Trial Outcomes & Findings for A Study of Nivolumab, Nivolumab Plus Ipilimumab, or Investigator's Choice Chemotherapy for the Treatment of Participants With Deficient Mismatch Repair (dMMR)/Microsatellite Instability High (MSI-H) Metastatic Colorectal Cancer (mCRC) (NCT NCT04008030)

Last Updated: 2025-10-03

Results Overview

BICR-assessed Progression-free survival (PFS) is defined as the time from the randomization date to the date of first objectively documented disease progression per RECIST 1.1 (i.e, radiologic) or death due to any cause, whichever occurs first.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE3

Target enrollment

839 participants

Primary outcome timeframe

From date of randomization to the date of first objectively documented disease progression or death due to any cause, whichever occurs first (Up to approximately 60 months)

Results posted on

2025-10-03

Participant Flow

Participant milestones

Participant milestones
Measure	Arm A - Nivolumab Monotherapy Nivolumab 240 mg infusion on Day 1 and every two weeks during cycles 1 and 2 for a total of 6 doses. Starting from Cycle 3 Day 1 participants received Nivolumab 480 mg infusion every 4 weeks.	Arm B - Nivolumab + Ipilimumab Nivolumab 240 mg infusion followed by Ipilimumab 1 mg/kg IV on Day 1 and every three weeks during cycles 1 and 2 for a total of 4 doses. Starting from Cycle 3 Day 1, participants received Nivolumab 480 mg infusion every 4 weeks.	Arm C - Investigator's Choice Chemotherapy Participants received standard of care chemotherapy
Pre-Treatment STARTED	353	354	132
Pre-Treatment COMPLETED	351	352	115
Pre-Treatment NOT COMPLETED	2	2	17
Treatment STARTED	351	352	115
Treatment Crossover to Arm B	0	0	60
Treatment COMPLETED	137	159	0
Treatment NOT COMPLETED	214	193	115

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm A - Nivolumab Monotherapy Nivolumab 240 mg infusion on Day 1 and every two weeks during cycles 1 and 2 for a total of 6 doses. Starting from Cycle 3 Day 1 participants received Nivolumab 480 mg infusion every 4 weeks.	Arm B - Nivolumab + Ipilimumab Nivolumab 240 mg infusion followed by Ipilimumab 1 mg/kg IV on Day 1 and every three weeks during cycles 1 and 2 for a total of 4 doses. Starting from Cycle 3 Day 1, participants received Nivolumab 480 mg infusion every 4 weeks.	Arm C - Investigator's Choice Chemotherapy Participants received standard of care chemotherapy
Pre-Treatment Withdrawal by Subject	0	0	9
Pre-Treatment Participant no longer meets study criteria	2	1	2
Pre-Treatment Other reasons	0	1	6
Treatment Withdrawal by Subject	1	1	1
Treatment Death	2	4	0
Treatment Pregnancy	0	1	0
Treatment Participant no longer meets study criteria	0	1	0
Treatment Other reasons	5	13	6
Treatment Disease Progression	137	82	85
Treatment Study drug toxicity	28	48	8
Treatment Adverse Event unrelated to study drug	28	22	6
Treatment Maximum Clinical Benefit	0	1	9
Treatment On-going treatment	13	20	0

Baseline Characteristics

A Study of Nivolumab, Nivolumab Plus Ipilimumab, or Investigator's Choice Chemotherapy for the Treatment of Participants With Deficient Mismatch Repair (dMMR)/Microsatellite Instability High (MSI-H) Metastatic Colorectal Cancer (mCRC)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A - Nivolumab Monotherapy n=353 Participants Nivolumab 240 mg infusion on Day 1 and every two weeks during cycles 1 and 2 for a total of 6 doses. Starting from Cycle 3 Day 1 participants received Nivolumab 480 mg infusion every 4 weeks.	Arm B - Nivolumab + Ipilimumab n=354 Participants Nivolumab 240 mg infusion followed by Ipilimumab 1 mg/kg IV on Day 1 and every three weeks during cycles 1 and 2 for a total of 4 doses. Starting from Cycle 3 Day 1, participants received Nivolumab 480 mg infusion every 4 weeks.	Arm C - Investigator's Choice Chemotherapy n=132 Participants Participants received standard of care chemotherapy	Total n=839 Participants Total of all reporting groups
Age, Continuous	60.3 Years STANDARD_DEVIATION 13.76 • n=99 Participants	60.5 Years STANDARD_DEVIATION 13.14 • n=107 Participants	61.3 Years STANDARD_DEVIATION 14.93 • n=206 Participants	60.5 Years STANDARD_DEVIATION 13.69 • n=7 Participants
Sex: Female, Male Female	163 Participants n=99 Participants	192 Participants n=107 Participants	68 Participants n=206 Participants	423 Participants n=7 Participants
Sex: Female, Male Male	190 Participants n=99 Participants	162 Participants n=107 Participants	64 Participants n=206 Participants	416 Participants n=7 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	34 Participants n=99 Participants	32 Participants n=107 Participants	11 Participants n=206 Participants	77 Participants n=7 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	189 Participants n=99 Participants	165 Participants n=107 Participants	67 Participants n=206 Participants	421 Participants n=7 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	130 Participants n=99 Participants	157 Participants n=107 Participants	54 Participants n=206 Participants	341 Participants n=7 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Race (NIH/OMB) Asian	36 Participants n=99 Participants	27 Participants n=107 Participants	15 Participants n=206 Participants	78 Participants n=7 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Race (NIH/OMB) Black or African American	7 Participants n=99 Participants	4 Participants n=107 Participants	2 Participants n=206 Participants	13 Participants n=7 Participants
Race (NIH/OMB) White	305 Participants n=99 Participants	311 Participants n=107 Participants	113 Participants n=206 Participants	729 Participants n=7 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=99 Participants	12 Participants n=107 Participants	2 Participants n=206 Participants	19 Participants n=7 Participants

