Trial Outcomes & Findings for Study of Quavonlimab (MK-1308) in Combination With Pembrolizumab (MK-3475) in Advanced Solid Tumors (MK-1308-001) (NCT NCT03179436)

Last Updated: 2025-04-08

Results Overview

DLT was defined as toxicity that is possibly, probably, or definitely related to study therapy and may result in a change in the given dose. DLTs include Grade (Gr)4 non-hematologic toxicity (not laboratory); Gr 4 hematologic toxicity lasting ≥7 days (except thrombocytopenia); most non-hematologic AEs ≥ Gr 3 in severity; any Gr 3 or Gr 4 non-hematologic laboratory value that requires clinically significant medical intervention, leads to hospitalization, persists for \>1 week, or results in a drug-induced liver injury; Gr 3 or Gr 4 febrile neutropenia; a prolonged delay in initiating Cycle 2 or 3 of Dose Escalation or Cycle 2 of Dose Confirmation due to treatment-related toxicity; any treatment-related toxicity that causes the participant to discontinue treatment during the DLT observation period, and Gr 5 toxicity.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

415 participants

Primary outcome timeframe

Up to 6 weeks

Results posted on

2025-04-08

Participant Flow

Per protocol, twenty-one participants who progressed by radiographic evaluation on monotherapy with MK-1308 (Arm G) after consultation with the sponsor crossed over to the combination treatment arm (MK-1308 25 mg + Pembrolizumab 400 mg)

Participant milestones

Participant milestones
Measure	Cohort 1: MK-1308 25 mg Q3W + Pembro. 200 mg Q3W On cycle 1, day 1 of the dose escalation phase, participants with advanced solid tumors received 25 mg quavonlimab (MK-1308) monotherapy followed by 25 mg quavonlimab in combination with 200 mg pembrolizumab (pembro) every 3 weeks (Q3W) for cycles 2-5. Participants then received 200 mg pembrolizumab monotherapy Q3W starting on Cycle 6, for up to 35 cycles total (up to approximately 24 months).	Cohort 2: MK-1308 75 mg Q3W + Pembro. 200 mg Q3W On cycle 1, day 1 of the dose escalation phase, participants with advanced solid tumor except non-small cell lung cancer (NSCLC) received 75 mg quavonlimab monotherapy followed by 75 mg quavonlimab in combination with 200 mg pembrolizumab Q3W for cycles 2-5. Participants then received 200 mg pembrolizumab monotherapy Q3W starting on Cycle 6, for up to 35 cycles total (up to approximately 24 months).	Cohort 3: MK-1308 200 mg Q3W + Pembro. 200 mg Q3W On cycle 1, day 1 of the dose escalation phase, participants with advanced solid tumor except non-small cell lung cancer (NSCLC) received 200 mg quavonlimab monotherapy followed by 200 mg quavonlimab in combination with 200 mg pembrolizumab Q3W for cycles 2-5. Participants then received 200 mg pembrolizumab monotherapy Q3W starting on Cycle 6, for up to 35 cycles total (up to approximately 24 months).	Arm A: MK-1308 25 mg Q3W + Pembro. 200 mg Q3W On cycle 1, day 1 of the dose confirmation phase and during all subsequent cycles, participants with advanced/metastatic NSCLC received 25 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. Participants were treated for 35 cycles total (up to approximately 24 months).	Arm B: MK-1308 25 mg Q6W + Pembro. 200 mg Q3W On cycle 1, day 1 of the dose confirmation phase, participants with advanced/metastatic NSCLC received 25 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. On all subsequent cycles, participants received 200 mg pembrolizumab Q3W and 25 mg quavonlimab every 6 weeks (Q6W). Participants were treated for up to 35 cycles total (up to approximately 24 months).	Arm C: MK-1308 75 mg Q6W + Pembro. 200 mg Q3W On cycle 1, day 1 of the dose confirmation phase, participants with advanced/metastatic NSCLC received 75 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. On all subsequent cycles, participants received 200 mg pembrolizumab Q3W and 75 mg quavonlimab Q6W. Participants were treated for 35 cycles total (up to approximately 24 months).	Arm D: MK-1308 75 mg Q6W + Pembro. 200 mg Q3W On cycle 1, day 1 of the dose confirmation phase, participants with advanced/metastatic small cell lung cancer (SCLC) received 75 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. On all subsequent cycles, participants received 200 mg pembrolizumab Q3W and 75 mg quavonlimab Q6W. Participants were treated for 35 cycles total (up to approximately 24 months).	Arm E: MK-1308 75 mg Q3W + Pembro. 200 mg Q3W On cycle 1, day 1 of the dose confirmation phase and during all subsequent cycles, participants with NSCLC received 75 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. Participants were treated for 35 cycles total (up to approximately 24 months).	Arm F: MK-1308 25 mg Q6W + Pembro. 400 mg Q6W Co-admin On cycle 1, day 1 of the efficacy expansion phase and during all subsequent cycles, participants with programmed cell death protein 1 (PD-1)/programmed cell death ligand 1 (PD-L1) refractory melanoma received 25 mg quavonlimab in combination with 400 mg pembrolizumab. Both quavonlimab and pembrolizumab were administered Q6W for 24 months.	Arm G: MK-1308 25 mg Q6W On cycle 1, day 1 of the efficacy expansion phase and during all subsequent cycles, participants with PD-1/PD-L1 refractory melanoma received 25 mg quavonlimab Q6W for up to 24 months.	Arm I: MK-1308A Q6W (Co-form) On cycle 1, day 1 of the coformulation (Co-form) phase and during all subsequent cycles, participants with advanced/metastatic solid tumors received 400 mg pembrolizumab co-formulated with 25 mg quavonlimab (MK-1308A) Q6W for 24 months.	Arm K: MK-1308A Q6W (Co-form) On cycle 1, day 1 of the coformulation phase and during all subsequent cycles, participants in mainland China with advanced/metastatic solid tumors received 400 mg pembrolizumab co-formulated with 25 mg quavonlimab (MK-1308A) Q6W for 24 months.
Overall Study STARTED	14	18	8	40	40	41	40	14	111	40	29	20
Overall Study Treated	14	17	8	40	40	40	40	14	111	40	29	20
Overall Study Crossed Over to Combination Treatment	0	0	0	0	0	0	0	0	0	21	0	0
Overall Study COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0
Overall Study NOT COMPLETED	14	18	8	40	40	41	40	14	111	40	29	20

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1: MK-1308 25 mg Q3W + Pembro. 200 mg Q3W On cycle 1, day 1 of the dose escalation phase, participants with advanced solid tumors received 25 mg quavonlimab (MK-1308) monotherapy followed by 25 mg quavonlimab in combination with 200 mg pembrolizumab (pembro) every 3 weeks (Q3W) for cycles 2-5. Participants then received 200 mg pembrolizumab monotherapy Q3W starting on Cycle 6, for up to 35 cycles total (up to approximately 24 months).	Cohort 2: MK-1308 75 mg Q3W + Pembro. 200 mg Q3W On cycle 1, day 1 of the dose escalation phase, participants with advanced solid tumor except non-small cell lung cancer (NSCLC) received 75 mg quavonlimab monotherapy followed by 75 mg quavonlimab in combination with 200 mg pembrolizumab Q3W for cycles 2-5. Participants then received 200 mg pembrolizumab monotherapy Q3W starting on Cycle 6, for up to 35 cycles total (up to approximately 24 months).	Cohort 3: MK-1308 200 mg Q3W + Pembro. 200 mg Q3W On cycle 1, day 1 of the dose escalation phase, participants with advanced solid tumor except non-small cell lung cancer (NSCLC) received 200 mg quavonlimab monotherapy followed by 200 mg quavonlimab in combination with 200 mg pembrolizumab Q3W for cycles 2-5. Participants then received 200 mg pembrolizumab monotherapy Q3W starting on Cycle 6, for up to 35 cycles total (up to approximately 24 months).	Arm A: MK-1308 25 mg Q3W + Pembro. 200 mg Q3W On cycle 1, day 1 of the dose confirmation phase and during all subsequent cycles, participants with advanced/metastatic NSCLC received 25 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. Participants were treated for 35 cycles total (up to approximately 24 months).	Arm B: MK-1308 25 mg Q6W + Pembro. 200 mg Q3W On cycle 1, day 1 of the dose confirmation phase, participants with advanced/metastatic NSCLC received 25 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. On all subsequent cycles, participants received 200 mg pembrolizumab Q3W and 25 mg quavonlimab every 6 weeks (Q6W). Participants were treated for up to 35 cycles total (up to approximately 24 months).	Arm C: MK-1308 75 mg Q6W + Pembro. 200 mg Q3W On cycle 1, day 1 of the dose confirmation phase, participants with advanced/metastatic NSCLC received 75 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. On all subsequent cycles, participants received 200 mg pembrolizumab Q3W and 75 mg quavonlimab Q6W. Participants were treated for 35 cycles total (up to approximately 24 months).	Arm D: MK-1308 75 mg Q6W + Pembro. 200 mg Q3W On cycle 1, day 1 of the dose confirmation phase, participants with advanced/metastatic small cell lung cancer (SCLC) received 75 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. On all subsequent cycles, participants received 200 mg pembrolizumab Q3W and 75 mg quavonlimab Q6W. Participants were treated for 35 cycles total (up to approximately 24 months).	Arm E: MK-1308 75 mg Q3W + Pembro. 200 mg Q3W On cycle 1, day 1 of the dose confirmation phase and during all subsequent cycles, participants with NSCLC received 75 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. Participants were treated for 35 cycles total (up to approximately 24 months).	Arm F: MK-1308 25 mg Q6W + Pembro. 400 mg Q6W Co-admin On cycle 1, day 1 of the efficacy expansion phase and during all subsequent cycles, participants with programmed cell death protein 1 (PD-1)/programmed cell death ligand 1 (PD-L1) refractory melanoma received 25 mg quavonlimab in combination with 400 mg pembrolizumab. Both quavonlimab and pembrolizumab were administered Q6W for 24 months.	Arm G: MK-1308 25 mg Q6W On cycle 1, day 1 of the efficacy expansion phase and during all subsequent cycles, participants with PD-1/PD-L1 refractory melanoma received 25 mg quavonlimab Q6W for up to 24 months.	Arm I: MK-1308A Q6W (Co-form) On cycle 1, day 1 of the coformulation (Co-form) phase and during all subsequent cycles, participants with advanced/metastatic solid tumors received 400 mg pembrolizumab co-formulated with 25 mg quavonlimab (MK-1308A) Q6W for 24 months.	Arm K: MK-1308A Q6W (Co-form) On cycle 1, day 1 of the coformulation phase and during all subsequent cycles, participants in mainland China with advanced/metastatic solid tumors received 400 mg pembrolizumab co-formulated with 25 mg quavonlimab (MK-1308A) Q6W for 24 months.
Overall Study Withdrawal by Subject	1	0	0	4	2	2	5	0	3	0	0	0
Overall Study Withdrawal by Parent/Guardian	0	0	0	0	0	0	0	1	0	0	0	0
Overall Study Sponsor Decision	0	0	1	3	9	7	2	4	23	6	7	5
Overall Study Randomized by Mistake without Study Treatment	0	1	0	0	0	1	0	0	0	0	0	0
Overall Study Lost to Follow-up	1	0	0	1	0	1	0	0	1	1	0	0
Overall Study Death	12	17	7	32	29	30	33	9	84	33	22	15

