Trial Outcomes & Findings for A Study of NKTR-214 Combined With Nivolumab vs Nivolumab Alone in Participants With Previously Untreated Inoperable or Metastatic Melanoma (NCT NCT03635983)

NCT ID: NCT03635983

Last Updated: 2025-04-01

Results Overview

ORR is defined as the percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR) using RECIST v 1.1 per blinded independent central review (BICR) assessment. CR=Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \< 10 mm. PR=At least a 30% decrease in the sum of diameters of target lesions.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 783 participants
• Primary outcome timeframe: From date of randomization to disease progression (Up to 37 months)
• Results posted on: 2025-04-01

Participant Flow

Participant milestones

Measure	Bempegaldesleukin + Nivolumab Bempegaldesleukin 0.006 mg/kg IV every 3 weeks + Nivolumab 360 mg IV every 3 weeks	Nivolumab Nivolumab 360 mg IV every 3 weeks
Pre-Treatment Period STARTED	391	392
Pre-Treatment Period COMPLETED	388	382
Pre-Treatment Period NOT COMPLETED	3	10
Treatment Period STARTED	388	382
Treatment Period COMPLETED	82	96
Treatment Period NOT COMPLETED	306	286

Reasons for withdrawal

Measure	Bempegaldesleukin + Nivolumab Bempegaldesleukin 0.006 mg/kg IV every 3 weeks + Nivolumab 360 mg IV every 3 weeks	Nivolumab Nivolumab 360 mg IV every 3 weeks
Pre-Treatment Period Withdrawal by Subject	0	7
Pre-Treatment Period Participant no longer meets study criteria	1	0
Pre-Treatment Period Other reasons	0	1
Pre-Treatment Period Disease Progression	0	1
Pre-Treatment Period Adverse Event unrelated to Study drug	2	1
Treatment Period Participant request to discontinue Study treatment	6	7
Treatment Period Withdrawal by Subject	3	5
Treatment Period Death	3	5
Treatment Period Poor/Non-compliance	2	1
Treatment Period Participant no longer meets Study criteria	1	4
Treatment Period Other reasons	7	4
Treatment Period Disease progression	230	201
Treatment Period Study drug toxicity	35	36
Treatment Period Adverse event unrelated to Study drug	15	15
Treatment Period Maximum clinical benefit	3	5
Treatment Period Administrative reason by the sponsor	1	2
Treatment Period Lost to Follow-up	0	1

Baseline Characteristics

A Study of NKTR-214 Combined With Nivolumab vs Nivolumab Alone in Participants With Previously Untreated Inoperable or Metastatic Melanoma

Baseline characteristics by cohort

Measure	Bempegaldesleukin + Nivolumab n=391 Participants Bempegaldesleukin 0.006 mg/kg IV every 3 weeks + Nivolumab 360 mg IV every 3 weeks	Nivolumab n=392 Participants Nivolumab 360 mg IV every 3 weeks	Total n=783 Participants Total of all reporting groups
Age, Continuous	61.3 Years STANDARD_DEVIATION 13.2 • n=5 Participants	60.4 Years STANDARD_DEVIATION 13.5 • n=7 Participants	60.8 Years STANDARD_DEVIATION 13.3 • n=5 Participants
Sex: Female, Male Female	162 Participants n=5 Participants	163 Participants n=7 Participants	325 Participants n=5 Participants
Sex: Female, Male Male	229 Participants n=5 Participants	229 Participants n=7 Participants	458 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	81 Participants n=5 Participants	73 Participants n=7 Participants	154 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	165 Participants n=5 Participants	153 Participants n=7 Participants	318 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	145 Participants n=5 Participants	166 Participants n=7 Participants	311 Participants n=5 Participants
Race/Ethnicity, Customized White	379 Participants n=5 Participants	379 Participants n=7 Participants	758 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Race/Ethnicity, Customized Other	4 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants

PRIMARY outcome

Timeframe: From date of randomization to disease progression (Up to 37 months)

Population: All randomized participants with at least 6 months of follow-up at the time point of the final ORR analysis. A follow-up time is defined as the time between randomization date and clinical data cut-off date.

ORR is defined as the percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR) using RECIST v 1.1 per blinded independent central review (BICR) assessment. CR=Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm. PR=At least a 30% decrease in the sum of diameters of target lesions.

Outcome measures

Measure	Bempegaldesleukin + Nivolumab n=271 Participants Bempegaldesleukin 0.006 mg/kg IV every 3 weeks + Nivolumab 360 mg IV every 3 weeks	Nivolumab n=272 Participants Nivolumab 360 mg IV every 3 weeks
Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR)	27.7 Percentage of participants Interval 22.4 to 33.4	36.0 Percentage of participants Interval 30.3 to 42.0

PRIMARY outcome

Timeframe: From date of randomization to disease progression, or death, whichever comes first (Up to 37 months)

Population: All randomized participants

PFS is defined as the time between the date of randomization and the first date of documented tumor progression using RECIST v 1.1 per blinded independent central review (BICR), or death due to any cause, whichever comes first. Progressive disease (PD)=At least a 20% increase in the sum of diameters of target lesions. The sum must also demonstrate an absolute increase of at least 5 mm.

Outcome measures

Measure	Bempegaldesleukin + Nivolumab n=391 Participants Bempegaldesleukin 0.006 mg/kg IV every 3 weeks + Nivolumab 360 mg IV every 3 weeks	Nivolumab n=392 Participants Nivolumab 360 mg IV every 3 weeks
Progression-free Survival (PFS) Per Blinded Independent Central Review (BICR)	4.17 Months Interval 3.52 to 5.55	4.99 Months Interval 4.14 to 7.82

PRIMARY outcome

Timeframe: From date of randomization to date of death (Up to 37 months)

Population: All randomized participants

OS is defined as the time between the date of randomization and the date of death due to any cause. Participants who do not have a date of death will be censored on the last date for which a participant was known to be alive.