PRIMARY outcome

Timeframe: From date of randomization to the date of first objectively documented disease progression or death due to any cause, whichever occurs first (Up to approximately 60 months)

Population: All randomized participants with centrally confirmed DNA mismatch repairdeficient/microsatellite instability-high metastatic colorectal cancer (dMMR/MSI-H mCRC) in Arm A and Arm B only

Outcome measures

Outcome measures
Measure	Arm A - Nivolumab Monotherapy n=286 Participants Nivolumab 240 mg infusion on Day 1 and every two weeks during cycles 1 and 2 for a total of 6 doses. Starting from Cycle 3 Day 1 participants received Nivolumab 480 mg infusion every 4 weeks.	Arm B - Nivolumab + Ipilimumab n=296 Participants Nivolumab 240 mg infusion followed by Ipilimumab 1 mg/kg IV on Day 1 and every three weeks during cycles 1 and 2 for a total of 4 doses. Starting from Cycle 3 Day 1, participants received Nivolumab 480 mg infusion every 4 weeks.	Arm C - Investigator's Choice Chemotherapy Participants received standard of care chemotherapy
Progression-free Survival (PFS) by Blinded Independent Review Center (BICR) - Arm B vs. Arm A All Lines Centrally Confirmed MSI-H/dMMR	39.26 Months Interval 2.11 to Insufficient number of participants with events based on Kaplan-Meier Estimates	NA Months Interval 53.82 to Insufficient number of participants with events based on Kaplan-Meier Estimates	—

PRIMARY outcome

Timeframe: From date of randomization to the date of first objectively documented disease progression or death due to any cause, whichever occurs first (Up to approximately 32 months)

Population: All randomized participants with centrally confirmed DNA mismatch repairdeficient/microsatellite instability-high metastatic colorectal cancer (dMMR/MSI-H mCRC) who have not received prior therapy for metastatic disease (1L) in Arm B and Arm C only

Outcome measures

Outcome measures
Measure	Arm A - Nivolumab Monotherapy n=171 Participants Nivolumab 240 mg infusion on Day 1 and every two weeks during cycles 1 and 2 for a total of 6 doses. Starting from Cycle 3 Day 1 participants received Nivolumab 480 mg infusion every 4 weeks.	Arm B - Nivolumab + Ipilimumab n=84 Participants Nivolumab 240 mg infusion followed by Ipilimumab 1 mg/kg IV on Day 1 and every three weeks during cycles 1 and 2 for a total of 4 doses. Starting from Cycle 3 Day 1, participants received Nivolumab 480 mg infusion every 4 weeks.	Arm C - Investigator's Choice Chemotherapy Participants received standard of care chemotherapy
Progression-free Survival (PFS) by Blinded Independent Review Center (BICR) - Arm B vs. Arm C 1L Participants Centrally Confirmed MSI-H/dMMR	NA Months Interval 38.44 to Insufficient number of participants with events based on Kaplan-Meier Estimates	5.85 Months Interval 4.37 to 7.79	—

SECONDARY outcome

Timeframe: From date of randomization to the date of first objectively documented disease progression or death due to any cause, whichever occurs first

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From date of randomization to the date of first objectively documented disease progression or death due to any cause, whichever occurs first (Up to approximately 60 months)

Population: All randomized participants in Arm A and Arm B only.

