Trial Outcomes & Findings for An Investigational Immuno-therapy Study of Temozolomide Plus Radiation Therapy With Nivolumab or Placebo, for Newly Diagnosed Patients With Glioblastoma (GBM, a Malignant Brain Cancer) (NCT NCT02667587)

NCT ID: NCT02667587

Last Updated: 2025-06-18

Results Overview

The time from randomization to the date of the first documented tumor progression or death by any cause. PFS will be determined by a Blinded Independent Central Review (BICR) assessed based on Radiologic Assessment in Neuro-Oncology (RANO) criteria. Specifically, RANO response criteria indicates that within the first 12 weeks of completion of radiotherapy, progression can only be assessed if the majority of the new enhancement is outside of the radiation field or if there is pathologic confirmation of progressive disease.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 716 participants
• Primary outcome timeframe: From randomization to the date of the first documented tumor progression or death by any cause. (up to approximately 4.5 years)
• Results posted on: 2025-06-18

Participant Flow

716 participants were randomized into the study, 709 participants received study treatment

Participant milestones

Measure	Radiotherapy, Temozolomide Plus Nivolumab Radiotherapy: A total dose of 60 Gy \[Gray (radiotherapy dose)\], in 2 Gy daily fractions on 5 days/week, will be administered in 6 weeks (30 fractions). Nivolumab: 240 mg administered intravenously (IV) as a 30 minute infusion every 2 weeks for 8 doses followed by nivolumab 480 mg as a 30 minute infusion every 4 weeks beginning after 8 doses Temozolomide: 75 mg/m2 orally daily during radiation therapy followed by 4 week break then 6 (28-day) cycles temozolomide on Days 1-5 at 150 mg/m2 in Cycle 1 increasing to 200 mg/m2 as tolerated up to 6 cycles.	Radiotherapy, Temozolomide Plus Placebo Radiotherapy: A total dose of 60 Gy \[Gray (radiotherapy dose)\], in 2 Gy daily fractions on 5 days/week, will be administered in 6 weeks (30 fractions). Placebo: administered intravenously (IV) as a 30 minute infusion every 2 weeks for 8 doses followed by a 30 minute infusion every 4 weeks beginning after 8 doses Temozolomide: 75 mg/m2 orally daily during radiation therapy followed by 4 week break then 6 (28-day) cycles temozolomide on Days 1-5 at 150 mg/m2 in Cycle 1 increasing to 200 mg/m2 as tolerated up to 6 cycles.
Pre-Treatment STARTED	358	358
Pre-Treatment COMPLETED	354	355
Pre-Treatment NOT COMPLETED	4	3
End of Treatment STARTED	355	354
End of Treatment COMPLETED	0	0
End of Treatment NOT COMPLETED	355	354

Reasons for withdrawal

Measure	Radiotherapy, Temozolomide Plus Nivolumab Radiotherapy: A total dose of 60 Gy \[Gray (radiotherapy dose)\], in 2 Gy daily fractions on 5 days/week, will be administered in 6 weeks (30 fractions). Nivolumab: 240 mg administered intravenously (IV) as a 30 minute infusion every 2 weeks for 8 doses followed by nivolumab 480 mg as a 30 minute infusion every 4 weeks beginning after 8 doses Temozolomide: 75 mg/m2 orally daily during radiation therapy followed by 4 week break then 6 (28-day) cycles temozolomide on Days 1-5 at 150 mg/m2 in Cycle 1 increasing to 200 mg/m2 as tolerated up to 6 cycles.	Radiotherapy, Temozolomide Plus Placebo Radiotherapy: A total dose of 60 Gy \[Gray (radiotherapy dose)\], in 2 Gy daily fractions on 5 days/week, will be administered in 6 weeks (30 fractions). Placebo: administered intravenously (IV) as a 30 minute infusion every 2 weeks for 8 doses followed by a 30 minute infusion every 4 weeks beginning after 8 doses Temozolomide: 75 mg/m2 orally daily during radiation therapy followed by 4 week break then 6 (28-day) cycles temozolomide on Days 1-5 at 150 mg/m2 in Cycle 1 increasing to 200 mg/m2 as tolerated up to 6 cycles.
Pre-Treatment Not reported	1	0
Pre-Treatment Participant no longer meets study criteria	2	2
Pre-Treatment Participant withdrew consent	0	1
Pre-Treatment Adverse event unrelated to study drug	1	0
End of Treatment Disease Progression	193	226
End of Treatment Study Drug Toxicity	75	19
End of Treatment Death	2	1
End of Treatment Adverse Event Unrelated to Study Drug	19	20
End of Treatment participant request to discontinue treatment	33	35
End of Treatment participant withdrew consent	5	6
End of Treatment Lost to Follow-up	1	2
End of Treatment maximum clinical benefit	4	4
End of Treatment poor or non compliant	0	1
End of Treatment participant no longer meets study criteria	1	1
End of Treatment administrative reason by sponsor	1	29
End of Treatment other reasonse	21	10

Baseline Characteristics

An Investigational Immuno-therapy Study of Temozolomide Plus Radiation Therapy With Nivolumab or Placebo, for Newly Diagnosed Patients With Glioblastoma (GBM, a Malignant Brain Cancer)

