Trial Outcomes & Findings for A Study of Ocrelizumab in Combination With Methotrexate in Patients With Rheumatoid Arthritis Who Are Naive to Methotrexate (FILM) (NCT NCT00485589)

Last Updated: 2020-11-03

Results Overview

The mTSS is a measure of joint damage and includes measures of joint erosion (JE) and joint space narrowing (JSN). The JE score, using the van der Heijde modification, measures erosion severity in 32 hand joints and 12 foot joints. Each hand joint is scored from 0 to 5 and each foot joint is scored from 0 to 10; the total score ranges from 0 to 280. Each joint is scored according to the surface area involved. A score of 10 indicates extensive loss of bone from more than one-half of the articulating bone; a score of 0 indicates no erosion. The JSN score measures the severity of JSN in 30 hand joints (15 per hand) and 12 foot joints (6 per foot). Each joint is scored from 0 to 4; the total score ranges from 0 to 168. A higher score indicates more joint space narrowing. The mTSS ranges from 0 to 448 (280+168). A higher mTSS score indicates greater damage. A negative change score indicates improvement.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

613 participants

Primary outcome timeframe

Baseline to Week 52

Results posted on

2020-11-03

Participant Flow

The study population comprised adult patients with active rheumatoid arthritis (RA) of at least 3 months' but less than 5 years' duration who were naïve to methotrexate. Additionally, patients were required to be naïve to any biologic therapy for RA prior to enrollment.

Participant milestones

Participant milestones
Measure	Placebo Participants received placebo intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54, 76, and 78. Participants also received methotrexate 7.5 mg orally weekly starting on Day 1. The dose of methodrexate was increased to a dose of 20 mg per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone or prednisolone.	Ocrelizumab 200 mg Participants received ocrelizumab 200 mg intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54 and 76. Participants also received methotrexate 7.5 mg orally weekly starting on Day 1. The dose of methodrexate was increased to a dose of 20 mg per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone or prednisolone.	Ocrelizumab 500 mg Participants received ocrelizumab 500 mg intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54, and 76. Participants also received methotrexate 7.5 mg orally weekly starting on Day 1. The dose of methodrexate was increased to a dose of 20 mg per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone or prednisolone.
Overall Study STARTED	210	200	203
Overall Study COMPLETED	183	180	185
Overall Study NOT COMPLETED	27	20	18

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants received placebo intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54, 76, and 78. Participants also received methotrexate 7.5 mg orally weekly starting on Day 1. The dose of methodrexate was increased to a dose of 20 mg per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone or prednisolone.	Ocrelizumab 200 mg Participants received ocrelizumab 200 mg intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54 and 76. Participants also received methotrexate 7.5 mg orally weekly starting on Day 1. The dose of methodrexate was increased to a dose of 20 mg per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone or prednisolone.	Ocrelizumab 500 mg Participants received ocrelizumab 500 mg intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54, and 76. Participants also received methotrexate 7.5 mg orally weekly starting on Day 1. The dose of methodrexate was increased to a dose of 20 mg per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone or prednisolone.
Overall Study Death	2	2	0
Overall Study Failure to return	6	5	1
Overall Study Protocol Violation	1	0	0
Overall Study Violation of selection criteria at entry	0	3	1
Overall Study Administrative/Other	1	2	1
Overall Study Insufficient therapeutic response	10	3	1
Overall Study Refused treatment/did not cooperate	1	0	2
Overall Study Withdrawal by Subject	3	2	2
Overall Study Adverse Event	3	3	10

Baseline Characteristics

A Study of Ocrelizumab in Combination With Methotrexate in Patients With Rheumatoid Arthritis Who Are Naive to Methotrexate (FILM)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=207 Participants Participants received placebo intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54, 76, and 78. Participants also received methotrexate 7.5 mg orally weekly starting on Day 1. The dose of methodrexate was increased to a dose of 20 mg per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone or prednisolone.	Ocrelizumab 200 mg n=196 Participants Participants received ocrelizumab 200 mg intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54 and 76. Participants also received methotrexate 7.5 mg orally weekly starting on Day 1. The dose of methodrexate was increased to a dose of 20 mg per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone or prednisolone.	Ocrelizumab 500 mg n=202 Participants Participants received ocrelizumab 500 mg intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54, and 76. Participants also received methotrexate 7.5 mg orally weekly starting on Day 1. The dose of methodrexate was increased to a dose of 20 mg per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone or prednisolone.	Total n=605 Participants Total of all reporting groups
Age, Continuous	49.2 Years STANDARD_DEVIATION 12.43 • n=5 Participants	50.8 Years STANDARD_DEVIATION 13.17 • n=7 Participants	48.6 Years STANDARD_DEVIATION 12.29 • n=5 Participants	49.5 Years STANDARD_DEVIATION 12.66 • n=4 Participants
Sex/Gender, Customized Female	153 Participants n=5 Participants	154 Participants n=7 Participants	161 Participants n=5 Participants	468 Participants n=4 Participants
Sex/Gender, Customized Male	54 Participants n=5 Participants	42 Participants n=7 Participants	41 Participants n=5 Participants	137 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline to Week 52