Outcome measures

Outcome measures
Measure	Arm A - Nivolumab Monotherapy n=353 Participants Nivolumab 240 mg infusion on Day 1 and every two weeks during cycles 1 and 2 for a total of 6 doses. Starting from Cycle 3 Day 1 participants received Nivolumab 480 mg infusion every 4 weeks.	Arm B - Nivolumab + Ipilimumab n=354 Participants Nivolumab 240 mg infusion followed by Ipilimumab 1 mg/kg IV on Day 1 and every three weeks during cycles 1 and 2 for a total of 4 doses. Starting from Cycle 3 Day 1, participants received Nivolumab 480 mg infusion every 4 weeks.	Arm C - Investigator's Choice Chemotherapy Participants received standard of care chemotherapy
Progression-free Survival (PFS) by Blinded Independent Review Center (BICR) - Arm B vs. Arm A All Randomized Participants	18.43 Months Interval 9.2 to 28.16	54.08 Months Interval 44.02 to Insufficient number of participants with events based on Kaplan-Meier Estimates	—

SECONDARY outcome

Timeframe: From date of randomization to the date of first objectively documented disease progression or death due to any cause, whichever occurs first (Up to approximately 60 months)

Population: All randomized participants who have not received prior therapy for metastatic disease (1L)

Outcome measures

Outcome measures
Measure	Arm A - Nivolumab Monotherapy n=201 Participants Nivolumab 240 mg infusion on Day 1 and every two weeks during cycles 1 and 2 for a total of 6 doses. Starting from Cycle 3 Day 1 participants received Nivolumab 480 mg infusion every 4 weeks.	Arm B - Nivolumab + Ipilimumab n=202 Participants Nivolumab 240 mg infusion followed by Ipilimumab 1 mg/kg IV on Day 1 and every three weeks during cycles 1 and 2 for a total of 4 doses. Starting from Cycle 3 Day 1, participants received Nivolumab 480 mg infusion every 4 weeks.	Arm C - Investigator's Choice Chemotherapy n=101 Participants Participants received standard of care chemotherapy
Progression-free Survival (PFS) by Blinded Independent Review Center (BICR) - 1L Randomized Participants	44.85 Months Interval 18.23 to Insufficient number of participants with events based on Kaplan-Meier Estimates	NA Months Interval 34.3 to Insufficient number of participants with events based on Kaplan-Meier Estimates	6.21 Months Interval 4.7 to 9.0

SECONDARY outcome

Timeframe: From date of randomization to the date of first objectively documented disease progression or death due to any cause, whichever occurs first

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From date of randomization to the date of first objectively documented disease progression or death due to any cause, whichever occurs first (Up to approximately 60 months)

Population: All randomized participants with centrally confirmed microsatellite instability-high (MSI-H) in Arm A and Arm B only

Outcome measures

Outcome measures
Measure	Arm A - Nivolumab Monotherapy n=246 Participants Nivolumab 240 mg infusion on Day 1 and every two weeks during cycles 1 and 2 for a total of 6 doses. Starting from Cycle 3 Day 1 participants received Nivolumab 480 mg infusion every 4 weeks.	Arm B - Nivolumab + Ipilimumab n=257 Participants Nivolumab 240 mg infusion followed by Ipilimumab 1 mg/kg IV on Day 1 and every three weeks during cycles 1 and 2 for a total of 4 doses. Starting from Cycle 3 Day 1, participants received Nivolumab 480 mg infusion every 4 weeks.	Arm C - Investigator's Choice Chemotherapy Participants received standard of care chemotherapy
Progression-free Survival (PFS) by Blinded Independent Review Center (BICR) by Polymerase Chain Reaction (PCR) - Arm B vs. Arm A	NA Months Interval 24.8 to Insufficient number of participants with events based on Kaplan-Meier Estimates	NA Months Interval 53.82 to Insufficient number of participants with events based on Kaplan-Meier Estimates	—

SECONDARY outcome

Timeframe: From date of randomization to the date of first objectively documented disease progression or death due to any cause, whichever occurs first (Up to approximately 60 months)

Population: All randomized participants with centrally confirmed DNA mismatch repairdeficient (dMMR) in Arm A and Arm B only