Baseline characteristics by cohort

Measure	Radiotherapy, Temozolomide Plus Nivolumab n=358 Participants Nivolumab: specified dose on specified days; IV (intravenous) infusion Temozolomide: 75 mg (milligram)/meter squared daily during Radiotherapy, 4 week treatment break, 150 mg/meter squared Day 1-5 for Cycle 1 and increased to 200 mg/meter squared Day 1-5 for Cycle2-Cycle 6 as tolerated; orally (additional cycles may be permitted with approval of sponsor) Radiotherapy: 2 gray units (joule of radiation energy per kilogram) 5 times per week for 6 weeks	Radiotherapy, Temozolomide Plus Placebo n=358 Participants Radiotherapy: A total dose of 60 Gy \[Gray (radiotherapy dose)\], in 2 Gy daily fractions on 5 days/week, will be administered in 6 weeks (30 fractions). Placebo: administered intravenously (IV) as a 30 minute infusion every 2 weeks for 8 doses followed by a 30 minute infusion every 4 weeks beginning after 8 doses Temozolomide: 75 mg/m2 orally daily during radiation therapy followed by 4 week break then 6 (28-day) cycles temozolomide on Days 1-5 at 150 mg/m2 in Cycle 1 increasing to 200 mg/m2 as tolerated up to 6 cycles.	Total n=716 Participants Total of all reporting groups
Age, Continuous	57.9 Years STANDARD_DEVIATION 12.2 • n=5 Participants	58.7 Years STANDARD_DEVIATION 11.4 • n=7 Participants	58.3 Years STANDARD_DEVIATION 11.8 • n=5 Participants
Sex: Female, Male Female	153 Participants n=5 Participants	161 Participants n=7 Participants	314 Participants n=5 Participants
Sex: Female, Male Male	205 Participants n=5 Participants	197 Participants n=7 Participants	402 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=5 Participants	11 Participants n=7 Participants	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	171 Participants n=5 Participants	178 Participants n=7 Participants	349 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	180 Participants n=5 Participants	169 Participants n=7 Participants	349 Participants n=5 Participants
Race/Ethnicity, Customized White	301 Participants n=5 Participants	318 Participants n=7 Participants	619 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Race/Ethnicity, Customized Asian	35 Participants n=5 Participants	33 Participants n=7 Participants	68 Participants n=5 Participants
Race/Ethnicity, Customized Other	17 Participants n=5 Participants	3 Participants n=7 Participants	20 Participants n=5 Participants
Race/Ethnicity, Customized Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: From randomization to the date of the first documented tumor progression or death by any cause. (up to approximately 4.5 years)

Population: All randomized participants

The time from randomization to the date of the first documented tumor progression or death by any cause. PFS will be determined by a Blinded Independent Central Review (BICR) assessed based on Radiologic Assessment in Neuro-Oncology (RANO) criteria. Specifically, RANO response criteria indicates that within the first 12 weeks of completion of radiotherapy, progression can only be assessed if the majority of the new enhancement is outside of the radiation field or if there is pathologic confirmation of progressive disease.

Outcome measures

Measure	Radiotherapy, Temozolomide Plus Nivolumab n=358 Participants Nivolumab: specified dose on specified days; IV (intravenous) infusion Temozolomide: 75 mg (milligram)/meter squared daily during Radiotherapy, 4 week treatment break, 150 mg/meter squared Day 1-5 for Cycle 1 and increased to 200 mg/meter squared Day 1-5 for Cycle2-Cycle 6 as tolerated; orally (additional cycles may be permitted with approval of sponsor) Radiotherapy: 2 gray units (joule of radiation energy per kilogram) 5 times per week for 6 weeks	Radiotherapy, Temozolomide Plus Placebo n=358 Participants Radiotherapy: A total dose of 60 Gy \[Gray (radiotherapy dose)\], in 2 Gy daily fractions on 5 days/week, will be administered in 6 weeks (30 fractions). Placebo: administered intravenously (IV) as a 30 minute infusion every 2 weeks for 8 doses followed by a 30 minute infusion every 4 weeks beginning after 8 doses Temozolomide: 75 mg/m2 orally daily during radiation therapy followed by 4 week break then 6 (28-day) cycles temozolomide on Days 1-5 at 150 mg/m2 in Cycle 1 increasing to 200 mg/m2 as tolerated up to 6 cycles.
Progression-free Survival (PFS) Determined by BICR	10.64 Months Interval 8.9 to 11.79	10.32 Months Interval 9.69 to 12.45

PRIMARY outcome

Timeframe: From randomization to date of death (up to approximately 4.5 years)

Population: All randomized participants

The time from the date of randomization to the date of death. who have not died by the end of the study will be censored to last known date alive. OS is assessed in the randomized population with no corticosteroids at baseline population and in the overall randomized population.