Outcome measures

Measure	Bempegaldesleukin + Nivolumab n=391 Participants Bempegaldesleukin 0.006 mg/kg IV every 3 weeks + Nivolumab 360 mg IV every 3 weeks	Nivolumab n=392 Participants Nivolumab 360 mg IV every 3 weeks
Overall Survival (OS)	29.67 Months Interval 22.14 to insufficient number of participants with events	28.88 Months Interval 21.32 to insufficient number of participants with events

SECONDARY outcome

Timeframe: From date of randomization to disease progression (Up to 37 months)

Population: All randomized participants with at least 6 months of follow-up at the time point of the final ORR analysis. A follow-up time is defined as the time between randomization date and clinical data cut-off date.

CBR, or equivalently the disease control rate (DCR) is defined as the percentage of participants with a best overall response of complete response (CR), partial response (PR), or stable disease (SD) as assessed by blinded independent central review (BICR) using RECIST v 1.1. CR=Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm. PR=At least a 30% decrease in the sum of diameters of target lesions.SD=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease.

Outcome measures

Measure	Bempegaldesleukin + Nivolumab n=271 Participants Bempegaldesleukin 0.006 mg/kg IV every 3 weeks + Nivolumab 360 mg IV every 3 weeks	Nivolumab n=272 Participants Nivolumab 360 mg IV every 3 weeks
Clinical Benefit Rate (CBR) Per Blinded Independent Central Review (BICR)	56.1 Percentage of participants Interval 50.0 to 62.1	58.5 Percentage of participants Interval 52.4 to 64.4

SECONDARY outcome

Timeframe: From date of randomization to disease progression, or death, whichever is earlier (Up to 37 months)

Population: All randomized participants with partial or complete response and at least 6 months of follow-up at the time point of the final objective response rate analysis. A follow-up time is defined as the time between randomization date and clinical data cut-off date.

DOR is defined for participants who have a confirmed complete response (CR) or partial results (PR) as the date from first documented CR or PR using RECIST v 1.1 to the date of the documentation of disease progression per blinded independent central review (BICR) assessment or death due to any cause, whichever is earlier. CR=Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm. PR=At least a 30% decrease in the sum of diameters of target lesions.

Outcome measures

Measure	Bempegaldesleukin + Nivolumab n=75 Participants Bempegaldesleukin 0.006 mg/kg IV every 3 weeks + Nivolumab 360 mg IV every 3 weeks	Nivolumab n=98 Participants Nivolumab 360 mg IV every 3 weeks
Duration of Response (DoR) Per Blinded Independent Central Review (BICR)	29.67 Months Interval 18.89 to insufficient number of participants with events	NA Months Interval 26.74 to insufficient number of participants with events

SECONDARY outcome

Timeframe: From date of randomization to disease progression (Up to 37 months)

Population: All randomized participants with partial or complete response and at least 6 months of follow-up at the time point of the final objective response rate analysis. A follow-up time is defined as the time between randomization date and clinical data cut-off date.

Time to response (TTR) is defined for participants who had a confirmed complete response (CR) or partial response (PR) as the time from the date of randomization to date of first documented CR or PR per blinded independent central review (BICR) assessment using RECIST v 1.1. CR=Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm. PR=At least a 30% decrease in the sum of diameters of target lesions.

Outcome measures

Measure	Bempegaldesleukin + Nivolumab n=75 Participants Bempegaldesleukin 0.006 mg/kg IV every 3 weeks + Nivolumab 360 mg IV every 3 weeks	Nivolumab n=98 Participants Nivolumab 360 mg IV every 3 weeks
Time to Objective Response (TTR) Per Blinded Independent Central Review (BICR)	2.17 Months Interval 1.0 to 15.3	2.20 Months Interval 1.2 to 15.5

SECONDARY outcome

Timeframe: From date of randomization to disease progression (Up to 37 months)

Population: All randomized participants with at least 6 months of follow-up at the time point of the final ORR analysis. A follow-up time is defined as the time between randomization date and clinical data cut-off date.

ORR is defined as the percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR) using RECIST v 1.1 per investigator assessment. CR=Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm. PR=At least a 30% decrease in the sum of diameters of target lesions.

Outcome measures

Measure	Bempegaldesleukin + Nivolumab n=271 Participants Bempegaldesleukin 0.006 mg/kg IV every 3 weeks + Nivolumab 360 mg IV every 3 weeks	Nivolumab n=272 Participants Nivolumab 360 mg IV every 3 weeks
Objective Response Rate (ORR) Per Investigator	29.2 Percentage of participants Interval 23.8 to 35.0	36.4 Percentage of participants Interval 30.7 to 42.4

SECONDARY outcome

Timeframe: From date of randomization to disease progression, or death, whichever comes first (Up to 37 months)

Population: All randomized participants

PFS is defined as the time between the date of randomization and the first date of documented tumor progression using RECIST v 1.1 per investigator, or death due to any cause, whichever comes first. Progressive disease (PD)=At least a 20% increase in the sum of diameters of target lesions. The sum must also demonstrate an absolute increase of at least 5 mm.

Outcome measures

Measure	Bempegaldesleukin + Nivolumab n=391 Participants Bempegaldesleukin 0.006 mg/kg IV every 3 weeks + Nivolumab 360 mg IV every 3 weeks	Nivolumab n=392 Participants Nivolumab 360 mg IV every 3 weeks
Progression-free Survival (PFS) Per Investigator	4.27 Months Interval 4.04 to 6.14	6.21 Months Interval 4.6 to 10.25

SECONDARY outcome

Timeframe: From date of randomization to disease progression (Up to 37 months)

Population: All randomized participants with at least 6 months of follow-up at the time point of the final ORR analysis. A follow-up time is defined as the time between randomization date and clinical data cut-off date.