Outcome measures

Outcome measures
Measure	Arm A - Nivolumab Monotherapy n=271 Participants Nivolumab 240 mg infusion on Day 1 and every two weeks during cycles 1 and 2 for a total of 6 doses. Starting from Cycle 3 Day 1 participants received Nivolumab 480 mg infusion every 4 weeks.	Arm B - Nivolumab + Ipilimumab n=280 Participants Nivolumab 240 mg infusion followed by Ipilimumab 1 mg/kg IV on Day 1 and every three weeks during cycles 1 and 2 for a total of 4 doses. Starting from Cycle 3 Day 1, participants received Nivolumab 480 mg infusion every 4 weeks.	Arm C - Investigator's Choice Chemotherapy Participants received standard of care chemotherapy
Progression-free Survival (PFS) by Blinded Independent Review Center (BICR) by Immunohistochemistry (IHC) - Arm B vs. Arm A	44.29 Months Interval 25.56 to Insufficient number of participants with events based on Kaplan-Meier Estimates	NA Months Interval 53.82 to Insufficient number of participants with events based on Kaplan-Meier Estimates	—

SECONDARY outcome

Timeframe: From date of randomization to the date of first objectively documented disease progression or death due to any cause, whichever occurs first (Up to approximately 32 months)

Population: All randomized participants with centrally confirmed microsatellite instability-high (MSI-H) who have not received prior therapy for metastatic disease (1L) in Arm B and Arm C only

Outcome measures

Outcome measures
Measure	Arm A - Nivolumab Monotherapy n=147 Participants Nivolumab 240 mg infusion on Day 1 and every two weeks during cycles 1 and 2 for a total of 6 doses. Starting from Cycle 3 Day 1 participants received Nivolumab 480 mg infusion every 4 weeks.	Arm B - Nivolumab + Ipilimumab n=71 Participants Nivolumab 240 mg infusion followed by Ipilimumab 1 mg/kg IV on Day 1 and every three weeks during cycles 1 and 2 for a total of 4 doses. Starting from Cycle 3 Day 1, participants received Nivolumab 480 mg infusion every 4 weeks.	Arm C - Investigator's Choice Chemotherapy Participants received standard of care chemotherapy
Progression-free Survival (PFS) by Blinded Independent Review Center (BICR) by Polymerase Chain Reaction (PCR) - Arm B vs. Arm C	NA Months Interval 38.44 to Insufficient number of participants with events based on Kaplan-Meier Estimates	6.21 Months Interval 4.7 to 9.03	—

SECONDARY outcome

Timeframe: From date of randomization to the date of first objectively documented disease progression or death due to any cause, whichever occurs first (Up to approximately 32 months)

Population: All randomized participants with centrally confirmed DNA mismatch repairdeficient (dMMR) who have not received prior therapy for metastatic disease (1L) in Arm B and Arm C only

Outcome measures

Outcome measures
Measure	Arm A - Nivolumab Monotherapy n=147 Participants Nivolumab 240 mg infusion on Day 1 and every two weeks during cycles 1 and 2 for a total of 6 doses. Starting from Cycle 3 Day 1 participants received Nivolumab 480 mg infusion every 4 weeks.	Arm B - Nivolumab + Ipilimumab n=71 Participants Nivolumab 240 mg infusion followed by Ipilimumab 1 mg/kg IV on Day 1 and every three weeks during cycles 1 and 2 for a total of 4 doses. Starting from Cycle 3 Day 1, participants received Nivolumab 480 mg infusion every 4 weeks.	Arm C - Investigator's Choice Chemotherapy Participants received standard of care chemotherapy
Progression-free Survival (PFS) by Blinded Independent Review Center (BICR) by Immunohistochemistry (IHC) - Arm B vs. Arm C	NA Months Interval 38.44 to Insufficient number of participants with events based on Kaplan-Meier Estimates	6.21 Months Interval 4.7 to 9.03	—

SECONDARY outcome

Timeframe: From date of randomization to the date of first objectively documented disease progression or death due to any cause, whichever occurs first (Up to approximately 60 months)

Population: All randomized participants in Arm A and Arm B only.

Investigator-assessed Progression-free survival (PFS) is defined as the time from the randomization date to the date of first objectively documented disease progression per RECIST 1.1 (i.e, radiologic) or death due to any cause, whichever occurs first.

Outcome measures

Outcome measures
Measure	Arm A - Nivolumab Monotherapy n=353 Participants Nivolumab 240 mg infusion on Day 1 and every two weeks during cycles 1 and 2 for a total of 6 doses. Starting from Cycle 3 Day 1 participants received Nivolumab 480 mg infusion every 4 weeks.	Arm B - Nivolumab + Ipilimumab n=354 Participants Nivolumab 240 mg infusion followed by Ipilimumab 1 mg/kg IV on Day 1 and every three weeks during cycles 1 and 2 for a total of 4 doses. Starting from Cycle 3 Day 1, participants received Nivolumab 480 mg infusion every 4 weeks.	Arm C - Investigator's Choice Chemotherapy Participants received standard of care chemotherapy
Progression-free Survival (PFS) by Investigator- Arm B vs. Arm A All Lines	22.18 Months Interval 11.7 to 29.44	54.08 Months Interval 41.17 to Insufficient number of participants with events based on Kaplan-Meier Estimates	—

SECONDARY outcome

Timeframe: From date of randomization to the date of first objectively documented disease progression or death due to any cause, whichever occurs first (Up to approximately 60 months)

Population: All randomized participants with centrally confirmed DNA mismatch repairdeficient/microsatellite instability-high metastatic colorectal cancer (dMMR/MSI-H mCRC) in Arm A and Arm B only.