Outcome measures

Outcome measures
Measure	Placebo n=193 Participants Participants received placebo intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54, 76, and 78. Participants also received methotrexate 7.5 mg orally weekly starting on Day 1. The dose of methodrexate was increased to a dose of 20 mg per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone or prednisolone.	Ocrelizumab 200 mg n=187 Participants Participants received ocrelizumab 200 mg intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54 and 76. Participants also received methotrexate 7.5 mg orally weekly starting on Day 1. The dose of methodrexate was increased to a dose of 20 mg per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone or prednisolone.	Ocrelizumab 500 mg n=194 Participants Participants received ocrelizumab 500 mg intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54, and 76. Participants also received methotrexate 7.5 mg orally weekly starting on Day 1. The dose of methodrexate was increased to a dose of 20 mg per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone or prednisolone.
Change From Baseline in the Modified Total Sharp Score (mTSS) at Week 52	1.59 Units on a scale Standard Deviation 4.815	0.66 Units on a scale Standard Deviation 4.509	0.27 Units on a scale Standard Deviation 2.908

SECONDARY outcome

Timeframe: Week 52

RP was defined as a change from Baseline in the modified Total Sharp Score (mTSS) ≤ 0. The mTSS is a measure of joint damage and includes measures of joint erosion (JE) and joint space narrowing (JSN). The JE score, using the van der Heijde modification, measures erosion severity in 32 hand joints and 12 foot joints. Each hand joint is scored from 0 to 5 and each foot joint is scored from 0 to 10; the total score ranges from 0 to 280. Each joint is scored according to the surface area involved. A score of 10 indicates extensive loss of bone from more than one-half of the articulating bone; a score of 0 indicates no erosion. The JSN score measures the severity of JSN in 30 hand joints (15 per hand) and 12 foot joints (6 per foot). Each joint is scored from 0 to 4; the total score ranges from 0 to 168. A higher score indicates more joint space narrowing. The mTSS ranges from 0 to 448 (280+168). A higher mTSS score indicates greater damage. A negative change score indicates improvement.

Outcome measures

Outcome measures
Measure	Placebo n=196 Participants Participants received placebo intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54, 76, and 78. Participants also received methotrexate 7.5 mg orally weekly starting on Day 1. The dose of methodrexate was increased to a dose of 20 mg per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone or prednisolone.	Ocrelizumab 200 mg n=187 Participants Participants received ocrelizumab 200 mg intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54 and 76. Participants also received methotrexate 7.5 mg orally weekly starting on Day 1. The dose of methodrexate was increased to a dose of 20 mg per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone or prednisolone.	Ocrelizumab 500 mg n=192 Participants Participants received ocrelizumab 500 mg intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54, and 76. Participants also received methotrexate 7.5 mg orally weekly starting on Day 1. The dose of methodrexate was increased to a dose of 20 mg per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone or prednisolone.
Percentage of Participants Without Radiographic Progression (RP) at Week 52	51 Percentage of participants Interval 44.0 to 58.0	66.3 Percentage of participants Interval 59.5 to 73.1	68.8 Percentage of participants Interval 62.2 to 75.3

SECONDARY outcome

Timeframe: Baseline to Week 52

Improvement must be seen in tender (68) and swollen (66) joint counts. Joints were assessed and classified as swollen/not swollen and tender/not tender by pressure and joint manipulation. Improvement must also be seen in at least 3 of the following 5 parameters: Separate patient and physician assessments of patient disease activity in the previous 24 hours on a visual analog scale (VAS, the extreme left end of the line "none" \[symptom-free and no arthritis symptoms\] and the extreme right end "maximum" \[maximum arthritis disease activity\]; patient assessment of pain in the previous 24 hours on a VAS (extreme left end of the line "none" and the extreme right end "unbearable"); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and C-reactive protein (CRP), or erythrocyte sedimentation rate if CRP was missing.

Outcome measures

Outcome measures
Measure	Placebo n=207 Participants Participants received placebo intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54, 76, and 78. Participants also received methotrexate 7.5 mg orally weekly starting on Day 1. The dose of methodrexate was increased to a dose of 20 mg per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone or prednisolone.	Ocrelizumab 200 mg n=196 Participants Participants received ocrelizumab 200 mg intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54 and 76. Participants also received methotrexate 7.5 mg orally weekly starting on Day 1. The dose of methodrexate was increased to a dose of 20 mg per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone or prednisolone.	Ocrelizumab 500 mg n=200 Participants Participants received ocrelizumab 500 mg intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54, and 76. Participants also received methotrexate 7.5 mg orally weekly starting on Day 1. The dose of methodrexate was increased to a dose of 20 mg per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone or prednisolone.
Percentage of Participants With an Improvement ≥ 20%, 50%, or 70% in American College of Rheumatology (ACR) Score (ACR20/50/70) From Baseline to Week 52 ACR70	20.3 Percentage of participants Interval 14.8 to 25.8	38.3 Percentage of participants Interval 31.5 to 45.1	38 Percentage of participants Interval 31.3 to 44.7
Percentage of Participants With an Improvement ≥ 20%, 50%, or 70% in American College of Rheumatology (ACR) Score (ACR20/50/70) From Baseline to Week 52 ACR20	57.5 Percentage of participants Interval 50.8 to 64.2	73 Percentage of participants Interval 66.7 to 79.2	71 Percentage of participants Interval 64.7 to 77.3
Percentage of Participants With an Improvement ≥ 20%, 50%, or 70% in American College of Rheumatology (ACR) Score (ACR20/50/70) From Baseline to Week 52 ACR50	39.6 Percentage of participants Interval 33.0 to 46.3	60.7 Percentage of participants Interval 53.9 to 67.6	54.5 Percentage of participants Interval 47.6 to 61.4