Baseline Characteristics

Study of Quavonlimab (MK-1308) in Combination With Pembrolizumab (MK-3475) in Advanced Solid Tumors (MK-1308-001)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1: MK-1308 25 mg Q3W + Pembro. 200 mg Q3W n=14 Participants On cycle 1, day 1 of the dose escalation phase, participants with advanced solid tumors received 25 mg quavonlimab (MK-1308) monotherapy followed by 25 mg quavonlimab in combination with 200 mg pembrolizumab (pembro) every 3 weeks (Q3W) for cycles 2-5. Participants then received 200 mg pembrolizumab monotherapy Q3W starting on Cycle 6, for up to 35 cycles total (up to approximately 24 months).	Cohort 2: MK-1308 75 mg Q3W + Pembro. 200 mg Q3W n=18 Participants On cycle 1, day 1 of the dose escalation phase, participants with advanced solid tumor except non-small cell lung cancer (NSCLC) received 75 mg quavonlimab monotherapy followed by 75 mg quavonlimab in combination with 200 mg pembrolizumab Q3W for cycles 2-5. Participants then received 200 mg pembrolizumab monotherapy Q3W starting on Cycle 6, for up to 35 cycles total (up to approximately 24 months).	Cohort 3: MK-1308 200 mg Q3W + Pembro. 200 mg Q3W n=8 Participants On cycle 1, day 1 of the dose escalation phase, participants with advanced solid tumor except non-small cell lung cancer (NSCLC) received 200 mg quavonlimab monotherapy followed by 200 mg quavonlimab in combination with 200 mg pembrolizumab Q3W for cycles 2-5. Participants then received 200 mg pembrolizumab monotherapy Q3W starting on Cycle 6, for up to 35 cycles total (up to approximately 24 months).	Arm A: MK-1308 25 mg Q3W + Pembro. 200 mg Q3W n=40 Participants On cycle 1, day 1 of the dose confirmation phase and during all subsequent cycles, participants with advanced/metastatic NSCLC received 25 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. Participants were treated for 35 cycles total (up to approximately 24 months).	Arm B: MK-1308 25 mg Q6W + Pembro. 200 mg Q3W n=40 Participants On cycle 1, day 1 of the dose confirmation phase, participants with advanced/metastatic NSCLC received 25 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. On all subsequent cycles, participants received 200 mg pembrolizumab Q3W and 25 mg quavonlimab every 6 weeks (Q6W). Participants were treated for up to 35 cycles total (up to approximately 24 months).	Arm C: MK-1308 75 mg Q6W + Pembro. 200 mg Q3W n=41 Participants On cycle 1, day 1 of the dose confirmation phase, participants with advanced/metastatic NSCLC received 75 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. On all subsequent cycles, participants received 200 mg pembrolizumab Q3W and 75 mg quavonlimab Q6W. Participants were treated for 35 cycles total (up to approximately 24 months).	Arm D: MK-1308 75 mg Q6W + Pembro. 200 mg Q3W n=40 Participants On cycle 1, day 1 of the dose confirmation phase, participants with advanced/metastatic small cell lung cancer (SCLC) received 75 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. On all subsequent cycles, participants received 200 mg pembrolizumab Q3W and 75 mg quavonlimab Q6W. Participants were treated for 35 cycles total (up to approximately 24 months).	Arm E: MK-1308 75 mg Q3W + Pembro. 200 mg Q3W n=14 Participants On cycle 1, day 1 of the dose confirmation phase and during all subsequent cycles, participants with NSCLC received 75 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. Participants were treated for 35 cycles total (up to approximately 24 months).	Arm F: MK-1308 25 mg Q6W + Pembro. 400 mg Q6W Co-admin n=111 Participants On cycle 1, day 1 of the efficacy expansion phase and during all subsequent cycles, participants with programmed cell death protein 1 (PD-1)/programmed cell death ligand 1 (PD-L1) refractory melanoma received 25 mg quavonlimab in combination with 400 mg pembrolizumab. Both quavonlimab and pembrolizumab were administered Q6W for 24 months.	Arm G: MK-1308 25 mg Q6W n=40 Participants On cycle 1, day 1 of the efficacy expansion phase and during all subsequent cycles, participants with PD-1/PD-L1 refractory melanoma received 25 mg quavonlimab Q6W for up to 24 months.	Arm I: MK-1308A Q6W (Co-form) n=29 Participants On cycle 1, day 1 of the coformulation (Co-form) phase and during all subsequent cycles, participants with advanced/metastatic solid tumors received 400 mg pembrolizumab co-formulated with 25 mg quavonlimab (MK-1308A) Q6W for 24 months.	Arm K: MK-1308A Q6W (Co-form) n=20 Participants On cycle 1, day 1 of the coformulation phase and during all subsequent cycles, participants in mainland China with advanced/metastatic solid tumors received 400 mg pembrolizumab co-formulated with 25 mg quavonlimab (MK-1308A) Q6W for 24 months.	Total n=415 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=40 Participants	0 Participants n=8 Participants	0 Participants n=62 Participants	0 Participants n=95 Participants	0 Participants n=129 Participants	0 Participants n=36 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=93 Participants	12 Participants n=4 Participants	2 Participants n=27 Participants	23 Participants n=483 Participants	18 Participants n=36 Participants	17 Participants n=10 Participants	17 Participants n=115 Participants	4 Participants n=40 Participants	53 Participants n=8 Participants	24 Participants n=62 Participants	16 Participants n=95 Participants	14 Participants n=129 Participants	208 Participants n=36 Participants
Age, Categorical >=65 years	6 Participants n=93 Participants	6 Participants n=4 Participants	6 Participants n=27 Participants	17 Participants n=483 Participants	22 Participants n=36 Participants	24 Participants n=10 Participants	23 Participants n=115 Participants	10 Participants n=40 Participants	58 Participants n=8 Participants	16 Participants n=62 Participants	13 Participants n=95 Participants	6 Participants n=129 Participants	207 Participants n=36 Participants
Sex: Female, Male Female	11 Participants n=93 Participants	10 Participants n=4 Participants	4 Participants n=27 Participants	10 Participants n=483 Participants	12 Participants n=36 Participants	17 Participants n=10 Participants	16 Participants n=115 Participants	5 Participants n=40 Participants	34 Participants n=8 Participants	18 Participants n=62 Participants	13 Participants n=95 Participants	8 Participants n=129 Participants	158 Participants n=36 Participants
Sex: Female, Male Male	3 Participants n=93 Participants	8 Participants n=4 Participants	4 Participants n=27 Participants	30 Participants n=483 Participants	28 Participants n=36 Participants	24 Participants n=10 Participants	24 Participants n=115 Participants	9 Participants n=40 Participants	77 Participants n=8 Participants	22 Participants n=62 Participants	16 Participants n=95 Participants	12 Participants n=129 Participants	257 Participants n=36 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants	0 Participants n=483 Participants	3 Participants n=36 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=40 Participants	1 Participants n=8 Participants	4 Participants n=62 Participants	0 Participants n=95 Participants	0 Participants n=129 Participants	11 Participants n=36 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=93 Participants	17 Participants n=4 Participants	7 Participants n=27 Participants	40 Participants n=483 Participants	37 Participants n=36 Participants	41 Participants n=10 Participants	39 Participants n=115 Participants	13 Participants n=40 Participants	102 Participants n=8 Participants	33 Participants n=62 Participants	29 Participants n=95 Participants	20 Participants n=129 Participants	391 Participants n=36 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants	1 Participants n=40 Participants	8 Participants n=8 Participants	3 Participants n=62 Participants	0 Participants n=95 Participants	0 Participants n=129 Participants	13 Participants n=36 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=40 Participants	0 Participants n=8 Participants	0 Participants n=62 Participants	0 Participants n=95 Participants	0 Participants n=129 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	30 Participants n=483 Participants	26 Participants n=36 Participants	26 Participants n=10 Participants	16 Participants n=115 Participants	8 Participants n=40 Participants	3 Participants n=8 Participants	0 Participants n=62 Participants	3 Participants n=95 Participants	20 Participants n=129 Participants	132 Participants n=36 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=40 Participants	0 Participants n=8 Participants	0 Participants n=62 Participants	3 Participants n=95 Participants	0 Participants n=129 Participants	3 Participants n=36 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	1 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	1 Participants n=10 Participants	1 Participants n=115 Participants	0 Participants n=40 Participants	0 Participants n=8 Participants	0 Participants n=62 Participants	0 Participants n=95 Participants	0 Participants n=129 Participants	3 Participants n=36 Participants
Race (NIH/OMB) White	14 Participants n=93 Participants	17 Participants n=4 Participants	8 Participants n=27 Participants	10 Participants n=483 Participants	14 Participants n=36 Participants	14 Participants n=10 Participants	23 Participants n=115 Participants	6 Participants n=40 Participants	105 Participants n=8 Participants	38 Participants n=62 Participants	23 Participants n=95 Participants	0 Participants n=129 Participants	272 Participants n=36 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=40 Participants	0 Participants n=8 Participants	0 Participants n=62 Participants	0 Participants n=95 Participants	0 Participants n=129 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=40 Participants	3 Participants n=8 Participants	2 Participants n=62 Participants	0 Participants n=95 Participants	0 Participants n=129 Participants	5 Participants n=36 Participants