CBR, or equivalently the disease control rate (DCR) is defined as the percentage of participants with a best overall response of complete response (CR), partial response (PR), or stable disease (SD) as assessed by investigator using RECIST v 1.1. CR=Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm. PR=At least a 30% decrease in the sum of diameters of target lesions. SD=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.

Outcome measures

Measure	Bempegaldesleukin + Nivolumab n=271 Participants Bempegaldesleukin 0.006 mg/kg IV every 3 weeks + Nivolumab 360 mg IV every 3 weeks	Nivolumab n=272 Participants Nivolumab 360 mg IV every 3 weeks
Clinical Benefit Rate (CBR) Per Investigator	60.5 Percentage of participants Interval 54.4 to 66.4	61.8 Percentage of participants Interval 55.7 to 67.6

SECONDARY outcome

Timeframe: From date of randomization to disease progression, or death, whichever is earlier (Up to 37 months)

Population: All randomized participants with partial or complete response and at least 6 months of follow-up at the time point of the final objective response rate analysis. A follow-up time is defined as the time between randomization date and clinical data cut-off date.

DOR is defined for participants who have a confirmed complete response (CR) or partial results (PR) as the date from first documented CR or PR using RECIST v 1.1 to the date of the documentation of disease progression per investigator assessment or death due to any cause, whichever is earlier. CR=Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm. PR=At least a 30% decrease in the sum of diameters of target lesions.

Outcome measures

Measure	Bempegaldesleukin + Nivolumab n=79 Participants Bempegaldesleukin 0.006 mg/kg IV every 3 weeks + Nivolumab 360 mg IV every 3 weeks	Nivolumab n=99 Participants Nivolumab 360 mg IV every 3 weeks
Duration of Response (DoR) Per Investigator	NA Months Interval 17.31 to insufficient number of participants with events	NA Months Interval 21.68 to insufficient number of participants with events

SECONDARY outcome

Timeframe: From date of randomization to disease progression (Up to 37 months)

Population: All randomized participants with partial or complete response and at least 6 months of follow-up at the time point of the final objective response rate analysis. A follow-up time is defined as the time between randomization date and clinical data cut-off date

Time to response (TTR) is defined for participants who had a confirmed complete response (CR) or partial response (PR) as the time from the date of randomization to date of first documented CR or PR per investigator assessment using RECIST v 1.1. CR=Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm. PR=At least a 30% decrease in the sum of diameters of target lesions.

Outcome measures

Measure	Bempegaldesleukin + Nivolumab n=79 Participants Bempegaldesleukin 0.006 mg/kg IV every 3 weeks + Nivolumab 360 mg IV every 3 weeks	Nivolumab n=99 Participants Nivolumab 360 mg IV every 3 weeks
Time to Objective Response (TTR) Per Investigator	2.14 Months Interval 1.6 to 18.3	2.14 Months Interval 1.8 to 12.2

SECONDARY outcome

Timeframe: From date of randomization to disease progression (Up to 37 months)

Population: All randomized participants with PD-L1 data available at baseline and at least 6 months of follow-up at the time point of the final objective response rate analysis. A follow-up time is defined as the time between randomization date and clinical data cut-off date

ORR by baseline PD-L1 tumor cells expression (PD-L1 negative: <1%) vs. (PD-L1 positive: >=1%). ORR is defined as the percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR) using RECIST v 1.1 per blinded independent central review (BICR) assessment. CR=Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm. PR=At least a 30% decrease in the sum of diameters of target lesions.

Outcome measures

Measure	Bempegaldesleukin + Nivolumab n=242 Participants Bempegaldesleukin 0.006 mg/kg IV every 3 weeks + Nivolumab 360 mg IV every 3 weeks	Nivolumab n=248 Participants Nivolumab 360 mg IV every 3 weeks
Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR) by Baseline PD-L1 Status Participants with baseline PD-L1 expression <1%	17.6 Percentage of participants Interval 10.8 to 26.4	25.2 Percentage of participants Interval 17.3 to 34.6
Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR) by Baseline PD-L1 Status Participants with baseline PD-L1 expression >=1%	36.4 Percentage of participants Interval 28.5 to 45.0	47.5 Percentage of participants Interval 39.1 to 56.1

SECONDARY outcome

Timeframe: From date of randomization to disease progression, or death, whichever comes first (Up to 37 months)

Population: All randomized participants with PD-L1 data available at baseline

PFS by baseline PD-L1 tumor cells expression (PD-L1 negative: <1%) vs. (PD-L1 positive: >=1%). PFS is defined as the time between the date of randomization and the first date of documented tumor progression using RECIST v 1.1 per blinded independent central review (BICR), or death due to any cause, whichever comes first. Progressive disease (PD)=At least a 20% increase in the sum of diameters of target lesions. The sum must also demonstrate an absolute increase of at least 5 mm.