SECONDARY outcome

Timeframe: Week 24 and Week 52

A participant was in DAS28 remission if their DAS28 score \< 2.6). The DAS28 is a combined index for measuring disease activity in rheumatic arthritis (RA) and includes swollen and tender joint counts, erythrocyte sedimentation rate (ESR), and general health (GH) status. The index is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(ESR)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints. GH = a patient's global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity \[symptom-free and no arthritis symptoms\], right end = maximum disease activity \[maximum arthritis disease activity\]). When ESR equaled 0 mm/hr, it was set to 1 mm/hr. The DAS28 scale ranges from 0 to 10, where a higher score indicates more disease activity.

Outcome measures

Outcome measures
Measure	Placebo n=207 Participants Participants received placebo intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54, 76, and 78. Participants also received methotrexate 7.5 mg orally weekly starting on Day 1. The dose of methodrexate was increased to a dose of 20 mg per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone or prednisolone.	Ocrelizumab 200 mg n=196 Participants Participants received ocrelizumab 200 mg intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54 and 76. Participants also received methotrexate 7.5 mg orally weekly starting on Day 1. The dose of methodrexate was increased to a dose of 20 mg per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone or prednisolone.	Ocrelizumab 500 mg n=200 Participants Participants received ocrelizumab 500 mg intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54, and 76. Participants also received methotrexate 7.5 mg orally weekly starting on Day 1. The dose of methodrexate was increased to a dose of 20 mg per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone or prednisolone.
Percentage of Participants in Disease Activity Score 28 (DAS28) Remission at Weeks 24 and 52 Week 24	9.7 Percentage of participants Interval 5.6 to 13.7	19.9 Percentage of participants Interval 14.3 to 25.5	18 Percentage of participants Interval 12.7 to 23.3
Percentage of Participants in Disease Activity Score 28 (DAS28) Remission at Weeks 24 and 52 Week 52	7.2 Percentage of participants Interval 3.7 to 10.8	27 Percentage of participants Interval 20.8 to 33.3	28 Percentage of participants Interval 21.8 to 34.2

Adverse Events

Placebo - Treatment Period

Serious events: 22 serious events

Other events: 128 other events

Deaths: 0 deaths

Placebo/Ocrelizumab 500 mg - Treatment Period

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Ocrelizumab 200 mg - Treatment Period

Serious events: 21 serious events

Other events: 135 other events

Deaths: 0 deaths

Ocrelizumab 200 mg/Ocrelizumab 500 mg - Treatment Period

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Ocrelizumab 500 mg - Treatment Period

Serious events: 31 serious events

Other events: 144 other events

Deaths: 0 deaths

Ocrelizumab 500 mg/Ocrelizumab 500 mg - Treatment Period

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo - Safety Follow-up Period

Serious events: 11 serious events

Other events: 35 other events

Deaths: 2 deaths

Placebo/Ocrelizumab 500 mg - Safety Follow-up Period

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Ocrelizumab 200 mg - Safety Follow-up Period

Serious events: 2 serious events

Other events: 32 other events

Deaths: 2 deaths

Ocrelizumab 200 mg/Ocrelizumab 500 Mg-safety Follow-up Period

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Ocrelizumab 500 mg - Safety Follow-up Period