PRIMARY outcome

Timeframe: Up to 6 weeks

Population: The DLT evaluable population consists of all participants who received ≥1 dose of study treatment who finished the DLT observation period in the dose escalation or dose confirmation phase. Per protocol, no analysis was planned for the efficacy expansion phase (Arms F and G), coformulation phase (Arms I and K) and cross over phase (MK-1308 25 mg and Pembrolizumab 400 mg).

Outcome measures

Outcome measures
Measure	Cohort 1: MK-1308 25 mg Q3W + Pembro. 200 mg Q3W n=13 Participants On cycle 1, day 1 of the dose escalation phase, participants with advanced solid tumors received 25 mg quavonlimab (MK-1308) monotherapy followed by 25 mg quavonlimab in combination with 200 mg pembrolizumab (pembro) every 3 weeks (Q3W) for cycles 2-5. Participants then received 200 mg pembrolizumab monotherapy Q3W starting on Cycle 6, for up to 35 cycles total (up to approximately 24 months).	Cohort 2: MK-1308 75 mg Q3W + Pembro. 200 mg Q3W n=15 Participants On cycle 1, day 1 of the dose escalation phase, participants with advanced solid tumor except non-small cell lung cancer (NSCLC) received 75 mg quavonlimab monotherapy followed by 75 mg quavonlimab in combination with 200 mg pembrolizumab Q3W for cycles 2-5. Participants then received 200 mg pembrolizumab monotherapy Q3W starting on Cycle 6, for up to 35 cycles total (up to approximately 24 months).	Cohort 3: MK-1308 200 mg Q3W + Pembro. 200 mg Q3W n=7 Participants On cycle 1, day 1 of the dose escalation phase, participants with advanced solid tumor except non-small cell lung cancer (NSCLC) received 200 mg quavonlimab monotherapy followed by 200 mg quavonlimab in combination with 200 mg pembrolizumab Q3W for cycles 2-5. Participants then received 200 mg pembrolizumab monotherapy Q3W starting on Cycle 6, for up to 35 cycles total (up to approximately 24 months).	Arm A: MK-1308 25 mg Q3W + Pembro. 200 mg Q3W n=40 Participants On cycle 1, day 1 of the dose confirmation phase and during all subsequent cycles, participants with advanced/metastatic NSCLC received 25 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. Participants were treated for 35 cycles total (up to approximately 24 months).	Arm B: MK-1308 25 mg Q6W + Pembro. 200 mg Q3W n=40 Participants On cycle 1, day 1 of the dose confirmation phase, participants with advanced/metastatic NSCLC received 25 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. On all subsequent cycles, participants received 200 mg pembrolizumab Q3W and 25 mg quavonlimab every 6 weeks (Q6W). Participants were treated for up to 35 cycles total (up to approximately 24 months).	Arm C: MK-1308 75 mg Q6W + Pembro. 200 mg Q3W n=40 Participants On cycle 1, day 1 of the dose confirmation phase, participants with advanced/metastatic NSCLC received 75 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. On all subsequent cycles, participants received 200 mg pembrolizumab Q3W and 75 mg quavonlimab Q6W. Participants were treated for 35 cycles total (up to approximately 24 months).	Arm D: MK-1308 75 mg Q6W + Pembro. 200 mg Q3W n=40 Participants On cycle 1, day 1 of the dose confirmation phase, participants with advanced/metastatic small cell lung cancer (SCLC) received 75 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. On all subsequent cycles, participants received 200 mg pembrolizumab Q3W and 75 mg quavonlimab Q6W. Participants were treated for 35 cycles total (up to approximately 24 months).	Arm E: MK-1308 75 mg Q3W + Pembro. 200 mg Q3W n=14 Participants On cycle 1, day 1 of the dose confirmation phase and during all subsequent cycles, participants with NSCLC received 75 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. Participants were treated for 35 cycles total (up to approximately 24 months).	Arm F: MK-1308 25 mg Q6W + Pembro. 400 mg Q6W Co-admin On cycle 1, day 1 of the efficacy expansion phase and during all subsequent cycles, participants with programmed cell death protein 1 (PD-1)/programmed cell death ligand 1 (PD-L1) refractory melanoma received 25 mg quavonlimab in combination with 400 mg pembrolizumab. Both quavonlimab and pembrolizumab were administered Q6W for 24 months.	Arm G: MK-1308 25 mg Q6W On cycle 1, day 1 of the efficacy expansion phase and during all subsequent cycles, participants with PD-1/PD-L1 refractory melanoma received 25 mg quavonlimab Q6W for up to 24 months.	Arm I: MK-1308A Q6W (Co-form) On cycle 1, day 1 of the coformulation (Co-form) phase and during all subsequent cycles, participants with advanced/metastatic solid tumors received 400 mg pembrolizumab co-formulated with 25 mg quavonlimab (MK-1308A) Q6W for 24 months.	Arm K: MK-1308A Q6W (Co-form) On cycle 1, day 1 of the coformulation phase and during all subsequent cycles, participants in mainland China with advanced/metastatic solid tumors received 400 mg pembrolizumab co-formulated with 25 mg quavonlimab (MK-1308A) Q6W for 24 months.
Percentage of Participants With ≥1 Dose Limiting Toxicity (DLT)	0.0 Percentage of Participants Interval 0.0 to 10.9	13.3 Percentage of Participants Interval 4.9 to 26.6	0.0 Percentage of Participants Interval 0.0 to 18.2	7.5 Percentage of Participants Interval 3.3 to 14.0	5.0 Percentage of Participants Interval 1.7 to 10.8	10.0 Percentage of Participants Interval 5.0 to 17.1	10.0 Percentage of Participants Interval 5.0 to 17.1	7.1 Percentage of Participants Interval 1.4 to 19.4	—	—	—	—

PRIMARY outcome

Timeframe: Up to approximately 77 months

Population: All participants who received at least one dose of study intervention

An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment. Per protocol, no analysis was planned for the cross over phase. The number of participants who experienced an AE are presented.

