Infections and infestations
Arthritis infective
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Infections and infestations
Bursitis infective
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.32%
2/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Infections and infestations
Pelvic abscess
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.54%
1/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Infections and infestations
Sepsis
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.54%
1/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Infections and infestations
Subcutaneous abscess
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.54%
1/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Infections and infestations
Abscess
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.54%
1/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Infections and infestations
Atypical pneumonia
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Infections and infestations
Bone tuberculosis
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Infections and infestations
Bronchitis
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Infections and infestations
Burkholderia pseudomallei infection
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.54%
1/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Infections and infestations
Dacryocystitis
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Infections and infestations
Device related infection
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
2.1%
1/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Infections and infestations
Empyema
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Infections and infestations
Endocarditis
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Infections and infestations
Groin abscess
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Infections and infestations
Infectious pleural effusion
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.54%
1/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Infections and infestations
Intervertebral discitis
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.54%
1/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Infections and infestations
Lobar pneumonia
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Infections and infestations
Localised infection
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Infections and infestations
Muscle abscess
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.54%
1/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.54%
1/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Infections and infestations
Pericolic abscess
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.54%
1/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Infections and infestations
Pharyngeal abscess
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Infections and infestations
Pseudomonal sepsis
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Infections and infestations
Pyelonephritis chronic
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Infections and infestations
Renal abscess
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.54%
1/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Infections and infestations
Retroperitoneal abscess
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Infections and infestations
Tracheitis
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Infections and infestations
Tracheobronchitis
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Infections and infestations
Urosepsis
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Infections and infestations
Whipple's disease
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.48%
3/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.79%
5/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
2.1%
1/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.32%
2/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.54%
1/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.32%
2/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.32%
2/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.32%
2/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Musculoskeletal and connective tissue disorders
Compartment syndrome
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.54%
1/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Nervous system disorders
Sciatica
|
0.32%
2/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.32%
2/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.48%
3/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Nervous system disorders
Cerebral infarction
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Nervous system disorders
Encephalopathy
|
0.32%
2/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.32%
2/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Nervous system disorders
Carotid artery thrombosis
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Nervous system disorders
Cerebellar ischaemia
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroadenoma of breast
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Nervous system disorders
Cerebrovascular insufficiency
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Nervous system disorders
Dysarthria
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Nervous system disorders
Grand mal convulsion
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Nervous system disorders
Headache
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Nervous system disorders
Hemiparesis
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Nervous system disorders
Ischaemic cerebral infarction
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.54%
1/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Nervous system disorders
Migraine
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Nervous system disorders
Syncope
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Nervous system disorders
Transient global amnesia
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.54%
1/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.54%
1/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Injury, poisoning and procedural complications
Adrenal gland injury
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.54%
1/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Injury, poisoning and procedural complications
Anastomotic ulcer haemorrhage
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.54%
1/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.54%
1/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Injury, poisoning and procedural complications
Chillblains
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Injury, poisoning and procedural complications
Comminuted fracture
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Injury, poisoning and procedural complications
Hepatic haematoma
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Injury, poisoning and procedural complications
Pubis fracture
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Injury, poisoning and procedural complications
Pulmonary contusion
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.54%
1/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.54%
1/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Injury, poisoning and procedural complications
Sternal fracture
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.54%
1/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Injury, poisoning and procedural complications
Synovial rupture
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
2.1%
1/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.32%
2/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.54%
1/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
2.1%
1/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
1.1%
2/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm malignant
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma stage 0
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial adenoma
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal tract adenoma
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leiomyoma
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lentigo maligna
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Morton's neuroma
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parathyroid tumour benign
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.54%
1/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Schwannoma
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Gastrointestinal disorders
Colitis
|
0.32%
2/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.54%
1/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.54%
1/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Gastrointestinal disorders
Gastritis
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Gastrointestinal disorders
Ileus
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Gastrointestinal disorders
Lumbar hernia
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Gastrointestinal disorders
Megacolon
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.54%
1/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Cardiac disorders
Angina unstable
|
0.32%
2/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Cardiac disorders
Atrial fibrillation
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Cardiac disorders
Coronary artery disease
|
0.32%
2/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Cardiac disorders
Myocardial infarction
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.54%
1/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Cardiac disorders
Atrial tachycardia
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.54%
1/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Cardiac disorders
Cardiac valve disease
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.32%
2/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.54%
1/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