Serious events: 4 serious events

Other events: 49 other events

Deaths: 1 deaths

Ocrelizumab 500 mg/Ocrelizumab 500 mg -Safety Follow-up Period

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo - Treatment Period n=207 participants at risk Participants received placebo intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54, 76 and 78. Participants also received methotrexate 20 mg orally per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received acetaminophen 1 g and an antihistamine (diphenhydramine HCl 50 mg or equivalent dose of an alternative) orally 30-60 minutes prior to each infusion of study treatment and methylprednisolone 100 mg intravenously 30 minutes prior to each infusion of study treatment. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone.	Placebo/Ocrelizumab 500 mg - Treatment Period n=10 participants at risk Participants received placebo intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54, 76, and 78 and ocrelizumab 500 mg intravenously on Weeks 100, 102, 124, and 126. Participants also received methotrexate 20 mg orally per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received acetaminophen 1 g and an antihistamine (diphenhydramine HCl 50 mg or equivalent dose of an alternative) orally 30-60 minutes prior to each infusion of study treatment and methylprednisolone 100 mg intravenously 30 minutes prior to each infusion of study treatment. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone.	Ocrelizumab 200 mg - Treatment Period n=196 participants at risk Participants received placebo intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54 and 76. Participants also received methotrexate 20 mg orally per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received acetaminophen 1 g and an antihistamine (diphenhydramine HCl 50 mg or equivalent dose of an alternative) orally 30-60 minutes prior to each infusion of study treatment and methylprednisolone 100 mg intravenously 30 minutes prior to each infusion of study treatment. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone.	Ocrelizumab 200 mg/Ocrelizumab 500 mg - Treatment Period n=12 participants at risk Participants received ocrelizumab 200 mg intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54 and 76 and ocrelizumab 500 mg intravenously on Weeks 100, 102, 124, and 126. Participants also received methotrexate 20 mg orally per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received acetaminophen 1 g and an antihistamine (diphenhydramine HCl 50 mg or equivalent dose of an alternative) orally 30-60 minutes prior to each infusion of study treatment and methylprednisolone 100 mg intravenously 30 minutes prior to each infusion of study treatment. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone.	Ocrelizumab 500 mg - Treatment Period n=202 participants at risk Participants received ocrelizumab 500 mg intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54 and 76. Participants also received methotrexate 20 mg orally per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received acetaminophen 1 g and an antihistamine (diphenhydramine HCl 50 mg or equivalent dose of an alternative) orally 30-60 minutes prior to each infusion of study treatment and methylprednisolone 100 mg intravenously 30 minutes prior to each infusion of study treatment. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone.	Ocrelizumab 500 mg/Ocrelizumab 500 mg - Treatment Period n=6 participants at risk Participants received ocrelizumab 500 mg intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54, 76, 100, 102, 124, and 126. Participants also received methotrexate 20 mg orally per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received acetaminophen 1 g and an antihistamine (diphenhydramine HCl 50 mg or equivalent dose of an alternative) orally 30-60 minutes prior to each infusion of study treatment and methylprednisolone 100 mg intravenously 30 minutes prior to each infusion of study treatment. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone.	Placebo - Safety Follow-up Period n=187 participants at risk Participants had received placebo intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54, 76 and 78. Participants also received methotrexate 20 mg orally per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received acetaminophen 1 g and an antihistamine (diphenhydramine HCl 50 mg or equivalent dose of an alternative) orally 30-60 minutes prior to each infusion of study treatment and methylprednisolone 100 mg intravenously 30 minutes prior to each infusion of study treatment. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone.	Placebo/Ocrelizumab 500 mg - Safety Follow-up Period n=9 participants at risk Participants had received placebo intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54, 76, and 78 and ocrelizumab 500 mg intravenously on Weeks 100, 102, 124, and 126. Participants also received methotrexate 20 mg orally per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received acetaminophen 1 g and an antihistamine (diphenhydramine HCl 50 mg or equivalent dose of an alternative) orally 30-60 minutes prior to each infusion of study treatment and methylprednisolone 100 mg intravenously 30 minutes prior to each infusion of study treatment. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone.	Ocrelizumab 200 mg - Safety Follow-up Period n=177 participants at risk Participants had received Ocrelizumab intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54 and 76. Participants received methotrexate 20 mg orally per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received acetaminophen 1 g and an antihistamine (diphenhydramine HCl 50 mg or equivalent dose of an alternative) orally 30-60 minutes prior to each infusion of study treatment and methylprednisolone 100 mg intravenously 30 minutes prior to each infusion of study treatment. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone.	Ocrelizumab 200 mg/Ocrelizumab 500 Mg-safety Follow-up Period n=11 participants at risk Participants had received ocrelizumab 200 mg intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54 and 76 and ocrelizumab 500 mg intravenously on Weeks 100, 102, 124, and 126. Participants also received methotrexate 20 mg orally per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received acetaminophen 1 g and an antihistamine (diphenhydramine HCl 50 mg or equivalent dose of an alternative) orally 30-60 minutes prior to each infusion of study treatment and methylprednisolone 100 mg intravenously 30 minutes prior to each infusion of study treatment. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone.	Ocrelizumab 500 mg - Safety Follow-up Period n=185 participants at risk Participants had received ocrelizumab 500 mg intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54, 76 and 78. Participants also received methotrexate 20 mg orally per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received acetaminophen 1 g and an antihistamine (diphenhydramine HCl 50 mg or equivalent dose of an alternative) orally 30-60 minutes prior to each infusion of study treatment and methylprednisolone 100 mg intravenously 30 minutes prior to each infusion of study treatment. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone.	Ocrelizumab 500 mg/Ocrelizumab 500 mg -Safety Follow-up Period n=6 participants at risk Participants had received ocrelizumab 500 mg intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54, 76, 100, 102, 124, and 126. Participants also received methotrexate 20 mg orally per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received acetaminophen 1 g and an antihistamine (diphenhydramine HCl 50 mg or equivalent dose of an alternative) orally 30-60 minutes prior to each infusion of study treatment and methylprednisolone 100 mg intravenously 30 minutes prior to each infusion of study treatment. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone.
General disorders Non-cardiac chest pain	0.48% 1/207 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
General disorders Pyrexia	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.50% 1/202 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.48% 1/207 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Injury, poisoning and procedural complications Road traffic accident	0.48% 1/207 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.50% 1/202 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Psychiatric disorders Depression	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.56% 1/177 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Injury, poisoning and procedural complications Forearm fracture	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.51% 1/196 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Injury, poisoning and procedural complications Hip fracture	0.48% 1/207 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.50% 1/202 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Injury, poisoning and procedural complications Limb traumatic amputation	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.50% 1/202 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Injury, poisoning and procedural complications Accidental overdose	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.51% 1/196 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Injury, poisoning and procedural complications Dislocation of vertebra	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.50% 1/202 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Injury, poisoning and procedural complications Upper limb fracture	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.50% 1/202 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.54% 1/185 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Cardiac disorders Acute myocardial infarction	0.48% 1/207 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.51% 1/196 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.54% 1/185 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.53% 1/187 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Injury, poisoning and procedural complications Lower limb fracture	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.54% 1/185 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.54% 1/185 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Cardiac disorders Coronary artery disease	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.51% 1/196 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.50% 1/202 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Cardiac disorders Arteriosclerosis coronary artery	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.51% 1/196 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Cardiac disorders Atrial fibrillation	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.50% 1/202 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Cardiac disorders Tachycardia	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.51% 1/196 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Cardiac disorders Supraventricular tachycardia	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.53% 1/187 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Congenital, familial and genetic disorders Bronchogenic cyst	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.50% 1/202 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	1.5% 3/202 • Number of events 3 