Outcome measures

Outcome measures
Measure	Arm A - Nivolumab Monotherapy n=286 Participants Nivolumab 240 mg infusion on Day 1 and every two weeks during cycles 1 and 2 for a total of 6 doses. Starting from Cycle 3 Day 1 participants received Nivolumab 480 mg infusion every 4 weeks.	Arm B - Nivolumab + Ipilimumab n=296 Participants Nivolumab 240 mg infusion followed by Ipilimumab 1 mg/kg IV on Day 1 and every three weeks during cycles 1 and 2 for a total of 4 doses. Starting from Cycle 3 Day 1, participants received Nivolumab 480 mg infusion every 4 weeks.	Arm C - Investigator's Choice Chemotherapy Participants received standard of care chemotherapy
Progression-free Survival (PFS) by Investigator - Arm A and Arm B All Lines With dMMR/MSI-H mCRC	38.14 Months Interval 27.2 to Insufficient number of participants with events based on Kaplan-Meier Estimates	NA Months Interval 54.08 to Insufficient number of participants with events based on Kaplan-Meier Estimates	—

SECONDARY outcome

Timeframe: From date of randomization to the date of first objectively documented disease progression or death due to any cause, whichever occurs first (Up to approximately 60 months for arm A and arm B; up to 32 months for arm C)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From date of randomization to the date of the initial objectively documented tumor progression, or the date of initiation of subsequent therapy, whichever occurs first (Up to approximately 60 months)

Population: All randomized participants with centrally confirmed DNA mismatch repairdeficient/microsatellite instability-high metastatic colorectal cancer (dMMR/MSI-H mCRC) in Arm A and Arm B only

Objective Response Rate (ORR) is defined as the percentage of all randomized participants whose best overall response is either confirmed complete response (CR) or confirmed partial response (PR). CR= Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR= At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. 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

Outcome measures
Measure	Arm A - Nivolumab Monotherapy n=286 Participants Nivolumab 240 mg infusion on Day 1 and every two weeks during cycles 1 and 2 for a total of 6 doses. Starting from Cycle 3 Day 1 participants received Nivolumab 480 mg infusion every 4 weeks.	Arm B - Nivolumab + Ipilimumab n=296 Participants Nivolumab 240 mg infusion followed by Ipilimumab 1 mg/kg IV on Day 1 and every three weeks during cycles 1 and 2 for a total of 4 doses. Starting from Cycle 3 Day 1, participants received Nivolumab 480 mg infusion every 4 weeks.	Arm C - Investigator's Choice Chemotherapy Participants received standard of care chemotherapy
Objective Response Rate (ORR) by Blinded Independent Review Center (BICR) - Arm A and Arm B All Lines With dMMR/MSI-H mCRC	57.7 Percentage of participants Interval 51.7 to 63.5	70.6 Percentage of participants Interval 65.1 to 75.7	—

SECONDARY outcome

Outcome measures

Outcome measures
Measure	Arm A - Nivolumab Monotherapy n=170 Participants Nivolumab 240 mg infusion on Day 1 and every two weeks during cycles 1 and 2 for a total of 6 doses. Starting from Cycle 3 Day 1 participants received Nivolumab 480 mg infusion every 4 weeks.	Arm B - Nivolumab + Ipilimumab n=171 Participants Nivolumab 240 mg infusion followed by Ipilimumab 1 mg/kg IV on Day 1 and every three weeks during cycles 1 and 2 for a total of 4 doses. Starting from Cycle 3 Day 1, participants received Nivolumab 480 mg infusion every 4 weeks.	Arm C - Investigator's Choice Chemotherapy n=84 Participants Participants received standard of care chemotherapy
Objective Response Rate (ORR) by Blinded Independent Review Center (BICR) - 1L Participants	61.2 Percentage of participants Interval 53.4 to 68.5	72.5 Percentage of participants Interval 65.2 to 79.1	27.4 Percentage of participants Interval 18.2 to 38.2

SECONDARY outcome

Timeframe: From randomization to the date of death due to any cause (Up to approximately 60 months)

Population: All randomized participants with centrally confirmed DNA mismatch repairdeficient/microsatellite instability-high metastatic colorectal cancer (dMMR/MSI-H mCRC) in Arm A and Arm B only

Overall Survival (OS) is defined as the time from the randomization date to the date of death due to any cause. A participant who has not died will be censored at last known date alive.