Outcome measures

Measure	Radiotherapy, Temozolomide Plus Nivolumab n=358 Participants Nivolumab: specified dose on specified days; IV (intravenous) infusion Temozolomide: 75 mg (milligram)/meter squared daily during Radiotherapy, 4 week treatment break, 150 mg/meter squared Day 1-5 for Cycle 1 and increased to 200 mg/meter squared Day 1-5 for Cycle2-Cycle 6 as tolerated; orally (additional cycles may be permitted with approval of sponsor) Radiotherapy: 2 gray units (joule of radiation energy per kilogram) 5 times per week for 6 weeks	Radiotherapy, Temozolomide Plus Placebo n=358 Participants Radiotherapy: A total dose of 60 Gy \[Gray (radiotherapy dose)\], in 2 Gy daily fractions on 5 days/week, will be administered in 6 weeks (30 fractions). Placebo: administered intravenously (IV) as a 30 minute infusion every 2 weeks for 8 doses followed by a 30 minute infusion every 4 weeks beginning after 8 doses Temozolomide: 75 mg/m2 orally daily during radiation therapy followed by 4 week break then 6 (28-day) cycles temozolomide on Days 1-5 at 150 mg/m2 in Cycle 1 increasing to 200 mg/m2 as tolerated up to 6 cycles.
Overall Survival (OS) All randomized participants	28.91 Months Interval 24.38 to 31.57	32.07 Months Interval 29.37 to 33.77
Overall Survival (OS) All randomized participants without baseline corticosteroids	31.34 Months Interval 28.62 to 34.76	32.99 Months Interval 31.01 to 35.09

SECONDARY outcome

Timeframe: From randomization to 12 months after first dose

Population: All randomized participants

Overall Survival (OS) rate is defined as the percentage of participants surviving at 12 months

Outcome measures

Measure	Radiotherapy, Temozolomide Plus Nivolumab n=358 Participants Nivolumab: specified dose on specified days; IV (intravenous) infusion Temozolomide: 75 mg (milligram)/meter squared daily during Radiotherapy, 4 week treatment break, 150 mg/meter squared Day 1-5 for Cycle 1 and increased to 200 mg/meter squared Day 1-5 for Cycle2-Cycle 6 as tolerated; orally (additional cycles may be permitted with approval of sponsor) Radiotherapy: 2 gray units (joule of radiation energy per kilogram) 5 times per week for 6 weeks	Radiotherapy, Temozolomide Plus Placebo n=358 Participants Radiotherapy: A total dose of 60 Gy \[Gray (radiotherapy dose)\], in 2 Gy daily fractions on 5 days/week, will be administered in 6 weeks (30 fractions). Placebo: administered intravenously (IV) as a 30 minute infusion every 2 weeks for 8 doses followed by a 30 minute infusion every 4 weeks beginning after 8 doses Temozolomide: 75 mg/m2 orally daily during radiation therapy followed by 4 week break then 6 (28-day) cycles temozolomide on Days 1-5 at 150 mg/m2 in Cycle 1 increasing to 200 mg/m2 as tolerated up to 6 cycles.
Overall Survival (OS) Rates at 12 Months	82.7 percentage of participants Interval 78.3 to 86.3	87.7 percentage of participants Interval 83.8 to 90.8

SECONDARY outcome

Timeframe: From randomization to 24 months after first dose

Population: All randomized participants

Overall Survival (OS) rate is defined as the percentage of participants surviving at 24 months

Outcome measures

Measure	Radiotherapy, Temozolomide Plus Nivolumab n=358 Participants Nivolumab: specified dose on specified days; IV (intravenous) infusion Temozolomide: 75 mg (milligram)/meter squared daily during Radiotherapy, 4 week treatment break, 150 mg/meter squared Day 1-5 for Cycle 1 and increased to 200 mg/meter squared Day 1-5 for Cycle2-Cycle 6 as tolerated; orally (additional cycles may be permitted with approval of sponsor) Radiotherapy: 2 gray units (joule of radiation energy per kilogram) 5 times per week for 6 weeks	Radiotherapy, Temozolomide Plus Placebo n=358 Participants Radiotherapy: A total dose of 60 Gy \[Gray (radiotherapy dose)\], in 2 Gy daily fractions on 5 days/week, will be administered in 6 weeks (30 fractions). Placebo: administered intravenously (IV) as a 30 minute infusion every 2 weeks for 8 doses followed by a 30 minute infusion every 4 weeks beginning after 8 doses Temozolomide: 75 mg/m2 orally daily during radiation therapy followed by 4 week break then 6 (28-day) cycles temozolomide on Days 1-5 at 150 mg/m2 in Cycle 1 increasing to 200 mg/m2 as tolerated up to 6 cycles.
Overall Survival (OS) Rates at 24 Months	55.9 percentage of participants Interval 50.5 to 61.0	63.3 percentage of participants Interval 58.0 to 68.2

SECONDARY outcome

Timeframe: From randomization to the date of the first documented tumor progression or death by any cause. (up to approximately 4.5 years)

Population: All randomized participants

The time from randomization to the date of the first documented tumor progression or death by any cause. PFS will be determined by investigator assessment based Radiologic Assessment in Neuro-Oncology (RANO) criteria. Specifically, RANO response criteria indicates that within the first 12 weeks of completion of radiotherapy, progression can only be assessed if the majority of the new enhancement is outside of the radiation field or if there is pathologic confirmation of progressive disease.