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Pulmonary alveolar haemorrhage	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.50% 1/202 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Pulmonary eosinophilia	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.50% 1/202 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Vocal cord polyp	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.50% 1/202 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.53% 1/187 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.56% 1/177 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Blood and lymphatic system disorders Agranulocytosis	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.50% 1/202 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Blood and lymphatic system disorders Anaemia	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.50% 1/202 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Blood and lymphatic system disorders Anaemia haemolytic autoimmune	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.51% 1/196 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Blood and lymphatic system disorders Neutropenia	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.51% 1/196 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Blood and lymphatic system disorders Leukopenia	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.54% 1/185 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.54% 1/185 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Nervous system disorders Autonomic neuropathy	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.51% 1/196 • Number of events 11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Nervous system disorders Carpal tunnel syndrome	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.51% 1/196 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Nervous system disorders Cerebellar infarction	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.50% 1/202 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Nervous system disorders Cerebrovascular accident	0.48% 1/207 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Nervous system disorders Leukoencephalopathy	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.51% 1/196 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Nervous system disorders Dementia	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.56% 1/177 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Nervous system disorders Ischaemic cerebral infarction	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.54% 1/185 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Eye disorders Cataract	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.51% 1/196 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Ear and labyrinth disorders Deafness bilateral	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.50% 1/202 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Ear and labyrinth disorders Vestibular disorder	0.48% 1/207 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Vascular disorders Deep vein thrombosis	0.48% 1/207 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Vascular disorders Orthostatic hypotension	0.48% 1/207 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.50% 1/202 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer metastatic	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.53% 1/187 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.53% 1/187 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian fibroma	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.50% 1/202 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Vascular disorders Aortic aneurysm	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.51% 1/196 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Vascular disorders Aortic stenosis	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.51% 1/196 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Gastrointestinal disorders Inguinal hernia	0.97% 2/207 • Number of events 2 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Gastrointestinal disorders Abdominal hernia obstructive	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.50% 1/202 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Gastrointestinal disorders Constipation	0.48% 1/207 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Gastrointestinal disorders Gastritis	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.51% 1/196 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.50% 1/202 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Gastrointestinal disorders Gastrointestinal inflammation	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.50% 1/202 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Gastrointestinal disorders Intestinal obstruction	0.48% 1/207 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Gastrointestinal disorders Colitis	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.53% 1/187 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.53% 1/187 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Renal and urinary disorders Nephrolithiasis	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.51% 1/196 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Renal and urinary disorders Renal failure	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.50% 1/202 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Hepatobiliary disorders Cholelithiasis	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.99% 2/202 • Number of events 2 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Hepatobiliary disorders Hepatic cirrhosis	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	11.1% 1/9 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Drug reaction with eosinophilia and systemic symptoms	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.53% 1/187 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Pustular psoriasis	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.53% 1/187 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Angioedema	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	11.1% 1/9 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.97% 2/207 • Number of events 2 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	1.0% 2/196 • Number of events 2 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.50% 1/202 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.53% 1/187 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	1.1% 2/177 • Number of events 2 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	1.0% 2/196 • Number of events 2 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.50% 1/202 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.54% 1/185 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.51% 1/196 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.48% 1/207 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Endocrine disorders Hyperthyroidism	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.50% 1/202 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Metabolism and nutrition disorders Hyperglycaemia	0.48% 1/207 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.50% 1/202 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.56% 1/177 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.53% 1/187 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Infections and infestations Urinary tract infection	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.51% 1/196 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.99% 2/202 • Number of events 4 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.54% 1/185 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Infections and infestations Abdominal wall infection	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	8.3% 1/12 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Infections and infestations Abscess	0.48% 1/207 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Infections and infestations Acute tonsillitis	0.48% 1/207 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Infections and infestations Bacteraemia	0.48% 1/207 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Infections and infestations Bronchitis	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.51% 1/196 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Infections and infestations Bronchopneumonia	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.50% 1/202 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Infections and infestations Cellulitis	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.50% 1/202 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.53% 1/187 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.56% 1/177 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Infections and infestations Diverticulitis	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.51% 1/196 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.54% 1/185 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Infections and infestations Encephalitis viral	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.50% 1/202 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Infections and infestations Histoplasmosis	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.51% 1/196 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Infections and infestations Infection	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.50% 1/202 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Infections and infestations Localised infection	0.48% 1/207 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Infections and infestations Pneumonia herpes viral	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.50% 1/202 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Infections and infestations Systemic candida	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.50% 1/202 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Infections and infestations Sepsis	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.56% 1/177 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.54% 1/185 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Infections and infestations Oesophageal candidiasis	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.54% 1/185 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Infections and infestations Peritonitis bacterial	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.56% 1/177 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Infections and infestations Pharyngitis	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.53% 1/187 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Infections and infestations Post procedural infection	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.53% 1/187 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Infections and infestations Urosepsis	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.54% 1/185 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Infections and infestations Pneumonia	1.4% 3/207 • Number of events 3 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.99% 2/202 • Number of events 2 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.53% 1/187 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	11.1% 1/9 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	1.1% 2/177 • Number of events 2 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.54% 1/185 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.