Outcome measures

Outcome measures
Measure	Arm A - Nivolumab Monotherapy n=286 Participants Nivolumab 240 mg infusion on Day 1 and every two weeks during cycles 1 and 2 for a total of 6 doses. Starting from Cycle 3 Day 1 participants received Nivolumab 480 mg infusion every 4 weeks.	Arm B - Nivolumab + Ipilimumab n=296 Participants Nivolumab 240 mg infusion followed by Ipilimumab 1 mg/kg IV on Day 1 and every three weeks during cycles 1 and 2 for a total of 4 doses. Starting from Cycle 3 Day 1, participants received Nivolumab 480 mg infusion every 4 weeks.	Arm C - Investigator's Choice Chemotherapy Participants received standard of care chemotherapy
Overall Survival (OS) - Arm B vs. Arm A All Lines With dMMR/MSI-H mCRC	NA Months Insufficient number of participants with events based on Kaplan-Meier Estimates	NA Months Insufficient number of participants with events based on Kaplan-Meier Estimates	—

SECONDARY outcome

Timeframe: From randomization to the date of death due to any cause

Overall Survival (OS) is defined as the time from the randomization date to the date of death due to any cause. A participant who has not died will be censored at last known date alive.

Outcome measures

Outcome data not reported

Adverse Events

Arm A: Nivolumab

Serious events: 161 serious events

Other events: 311 other events

Deaths: 150 deaths

Arm B: Nivolumab + Ipilimumab

Serious events: 174 serious events

Other events: 330 other events

Deaths: 103 deaths

Arm C: Chemotherapy

Serious events: 58 serious events

Other events: 114 other events

Deaths: 62 deaths

Crossover: Nivolumab + Ipilimumab

Serious events: 38 serious events

Other events: 52 other events

Deaths: 24 deaths

Serious adverse events

Other adverse events

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

Phone: Please Email:

Email: [email protected]