Outcome measures

Measure	Radiotherapy, Temozolomide Plus Nivolumab n=358 Participants Nivolumab: specified dose on specified days; IV (intravenous) infusion Temozolomide: 75 mg (milligram)/meter squared daily during Radiotherapy, 4 week treatment break, 150 mg/meter squared Day 1-5 for Cycle 1 and increased to 200 mg/meter squared Day 1-5 for Cycle2-Cycle 6 as tolerated; orally (additional cycles may be permitted with approval of sponsor) Radiotherapy: 2 gray units (joule of radiation energy per kilogram) 5 times per week for 6 weeks	Radiotherapy, Temozolomide Plus Placebo n=358 Participants Radiotherapy: A total dose of 60 Gy \[Gray (radiotherapy dose)\], in 2 Gy daily fractions on 5 days/week, will be administered in 6 weeks (30 fractions). Placebo: administered intravenously (IV) as a 30 minute infusion every 2 weeks for 8 doses followed by a 30 minute infusion every 4 weeks beginning after 8 doses Temozolomide: 75 mg/m2 orally daily during radiation therapy followed by 4 week break then 6 (28-day) cycles temozolomide on Days 1-5 at 150 mg/m2 in Cycle 1 increasing to 200 mg/m2 as tolerated up to 6 cycles.
Progression Free Survival (PFS) Based on Investigator Assessment	14.09 Months Interval 12.62 to 16.56	15.18 Months Interval 13.11 to 17.12

POST_HOC outcome

Timeframe: From randomization to the date of the first documented tumor progression or death by any cause. (up to approximately 82 Months)

Population: All randomized participants

The time from randomization to the date of the first documented tumor progression or death by any cause. PFS will be determined by a Blinded Independent Central Review (BICR) assessed based on Radiologic Assessment in Neuro-Oncology (RANO) criteria. Specifically, RANO response criteria indicates that within the first 12 weeks of completion of radiotherapy, progression can only be assessed if the majority of the new enhancement is outside of the radiation field or if there is pathologic confirmation of progressive disease.

Outcome measures

Measure	Radiotherapy, Temozolomide Plus Nivolumab n=358 Participants Nivolumab: specified dose on specified days; IV (intravenous) infusion Temozolomide: 75 mg (milligram)/meter squared daily during Radiotherapy, 4 week treatment break, 150 mg/meter squared Day 1-5 for Cycle 1 and increased to 200 mg/meter squared Day 1-5 for Cycle2-Cycle 6 as tolerated; orally (additional cycles may be permitted with approval of sponsor) Radiotherapy: 2 gray units (joule of radiation energy per kilogram) 5 times per week for 6 weeks	Radiotherapy, Temozolomide Plus Placebo n=358 Participants Radiotherapy: A total dose of 60 Gy \[Gray (radiotherapy dose)\], in 2 Gy daily fractions on 5 days/week, will be administered in 6 weeks (30 fractions). Placebo: administered intravenously (IV) as a 30 minute infusion every 2 weeks for 8 doses followed by a 30 minute infusion every 4 weeks beginning after 8 doses Temozolomide: 75 mg/m2 orally daily during radiation therapy followed by 4 week break then 6 (28-day) cycles temozolomide on Days 1-5 at 150 mg/m2 in Cycle 1 increasing to 200 mg/m2 as tolerated up to 6 cycles.
Progression-free Survival (PFS) Determined by BICR - Extended Collection	9.89 Months Interval 8.31 to 11.6	10.25 Months Interval 9.46 to 12.09

POST_HOC outcome

Timeframe: From randomization to date of death (up to approximately 82 Months)

Population: All randomized participants with no baseline corticosteroids

The time from the date of randomization to the date of death. who have not died by the end of the study will be censored to last known date alive. OS is assessed in the randomized population with no corticosteroids at baseline population.

Outcome measures

Measure	Radiotherapy, Temozolomide Plus Nivolumab n=246 Participants Nivolumab: specified dose on specified days; IV (intravenous) infusion Temozolomide: 75 mg (milligram)/meter squared daily during Radiotherapy, 4 week treatment break, 150 mg/meter squared Day 1-5 for Cycle 1 and increased to 200 mg/meter squared Day 1-5 for Cycle2-Cycle 6 as tolerated; orally (additional cycles may be permitted with approval of sponsor) Radiotherapy: 2 gray units (joule of radiation energy per kilogram) 5 times per week for 6 weeks	Radiotherapy, Temozolomide Plus Placebo n=262 Participants Radiotherapy: A total dose of 60 Gy \[Gray (radiotherapy dose)\], in 2 Gy daily fractions on 5 days/week, will be administered in 6 weeks (30 fractions). Placebo: administered intravenously (IV) as a 30 minute infusion every 2 weeks for 8 doses followed by a 30 minute infusion every 4 weeks beginning after 8 doses Temozolomide: 75 mg/m2 orally daily during radiation therapy followed by 4 week break then 6 (28-day) cycles temozolomide on Days 1-5 at 150 mg/m2 in Cycle 1 increasing to 200 mg/m2 as tolerated up to 6 cycles.
Overall Survival (OS) - Extended Collection	28.94 Months Interval 24.57 to 31.64	31.84 Months Interval 28.94 to 33.77