1.1%
2/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.32%
2/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.54%
1/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pulmonary fibrosis
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.54%
1/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Vascular disorders
Deep vein thrombosis
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.32%
2/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.54%
1/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Vascular disorders
Haematoma
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Vascular disorders
Shock
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Vascular disorders
Thrombosis
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Vascular disorders
Venous thrombosis
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.54%
1/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.48%
3/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.54%
1/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.54%
1/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Hepatobiliary disorders
Sphincter of oddi dysfunction
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Immune system disorders
Hypersensitivity
|
0.48%
3/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Immune system disorders
Amyloidosis
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.54%
1/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.54%
1/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
General disorders
Device dislocation
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
General disorders
Death
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
General disorders
Ischaemic ulcer
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Reproductive system and breast disorders
Ovarian cyst ruptured
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Reproductive system and breast disorders
Pelvic floor muscle weakness
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
2.1%
1/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.54%
1/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Renal and urinary disorders
Renal failure acute
|
0.32%
2/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Metabolism and nutrition disorders
Acidosis
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.32%
2/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Pregnancy, puerperium and perinatal conditions
Imminent abortion
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.32%
2/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Eye disorders
Amaurosis
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Eye disorders
Retinal artery occlusion
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Surgical and medical procedures
Abortion induced
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
2.1%
1/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Investigations
Lipase increased
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Injury, poisoning and procedural complications
Fall
|
0.48%
3/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.16%
1/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
Other adverse events
| Measure |
Tocilizumab SC
n=631 participants at risk
Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study.
|
Tocilizumab IV
n=631 participants at risk
Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study.
|
Tocilizumab SC Then Tocilizumab IV
n=48 participants at risk
Participants who received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for 24 weeks in double blind treatment period switched to tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study.
|
Tocilizumab IV Then Tocilizumab SC
n=186 participants at risk
Participants who received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly in double blind treatment period switched to tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose will be continued throughout the study.
|
|---|---|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
19.3%
122/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
20.6%
130/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
16.7%
8/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
17.7%
33/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Infections and infestations
Nasopharyngitis
|
13.9%
88/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
10.8%
68/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
14.6%
7/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
14.0%
26/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Infections and infestations
Urinary tract infection
|
10.6%
67/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
8.4%
53/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
8.3%
4/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
8.1%
15/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Investigations
Alanine aminotransferase increased
|
29.8%
188/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
22.2%
140/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
14.6%
7/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
15.6%
29/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Investigations
Aspartate aminotransferase increased
|
21.4%
135/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
15.2%
96/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
6.2%
3/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
7.5%
14/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Vascular disorders
Hypertension
|
7.8%
49/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
10.3%
65/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
8.3%
4/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
4.3%
8/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Nervous system disorders
Headache
|
7.3%
46/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
6.5%
41/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
6.2%
3/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
4.8%
9/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Infections and infestations
Bronchitis
|
7.0%
44/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
5.5%
35/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
4.2%
2/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
3.2%
6/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Infections and infestations
Gastroenteritis
|
6.5%
41/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
4.1%
26/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
6.2%
3/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
3.2%
6/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Infections and infestations
Pharyngitis
|
3.6%
23/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
6.2%
39/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
4.2%
2/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
2.2%
4/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Infections and infestations
Sinusitis
|
5.2%
33/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
3.0%
19/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.00%
0/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
3.2%
6/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.2%
33/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
5.4%
34/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
4.2%
2/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
4.8%
9/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
4.6%
29/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
4.1%
26/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
6.2%
3/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
5.9%
11/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.8%
24/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
4.4%
28/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
6.2%
3/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
3.2%
6/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
3.3%
21/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
1.7%
11/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
6.2%
3/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.54%
1/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Gastrointestinal disorders
Diarrhoea
|
8.7%
55/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
6.2%
39/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
2.1%
1/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
7.5%
14/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Gastrointestinal disorders
Nausea
|
5.5%
35/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
6.3%
40/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
4.2%
2/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
2.2%
4/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Blood and lymphatic system disorders
Neutropenia
|
9.8%
62/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
7.9%
50/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
4.2%
2/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
7.0%
13/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Injury, poisoning and procedural complications
Fall
|
5.2%
33/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
4.0%
25/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
2.1%
1/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
3.8%
7/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.1%
32/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
4.3%
27/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
2.1%
1/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
1.1%
2/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
|
General disorders
Injection site erythema
|
5.2%
33/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
0.79%
5/631 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
2.1%
1/48 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
4.8%
9/186 • Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.
|
Additional Information
Medical Communications
Hoffman-LaRoche
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