Outcome measures

Outcome measures
Measure	Cohort 1: MK-1308 25 mg Q3W + Pembro. 200 mg Q3W n=14 Participants On cycle 1, day 1 of the dose escalation phase, participants with advanced solid tumors received 25 mg quavonlimab (MK-1308) monotherapy followed by 25 mg quavonlimab in combination with 200 mg pembrolizumab (pembro) every 3 weeks (Q3W) for cycles 2-5. Participants then received 200 mg pembrolizumab monotherapy Q3W starting on Cycle 6, for up to 35 cycles total (up to approximately 24 months).	Cohort 2: MK-1308 75 mg Q3W + Pembro. 200 mg Q3W n=17 Participants On cycle 1, day 1 of the dose escalation phase, participants with advanced solid tumor except non-small cell lung cancer (NSCLC) received 75 mg quavonlimab monotherapy followed by 75 mg quavonlimab in combination with 200 mg pembrolizumab Q3W for cycles 2-5. Participants then received 200 mg pembrolizumab monotherapy Q3W starting on Cycle 6, for up to 35 cycles total (up to approximately 24 months).	Cohort 3: MK-1308 200 mg Q3W + Pembro. 200 mg Q3W n=8 Participants On cycle 1, day 1 of the dose escalation phase, participants with advanced solid tumor except non-small cell lung cancer (NSCLC) received 200 mg quavonlimab monotherapy followed by 200 mg quavonlimab in combination with 200 mg pembrolizumab Q3W for cycles 2-5. Participants then received 200 mg pembrolizumab monotherapy Q3W starting on Cycle 6, for up to 35 cycles total (up to approximately 24 months).	Arm A: MK-1308 25 mg Q3W + Pembro. 200 mg Q3W n=40 Participants On cycle 1, day 1 of the dose confirmation phase and during all subsequent cycles, participants with advanced/metastatic NSCLC received 25 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. Participants were treated for 35 cycles total (up to approximately 24 months).	Arm B: MK-1308 25 mg Q6W + Pembro. 200 mg Q3W n=40 Participants On cycle 1, day 1 of the dose confirmation phase, participants with advanced/metastatic NSCLC received 25 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. On all subsequent cycles, participants received 200 mg pembrolizumab Q3W and 25 mg quavonlimab every 6 weeks (Q6W). Participants were treated for up to 35 cycles total (up to approximately 24 months).	Arm C: MK-1308 75 mg Q6W + Pembro. 200 mg Q3W n=40 Participants On cycle 1, day 1 of the dose confirmation phase, participants with advanced/metastatic NSCLC received 75 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. On all subsequent cycles, participants received 200 mg pembrolizumab Q3W and 75 mg quavonlimab Q6W. Participants were treated for 35 cycles total (up to approximately 24 months).	Arm D: MK-1308 75 mg Q6W + Pembro. 200 mg Q3W n=40 Participants On cycle 1, day 1 of the dose confirmation phase, participants with advanced/metastatic small cell lung cancer (SCLC) received 75 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. On all subsequent cycles, participants received 200 mg pembrolizumab Q3W and 75 mg quavonlimab Q6W. Participants were treated for 35 cycles total (up to approximately 24 months).	Arm E: MK-1308 75 mg Q3W + Pembro. 200 mg Q3W n=14 Participants On cycle 1, day 1 of the dose confirmation phase and during all subsequent cycles, participants with NSCLC received 75 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. Participants were treated for 35 cycles total (up to approximately 24 months).	Arm F: MK-1308 25 mg Q6W + Pembro. 400 mg Q6W Co-admin n=111 Participants On cycle 1, day 1 of the efficacy expansion phase and during all subsequent cycles, participants with programmed cell death protein 1 (PD-1)/programmed cell death ligand 1 (PD-L1) refractory melanoma received 25 mg quavonlimab in combination with 400 mg pembrolizumab. Both quavonlimab and pembrolizumab were administered Q6W for 24 months.	Arm G: MK-1308 25 mg Q6W n=40 Participants On cycle 1, day 1 of the efficacy expansion phase and during all subsequent cycles, participants with PD-1/PD-L1 refractory melanoma received 25 mg quavonlimab Q6W for up to 24 months.	Arm I: MK-1308A Q6W (Co-form) n=29 Participants On cycle 1, day 1 of the coformulation (Co-form) phase and during all subsequent cycles, participants with advanced/metastatic solid tumors received 400 mg pembrolizumab co-formulated with 25 mg quavonlimab (MK-1308A) Q6W for 24 months.	Arm K: MK-1308A Q6W (Co-form) n=20 Participants On cycle 1, day 1 of the coformulation phase and during all subsequent cycles, participants in mainland China with advanced/metastatic solid tumors received 400 mg pembrolizumab co-formulated with 25 mg quavonlimab (MK-1308A) Q6W for 24 months.
Number of Participants With ≥1 Adverse Event (AE)	14 Participants	17 Participants	8 Participants	39 Participants	38 Participants	40 Participants	38 Participants	14 Participants	104 Participants	37 Participants	28 Participants	18 Participants

PRIMARY outcome

Timeframe: Up to approximately 26 months

Population: All participants who received at least one dose of study intervention.

Outcome measures

Outcome measures
Measure	Cohort 1: MK-1308 25 mg Q3W + Pembro. 200 mg Q3W n=14 Participants On cycle 1, day 1 of the dose escalation phase, participants with advanced solid tumors received 25 mg quavonlimab (MK-1308) monotherapy followed by 25 mg quavonlimab in combination with 200 mg pembrolizumab (pembro) every 3 weeks (Q3W) for cycles 2-5. Participants then received 200 mg pembrolizumab monotherapy Q3W starting on Cycle 6, for up to 35 cycles total (up to approximately 24 months).	Cohort 2: MK-1308 75 mg Q3W + Pembro. 200 mg Q3W n=17 Participants On cycle 1, day 1 of the dose escalation phase, participants with advanced solid tumor except non-small cell lung cancer (NSCLC) received 75 mg quavonlimab monotherapy followed by 75 mg quavonlimab in combination with 200 mg pembrolizumab Q3W for cycles 2-5. Participants then received 200 mg pembrolizumab monotherapy Q3W starting on Cycle 6, for up to 35 cycles total (up to approximately 24 months).	Cohort 3: MK-1308 200 mg Q3W + Pembro. 200 mg Q3W n=8 Participants On cycle 1, day 1 of the dose escalation phase, participants with advanced solid tumor except non-small cell lung cancer (NSCLC) received 200 mg quavonlimab monotherapy followed by 200 mg quavonlimab in combination with 200 mg pembrolizumab Q3W for cycles 2-5. Participants then received 200 mg pembrolizumab monotherapy Q3W starting on Cycle 6, for up to 35 cycles total (up to approximately 24 months).	Arm A: MK-1308 25 mg Q3W + Pembro. 200 mg Q3W n=40 Participants On cycle 1, day 1 of the dose confirmation phase and during all subsequent cycles, participants with advanced/metastatic NSCLC received 25 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. Participants were treated for 35 cycles total (up to approximately 24 months).	Arm B: MK-1308 25 mg Q6W + Pembro. 200 mg Q3W n=40 Participants On cycle 1, day 1 of the dose confirmation phase, participants with advanced/metastatic NSCLC received 25 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. On all subsequent cycles, participants received 200 mg pembrolizumab Q3W and 25 mg quavonlimab every 6 weeks (Q6W). Participants were treated for up to 35 cycles total (up to approximately 24 months).	Arm C: MK-1308 75 mg Q6W + Pembro. 200 mg Q3W n=40 Participants On cycle 1, day 1 of the dose confirmation phase, participants with advanced/metastatic NSCLC received 75 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. On all subsequent cycles, participants received 200 mg pembrolizumab Q3W and 75 mg quavonlimab Q6W. Participants were treated for 35 cycles total (up to approximately 24 months).	Arm D: MK-1308 75 mg Q6W + Pembro. 200 mg Q3W n=40 Participants On cycle 1, day 1 of the dose confirmation phase, participants with advanced/metastatic small cell lung cancer (SCLC) received 75 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. On all subsequent cycles, participants received 200 mg pembrolizumab Q3W and 75 mg quavonlimab Q6W. Participants were treated for 35 cycles total (up to approximately 24 months).	Arm E: MK-1308 75 mg Q3W + Pembro. 200 mg Q3W n=14 Participants On cycle 1, day 1 of the dose confirmation phase and during all subsequent cycles, participants with NSCLC received 75 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. Participants were treated for 35 cycles total (up to approximately 24 months).	Arm F: MK-1308 25 mg Q6W + Pembro. 400 mg Q6W Co-admin n=111 Participants On cycle 1, day 1 of the efficacy expansion phase and during all subsequent cycles, participants with programmed cell death protein 1 (PD-1)/programmed cell death ligand 1 (PD-L1) refractory melanoma received 25 mg quavonlimab in combination with 400 mg pembrolizumab. Both quavonlimab and pembrolizumab were administered Q6W for 24 months.	Arm G: MK-1308 25 mg Q6W n=40 Participants On cycle 1, day 1 of the efficacy expansion phase and during all subsequent cycles, participants with PD-1/PD-L1 refractory melanoma received 25 mg quavonlimab Q6W for up to 24 months.	Arm I: MK-1308A Q6W (Co-form) n=29 Participants On cycle 1, day 1 of the coformulation (Co-form) phase and during all subsequent cycles, participants with advanced/metastatic solid tumors received 400 mg pembrolizumab co-formulated with 25 mg quavonlimab (MK-1308A) Q6W for 24 months.	Arm K: MK-1308A Q6W (Co-form) n=20 Participants On cycle 1, day 1 of the coformulation phase and during all subsequent cycles, participants in mainland China with advanced/metastatic solid tumors received 400 mg pembrolizumab co-formulated with 25 mg quavonlimab (MK-1308A) Q6W for 24 months.
Number of Participants Discontinuing Study Treatment Due to an AE	1 Participants	4 Participants	3 Participants	7 Participants	7 Participants	17 Participants	7 Participants	6 Participants	14 Participants	1 Participants	4 Participants	2 Participants

PRIMARY outcome

Timeframe: Up to approximately 72 months

Population: All participants with a baseline scan that demonstrated measurable disease and who were administered at least 1 dose of study intervention.

ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per adjusted Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR in the concurrent randomized subset as assessed by Blinded Independent Central Review (BICR) will be presented. Per protocol, only data for arms F and G were presented for this endpoint.