Outcome measures

Measure	Bempegaldesleukin + Nivolumab n=349 Participants Bempegaldesleukin 0.006 mg/kg IV every 3 weeks + Nivolumab 360 mg IV every 3 weeks	Nivolumab n=357 Participants Nivolumab 360 mg IV every 3 weeks
Progression-free Survival (PFS) Per Blinded Independent Central Review (BICR) by Baseline PD-L1 Status Participants with baseline PD-L1 expression <1%	3.25 Months Interval 2.2 to 4.24	2.30 Months Interval 2.17 to 4.17
Progression-free Survival (PFS) Per Blinded Independent Central Review (BICR) by Baseline PD-L1 Status Participants with baseline PD-L1 expression >=1%	6.24 Months Interval 4.47 to 10.45	10.51 Months Interval 6.05 to 28.88

SECONDARY outcome

Timeframe: From date of randomization to date of death (Up to 37 months)

Population: All randomized participants with PD-L1 data available at baseline

OS by baseline PD-L1 tumor cells expression (PD-L1 negative: <1%) vs. (PD-L1 positive: >=1%). OS is defined as the time between the date of randomization and the date of death due to any cause. Participants who do not have a date of death will be censored on the last date for which a participant was known to be alive.

Outcome measures

Measure	Bempegaldesleukin + Nivolumab n=349 Participants Bempegaldesleukin 0.006 mg/kg IV every 3 weeks + Nivolumab 360 mg IV every 3 weeks	Nivolumab n=357 Participants Nivolumab 360 mg IV every 3 weeks
Overall Survival (OS) by Baseline PD-L1 Status Participants with baseline PD-L1 expression <1%	21.16 Months Interval 15.51 to 26.68	21.13 Months Interval 16.62 to insufficient number of participants with events
Overall Survival (OS) by Baseline PD-L1 Status Participants with baseline PD-L1 expression >=1%	NA Months Interval 29.67 to insufficient number of participants with events	NA Months Interval 28.88 to insufficient number of participants with events

SECONDARY outcome

Timeframe: From first dose to 30 days post last dose (Average of 11 months and a maximum up to 26 months)

Population: All treated participants

Number of participants with any grade adverse events (AEs) including treatment-related AEs, AEs leading to discontinuation of any drug, serious adverse events (SAEs), treatment-related SAEs, and deaths from first dose to 30 days post last dose. An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.

Outcome measures

Measure	Bempegaldesleukin + Nivolumab n=387 Participants Bempegaldesleukin 0.006 mg/kg IV every 3 weeks + Nivolumab 360 mg IV every 3 weeks	Nivolumab n=382 Participants Nivolumab 360 mg IV every 3 weeks
Number of Participants With Adverse Events (AEs) AEs	378 Participants	364 Participants
Number of Participants With Adverse Events (AEs) Drug-related AEs	351 Participants	281 Participants
Number of Participants With Adverse Events (AEs) SAEs	132 Participants	130 Participants
Number of Participants With Adverse Events (AEs) Drug-related SAEs	57 Participants	32 Participants
Number of Participants With Adverse Events (AEs) AEs leading to discontinuation of any Drug	65 Participants	56 Participants
Number of Participants With Adverse Events (AEs) Deaths	21 Participants	21 Participants

SECONDARY outcome

Timeframe: From first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months)

Population: All treated participants with laboratory baseline measures

Number of participants with on-treatment laboratory parameters that worsened relative to baseline. Parameters include hematology, chemistry, liver function, and renal function using worst grade (grade 1-4 and grade 3-4) per national cancer institute (NCI) common terminology criteria for adverse events (CTCAE) v5 criteria.

Grade 1=Mild event Grade 2=Moderate event Grade 3=Severe event Grade 4=Life threatening event