Other adverse events

Other adverse events
Measure	Placebo - Treatment Period n=207 participants at risk Participants received placebo intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54, 76 and 78. Participants also received methotrexate 20 mg orally per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received acetaminophen 1 g and an antihistamine (diphenhydramine HCl 50 mg or equivalent dose of an alternative) orally 30-60 minutes prior to each infusion of study treatment and methylprednisolone 100 mg intravenously 30 minutes prior to each infusion of study treatment. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone.	Placebo/Ocrelizumab 500 mg - Treatment Period n=10 participants at risk Participants received placebo intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54, 76, and 78 and ocrelizumab 500 mg intravenously on Weeks 100, 102, 124, and 126. Participants also received methotrexate 20 mg orally per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received acetaminophen 1 g and an antihistamine (diphenhydramine HCl 50 mg or equivalent dose of an alternative) orally 30-60 minutes prior to each infusion of study treatment and methylprednisolone 100 mg intravenously 30 minutes prior to each infusion of study treatment. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone.	Ocrelizumab 200 mg - Treatment Period n=196 participants at risk Participants received placebo intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54 and 76. Participants also received methotrexate 20 mg orally per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received acetaminophen 1 g and an antihistamine (diphenhydramine HCl 50 mg or equivalent dose of an alternative) orally 30-60 minutes prior to each infusion of study treatment and methylprednisolone 100 mg intravenously 30 minutes prior to each infusion of study treatment. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone.	Ocrelizumab 200 mg/Ocrelizumab 500 mg - Treatment Period n=12 participants at risk Participants received ocrelizumab 200 mg intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54 and 76 and ocrelizumab 500 mg intravenously on Weeks 100, 102, 124, and 126. Participants also received methotrexate 20 mg orally per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received acetaminophen 1 g and an antihistamine (diphenhydramine HCl 50 mg or equivalent dose of an alternative) orally 30-60 minutes prior to each infusion of study treatment and methylprednisolone 100 mg intravenously 30 minutes prior to each infusion of study treatment. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone.	Ocrelizumab 500 mg - Treatment Period n=202 participants at risk Participants received ocrelizumab 500 mg intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54 and 76. Participants also received methotrexate 20 mg orally per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received acetaminophen 1 g and an antihistamine (diphenhydramine HCl 50 mg or equivalent dose of an alternative) orally 30-60 minutes prior to each infusion of study treatment and methylprednisolone 100 mg intravenously 30 minutes prior to each infusion of study treatment. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone.	Ocrelizumab 500 mg/Ocrelizumab 500 mg - Treatment Period n=6 participants at risk Participants received ocrelizumab 500 mg intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54, 76, 100, 102, 124, and 126. Participants also received methotrexate 20 mg orally per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received acetaminophen 1 g and an antihistamine (diphenhydramine HCl 50 mg or equivalent dose of an alternative) orally 30-60 minutes prior to each infusion of study treatment and methylprednisolone 100 mg intravenously 30 minutes prior to each infusion of study treatment. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone.	Placebo - Safety Follow-up Period n=187 participants at risk Participants had received placebo intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54, 76 and 78. Participants also received methotrexate 20 mg orally per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received acetaminophen 1 g and an antihistamine (diphenhydramine HCl 50 mg or equivalent dose of an alternative) orally 30-60 minutes prior to each infusion of study treatment and methylprednisolone 100 mg intravenously 30 minutes prior to each infusion of study treatment. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone.	Placebo/Ocrelizumab 500 mg - Safety Follow-up Period n=9 participants at risk Participants had received placebo intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54, 76, and 78 and ocrelizumab 500 mg intravenously on Weeks 100, 102, 124, and 126. Participants also received methotrexate 20 mg orally per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received acetaminophen 1 g and an antihistamine (diphenhydramine HCl 50 mg or equivalent dose of an alternative) orally 30-60 minutes prior to each infusion of study treatment and methylprednisolone 100 mg intravenously 30 minutes prior to each infusion of study treatment. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone.	Ocrelizumab 200 mg - Safety Follow-up Period n=177 participants at risk Participants had received Ocrelizumab intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54 and 76. Participants received methotrexate 20 mg orally per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received acetaminophen 1 g and an antihistamine (diphenhydramine HCl 50 mg or equivalent dose of an alternative) orally 30-60 minutes prior to each infusion of study treatment and methylprednisolone 100 mg intravenously 30 minutes prior to each infusion of study treatment. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone.	Ocrelizumab 200 mg/Ocrelizumab 500 Mg-safety Follow-up Period n=11 participants at risk Participants had received ocrelizumab 200 mg intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54 and 76 and ocrelizumab 500 mg intravenously on Weeks 100, 102, 124, and 126. Participants also received methotrexate 20 mg orally per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received acetaminophen 1 g and an antihistamine (diphenhydramine HCl 50 mg or equivalent dose of an alternative) orally 30-60 minutes prior to each infusion of study treatment and methylprednisolone 100 mg intravenously 30 minutes prior to each infusion of study treatment. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone.	Ocrelizumab 500 mg - Safety Follow-up Period n=185 participants at risk Participants had received ocrelizumab 500 mg intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54, 76 and 78. Participants also received methotrexate 20 mg orally per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received acetaminophen 1 g and an antihistamine (diphenhydramine HCl 50 mg or equivalent dose of an alternative) orally 30-60 minutes prior to each infusion of study treatment and methylprednisolone 100 mg intravenously 30 minutes prior to each infusion of study treatment. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone.	Ocrelizumab 500 mg/Ocrelizumab 500 mg -Safety Follow-up Period n=6 participants at risk Participants had received ocrelizumab 500 mg intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54, 76, 100, 102, 124, and 126. Participants also received methotrexate 20 mg orally per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received acetaminophen 1 g and an antihistamine (diphenhydramine HCl 50 mg or equivalent dose of an alternative) orally 30-60 minutes prior to each infusion of study treatment and methylprednisolone 100 mg intravenously 30 minutes prior to each infusion of study treatment. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone.