Outcome measures

Outcome measures
Measure	Cohort 1: MK-1308 25 mg Q3W + Pembro. 200 mg Q3W On cycle 1, day 1 of the dose escalation phase, participants with advanced solid tumors received 25 mg quavonlimab (MK-1308) monotherapy followed by 25 mg quavonlimab in combination with 200 mg pembrolizumab (pembro) every 3 weeks (Q3W) for cycles 2-5. Participants then received 200 mg pembrolizumab monotherapy Q3W starting on Cycle 6, for up to 35 cycles total (up to approximately 24 months).	Cohort 2: MK-1308 75 mg Q3W + Pembro. 200 mg Q3W On cycle 1, day 1 of the dose escalation phase, participants with advanced solid tumor except non-small cell lung cancer (NSCLC) received 75 mg quavonlimab monotherapy followed by 75 mg quavonlimab in combination with 200 mg pembrolizumab Q3W for cycles 2-5. Participants then received 200 mg pembrolizumab monotherapy Q3W starting on Cycle 6, for up to 35 cycles total (up to approximately 24 months).	Cohort 3: MK-1308 200 mg Q3W + Pembro. 200 mg Q3W On cycle 1, day 1 of the dose escalation phase, participants with advanced solid tumor except non-small cell lung cancer (NSCLC) received 200 mg quavonlimab monotherapy followed by 200 mg quavonlimab in combination with 200 mg pembrolizumab Q3W for cycles 2-5. Participants then received 200 mg pembrolizumab monotherapy Q3W starting on Cycle 6, for up to 35 cycles total (up to approximately 24 months).	Arm A: MK-1308 25 mg Q3W + Pembro. 200 mg Q3W On cycle 1, day 1 of the dose confirmation phase and during all subsequent cycles, participants with advanced/metastatic NSCLC received 25 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. Participants were treated for 35 cycles total (up to approximately 24 months).	Arm B: MK-1308 25 mg Q6W + Pembro. 200 mg Q3W On cycle 1, day 1 of the dose confirmation phase, participants with advanced/metastatic NSCLC received 25 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. On all subsequent cycles, participants received 200 mg pembrolizumab Q3W and 25 mg quavonlimab every 6 weeks (Q6W). Participants were treated for up to 35 cycles total (up to approximately 24 months).	Arm C: MK-1308 75 mg Q6W + Pembro. 200 mg Q3W On cycle 1, day 1 of the dose confirmation phase, participants with advanced/metastatic NSCLC received 75 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. On all subsequent cycles, participants received 200 mg pembrolizumab Q3W and 75 mg quavonlimab Q6W. Participants were treated for 35 cycles total (up to approximately 24 months).	Arm D: MK-1308 75 mg Q6W + Pembro. 200 mg Q3W On cycle 1, day 1 of the dose confirmation phase, participants with advanced/metastatic small cell lung cancer (SCLC) received 75 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. On all subsequent cycles, participants received 200 mg pembrolizumab Q3W and 75 mg quavonlimab Q6W. Participants were treated for 35 cycles total (up to approximately 24 months).	Arm E: MK-1308 75 mg Q3W + Pembro. 200 mg Q3W On cycle 1, day 1 of the dose confirmation phase and during all subsequent cycles, participants with NSCLC received 75 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. Participants were treated for 35 cycles total (up to approximately 24 months).	Arm F: MK-1308 25 mg Q6W + Pembro. 400 mg Q6W Co-admin n=41 Participants On cycle 1, day 1 of the efficacy expansion phase and during all subsequent cycles, participants with programmed cell death protein 1 (PD-1)/programmed cell death ligand 1 (PD-L1) refractory melanoma received 25 mg quavonlimab in combination with 400 mg pembrolizumab. Both quavonlimab and pembrolizumab were administered Q6W for 24 months.	Arm G: MK-1308 25 mg Q6W n=40 Participants On cycle 1, day 1 of the efficacy expansion phase and during all subsequent cycles, participants with PD-1/PD-L1 refractory melanoma received 25 mg quavonlimab Q6W for up to 24 months.	Arm I: MK-1308A Q6W (Co-form) On cycle 1, day 1 of the coformulation (Co-form) phase and during all subsequent cycles, participants with advanced/metastatic solid tumors received 400 mg pembrolizumab co-formulated with 25 mg quavonlimab (MK-1308A) Q6W for 24 months.	Arm K: MK-1308A Q6W (Co-form) On cycle 1, day 1 of the coformulation phase and during all subsequent cycles, participants in mainland China with advanced/metastatic solid tumors received 400 mg pembrolizumab co-formulated with 25 mg quavonlimab (MK-1308A) Q6W for 24 months.
Efficacy Expansion: Objective Response Rate (ORR) as Assessed by Blinded Independent Central Review (BICR) Based on Adjusted Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)	—	—	—	—	—	—	—	—	4.9 Percentage of participants Interval 0.6 to 16.5	2.5 Percentage of participants Interval 0.1 to 13.2	—	—

SECONDARY outcome

Timeframe: At designated time points up to - Cohorts 1-3: Day 15 Cycle 3, Arms A, B, C, D, E: Day 15 Cycle 3, Arm F: Day 21 Cycle 3, Arm I: Day 21 Cycle 3, Arm K: Day 21 Cycle 3. Each cycle is 21 days.

Population: Participants who complied with the protocol sufficiently to ensure that their data will be likely to show the effects of treatment, according to the underlying scientific model and had available data from at least 1 dose of study intervention.

AUC was defined as a measure of pembrolizumab exposure that was calculated as the product of plasma drug concentration and time after drug administration. AUC determined by blood samples collected pre-dose and at designated timepoints post-dose are presented. Per protocol, no analysis was planned for participants in arm G and cross over phase. AUC of pembrolizumab is presented. Blood sampling was taken for Cohorts 1-3: Predose and Postdose on Days 1, 8, 15 on Cycles 2 and 3. Arms A, B, C, D, E: Predose and Postdose on Days 1, 8, 15 on Cycles 1, 2, 3. Arm F: Predose and Postdose on Day 1 and 21 on Cycles 1, 2, 3. Arm I: Predose and Postdose on Day 1 and 21 on Cycles 1, 2, 3. Arm K: Predose and Postdose on Days 1, 2, 8, 15, 21 on Cycles 1, 2; Days 1, 21 on Cycle 3. Each cycle is 21 days.

Outcome measures

Outcome measures
Measure	Cohort 1: MK-1308 25 mg Q3W + Pembro. 200 mg Q3W n=11 Participants On cycle 1, day 1 of the dose escalation phase, participants with advanced solid tumors received 25 mg quavonlimab (MK-1308) monotherapy followed by 25 mg quavonlimab in combination with 200 mg pembrolizumab (pembro) every 3 weeks (Q3W) for cycles 2-5. Participants then received 200 mg pembrolizumab monotherapy Q3W starting on Cycle 6, for up to 35 cycles total (up to approximately 24 months).	Cohort 2: MK-1308 75 mg Q3W + Pembro. 200 mg Q3W n=8 Participants On cycle 1, day 1 of the dose escalation phase, participants with advanced solid tumor except non-small cell lung cancer (NSCLC) received 75 mg quavonlimab monotherapy followed by 75 mg quavonlimab in combination with 200 mg pembrolizumab Q3W for cycles 2-5. Participants then received 200 mg pembrolizumab monotherapy Q3W starting on Cycle 6, for up to 35 cycles total (up to approximately 24 months).	Cohort 3: MK-1308 200 mg Q3W + Pembro. 200 mg Q3W n=3 Participants On cycle 1, day 1 of the dose escalation phase, participants with advanced solid tumor except non-small cell lung cancer (NSCLC) received 200 mg quavonlimab monotherapy followed by 200 mg quavonlimab in combination with 200 mg pembrolizumab Q3W for cycles 2-5. Participants then received 200 mg pembrolizumab monotherapy Q3W starting on Cycle 6, for up to 35 cycles total (up to approximately 24 months).	Arm A: MK-1308 25 mg Q3W + Pembro. 200 mg Q3W n=30 Participants On cycle 1, day 1 of the dose confirmation phase and during all subsequent cycles, participants with advanced/metastatic NSCLC received 25 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. Participants were treated for 35 cycles total (up to approximately 24 months).	Arm B: MK-1308 25 mg Q6W + Pembro. 200 mg Q3W n=34 Participants On cycle 1, day 1 of the dose confirmation phase, participants with advanced/metastatic NSCLC received 25 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. On all subsequent cycles, participants received 200 mg pembrolizumab Q3W and 25 mg quavonlimab every 6 weeks (Q6W). Participants were treated for up to 35 cycles total (up to approximately 24 months).	Arm C: MK-1308 75 mg Q6W + Pembro. 200 mg Q3W n=27 Participants On cycle 1, day 1 of the dose confirmation phase, participants with advanced/metastatic NSCLC received 75 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. On all subsequent cycles, participants received 200 mg pembrolizumab Q3W and 75 mg quavonlimab Q6W. Participants were treated for 35 cycles total (up to approximately 24 months).	Arm D: MK-1308 75 mg Q6W + Pembro. 200 mg Q3W n=28 Participants On cycle 1, day 1 of the dose confirmation phase, participants with advanced/metastatic small cell lung cancer (SCLC) received 75 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. On all subsequent cycles, participants received 200 mg pembrolizumab Q3W and 75 mg quavonlimab Q6W. Participants were treated for 35 cycles total (up to approximately 24 months).	Arm E: MK-1308 75 mg Q3W + Pembro. 200 mg Q3W n=9 Participants On cycle 1, day 1 of the dose confirmation phase and during all subsequent cycles, participants with NSCLC received 75 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. Participants were treated for 35 cycles total (up to approximately 24 months).	Arm F: MK-1308 25 mg Q6W + Pembro. 400 mg Q6W Co-admin n=31 Participants On cycle 1, day 1 of the efficacy expansion phase and during all subsequent cycles, participants with programmed cell death protein 1 (PD-1)/programmed cell death ligand 1 (PD-L1) refractory melanoma received 25 mg quavonlimab in combination with 400 mg pembrolizumab. Both quavonlimab and pembrolizumab were administered Q6W for 24 months.	Arm G: MK-1308 25 mg Q6W On cycle 1, day 1 of the efficacy expansion phase and during all subsequent cycles, participants with PD-1/PD-L1 refractory melanoma received 25 mg quavonlimab Q6W for up to 24 months.	Arm I: MK-1308A Q6W (Co-form) n=8 Participants On cycle 1, day 1 of the coformulation (Co-form) phase and during all subsequent cycles, participants with advanced/metastatic solid tumors received 400 mg pembrolizumab co-formulated with 25 mg quavonlimab (MK-1308A) Q6W for 24 months.	Arm K: MK-1308A Q6W (Co-form) n=20 Participants On cycle 1, day 1 of the coformulation phase and during all subsequent cycles, participants in mainland China with advanced/metastatic solid tumors received 400 mg pembrolizumab co-formulated with 25 mg quavonlimab (MK-1308A) Q6W for 24 months.
Area Under the Plasma Concentration Time Curve (AUC) of Pembrolizumab Cycle 1	—	—	—	608 day*μg/mL Geometric Coefficient of Variation 24.6	620 day*μg/mL Geometric Coefficient of Variation 25.9	627 day*μg/mL Geometric Coefficient of Variation 20.6	642 day*μg/mL Geometric Coefficient of Variation 23.9	554 day*μg/mL Geometric Coefficient of Variation 15.6	2050 day*μg/mL Geometric Coefficient of Variation 33.6	—	2250 day*μg/mL Geometric Coefficient of Variation 18.7	1610 day*μg/mL Geometric Coefficient of Variation 25.0
Area Under the Plasma Concentration Time Curve (AUC) of Pembrolizumab Cycle 2	729 day*μg/mL Geometric Coefficient of Variation 18.3	546 day*μg/mL Geometric Coefficient of Variation 40.5	727 day*μg/mL Geometric Coefficient of Variation 24.5	788 day*μg/mL Geometric Coefficient of Variation 24.7	854 day*μg/mL Geometric Coefficient of Variation 19.9	822 day*μg/mL Geometric Coefficient of Variation 25.0	877 day*μg/mL Geometric Coefficient of Variation 28.3	794 day*μg/mL Geometric Coefficient of Variation 18.0	2370 day*μg/mL Geometric Coefficient of Variation 40.6	—	2820 day*μg/mL Geometric Coefficient of Variation 29.7	1770 day*μg/mL Geometric Coefficient of Variation 34.4
Area Under the Plasma Concentration Time Curve (AUC) of Pembrolizumab Cycle 3	—	—	—	911 day*μg/mL Geometric Coefficient of Variation 22.7	971 day*μg/mL Geometric Coefficient of Variation 22.9	944 day*μg/mL Geometric Coefficient of Variation 26.0	1050 day*μg/mL Geometric Coefficient of Variation 20.8	872 day*μg/mL Geometric Coefficient of Variation 16.3	2410 day*μg/mL Geometric Coefficient of Variation 29.5	—	3410 day*μg/mL Geometric Coefficient of Variation 16.1	2440 day*μg/mL Geometric Coefficient of Variation 39.8