Outcome measures

Measure	Bempegaldesleukin + Nivolumab n=383 Participants Bempegaldesleukin 0.006 mg/kg IV every 3 weeks + Nivolumab 360 mg IV every 3 weeks	Nivolumab n=380 Participants Nivolumab 360 mg IV every 3 weeks
Number of Participants With On-Treatment Laboratory Parameters That Worsened Relative to Baseline Hemoglobin decreased grade 1-4	194 Participants	173 Participants
Number of Participants With On-Treatment Laboratory Parameters That Worsened Relative to Baseline Hemoglobin decreased grade 3-4	17 Participants	22 Participants
Number of Participants With On-Treatment Laboratory Parameters That Worsened Relative to Baseline Platelet count decreased grade 1-4	36 Participants	41 Participants
Number of Participants With On-Treatment Laboratory Parameters That Worsened Relative to Baseline Platelet count decreased grade 3-4	2 Participants	6 Participants
Number of Participants With On-Treatment Laboratory Parameters That Worsened Relative to Baseline Leukocytes decreased grade 1-4	29 Participants	46 Participants
Number of Participants With On-Treatment Laboratory Parameters That Worsened Relative to Baseline Leukocytes decreased grade 3-4	2 Participants	2 Participants
Number of Participants With On-Treatment Laboratory Parameters That Worsened Relative to Baseline Lymphocytes (absolute) decreased grade 1-4	304 Participants	194 Participants
Number of Participants With On-Treatment Laboratory Parameters That Worsened Relative to Baseline Lymphocytes (absolute) decreased grade 3-4	199 Participants	30 Participants
Number of Participants With On-Treatment Laboratory Parameters That Worsened Relative to Baseline Absolute Neutrophil count decreased grade 1-4	71 Participants	31 Participants
Number of Participants With On-Treatment Laboratory Parameters That Worsened Relative to Baseline Absolute Neutrophil, count decreased grade 3-4	8 Participants	2 Participants
Number of Participants With On-Treatment Laboratory Parameters That Worsened Relative to Baseline Neutrophils (absolute) decreased grade 1-4	57 Participants	29 Participants
Number of Participants With On-Treatment Laboratory Parameters That Worsened Relative to Baseline Aspartate Aminotransferase increased grade 1-4	96 Participants	115 Participants
Number of Participants With On-Treatment Laboratory Parameters That Worsened Relative to Baseline Aspartate Aminotransferase increased grade 3-4	9 Participants	17 Participants
Number of Participants With On-Treatment Laboratory Parameters That Worsened Relative to Baseline Alanine Aminotransferase increased grade 1-4	104 Participants	132 Participants
Number of Participants With On-Treatment Laboratory Parameters That Worsened Relative to Baseline Alanine Aminotransferase increased grade 3-4	11 Participants	13 Participants
Number of Participants With On-Treatment Laboratory Parameters That Worsened Relative to Baseline Bilirubin, total increased grade 1-4	36 Participants	46 Participants
Number of Participants With On-Treatment Laboratory Parameters That Worsened Relative to Baseline Amylase increased grade 3-4	3 Participants	6 Participants
Number of Participants With On-Treatment Laboratory Parameters That Worsened Relative to Baseline Lipase, total increased grade 1-4	90 Participants	126 Participants
Number of Participants With On-Treatment Laboratory Parameters That Worsened Relative to Baseline Lipase, total increased grade 3-4	17 Participants	17 Participants
Number of Participants With On-Treatment Laboratory Parameters That Worsened Relative to Baseline Hypernatremia grade 1-4	29 Participants	47 Participants
Number of Participants With On-Treatment Laboratory Parameters That Worsened Relative to Baseline Hypernatremia grade 3-4	2 Participants	0 Participants
Number of Participants With On-Treatment Laboratory Parameters That Worsened Relative to Baseline Hyponatremia grade 1-4	112 Participants	123 Participants
Number of Participants With On-Treatment Laboratory Parameters That Worsened Relative to Baseline Hyponatremia grade 3-4	6 Participants	11 Participants
Number of Participants With On-Treatment Laboratory Parameters That Worsened Relative to Baseline Hyperkalemia grade 1-4	91 Participants	85 Participants
Number of Participants With On-Treatment Laboratory Parameters That Worsened Relative to Baseline Hyperkalemia grade 3-4	9 Participants	6 Participants
Number of Participants With On-Treatment Laboratory Parameters That Worsened Relative to Baseline Hypokalemia grade 1-4	32 Participants	51 Participants
Number of Participants With On-Treatment Laboratory Parameters That Worsened Relative to Baseline Hypokalemia grade 3-4	5 Participants	2 Participants
Number of Participants With On-Treatment Laboratory Parameters That Worsened Relative to Baseline Hypercalcemia grade 1-4	45 Participants	45 Participants
Number of Participants With On-Treatment Laboratory Parameters That Worsened Relative to Baseline Hypercalcemia grade 3-4	1 Participants	0 Participants
Number of Participants With On-Treatment Laboratory Parameters That Worsened Relative to Baseline Hypocalcemia grade 1-4	78 Participants	82 Participants
Number of Participants With On-Treatment Laboratory Parameters That Worsened Relative to Baseline Hypocalcemia grade 3-4	5 Participants	0 Participants
Number of Participants With On-Treatment Laboratory Parameters That Worsened Relative to Baseline Hypoglycemia grade 1-4	42 Participants	39 Participants
Number of Participants With On-Treatment Laboratory Parameters That Worsened Relative to Baseline Hypoglycemia grade 3-4	3 Participants	0 Participants
Number of Participants With On-Treatment Laboratory Parameters That Worsened Relative to Baseline Neutrophils (absolute) decreased grade 3-4	10 Participants	2 Participants
Number of Participants With On-Treatment Laboratory Parameters That Worsened Relative to Baseline Alkaline Phosphatase increased grade 1-4	96 Participants	90 Participants
Number of Participants With On-Treatment Laboratory Parameters That Worsened Relative to Baseline Alkaline Phosphatase increased grade 3-4	2 Participants	6 Participants
Number of Participants With On-Treatment Laboratory Parameters That Worsened Relative to Baseline Bilirubin, total increased grade 3-4	2 Participants	4 Participants
Number of Participants With On-Treatment Laboratory Parameters That Worsened Relative to Baseline Creatinine increased grade 1-4	81 Participants	94 Participants
Number of Participants With On-Treatment Laboratory Parameters That Worsened Relative to Baseline Creatinine increased grade 3-4	2 Participants	6 Participants
Number of Participants With On-Treatment Laboratory Parameters That Worsened Relative to Baseline Amylase increased grade 1-4	51 Participants	78 Participants