Adverse Events

Radiotherapy, Temozolomide Plus Nivolumab

Serious events: 259 serious events

Other events: 351 other events

Deaths: 263 deaths

Radiotherapy, Temozolomide Plus Placebo

Serious events: 217 serious events

Other events: 343 other events

Deaths: 255 deaths

Serious adverse events

Measure	Radiotherapy, Temozolomide Plus Nivolumab n=355 participants at risk Nivolumab: specified dose on specified days; IV (intravenous) infusion Temozolomide: 75 mg (milligram)/meter squared daily during Radiotherapy, 4 week treatment break, 150 mg/meter squared Day 1-5 for Cycle 1 and increased to 200 mg/meter squared Day 1-5 for Cycle2-Cycle 6 as tolerated; orally (additional cycles may be permitted with approval of sponsor) Radiotherapy: 2 gray units (joule of radiation energy per kilogram) 5 times per week for 6 weeks	Radiotherapy, Temozolomide Plus Placebo n=354 participants at risk Radiotherapy: A total dose of 60 Gy \[Gray (radiotherapy dose)\], in 2 Gy daily fractions on 5 days/week, will be administered in 6 weeks (30 fractions). Placebo: administered intravenously (IV) as a 30 minute infusion every 2 weeks for 8 doses followed by a 30 minute infusion every 4 weeks beginning after 8 doses Temozolomide: 75 mg/m2 orally daily during radiation therapy followed by 4 week break then 6 (28-day) cycles temozolomide on Days 1-5 at 150 mg/m2 in Cycle 1 increasing to 200 mg/m2 as tolerated up to 6 cycles.
Blood and lymphatic system disorders Anaemia	0.85% 3/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Blood and lymphatic system disorders Autoimmune haemolytic anaemia	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Blood and lymphatic system disorders Febrile neutropenia	0.85% 3/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.56% 2/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Blood and lymphatic system disorders Haemolysis	0.00% 0/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Blood and lymphatic system disorders Leukopenia	0.00% 0/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Blood and lymphatic system disorders Lymphopenia	0.00% 0/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Blood and lymphatic system disorders Microcytic anaemia	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Blood and lymphatic system disorders Neutropenia	1.7% 6/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Blood and lymphatic system disorders Pancytopenia	2.3% 8/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.56% 2/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Blood and lymphatic system disorders Thrombocytopenia	2.0% 7/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.0% 7/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders Acute myocardial infarction	0.00% 0/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders Angina pectoris	0.00% 0/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders Atrial fibrillation	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders Atrial flutter	0.56% 2/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders Atrial tachycardia	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders Bundle branch block right	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders Cardiac arrest	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders Cardiac failure	0.56% 2/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders Cardiac failure congestive	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders Left ventricular failure	0.00% 0/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders Myocardial infarction	0.00% 0/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders Myocarditis	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders Pericarditis	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders Sinus tachycardia	0.00% 0/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders Stress cardiomyopathy	0.00% 0/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders Supraventricular tachycardia	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders Ventricular tachycardia	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Congenital, familial and genetic disorders Branchial cyst	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Ear and labyrinth disorders Vertigo	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Endocrine disorders Adrenal insufficiency	0.56% 2/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.56% 2/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Endocrine disorders Diabetes insipidus	0.00% 0/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Endocrine disorders Hypothyroidism	0.85% 3/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Eye disorders Cataract	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Eye disorders Diplopia	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Eye disorders Eye swelling	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Eye disorders Eyelid ptosis	0.00% 0/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Eye disorders Iridocyclitis	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Eye disorders Retinal detachment	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Eye disorders Vision blurred	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Abdominal pain	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Abdominal pain upper	0.00% 0/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Autoimmune colitis	0.56% 2/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Colitis	1.4% 5/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Constipation	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Diarrhoea	1.1% 4/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Diverticular perforation	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Dysphagia	0.56% 2/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Enterocolitis	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Gastritis	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Gastritis haemorrhagic	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Intestinal obstruction	0.00% 0/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Large intestinal obstruction	0.00% 0/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Nausea	1.1% 4/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Oesophagitis	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Vomiting	0.56% 2/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.85% 3/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Asthenia	0.85% 3/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.85% 3/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Cyst	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Death	1.1% 4/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.85% 3/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Drowning	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Fatigue	0.56% 2/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Gait disturbance	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Gait inability	0.00% 0/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders General physical health deterioration	2.3% 8/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.1% 4/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Hyperthermia	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Influenza like illness	0.56% 2/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Localised oedema	0.00% 0/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Malaise	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Non-cardiac chest pain	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Oedema peripheral	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Pyrexia	4.5% 16/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.1% 4/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Sudden death	0.56% 2/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.85% 3/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Systemic inflammatory response syndrome	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Hepatobiliary disorders Autoimmune hepatitis	0.85% 3/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Hepatobiliary disorders Cholecystitis	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Hepatobiliary disorders Cholelithiasis	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Hepatobiliary disorders Drug-induced liver injury	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Hepatobiliary disorders Haemorrhagic hepatic cyst	0.00% 0/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Hepatobiliary disorders Hepatic cytolysis	0.00% 0/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Hepatobiliary disorders Hepatic function abnormal	0.56% 2/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Hepatobiliary disorders Hepatitis	0.85% 3/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Hepatobiliary disorders Hepatitis acute	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Hepatobiliary disorders Hepatotoxicity	0.00% 0/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Hepatobiliary disorders Liver disorder	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Immune system disorders Drug hypersensitivity	