SECONDARY outcome

Cmax was defined as the maximum concentration of pembrolizumab observed in plasma. Cmax determined by blood samples collected pre-dose and at designated timepoints post-dose are presented. Per protocol, no analysis was planned for participants in arm G and cross over phase. Cmax of pembrolizumab is presented. Blood sampling was taken for Cohorts 1-3: Predose and Postdose on Days 1, 8, 15 on Cycles 2 and 3. Arms A, B, C, D, E: Predose and Postdose on Days 1, 8, 15 on Cycles 1, 2, 3. Arm F: Predose and Postdose on Day 1 and 21 on Cycles 1, 2, 3. Arm I: Predose and Postdose on Day 1 and 21 on Cycles 1, 2, 3. Arm K: Predose and Postdose on Days 1, 2, 8, 15, 21 on Cycles 1, 2; Days 1, 21 on Cycle 3. Each cycle is 21 days.

Outcome measures

Outcome measures
Measure	Cohort 1: MK-1308 25 mg Q3W + Pembro. 200 mg Q3W n=13 Participants On cycle 1, day 1 of the dose escalation phase, participants with advanced solid tumors received 25 mg quavonlimab (MK-1308) monotherapy followed by 25 mg quavonlimab in combination with 200 mg pembrolizumab (pembro) every 3 weeks (Q3W) for cycles 2-5. Participants then received 200 mg pembrolizumab monotherapy Q3W starting on Cycle 6, for up to 35 cycles total (up to approximately 24 months).	Cohort 2: MK-1308 75 mg Q3W + Pembro. 200 mg Q3W n=13 Participants On cycle 1, day 1 of the dose escalation phase, participants with advanced solid tumor except non-small cell lung cancer (NSCLC) received 75 mg quavonlimab monotherapy followed by 75 mg quavonlimab in combination with 200 mg pembrolizumab Q3W for cycles 2-5. Participants then received 200 mg pembrolizumab monotherapy Q3W starting on Cycle 6, for up to 35 cycles total (up to approximately 24 months).	Cohort 3: MK-1308 200 mg Q3W + Pembro. 200 mg Q3W n=8 Participants On cycle 1, day 1 of the dose escalation phase, participants with advanced solid tumor except non-small cell lung cancer (NSCLC) received 200 mg quavonlimab monotherapy followed by 200 mg quavonlimab in combination with 200 mg pembrolizumab Q3W for cycles 2-5. Participants then received 200 mg pembrolizumab monotherapy Q3W starting on Cycle 6, for up to 35 cycles total (up to approximately 24 months).	Arm A: MK-1308 25 mg Q3W + Pembro. 200 mg Q3W n=39 Participants On cycle 1, day 1 of the dose confirmation phase and during all subsequent cycles, participants with advanced/metastatic NSCLC received 25 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. Participants were treated for 35 cycles total (up to approximately 24 months).	Arm B: MK-1308 25 mg Q6W + Pembro. 200 mg Q3W n=40 Participants On cycle 1, day 1 of the dose confirmation phase, participants with advanced/metastatic NSCLC received 25 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. On all subsequent cycles, participants received 200 mg pembrolizumab Q3W and 25 mg quavonlimab every 6 weeks (Q6W). Participants were treated for up to 35 cycles total (up to approximately 24 months).	Arm C: MK-1308 75 mg Q6W + Pembro. 200 mg Q3W n=37 Participants On cycle 1, day 1 of the dose confirmation phase, participants with advanced/metastatic NSCLC received 75 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. On all subsequent cycles, participants received 200 mg pembrolizumab Q3W and 75 mg quavonlimab Q6W. Participants were treated for 35 cycles total (up to approximately 24 months).	Arm D: MK-1308 75 mg Q6W + Pembro. 200 mg Q3W n=39 Participants On cycle 1, day 1 of the dose confirmation phase, participants with advanced/metastatic small cell lung cancer (SCLC) received 75 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. On all subsequent cycles, participants received 200 mg pembrolizumab Q3W and 75 mg quavonlimab Q6W. Participants were treated for 35 cycles total (up to approximately 24 months).	Arm E: MK-1308 75 mg Q3W + Pembro. 200 mg Q3W n=14 Participants On cycle 1, day 1 of the dose confirmation phase and during all subsequent cycles, participants with NSCLC received 75 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. Participants were treated for 35 cycles total (up to approximately 24 months).	Arm F: MK-1308 25 mg Q6W + Pembro. 400 mg Q6W Co-admin n=105 Participants On cycle 1, day 1 of the efficacy expansion phase and during all subsequent cycles, participants with programmed cell death protein 1 (PD-1)/programmed cell death ligand 1 (PD-L1) refractory melanoma received 25 mg quavonlimab in combination with 400 mg pembrolizumab. Both quavonlimab and pembrolizumab were administered Q6W for 24 months.	Arm G: MK-1308 25 mg Q6W On cycle 1, day 1 of the efficacy expansion phase and during all subsequent cycles, participants with PD-1/PD-L1 refractory melanoma received 25 mg quavonlimab Q6W for up to 24 months.	Arm I: MK-1308A Q6W (Co-form) n=28 Participants On cycle 1, day 1 of the coformulation (Co-form) phase and during all subsequent cycles, participants with advanced/metastatic solid tumors received 400 mg pembrolizumab co-formulated with 25 mg quavonlimab (MK-1308A) Q6W for 24 months.	Arm K: MK-1308A Q6W (Co-form) n=20 Participants On cycle 1, day 1 of the coformulation phase and during all subsequent cycles, participants in mainland China with advanced/metastatic solid tumors received 400 mg pembrolizumab co-formulated with 25 mg quavonlimab (MK-1308A) Q6W for 24 months.
Maximum Concentration (Cmax) of Pembrolizumab Cycle 3	93.9 μg/mL Geometric Coefficient of Variation 21.0	74.9 μg/mL Geometric Coefficient of Variation 28.1	88.6 μg/mL Geometric Coefficient of Variation 12.2	84.2 μg/mL Geometric Coefficient of Variation 16.9	92.3 μg/mL Geometric Coefficient of Variation 27.5	91.8 μg/mL Geometric Coefficient of Variation 21.7	98.0 μg/mL Geometric Coefficient of Variation 27.4	84.5 μg/mL Geometric Coefficient of Variation 13.8	153 μg/mL Geometric Coefficient of Variation 22.1	—	168 μg/mL Geometric Coefficient of Variation 22.3	138 μg/mL Geometric Coefficient of Variation 31.1
Maximum Concentration (Cmax) of Pembrolizumab Cycle 1	—	—	—	71.8 μg/mL Geometric Coefficient of Variation 24.0	77.1 μg/mL Geometric Coefficient of Variation 26.7	74.0 μg/mL Geometric Coefficient of Variation 27.8	73.6 μg/mL Geometric Coefficient of Variation 22.3	70.9 μg/mL Geometric Coefficient of Variation 35.3	149 μg/mL Geometric Coefficient of Variation 29.1	—	149 μg/mL Geometric Coefficient of Variation 23.8	128 μg/mL Geometric Coefficient of Variation 21.9
Maximum Concentration (Cmax) of Pembrolizumab Cycle 2	79.8 μg/mL Geometric Coefficient of Variation 31.3	82.3 μg/mL Geometric Coefficient of Variation 32.3	78.7 μg/mL Geometric Coefficient of Variation 32.4	82.9 μg/mL Geometric Coefficient of Variation 20.2	88.2 μg/mL Geometric Coefficient of Variation 20.9	83.9 μg/mL Geometric Coefficient of Variation 23.2	90.4 μg/mL Geometric Coefficient of Variation 23.7	84.8 μg/mL Geometric Coefficient of Variation 18.6	150 μg/mL Geometric Coefficient of Variation 28.9	—	164 μg/mL Geometric Coefficient of Variation 22.8	139 μg/mL Geometric Coefficient of Variation 20.5

SECONDARY outcome

Timeframe: At designated time points up to - Cohorts 1-3: Day 1 Cycle 4, Arms A, B, C, D, E: Day 15 Cycle 3, Arm F: Day 21 Cycle 3, Arm I: Day 21 Cycle 3, Arm K: Day 21 Cycle 3. Each cycle is 21 days.