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

Serious adverse events
Measure	Arm A: Nivolumab n=351 participants at risk Nivolumab 240 mg infusion on Day 1 and every two weeks during cycles 1 and 2 for a total of 6 doses. Starting from Cycle 3 Day 1 participants received Nivolumab 480 mg infusion every 4 weeks.	Arm B: Nivolumab + Ipilimumab n=352 participants at risk Nivolumab 240 mg infusion followed by Ipilimumab 1 mg/kg IV on Day 1 and every three weeks during cycles 1 and 2 for a total of 4 doses. Starting from Cycle 3 Day 1, participants received Nivolumab 480 mg infusion every 4 weeks.	Arm C: Chemotherapy n=115 participants at risk Participants received standard of care chemotherapy	Crossover: Nivolumab + Ipilimumab n=60 participants at risk Participants assigned to Arm C that experience documented progression of disease (PD) per RECIST 1.1 by Blinded Independent Central Review (BICR) will have an option to crossover to nivolumab plus ipilimumab therapy (Arm B)
Blood and lymphatic system disorders Anaemia	1.1% 4/351 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.1% 4/352 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.87% 1/115 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.7% 1/60 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.00% 0/351 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.28% 1/352 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/115 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/60 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Blood and lymphatic system disorders Eosinophilia	0.28% 1/351 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/352 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/115 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/60 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/351 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.28% 1/352 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.87% 1/115 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/60 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Blood and lymphatic system disorders Neutropenia	0.00% 0/351 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.28% 1/352 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.87% 1/115 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/60 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/351 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.28% 1/352 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/115 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/60 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/351 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.28% 1/352 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/115 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/60 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Cardiac disorders Acute coronary syndrome	0.00% 0/351 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.28% 1/352 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/115 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.7% 1/60 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Cardiac disorders Acute myocardial infarction	0.00% 0/351 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.28% 1/352 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/115 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/60 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Cardiac disorders Atrial fibrillation	0.28% 1/351 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.28% 1/352 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/115 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/60 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Cardiac disorders Cardiac arrest	0.85% 3/351 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/352 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/115 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/60 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Cardiac disorders Cardiac failure	0.28% 1/351 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/352 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.87% 1/115 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/60 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Cardiac disorders Cardio-respiratory arrest	0.28% 1/351 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/352 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/115 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/60 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Cardiac disorders Cardiogenic shock	0.00% 0/351 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/352 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/115 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.7% 1/60 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Cardiac disorders Immune-mediated myocarditis	0.00% 0/351 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.28% 1/352 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/115 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/60 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Cardiac disorders Myocardial infarction	0.85% 3/351 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/352 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/115 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/60 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Cardiac disorders Myocarditis	0.00% 0/351 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.57% 2/352 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/115 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.7% 1/60 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Cardiac disorders Pericardial effusion	0.00% 0/351 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.57% 2/352 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/115 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/60 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Cardiac disorders Sinoatrial block	0.28% 1/351 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/352 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/115 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/60 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Endocrine disorders Adrenal insufficiency	1.1% 4/351 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 11/352 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/115 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.3% 2/60 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Endocrine disorders Adrenocorticotropic hormone deficiency	0.00% 0/351 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.28% 1/352 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/115 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/60 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Endocrine disorders Glucocorticoid deficiency	0.00% 0/351 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.28% 1/352 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/115 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/60 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Endocrine disorders Hypophysitis	0.85% 3/351 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.8% 10/352 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/115 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.3% 2/60 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Endocrine disorders Hypopituitarism	0.28% 1/351 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.28% 1/352 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/115 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/60 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Endocrine disorders Hypothyroidism	0.00% 0/351 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.28% 1/352 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/115 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/60 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Endocrine disorders Lymphocytic hypophysitis	0.00% 0/351 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.28% 1/352 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/115 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/60 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Endocrine disorders Primary adrenal insufficiency	0.00% 0/351 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.28% 1/352 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/115 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/60 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Eye disorders Diplopia	0.00% 0/351 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/352 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/115 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.7% 1/60 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Abdominal pain	1.7% 6/351 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.0% 7/352 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	5.2% 6/115 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.7% 1/60 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Abdominal pain upper	0.57% 2/351 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.28% 1/352 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/115 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/60 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Ascites	0.57% 2/351 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/352 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/115 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/60 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Colitis	0.57% 2/351 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.4% 5/352 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.87% 1/115 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.3% 2/60 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Colonic fistula	0.00% 0/351 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.57% 2/352 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.87% 1/115 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/60 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Constipation	0.57% 2/351 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.28% 1/352 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.7% 2/115 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/60 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Diarrhoea	1.7% 6/351 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.3% 8/352 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.5% 4/115 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	5.0% 3/60 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Diverticulum	0.28% 1/351 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/352 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/115 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/60 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Duodenal obstruction	0.28% 1/351 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/352 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/115 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/60 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Duodenal stenosis	0.00% 0/351 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/352 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.87% 1/115 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/60 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Dysphagia	0.57% 2/351 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/352 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/115 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/60 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Enteritis	0.00% 0/351 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/352 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/115 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.7% 1/60 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.