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Immune system disorders Hypersensitivity	0.85% 3/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Immune system disorders Immunodeficiency	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Abscess limb	0.00% 0/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Appendicitis	0.00% 0/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.56% 2/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Bacterial infection	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations COVID-19	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Cellulitis	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Cystitis	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Device related infection	0.00% 0/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Diverticulitis	0.00% 0/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Encephalitis	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.56% 2/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Gastrointestinal infection	0.00% 0/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Herpes simplex	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Herpes zoster	1.4% 5/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Influenza	0.00% 0/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.56% 2/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Intervertebral discitis	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Meningitis	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Meningitis aseptic	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Meningitis viral	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Parotitis	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Pneumocystis jirovecii pneumonia	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Pneumonia	3.9% 14/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.4% 5/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Pneumonia aspiration	1.1% 4/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Pneumonia viral	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Post procedural infection	0.00% 0/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Postoperative wound infection	0.00% 0/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.56% 2/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Pulmonary sepsis	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Pyometra	0.00% 0/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Respiratory tract infection	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Rhinitis	0.00% 0/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Sepsis	1.1% 4/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Septic shock	0.56% 2/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Sinusitis	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Staphylococcal bacteraemia	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Upper respiratory tract infection	0.00% 0/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Urinary tract infection	2.0% 7/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.1% 4/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Urosepsis	0.00% 0/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Wound infection	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications Accidental overdose	0.00% 0/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications Compression fracture	0.00% 0/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.56% 2/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications Fall	0.85% 3/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.56% 2/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications Femoral neck fracture	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications Femur fracture	0.00% 0/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications Foot fracture	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications Foreign body	0.00% 0/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications Hip fracture	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications Incision site swelling	0.00% 0/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications Overdose	0.00% 0/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications Post procedural complication	0.00% 0/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications Postoperative wound complication	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications Radiation necrosis	0.00% 0/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications Radiation skin injury	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications Spinal compression fracture	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications Spinal fracture	0.56% 2/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.56% 2/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications Subdural haematoma	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.56% 2/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications Toxicity to various agents	0.00% 0/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications Traumatic intracranial haemorrhage	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications Wound complication	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications Wound dehiscence	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.56% 2/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Alanine aminotransferase increased	0.85% 3/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Aspartate aminotransferase increased	0.56% 2/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Blood bilirubin increased	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Influenza A virus test positive	0.00% 0/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Neutrophil count decreased	0.56% 2/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Platelet count decreased	1.7% 6/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.85% 3/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations White blood cell count decreased	1.1% 4/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Metabolism and nutrition disorders Adult failure to thrive	0.00% 0/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Metabolism and nutrition disorders Decreased appetite	0.56% 2/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Metabolism and nutrition disorders Dehydration	0.85% 3/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.1% 4/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Metabolism and nutrition disorders Diabetes mellitus	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Metabolism and nutrition disorders Failure to thrive	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Metabolism and nutrition disorders Hyperglycaemia	0.56% 2/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Metabolism and nutrition disorders Hyponatraemia	0.56% 2/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Musculoskeletal and connective tissue disorders Ankylosing spondylitis	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Musculoskeletal and connective tissue disorders Arthralgia	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Musculoskeletal and connective tissue disorders Autoimmune myositis	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Musculoskeletal and connective tissue disorders Eosinophilic fasciitis	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Musculoskeletal and connective tissue disorders Mobility decreased	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Musculoskeletal and connective tissue disorders Muscular weakness	0.85% 3/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.85% 3/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic leukaemia	0.00% 0/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioblastoma	2.0% 7/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	3.4% 12/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioblastoma multiforme	0.00% 0/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.00% 0/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma in situ	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	21.1% 75/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	20.6% 73/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to meninges	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm	0.00% 0/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.56% 2/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm progression	1.7% 6/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	3.1% 11/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm recurrence	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer	0.00% 0/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Peritumoural oedema	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Recurrent cancer	0.56% 2/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour flare	2.8% 10/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.0% 7/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pseudoprogression	0.00% 0/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Acute disseminated encephalomyelitis	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Altered state of consciousness	0.00% 