Cmin was defined as the minimum or "trough" concentration of pembrolizumab observed after its administration and just prior to the administration of a subsequent dose. Cmin determined by blood samples collected pre-dose and at designated timepoints post-dose are presented. Per protocol, no analysis was planned for participants in arm G and cross over phase. Cmin of pembrolizumab is presented. Blood sampling was taken for Cohorts 1-3: Predose and Postdose on Days 1, 8, 15 on Cycles 2 and 3, Day 1 on Cycle 4. Arms A, B, C, D, E: Predose and Postdose on Days 1, 8, 15 on Cycles 1, 2, 3. Arm F: Predose and Postdose on Day 1 and 21 on Cycles 1, 2, 3. Arm I: Predose and Postdose on Day 1 and 21 on Cycles 1, 2, 3. Arm K: Predose and Postdose on Days 1, 2, 8, 15, 21 on Cycles 1, 2; Days 1, 21 on Cycle 3. Each cycle is 21 days.

Outcome measures

Outcome measures
Measure	Cohort 1: MK-1308 25 mg Q3W + Pembro. 200 mg Q3W n=11 Participants On cycle 1, day 1 of the dose escalation phase, participants with advanced solid tumors received 25 mg quavonlimab (MK-1308) monotherapy followed by 25 mg quavonlimab in combination with 200 mg pembrolizumab (pembro) every 3 weeks (Q3W) for cycles 2-5. Participants then received 200 mg pembrolizumab monotherapy Q3W starting on Cycle 6, for up to 35 cycles total (up to approximately 24 months).	Cohort 2: MK-1308 75 mg Q3W + Pembro. 200 mg Q3W n=10 Participants On cycle 1, day 1 of the dose escalation phase, participants with advanced solid tumor except non-small cell lung cancer (NSCLC) received 75 mg quavonlimab monotherapy followed by 75 mg quavonlimab in combination with 200 mg pembrolizumab Q3W for cycles 2-5. Participants then received 200 mg pembrolizumab monotherapy Q3W starting on Cycle 6, for up to 35 cycles total (up to approximately 24 months).	Cohort 3: MK-1308 200 mg Q3W + Pembro. 200 mg Q3W n=3 Participants On cycle 1, day 1 of the dose escalation phase, participants with advanced solid tumor except non-small cell lung cancer (NSCLC) received 200 mg quavonlimab monotherapy followed by 200 mg quavonlimab in combination with 200 mg pembrolizumab Q3W for cycles 2-5. Participants then received 200 mg pembrolizumab monotherapy Q3W starting on Cycle 6, for up to 35 cycles total (up to approximately 24 months).	Arm A: MK-1308 25 mg Q3W + Pembro. 200 mg Q3W n=33 Participants On cycle 1, day 1 of the dose confirmation phase and during all subsequent cycles, participants with advanced/metastatic NSCLC received 25 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. Participants were treated for 35 cycles total (up to approximately 24 months).	Arm B: MK-1308 25 mg Q6W + Pembro. 200 mg Q3W n=35 Participants On cycle 1, day 1 of the dose confirmation phase, participants with advanced/metastatic NSCLC received 25 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. On all subsequent cycles, participants received 200 mg pembrolizumab Q3W and 25 mg quavonlimab every 6 weeks (Q6W). Participants were treated for up to 35 cycles total (up to approximately 24 months).	Arm C: MK-1308 75 mg Q6W + Pembro. 200 mg Q3W n=30 Participants On cycle 1, day 1 of the dose confirmation phase, participants with advanced/metastatic NSCLC received 75 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. On all subsequent cycles, participants received 200 mg pembrolizumab Q3W and 75 mg quavonlimab Q6W. Participants were treated for 35 cycles total (up to approximately 24 months).	Arm D: MK-1308 75 mg Q6W + Pembro. 200 mg Q3W n=29 Participants On cycle 1, day 1 of the dose confirmation phase, participants with advanced/metastatic small cell lung cancer (SCLC) received 75 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. On all subsequent cycles, participants received 200 mg pembrolizumab Q3W and 75 mg quavonlimab Q6W. Participants were treated for 35 cycles total (up to approximately 24 months).	Arm E: MK-1308 75 mg Q3W + Pembro. 200 mg Q3W n=9 Participants On cycle 1, day 1 of the dose confirmation phase and during all subsequent cycles, participants with NSCLC received 75 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. Participants were treated for 35 cycles total (up to approximately 24 months).	Arm F: MK-1308 25 mg Q6W + Pembro. 400 mg Q6W Co-admin n=92 Participants On cycle 1, day 1 of the efficacy expansion phase and during all subsequent cycles, participants with programmed cell death protein 1 (PD-1)/programmed cell death ligand 1 (PD-L1) refractory melanoma received 25 mg quavonlimab in combination with 400 mg pembrolizumab. Both quavonlimab and pembrolizumab were administered Q6W for 24 months.	Arm G: MK-1308 25 mg Q6W On cycle 1, day 1 of the efficacy expansion phase and during all subsequent cycles, participants with PD-1/PD-L1 refractory melanoma received 25 mg quavonlimab Q6W for up to 24 months.	Arm I: MK-1308A Q6W (Co-form) n=21 Participants On cycle 1, day 1 of the coformulation (Co-form) phase and during all subsequent cycles, participants with advanced/metastatic solid tumors received 400 mg pembrolizumab co-formulated with 25 mg quavonlimab (MK-1308A) Q6W for 24 months.	Arm K: MK-1308A Q6W (Co-form) n=16 Participants On cycle 1, day 1 of the coformulation phase and during all subsequent cycles, participants in mainland China with advanced/metastatic solid tumors received 400 mg pembrolizumab co-formulated with 25 mg quavonlimab (MK-1308A) Q6W for 24 months.
Minimum Concentration (Cmin) of Pembrolizumab Cycle 1	—	—	—	13.3 μg/mL Interval 0.0 to 22.3	13.1 μg/mL Interval 3.93 to 24.9	14.3 μg/mL Interval 5.59 to 90.4	15.6 μg/mL Interval 6.35 to 35.9	11.5 μg/mL Interval 4.77 to 18.0	21.9 μg/mL Interval 1.89 to 143.0	—	19.5 μg/mL Interval 7.25 to 35.8	14.4 μg/mL Interval 5.74 to 26.0
Minimum Concentration (Cmin) of Pembrolizumab Cycle 2	18.3 μg/mL Interval 11.3 to 27.8	11.3 μg/mL Interval 0.0 to 28.1	19.0 μg/mL Interval 9.21 to 24.6	19.6 μg/mL Interval 6.62 to 37.4	24.3 μg/mL Interval 9.06 to 34.6	20.4 μg/mL Interval 9.19 to 44.9	25.2 μg/mL Interval 10.1 to 55.1	18.9 μg/mL Interval 8.52 to 25.5	23.1 μg/mL Interval 0.0266 to 51.6	—	30.0 μg/mL Interval 16.2 to 60.4	22.5 μg/mL Interval 8.74 to 37.1
Minimum Concentration (Cmin) of Pembrolizumab Cycle 3	—	—	—	25.7 μg/mL Interval 13.7 to 40.3	27.5 μg/mL Interval 12.4 to 42.2	25.5 μg/mL Interval 11.3 to 98.2	29.3 μg/mL Interval 10.4 to 56.7	27.7 μg/mL Interval 14.5 to 30.5	24.5 μg/mL Interval 2.22 to 127.0	—	34.0 μg/mL Interval 18.9 to 72.2	26.6 μg/mL Interval 7.74 to 32.6
Minimum Concentration (Cmin) of Pembrolizumab Cycle 4	34.3 μg/mL Interval 29.8 to 39.9	14.1 μg/mL Interval 0.0 to 38.1	23.5 μg/mL Interval 23.5 to 23.5	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: At designated time points up to - Cohorts 1-3: Day 15 Cycle 3, Arms A, B, C, D, E: Day 15 Cycle 3, Arm F, G, I: Day 21 Cycle 3, Arm K: Day 21 Cycle 3. Each cycle is 21 days.