Musculoskeletal and connective tissue disorders Tenosynovitis stenosans	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	11.1% 1/9 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Vascular disorders Hypertension	11.1% 23/207 • Number of events 23 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	7.1% 14/196 • Number of events 14 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	8.9% 18/202 • Number of events 18 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Surgical and medical procedures Hip arthroplasty	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	8.3% 1/12 • Number of events 2 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Surgical and medical procedures Bunion operation	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	16.7% 1/6 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid neoplasm	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.53% 1/187 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
General disorders Oedema	0.97% 2/207 • Number of events 2 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	16.7% 1/6 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Psychiatric disorders Anxiety	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	11.1% 1/9 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.54% 1/185 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Injury, poisoning and procedural complications Infusion related reaction	10.1% 21/207 • Number of events 36 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	40.0% 4/10 • Number of events 4 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	28.6% 56/196 • Number of events 79 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	31.7% 64/202 • Number of events 91 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	16.7% 1/6 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Injury, poisoning and procedural complications Meniscus injury	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	1.1% 2/187 • Number of events 2 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.56% 1/177 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	9.1% 1/11 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Injury, poisoning and procedural complications Limb injury	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.53% 1/187 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	9.1% 1/11 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Injury, poisoning and procedural complications Muscle strain	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	11.1% 1/9 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.54% 1/185 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	9.1% 1/11 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Investigations Liver function test abnormal	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	8.3% 1/12 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Investigations Blood creatine phosphokinase increased	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	11.1% 1/9 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.56% 1/177 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.53% 1/187 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.54% 1/185 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Blood and lymphatic system disorders Neutropenia	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.53% 1/187 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.54% 1/185 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Blood and lymphatic system disorders Anaemia	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	1.7% 3/177 • Number of events 3 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	1.1% 2/185 • Number of events 3 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	10.0% 1/10 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	1.1% 2/187 • Number of events 2 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	11.1% 1/9 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	1.1% 2/177 • Number of events 2 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.54% 1/185 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Sinusitis noninfective	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	16.7% 1/6 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Nervous system disorders Headache	6.3% 13/207 • Number of events 13 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	6.1% 12/196 • Number of events 12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	3.5% 7/202 • Number of events 7 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Eye disorders Conjunctivitis	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	10.0% 1/10 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.50% 1/202 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Gastrointestinal disorders Abdominal hernia	0.48% 1/207 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	8.3% 1/12 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Gastrointestinal disorders Nausea	11.6% 24/207 • Number of events 24 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	8.2% 16/196 • Number of events 16 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	10.9% 22/202 • Number of events 22 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Gastrointestinal disorders Diarrhoea	6.8% 14/207 • Number of events 14 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	3.6% 7/196 • Number of events 7 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	6.9% 14/202 • Number of events 14 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.53% 1/187 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	1.7% 3/177 • Number of events 3 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	9.1% 1/11 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	1.6% 3/185 • Number of events 3 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Gastrointestinal disorders Dyspepsia	6.8% 14/207 • Number of events 14 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	4.1% 8/196 • Number of events 8 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	6.4% 13/202 • Number of events 13 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Gastrointestinal disorders Abdominal distension	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.53% 1/187 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Gastrointestinal disorders Gastric ulcer	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	9.1% 1/11 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Gastrointestinal disorders Gastritis atrophic	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	9.1% 1/11 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Hepatobiliary disorders Drug-induced liver injury	8.7% 18/207 • Number of events 18 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	14.3% 28/196 • Number of events 28 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	13.4% 27/202 • Number of events 27 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Dry skin	0.97% 2/207 • Number of events 3 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.51% 1/196 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	8.3% 1/12 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	10.0% 1/10 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Rosacea	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	8.3% 1/12 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Exfoliative rash	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.53% 1/187 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Rash	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.53% 1/187 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	1.1% 2/177 • Number of events 2 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	9.1% 1/11 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.54% 1/185 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	1.1% 2/187 • Number of events 2 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	16.7% 1/6 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Angioedema	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	11.1% 1/9 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Onychoclasis	