Adverse Events

Bempegaldesleukin + Nivolumab

Serious events: 161 serious events

Other events: 357 other events

Deaths: 170 deaths

Nivolumab

Serious events: 172 serious events

Other events: 336 other events

Deaths: 173 deaths

Serious adverse events

Measure	Bempegaldesleukin + Nivolumab n=388 participants at risk Bempegaldesleukin 0.006 mg/kg IV every 3 weeks + Nivolumab 360 mg IV every 3 weeks	Nivolumab n=382 participants at risk Nivolumab 360 mg IV every 3 weeks
Blood and lymphatic system disorders Anaemia	0.77% 3/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.52% 2/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Blood and lymphatic system disorders Eosinophilia	0.77% 3/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Blood and lymphatic system disorders Lymph node haemorrhage	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Blood and lymphatic system disorders Pancytopenia	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Cardiac disorders Acute myocardial infarction	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Cardiac disorders Angina pectoris	0.52% 2/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Cardiac disorders Atrial fibrillation	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Cardiac disorders Atrial tachycardia	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Cardiac disorders Bradyarrhythmia	0.00% 0/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Cardiac disorders Cardiac arrest	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Cardiac disorders Cardiac failure	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Cardiac disorders Cardio-respiratory arrest	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Cardiac disorders Cardiogenic shock	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Cardiac disorders Cardiovascular disorder	0.00% 0/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Cardiac disorders Myocardial infarction	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Cardiac disorders Myocarditis	0.77% 3/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	1.0% 4/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Cardiac disorders Myopericarditis	0.00% 0/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Cardiac disorders Pericardial effusion	0.00% 0/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Cardiac disorders Right ventricular failure	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Cardiac disorders Sinus node dysfunction	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Cardiac disorders Tachycardia	0.52% 2/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Cardiac disorders Ventricular tachycardia	0.00% 0/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Endocrine disorders Adrenal insufficiency	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Endocrine disorders Hypophysitis	0.00% 0/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Endocrine disorders Hypothyroidism	0.00% 0/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Endocrine disorders Thyroiditis	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Eye disorders Uveitis	0.00% 0/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Gastrointestinal disorders Abdominal pain	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.79% 3/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Gastrointestinal disorders Abdominal wall haematoma	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Gastrointestinal disorders Ascites	0.00% 0/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.79% 3/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Gastrointestinal disorders Autoimmune colitis	0.77% 3/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.52% 2/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Gastrointestinal disorders Autoimmune pancreatitis	0.00% 0/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.52% 2/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Gastrointestinal disorders Colitis	0.52% 2/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.79% 3/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Gastrointestinal disorders Colitis ulcerative	0.00% 0/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Gastrointestinal disorders Constipation	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.52% 2/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Gastrointestinal disorders Diarrhoea	0.77% 3/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	1.6% 6/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Gastrointestinal disorders Dysphagia	0.52% 2/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Gastrointestinal disorders Gastric haemorrhage	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Gastrointestinal disorders Gastric ulcer	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Gastrointestinal disorders Gastritis	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.00% 0/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Gastrointestinal disorders Ileus	0.00% 0/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Gastrointestinal disorders Immune-mediated enterocolitis	0.52% 2/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.52% 2/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Gastrointestinal disorders Immune-mediated pancreatitis	0.00% 0/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Gastrointestinal disorders Inguinal hernia	0.00% 0/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Gastrointestinal disorders Intestinal obstruction	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Gastrointestinal disorders Intestinal perforation	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Gastrointestinal disorders Nausea	0.00% 0/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Gastrointestinal disorders Obstructive pancreatitis	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Gastrointestinal disorders Pancreatitis	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.52% 2/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Gastrointestinal disorders Pancreatitis acute	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Gastrointestinal disorders Rectal haemorrhage	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Gastrointestinal disorders Vomiting	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
General disorders Asthenia	0.00% 0/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
General disorders Chest pain	0.52% 2/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
General disorders Death	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
General disorders Drowning	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
General disorders Face oedema	0.52% 2/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
General disorders Fatigue	0.52% 2/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	1.0% 4/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
General disorders General physical health deterioration	1.0% 4/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.79% 3/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
General disorders Hanging	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
General disorders Implant site haemorrhage	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
General disorders Localised oedema	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
General disorders Mucosal inflammation	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
General disorders Non-cardiac chest pain	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
General disorders Pain	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
General disorders Pyrexia	0.52% 2/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	1.0% 4/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
General disorders Sudden death	0.00% 0/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.52% 2/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
General disorders Systemic inflammatory response syndrome	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Hepatobiliary disorders Autoimmune hepatitis	0.00% 0/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Hepatobiliary disorders Biliary obstruction	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Hepatobiliary disorders Cholangitis	0.00% 0/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Hepatobiliary disorders Cholecystitis acute	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Hepatobiliary disorders Cholestasis	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Hepatobiliary disorders Hepatic cytolysis	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Hepatobiliary disorders Hepatic failure	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Hepatobiliary disorders Hepatitis	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Hepatobiliary disorders Immune-mediated hepatitis	0.00% 0/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Hepatobiliary disorders Portal vein thrombosis	0.00% 0/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Immune system disorders Anaphylactic reaction	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Immune system disorders Anaphylactic shock	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Immune system disorders Contrast media allergy	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Immune system disorders Cytokine release syndrome	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Immune system disorders Sarcoidosis	0.00% 0/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Infections and infestations Bacteraemia	0.00% 0/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Infections and infestations Bacterial infection	0.00% 0/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Infections and infestations Biliary tract infection	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Infections and infestations COVID-19	0.52% 2/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	1.3% 5/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Infections and infestations COVID-19 pneumonia	0.00% 0/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.52% 2/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Infections and infestations Cellulitis	0.52% 2/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Infections and infestations Cystitis	0.00% 0/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Infections and infestations Cystitis klebsiella	0.00% 0/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Infections and infestations Diverticulitis	0.00% 0/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Infections and infestations Encephalitis	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Infections and infestations Erysipelas	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Infections and infestations Gastroenteritis	0.52% 2/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Infections and infestations Herpes zoster	0.00% 0/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Infections and infestations Infection	0.52% 2/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Infections and infestations Influenza	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Infections and infestations Klebsiella urinary tract infection	0.00% 0/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Infections and infestations Localised infection	0.00% 0/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Infections and infestations Meningitis bacterial	0.00% 0/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Infections and infestations Orchitis	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Infections and infestations Osteomyelitis	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Infections and infestations Periorbital cellulitis	0.00% 0/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Infections and infestations Peritonitis	0.00% 0/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Infections and infestations Pneumonia	1.0% 4/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	2.1% 8/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Infections and infestations Pneumonia aspiration	0.00% 0/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Infections and infestations Pneumonia bacterial	0.00% 0/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Infections and infestations Sepsis	1.3% 5/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	1.0% 4/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Infections and infestations Septic shock	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Infections and infestations Severe acute respiratory syndrome	0.00% 0/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Infections and infestations Skin infection	0.77% 3/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Infections and infestations Soft tissue infection	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Infections and infestations Subcutaneous abscess	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Infections and infestations Tonsillitis