0/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Aphasia	0.85% 3/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.4% 5/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Brain oedema	2.3% 8/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.0% 7/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Central nervous system lesion	0.00% 0/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Central nervous system necrosis	0.00% 0/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Cerebral cyst	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Cerebral haemorrhage	0.00% 0/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Cerebral infarction	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.85% 3/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Cerebral ischaemia	0.56% 2/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.85% 3/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Cerebral venous sinus thrombosis	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Cerebrospinal fluid leakage	0.85% 3/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Cerebrovascular accident	1.1% 4/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.56% 2/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Change in seizure presentation	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Cognitive disorder	0.56% 2/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.7% 6/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Coma	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Depressed level of consciousness	0.00% 0/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Dizziness	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.1% 4/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Drooling	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Dysarthria	0.56% 2/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Encephalopathy	1.1% 4/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.4% 5/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Epilepsy	4.2% 15/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	3.4% 12/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Generalised tonic-clonic seizure	0.56% 2/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Haemorrhage intracranial	0.85% 3/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.56% 2/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Headache	2.3% 8/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.7% 6/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Hemiparesis	2.0% 7/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.5% 9/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Hemiplegia	0.85% 3/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Hydrocephalus	2.8% 10/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.5% 9/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Intracranial pressure increased	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.85% 3/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Ischaemic stroke	0.56% 2/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Lacunar infarction	0.00% 0/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Lethargy	0.00% 0/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Muscle contractions involuntary	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Nervous system disorder	0.00% 0/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.56% 2/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Neurological decompensation	0.00% 0/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.56% 2/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Neurological symptom	0.00% 0/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Neuropathy peripheral	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Optic neuritis	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Partial seizures	0.56% 2/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Psychomotor skills impaired	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Radiculopathy	0.56% 2/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Seizure	13.5% 48/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	11.3% 40/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Simple partial seizures	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Somnolence	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Status epilepticus	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Subdural hygroma	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Syncope	0.56% 2/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Vasogenic cerebral oedema	0.00% 0/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.56% 2/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Product Issues Device malfunction	0.00% 0/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Psychiatric disorders Agitation	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Psychiatric disorders Confusional state	0.56% 2/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.56% 2/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Psychiatric disorders Delirium	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Psychiatric disorders Depression	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Psychiatric disorders Mental status changes	1.4% 5/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Psychiatric disorders Mood altered	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Psychiatric disorders Paranoia	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Psychiatric disorders Suicidal ideation	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Renal and urinary disorders Acute kidney injury	1.1% 4/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.56% 2/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Renal and urinary disorders Bladder stenosis	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Renal and urinary disorders Haematuria	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Renal and urinary disorders Nephritis	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Renal and urinary disorders Nephrolithiasis	0.00% 0/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Renal and urinary disorders Nephropathy	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Renal and urinary disorders Renal failure	0.56% 2/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Renal and urinary disorders Tubulointerstitial nephritis	0.56% 2/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Renal and urinary disorders Urinary retention	0.00% 0/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Reproductive system and breast disorders Cystocele	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.85% 3/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.85% 3/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Laryngeal obstruction	0.00% 0/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Lung disorder	0.56% 2/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.85% 3/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	2.5% 9/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	3.7% 13/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Respiratory disorder	0.00% 0/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Skin and subcutaneous tissue disorders Drug eruption	0.56% 2/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Skin and subcutaneous tissue disorders Drug reaction with eosinophilia and systemic symptoms	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Skin and subcutaneous tissue disorders Rash	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.56% 2/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Skin and subcutaneous tissue disorders Rash maculo-papular	0.56% 2/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.56% 2/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Skin and subcutaneous tissue disorders Scar pain	0.00% 0/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Skin and subcutaneous tissue disorders Skin reaction	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Skin and subcutaneous tissue disorders Stevens-Johnson syndrome	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Surgical and medical procedures Assisted suicide	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Surgical and medical procedures Cholecystectomy	0.00% 0/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Surgical and medical procedures Euthanasia	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Vascular disorders Axillary vein thrombosis	0.00% 0/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Vascular disorders Deep vein thrombosis	0.56% 2/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.56% 2/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Vascular disorders Embolism	1.4% 5/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.4% 5/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Vascular disorders Hypotension	0.56% 2/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.28% 1/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Vascular disorders Orthostatic hypotension	0.28% 1/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Vascular disorders Thrombosis	0.56% 2/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication