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	9.1% 1/11 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	11.1% 1/9 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Periarthritis	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.51% 1/196 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	8.3% 1/12 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.50% 1/202 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Back pain	4.3% 9/207 • Number of events 9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	5.1% 10/196 • Number of events 10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	3.5% 7/202 • Number of events 7 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	2.1% 4/187 • Number of events 4 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	11.1% 1/9 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	1.1% 2/177 • Number of events 2 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	3.2% 6/185 • Number of events 7 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.53% 1/187 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.56% 1/177 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	9.1% 1/11 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	1.1% 2/185 • Number of events 2 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Metabolism and nutrition disorders Hyperlipidaemia	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.53% 1/187 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.54% 1/185 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Metabolism and nutrition disorders Vitamin D deficiency	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.54% 1/185 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	16.7% 1/6 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Metabolism and nutrition disorders Dyslipidaemia	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.56% 1/177 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.54% 1/185 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	16.7% 1/6 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	11.1% 1/9 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Infections and infestations Upper respiratory tract infection	17.4% 36/207 • Number of events 45 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	15.8% 31/196 • Number of events 38 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	11.4% 23/202 • Number of events 29 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	16.7% 1/6 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	3.7% 7/187 • Number of events 7 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	11.1% 1/9 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	1.7% 3/177 • Number of events 3 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	18.2% 2/11 • Number of events 3 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	3.8% 7/185 • Number of events 7 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Infections and infestations Cystitis	1.4% 3/207 • Number of events 4 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	2.0% 4/196 • Number of events 6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	2.0% 4/202 • Number of events 4 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	16.7% 1/6 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.53% 1/187 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.56% 1/177 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Infections and infestations Tooth infection	0.48% 1/207 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	10.0% 1/10 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.51% 1/196 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.50% 1/202 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Infections and infestations Bronchitis	10.1% 21/207 • Number of events 21 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	11.2% 22/196 • Number of events 22 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	7.4% 15/202 • Number of events 15 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	1.6% 3/187 • Number of events 3 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	11.1% 1/9 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	2.8% 5/177 • Number of events 5 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	1.6% 3/185 • Number of events 5 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Infections and infestations Urinary tract infection	5.8% 12/207 • Number of events 12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	10.7% 21/196 • Number of events 21 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	12.4% 25/202 • Number of events 25 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	2.8% 5/177 • Number of events 5 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	6.5% 12/185 • Number of events 12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Infections and infestations Nasopharyngitis	5.3% 11/207 • Number of events 11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	9.2% 18/196 • Number of events 18 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	7.9% 16/202 • Number of events 16 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Infections and infestations Sinusitis	4.8% 10/207 • Number of events 10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	3.6% 7/196 • Number of events 7 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	7.4% 15/202 • Number of events 15 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Infections and infestations Gastroenteritis	4.3% 9/207 • Number of events 9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	5.1% 10/196 • Number of events 10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.50% 1/202 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Infections and infestations Cellulitis	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.56% 1/177 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Infections and infestations Influenza	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	1.1% 2/187 • Number of events 2 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	11.1% 1/9 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.56% 1/177 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	9.1% 1/11 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	1.6% 3/185 • Number of events 4 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Infections and infestations Tinea versicolour	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	1.1% 2/185 • Number of events 2 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Infections and infestations Fungal skin infection	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.53% 1/187 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Infections and infestations Lower respiratory tract infection	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.53% 1/187 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/9 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.
Infections and infestations Sinusitis bacterial	0.00% 0/207 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/10 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/196 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/12 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/202 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/187 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	11.1% 1/9 • Number of events 1 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/177 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/11 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/185 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.	0.00% 0/6 • Baseline up to 30 months. Safety population: All randomized participants who received at least 1 dose of study medication.

Additional Information

Medical Communications

F. Hoffmann-La Roche AG

Phone: 41 616878333

Email: [email protected]

Results disclosure agreements

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

Restriction type: OTHER