bacterial	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Infections and infestations Upper respiratory tract infection	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Infections and infestations Urinary tract infection	0.52% 2/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Infections and infestations Urosepsis	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.79% 3/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Injury, poisoning and procedural complications Fall	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Injury, poisoning and procedural complications Femoral neck fracture	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Injury, poisoning and procedural complications Head injury	0.00% 0/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Injury, poisoning and procedural complications Immunisation reaction	0.00% 0/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Injury, poisoning and procedural complications Infusion related reaction	0.52% 2/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Injury, poisoning and procedural complications Postoperative ileus	0.00% 0/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Injury, poisoning and procedural complications Spinal fracture	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Injury, poisoning and procedural complications Subdural haematoma	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.00% 0/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Injury, poisoning and procedural complications Toxicity to various agents	0.00% 0/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Injury, poisoning and procedural complications Wrist fracture	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Investigations Alanine aminotransferase increased	0.52% 2/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Investigations Aspartate aminotransferase increased	0.77% 3/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Investigations Blood creatinine increased	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Investigations Lipase increased	0.00% 0/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.79% 3/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Investigations Liver function test increased	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Investigations Lymph node palpable	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Investigations Troponin increased	0.00% 0/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Metabolism and nutrition disorders Decreased appetite	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Metabolism and nutrition disorders Dehydration	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Metabolism and nutrition disorders Electrolyte imbalance	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.52% 2/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Metabolism and nutrition disorders Hyponatraemia	0.77% 3/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.52% 2/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Metabolism and nutrition disorders Metabolic acidosis	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Metabolism and nutrition disorders Tumour lysis syndrome	0.00% 0/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Musculoskeletal and connective tissue disorders Arthralgia	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.52% 2/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Musculoskeletal and connective tissue disorders Back pain	0.52% 2/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.52% 2/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Musculoskeletal and connective tissue disorders Groin pain	0.52% 2/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Musculoskeletal and connective tissue disorders Morphoea	0.00% 0/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.79% 3/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Musculoskeletal and connective tissue disorders Myositis	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	1.3% 5/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Musculoskeletal and connective tissue disorders Pain in extremity	0.52% 2/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.52% 2/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Musculoskeletal and connective tissue disorders Spinal stenosis	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.52% 2/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.79% 3/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal stromal tumour	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Infected neoplasm	0.00% 0/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intestinal metastasis	0.00% 0/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.00% 0/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.52% 2/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	9.5% 37/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	10.5% 40/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant pleural effusion	0.52% 2/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.79% 3/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lymph nodes	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to meninges	0.00% 0/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic malignant melanoma	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic neoplasm	0.00% 0/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm malignant	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm progression	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oncologic complication	0.00% 0/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.00% 0/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.52% 2/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Nervous system disorders Cerebral haemorrhage	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Nervous system disorders Cerebral infarction	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Nervous system disorders Cerebral ischaemia	0.00% 0/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Nervous system disorders Cerebrovascular accident	1.8% 7/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Nervous system disorders Cerebrovascular disorder	0.00% 0/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Nervous system disorders Dizziness	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Nervous system disorders Encephalitis autoimmune	0.00% 0/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.52% 2/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Nervous system disorders Encephalopathy	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Nervous system disorders Facial paralysis	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Nervous system disorders Guillain-Barre syndrome	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Nervous system disorders Haemorrhage intracranial	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Nervous system disorders Headache	0.00% 0/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Nervous system disorders Hemiparesis	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Nervous system disorders Hydrocephalus	0.00% 0/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Nervous system disorders Ischaemic stroke	0.52% 2/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.79% 3/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Nervous system disorders Myasthenia gravis	0.00% 0/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Nervous system disorders Nervous system disorder	0.00% 0/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Nervous system disorders Paraesthesia	0.00% 0/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Nervous system disorders Peripheral sensorimotor neuropathy	0.00% 0/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Nervous system disorders Polyneuropathy	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Nervous system disorders Presyncope	0.00% 0/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.52% 2/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Nervous system disorders Seizure	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	1.0% 4/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Nervous system disorders Spinal cord compression	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	1.0% 4/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Nervous system disorders Syncope	0.52% 2/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.52% 2/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Nervous system disorders Transient ischaemic attack	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Psychiatric disorders Adjustment disorder	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Psychiatric disorders Confusional state	0.00% 0/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Psychiatric disorders Disorientation	0.00% 0/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Psychiatric disorders Suicide attempt	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Renal and urinary disorders Acute kidney injury	1.8% 7/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.79% 3/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Renal and urinary disorders Autoimmune nephritis	0.00% 0/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.79% 3/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Renal and urinary disorders Chronic kidney disease	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Renal and urinary disorders Hydronephrosis	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Renal and urinary disorders Pelvi-ureteric obstruction	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Renal and urinary disorders Renal colic	0.00% 0/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Renal and urinary disorders Tubulointerstitial nephritis	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Reproductive system and breast disorders Prostatitis	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Reproductive system and breast disorders Testicular mass	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.52% 2/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Respiratory, thoracic and mediastinal disorders Alveolitis	0.00% 0/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Respiratory, thoracic and mediastinal disorders Asthma-chronic obstructive pulmonary disease overlap syndrome	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Respiratory, thoracic and mediastinal disorders Autoimmune lung disease	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.52% 2/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.52% 2/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Respiratory, thoracic and mediastinal disorders Epiglottic polyp	0.00% 0/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.77% 3/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.52% 2/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.52% 2/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.0% 4/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.52% 2/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.52% 2/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.79% 3/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Skin and subcutaneous tissue disorders Dermatitis exfoliative generalised	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Skin and subcutaneous tissue disorders Hidradenitis	0.00% 0/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Skin and subcutaneous tissue disorders Immune-mediated dermatitis	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Skin and subcutaneous tissue disorders Ingrowing nail	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Skin and subcutaneous tissue disorders Pain of skin	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Skin and subcutaneous tissue disorders Rash	0.52% 2/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 0/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Skin and subcutaneous tissue disorders Sarcoid-like reaction	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Skin and subcutaneous tissue disorders Skin lesion	0.52% 2/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Vascular disorders Arterial occlusive disease	0.00% 0/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Vascular disorders Deep vein thrombosis	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Vascular disorders Embolism	0.26% 1/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Vascular disorders Hypotension	0.77% 3/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.52% 2/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Vascular disorders Ischaemia	0.00% 0/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Vascular disorders Shock haemorrhagic	0.00% 0/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Vascular disorders Vena cava thrombosis	0.00% 0/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.26% 1/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.