Other adverse events
Measure	Arm A: Nivolumab n=351 participants at risk Nivolumab 240 mg infusion on Day 1 and every two weeks during cycles 1 and 2 for a total of 6 doses. Starting from Cycle 3 Day 1 participants received Nivolumab 480 mg infusion every 4 weeks.	Arm B: Nivolumab + Ipilimumab n=352 participants at risk Nivolumab 240 mg infusion followed by Ipilimumab 1 mg/kg IV on Day 1 and every three weeks during cycles 1 and 2 for a total of 4 doses. Starting from Cycle 3 Day 1, participants received Nivolumab 480 mg infusion every 4 weeks.	Arm C: Chemotherapy n=115 participants at risk Participants received standard of care chemotherapy	Crossover: Nivolumab + Ipilimumab n=60 participants at risk Participants assigned to Arm C that experience documented progression of disease (PD) per RECIST 1.1 by Blinded Independent Central Review (BICR) will have an option to crossover to nivolumab plus ipilimumab therapy (Arm B)
Blood and lymphatic system disorders Anaemia	20.2% 71/351 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	16.5% 58/352 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	22.6% 26/115 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	18.3% 11/60 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Blood and lymphatic system disorders Neutropenia	0.85% 3/351 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.8% 10/352 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	22.6% 26/115 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.3% 2/60 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Blood and lymphatic system disorders Thrombocytopenia	2.3% 8/351 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.4% 5/352 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	9.6% 11/115 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/60 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Endocrine disorders Adrenal insufficiency	2.6% 9/351 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	8.5% 30/352 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/115 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	5.0% 3/60 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Endocrine disorders Hyperthyroidism	5.1% 18/351 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	12.2% 43/352 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.87% 1/115 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.7% 4/60 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Endocrine disorders Hypothyroidism	10.0% 35/351 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	18.5% 65/352 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.87% 1/115 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	15.0% 9/60 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Abdominal pain	19.1% 67/351 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	18.2% 64/352 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	27.0% 31/115 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	15.0% 9/60 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Abdominal pain upper	5.7% 20/351 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	7.7% 27/352 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.1% 7/115 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	10.0% 6/60 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Constipation	11.1% 39/351 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	16.2% 57/352 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	20.9% 24/115 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.7% 4/60 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Diarrhoea	29.1% 102/351 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	33.8% 119/352 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	57.4% 66/115 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	30.0% 18/60 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Dry mouth	5.1% 18/351 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 22/352 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.7% 2/115 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	5.0% 3/60 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Nausea	16.5% 58/351 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	20.5% 72/352 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	47.8% 55/115 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	25.0% 15/60 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Stomatitis	4.0% 14/351 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.6% 9/352 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	10.4% 12/115 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.7% 1/60 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Vomiting	10.8% 38/351 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	11.1% 39/352 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	23.5% 27/115 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	11.7% 7/60 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
General disorders Asthenia	23.9% 84/351 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	26.4% 93/352 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	39.1% 45/115 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	20.0% 12/60 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
General disorders Fatigue	19.1% 67/351 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	19.9% 70/352 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	20.0% 23/115 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	18.3% 11/60 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
General disorders Mucosal inflammation	1.7% 6/351 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.6% 9/352 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.1% 7/115 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.7% 1/60 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
General disorders Oedema peripheral	8.8% 31/351 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	10.8% 38/352 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	9.6% 11/115 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.7% 4/60 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
General disorders Pyrexia	13.7% 48/351 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	12.2% 43/352 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	10.4% 12/115 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	8.3% 5/60 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations COVID-19	9.1% 32/351 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	11.9% 42/352 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	5.2% 6/115 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	13.3% 8/60 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Nasopharyngitis	3.1% 11/351 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	5.4% 19/352 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.5% 4/115 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.7% 1/60 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Urinary tract infection	6.6% 23/351 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	8.5% 30/352 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	9.6% 11/115 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.7% 1/60 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Injury, poisoning and procedural complications Infusion related reaction	1.7% 6/351 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 11/352 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	5.2% 6/115 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.7% 1/60 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Investigations Alanine aminotransferase increased	9.4% 33/351 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	12.2% 43/352 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.1% 7/115 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	5.0% 3/60 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Investigations Amylase increased	5.4% 19/351 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.0% 21/352 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.5% 4/115 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	8.3% 5/60 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Investigations Aspartate aminotransferase increased	9.4% 33/351 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	11.1% 39/352 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.3% 5/115 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.3% 2/60 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Investigations Blood alkaline phosphatase increased	6.3% 22/351 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	5.1% 18/352 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.7% 2/115 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/60 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Investigations Blood bilirubin increased	6.0% 21/351 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	5.7% 20/352 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.87% 1/115 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/60 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Investigations Blood creatinine increased	4.8% 17/351 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 22/352 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.6% 3/115 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	8.3% 5/60 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Investigations Lipase increased	5.1% 18/351 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	7.4% 26/352 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.5% 4/115 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	10.0% 6/60 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Investigations Neutrophil count decreased	1.7% 6/351 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.4% 5/352 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	16.5% 19/115 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.3% 2/60 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Investigations Platelet count decreased	2.8% 10/351 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.85% 3/352 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	7.0% 8/115 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/60 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Investigations Weight decreased	5.4% 19/351 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	5.7% 20/352 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	10.4% 12/115 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.7% 4/60 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Investigations White blood cell count decreased	1.4% 5/351 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.85% 3/352 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	7.0% 8/115 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/60 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Metabolism and nutrition disorders Decreased appetite	13.1% 46/351 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	15.1% 53/352 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	28.7% 33/115 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	18.3% 11/60 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Metabolism and nutrition disorders Hypoalbuminaemia	3.1% 11/351 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 11/352 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	5.2% 6/115 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.7% 1/60 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Metabolism and nutrition disorders Hypokalaemia	3.4% 12/351 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 22/352 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	16.5% 19/115 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	5.0% 3/60 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Metabolism and nutrition disorders Hypomagnesaemia	2.8% 10/351 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.4% 12/352 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	5.2% 6/115 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.3% 2/60 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Metabolism and nutrition disorders Hyponatraemia	2.6% 9/351 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	5.4% 19/352 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.3% 5/115 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.3% 2/60 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Arthralgia	15.4% 54/351 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	19.9% 70/352 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.3% 5/115 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	23.3% 14/60 • Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months). The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.