Other adverse events

Measure	Radiotherapy, Temozolomide Plus Nivolumab n=355 participants at risk Nivolumab: specified dose on specified days; IV (intravenous) infusion Temozolomide: 75 mg (milligram)/meter squared daily during Radiotherapy, 4 week treatment break, 150 mg/meter squared Day 1-5 for Cycle 1 and increased to 200 mg/meter squared Day 1-5 for Cycle2-Cycle 6 as tolerated; orally (additional cycles may be permitted with approval of sponsor) Radiotherapy: 2 gray units (joule of radiation energy per kilogram) 5 times per week for 6 weeks	Radiotherapy, Temozolomide Plus Placebo n=354 participants at risk Radiotherapy: A total dose of 60 Gy \[Gray (radiotherapy dose)\], in 2 Gy daily fractions on 5 days/week, will be administered in 6 weeks (30 fractions). Placebo: administered intravenously (IV) as a 30 minute infusion every 2 weeks for 8 doses followed by a 30 minute infusion every 4 weeks beginning after 8 doses Temozolomide: 75 mg/m2 orally daily during radiation therapy followed by 4 week break then 6 (28-day) cycles temozolomide on Days 1-5 at 150 mg/m2 in Cycle 1 increasing to 200 mg/m2 as tolerated up to 6 cycles.
General disorders Pain	5.1% 18/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.5% 9/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Pyrexia	19.7% 70/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	8.8% 31/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Blood and lymphatic system disorders Anaemia	11.8% 42/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	7.3% 26/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Blood and lymphatic system disorders Leukopenia	5.6% 20/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	8.5% 30/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Blood and lymphatic system disorders Lymphopenia	12.1% 43/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	11.0% 39/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Blood and lymphatic system disorders Neutropenia	9.3% 33/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	9.0% 32/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Blood and lymphatic system disorders Thrombocytopenia	19.4% 69/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	18.9% 67/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Endocrine disorders Hypothyroidism	7.9% 28/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.5% 9/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Eye disorders Dry eye	5.1% 18/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	4.2% 15/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Eye disorders Vision blurred	8.5% 30/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.5% 23/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Abdominal pain	9.0% 32/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	7.6% 27/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Constipation	45.9% 163/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	41.0% 145/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Diarrhoea	21.7% 77/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	20.3% 72/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Nausea	52.7% 187/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	44.9% 159/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Stomatitis	7.0% 25/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.5% 9/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Vomiting	25.4% 90/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	21.2% 75/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Asthenia	11.8% 42/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	11.3% 40/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Chills	7.0% 25/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	3.7% 13/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Fatigue	52.4% 186/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	49.7% 176/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Gait disturbance	8.2% 29/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	9.6% 34/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Malaise	4.8% 17/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.1% 18/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Oedema peripheral	8.5% 30/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	7.9% 28/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Conjunctivitis	5.6% 20/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	3.4% 12/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Nasopharyngitis	10.4% 37/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	8.8% 31/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Oral candidiasis	5.6% 20/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	3.4% 12/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Upper respiratory tract infection	5.9% 21/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.4% 19/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Urinary tract infection	12.7% 45/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	9.6% 34/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications Fall	10.4% 37/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	13.0% 46/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications Radiation skin injury	9.9% 35/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	10.7% 38/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Alanine aminotransferase increased	17.7% 63/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	11.0% 39/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Aspartate aminotransferase increased	13.0% 46/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	4.5% 16/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Blood creatinine increased	6.5% 23/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	4.0% 14/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Lymphocyte count decreased	18.9% 67/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	17.5% 62/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Neutrophil count decreased	9.6% 34/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	11.3% 40/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Platelet count decreased	21.1% 75/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	21.2% 75/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Weight decreased	14.1% 50/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	9.3% 33/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Weight increased	3.7% 13/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.9% 21/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations White blood cell count decreased	11.3% 40/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	12.4% 44/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Metabolism and nutrition disorders Decreased appetite	27.3% 97/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	24.6% 87/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Metabolism and nutrition disorders Hyperglycaemia	7.0% 25/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	9.6% 34/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Metabolism and nutrition disorders Hypokalaemia	9.6% 34/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	4.2% 15/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Musculoskeletal and connective tissue disorders Arthralgia	17.2% 61/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	15.0% 53/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Musculoskeletal and connective tissue disorders Back pain	11.5% 41/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	9.6% 34/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Musculoskeletal and connective tissue disorders Muscular weakness	9.9% 35/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	7.9% 28/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Musculoskeletal and connective tissue disorders Myalgia	8.5% 30/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	4.2% 15/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Musculoskeletal and connective tissue disorders Pain in extremity	7.9% 28/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	4.5% 16/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Aphasia	8.5% 30/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	9.0% 32/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Cognitive disorder	5.4% 19/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.4% 19/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Dizziness	13.2% 47/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	15.0% 53/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Dysgeusia	10.1% 36/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	7.6% 27/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Headache	40.0% 142/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	38.1% 135/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Hemiparesis	6.5% 23/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	7.1% 25/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Memory impairment	7.3% 26/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	10.2% 36/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Paraesthesia	7.3% 26/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.5% 23/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Seizure	17.7% 63/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	21.5% 76/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Tremor	6.2% 22/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	7.3% 26/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Psychiatric disorders Anxiety	9.0% 32/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	9.6% 34/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Psychiatric disorders Confusional state	5.6% 20/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.9% 21/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Psychiatric disorders Depression	8.5% 30/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	9.6% 34/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Psychiatric disorders Insomnia	15.2% 54/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	13.3% 47/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Renal and urinary disorders Pollakiuria	5.1% 18/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	3.7% 13/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Cough	16.6% 59/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.4% 51/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Dyspnoea	7.6% 27/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.6% 20/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Skin and subcutaneous tissue disorders Alopecia	32.4% 115/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	30.8% 109/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Skin and subcutaneous tissue disorders Dry skin	6.8% 24/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	7.6% 27/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Skin and subcutaneous tissue disorders Erythema	8.2% 29/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.2% 22/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Skin and subcutaneous tissue disorders Pruritus	24.2% 86/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	21.8% 77/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Skin and subcutaneous tissue disorders Rash	23.9% 85/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	16.4% 58/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Skin and subcutaneous tissue disorders Rash maculo-papular	9.0% 32/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	3.7% 13/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Vascular disorders Hypertension	8.2% 29/355 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	9.0% 32/354 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 48 Months All-Cause mortality (From randomization to end of study): Approximately up to 52 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

Phone: Please email

Email: Clinical.Trials@bms.com

Results disclosure agreements

• Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
• Publication restrictions are in place

Restriction type: OTHER