Other adverse events

Measure	Bempegaldesleukin + Nivolumab n=388 participants at risk Bempegaldesleukin 0.006 mg/kg IV every 3 weeks + Nivolumab 360 mg IV every 3 weeks	Nivolumab n=382 participants at risk Nivolumab 360 mg IV every 3 weeks
Injury, poisoning and procedural complications Infusion related reaction	12.4% 48/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	3.9% 15/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Blood and lymphatic system disorders Anaemia	15.7% 61/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	16.5% 63/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Blood and lymphatic system disorders Eosinophilia	15.5% 60/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	1.8% 7/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Endocrine disorders Hyperthyroidism	12.6% 49/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	7.3% 28/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Endocrine disorders Hypothyroidism	19.1% 74/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	13.6% 52/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Gastrointestinal disorders Abdominal pain	8.5% 33/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	8.9% 34/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Gastrointestinal disorders Abdominal pain upper	7.5% 29/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	4.2% 16/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Gastrointestinal disorders Constipation	10.1% 39/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	13.4% 51/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Gastrointestinal disorders Diarrhoea	24.7% 96/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	20.9% 80/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Gastrointestinal disorders Dry mouth	5.4% 21/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	3.4% 13/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Gastrointestinal disorders Nausea	29.1% 113/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	17.5% 67/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Gastrointestinal disorders Vomiting	16.5% 64/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	9.7% 37/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
General disorders Asthenia	17.5% 68/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	11.0% 42/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
General disorders Chills	9.3% 36/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	1.3% 5/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
General disorders Face oedema	5.2% 20/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	0.00% 0/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
General disorders Fatigue	33.0% 128/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	27.2% 104/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
General disorders Influenza like illness	18.3% 71/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	2.4% 9/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
General disorders Oedema peripheral	10.3% 40/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	7.9% 30/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
General disorders Pyrexia	37.9% 147/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	10.2% 39/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Infections and infestations COVID-19	8.2% 32/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	8.1% 31/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Infections and infestations Upper respiratory tract infection	2.3% 9/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	5.2% 20/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Investigations Alanine aminotransferase increased	8.0% 31/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	10.2% 39/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Investigations Amylase increased	5.2% 20/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	7.6% 29/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Investigations Aspartate aminotransferase increased	6.7% 26/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	8.9% 34/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Investigations Blood alkaline phosphatase increased	2.6% 10/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	5.2% 20/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Investigations Blood creatine phosphokinase increased	5.9% 23/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	9.9% 38/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Investigations Blood creatinine increased	5.2% 20/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	7.3% 28/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Investigations Lipase increased	5.7% 22/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	9.7% 37/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Investigations Weight decreased	4.1% 16/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	5.8% 22/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Metabolism and nutrition disorders Decreased appetite	17.5% 68/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	9.2% 35/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Metabolism and nutrition disorders Hyperglycaemia	5.2% 20/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	7.3% 28/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Metabolism and nutrition disorders Hyponatraemia	3.9% 15/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	5.2% 20/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Musculoskeletal and connective tissue disorders Arthralgia	25.5% 99/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	17.5% 67/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Musculoskeletal and connective tissue disorders Back pain	9.0% 35/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	12.3% 47/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Musculoskeletal and connective tissue disorders Myalgia	14.2% 55/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	7.3% 28/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Musculoskeletal and connective tissue disorders Pain in extremity	8.8% 34/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	9.4% 36/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Nervous system disorders Dizziness	9.8% 38/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	5.2% 20/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Nervous system disorders Headache	16.5% 64/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	14.7% 56/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Psychiatric disorders Insomnia	8.0% 31/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	6.3% 24/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Respiratory, thoracic and mediastinal disorders Cough	13.7% 53/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	11.8% 45/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Respiratory, thoracic and mediastinal disorders Dyspnoea	8.0% 31/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	8.1% 31/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Skin and subcutaneous tissue disorders Dry skin	7.7% 30/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	3.7% 14/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Skin and subcutaneous tissue disorders Erythema	7.2% 28/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	1.8% 7/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Skin and subcutaneous tissue disorders Pruritus	31.2% 121/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	20.9% 80/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Skin and subcutaneous tissue disorders Rash	27.8% 108/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	16.5% 63/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Skin and subcutaneous tissue disorders Rash maculo-papular	7.7% 30/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	4.7% 18/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Skin and subcutaneous tissue disorders Vitiligo	9.0% 35/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	8.9% 34/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Vascular disorders Hypertension	7.0% 27/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	8.9% 34/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.
Vascular disorders Hypotension	8.5% 33/388 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.	1.6% 6/382 • Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months). Participants were assessed for All-cause mortality from their date of randomization to study completion date (Up to approximately 66 months). The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants.

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