AUC was defined as a measure of quavonlimab exposure that was calculated as the product of plasma drug concentration and time after drug administration. AUC determined by blood samples collected pre-dose and at designated timepoints post-dose are presented. Per protocol, no analysis was planned for the cross over phase. AUC of quavonlimab is presented. Blood sampling was taken for Cohorts 1-3: Predose and Postdose on Days 1, 8, 15 on Cycles 1, 2 and 3. Arms A, B, C, D, E: Days 1, 8, 15 on Cycles 1, 2, 3. Arms F, G and I: Predose and Postdose on Day 1 and 21 on Cycles 1, 2, 3. Arm K: Days 1, 2, 8, 15, 21 on Cycles 1, 2; Days 1, 21 on Cycle 3. Each cycle is 21 days.

Outcome measures

Outcome measures
Measure	Cohort 1: MK-1308 25 mg Q3W + Pembro. 200 mg Q3W n=10 Participants On cycle 1, day 1 of the dose escalation phase, participants with advanced solid tumors received 25 mg quavonlimab (MK-1308) monotherapy followed by 25 mg quavonlimab in combination with 200 mg pembrolizumab (pembro) every 3 weeks (Q3W) for cycles 2-5. Participants then received 200 mg pembrolizumab monotherapy Q3W starting on Cycle 6, for up to 35 cycles total (up to approximately 24 months).	Cohort 2: MK-1308 75 mg Q3W + Pembro. 200 mg Q3W n=13 Participants On cycle 1, day 1 of the dose escalation phase, participants with advanced solid tumor except non-small cell lung cancer (NSCLC) received 75 mg quavonlimab monotherapy followed by 75 mg quavonlimab in combination with 200 mg pembrolizumab Q3W for cycles 2-5. Participants then received 200 mg pembrolizumab monotherapy Q3W starting on Cycle 6, for up to 35 cycles total (up to approximately 24 months).	Cohort 3: MK-1308 200 mg Q3W + Pembro. 200 mg Q3W n=8 Participants On cycle 1, day 1 of the dose escalation phase, participants with advanced solid tumor except non-small cell lung cancer (NSCLC) received 200 mg quavonlimab monotherapy followed by 200 mg quavonlimab in combination with 200 mg pembrolizumab Q3W for cycles 2-5. Participants then received 200 mg pembrolizumab monotherapy Q3W starting on Cycle 6, for up to 35 cycles total (up to approximately 24 months).	Arm A: MK-1308 25 mg Q3W + Pembro. 200 mg Q3W n=26 Participants On cycle 1, day 1 of the dose confirmation phase and during all subsequent cycles, participants with advanced/metastatic NSCLC received 25 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. Participants were treated for 35 cycles total (up to approximately 24 months).	Arm B: MK-1308 25 mg Q6W + Pembro. 200 mg Q3W n=21 Participants On cycle 1, day 1 of the dose confirmation phase, participants with advanced/metastatic NSCLC received 25 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. On all subsequent cycles, participants received 200 mg pembrolizumab Q3W and 25 mg quavonlimab every 6 weeks (Q6W). Participants were treated for up to 35 cycles total (up to approximately 24 months).	Arm C: MK-1308 75 mg Q6W + Pembro. 200 mg Q3W n=28 Participants On cycle 1, day 1 of the dose confirmation phase, participants with advanced/metastatic NSCLC received 75 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. On all subsequent cycles, participants received 200 mg pembrolizumab Q3W and 75 mg quavonlimab Q6W. Participants were treated for 35 cycles total (up to approximately 24 months).	Arm D: MK-1308 75 mg Q6W + Pembro. 200 mg Q3W n=28 Participants On cycle 1, day 1 of the dose confirmation phase, participants with advanced/metastatic small cell lung cancer (SCLC) received 75 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. On all subsequent cycles, participants received 200 mg pembrolizumab Q3W and 75 mg quavonlimab Q6W. Participants were treated for 35 cycles total (up to approximately 24 months).	Arm E: MK-1308 75 mg Q3W + Pembro. 200 mg Q3W n=10 Participants On cycle 1, day 1 of the dose confirmation phase and during all subsequent cycles, participants with NSCLC received 75 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. Participants were treated for 35 cycles total (up to approximately 24 months).	Arm F: MK-1308 25 mg Q6W + Pembro. 400 mg Q6W Co-admin n=34 Participants On cycle 1, day 1 of the efficacy expansion phase and during all subsequent cycles, participants with programmed cell death protein 1 (PD-1)/programmed cell death ligand 1 (PD-L1) refractory melanoma received 25 mg quavonlimab in combination with 400 mg pembrolizumab. Both quavonlimab and pembrolizumab were administered Q6W for 24 months.	Arm G: MK-1308 25 mg Q6W n=9 Participants On cycle 1, day 1 of the efficacy expansion phase and during all subsequent cycles, participants with PD-1/PD-L1 refractory melanoma received 25 mg quavonlimab Q6W for up to 24 months.	Arm I: MK-1308A Q6W (Co-form) n=8 Participants On cycle 1, day 1 of the coformulation (Co-form) phase and during all subsequent cycles, participants with advanced/metastatic solid tumors received 400 mg pembrolizumab co-formulated with 25 mg quavonlimab (MK-1308A) Q6W for 24 months.	Arm K: MK-1308A Q6W (Co-form) n=20 Participants On cycle 1, day 1 of the coformulation phase and during all subsequent cycles, participants in mainland China with advanced/metastatic solid tumors received 400 mg pembrolizumab co-formulated with 25 mg quavonlimab (MK-1308A) Q6W for 24 months.
Area Under the Plasma Concentration Time Curve (AUC) of Quavonlimab (MK-1308) Cycle 1	68.2 day*μg/mL Geometric Coefficient of Variation 17.7	160 day*μg/mL Geometric Coefficient of Variation 19.5	510 day*μg/mL Geometric Coefficient of Variation 25.7	55.0 day*μg/mL Geometric Coefficient of Variation 26.6	69.6 day*μg/mL Geometric Coefficient of Variation 33.5	199 day*μg/mL Geometric Coefficient of Variation 36.2	222 day*μg/mL Geometric Coefficient of Variation 39.7	178 day*μg/mL Geometric Coefficient of Variation 17.6	77.1 day*μg/mL Geometric Coefficient of Variation 32.7	92.8 day*μg/mL Geometric Coefficient of Variation 38.1	106 day*μg/mL Geometric Coefficient of Variation 34.7	85.8 day*μg/mL Geometric Coefficient of Variation 24.2
Area Under the Plasma Concentration Time Curve (AUC) of Quavonlimab (MK-1308) Cycle 2	91.5 day*μg/mL Geometric Coefficient of Variation 19.9	178 day*μg/mL Geometric Coefficient of Variation 53.9	751 day*μg/mL Geometric Coefficient of Variation 23.4	73.6 day*μg/mL Geometric Coefficient of Variation 26.4	—	—	—	192 day*μg/mL Geometric Coefficient of Variation 17.7	94.4 day*μg/mL Geometric Coefficient of Variation 43.9	65.9 day*μg/mL Geometric Coefficient of Variation 27.8	96.1 day*μg/mL Geometric Coefficient of Variation 39.7	86.0 day*μg/mL Geometric Coefficient of Variation 47.7
Area Under the Plasma Concentration Time Curve (AUC) of Quavonlimab (MK-1308) Cycle 3	—	—	—	64.3 day*μg/mL Geometric Coefficient of Variation 56.5	59.4 day*μg/mL Geometric Coefficient of Variation 74.9	182 day*μg/mL Geometric Coefficient of Variation 75.1	193 day*μg/mL Geometric Coefficient of Variation 90.8	186 day*μg/mL Geometric Coefficient of Variation 22.1	95.2 day*μg/mL Geometric Coefficient of Variation 63.4	95.0 day*μg/mL Geometric Coefficient of Variation 58.2	72.1 day*μg/mL Geometric Coefficient of Variation 9.92	92.3 day*μg/mL Geometric Coefficient of Variation 60.2

SECONDARY outcome

Timeframe: At designated time points up to - Cohorts 1-3: Day 15 Cycle 3, Arms A, B, C, D, E: Day 15 Cycle 3, Arm F, G, I: Day 21 Cycle 3, Arm K: Day 21 Cycle 3. Each cycle is 21 days.

Cmax was defined as the maximum concentration of quavonlimab observed in plasma. Cmax determined by blood samples collected pre-dose and at designated timepoints post-dose are presented. Per protocol, no analysis was planned for the cross over phase. Cmax of quavonlimab is presented. Blood sampling was taken for Cohorts 1-3: Predose and Postdose on Days 1, 8, 15 on Cycles 1, 2 and 3. Arms A, B, C, D, E: Days 1, 8, 15 on Cycles 1, 2, 3. Arms F, G and I: Predose and Postdose on Day 1 and 21 on Cycles 1, 2, 3. Arm K: Days 1, 2, 8, 15, 21 on Cycles 1, 2; Days 1, 21 on Cycle 3. Each cycle is 21 days.

Outcome measures

Outcome measures
Measure	Cohort 1: MK-1308 25 mg Q3W + Pembro. 200 mg Q3W n=13 Participants On cycle 1, day 1 of the dose escalation phase, participants with advanced solid tumors received 25 mg quavonlimab (MK-1308) monotherapy followed by 25 mg quavonlimab in combination with 200 mg pembrolizumab (pembro) every 3 weeks (Q3W) for cycles 2-5. Participants then received 200 mg pembrolizumab monotherapy Q3W starting on Cycle 6, for up to 35 cycles total (up to approximately 24 months).	Cohort 2: MK-1308 75 mg Q3W + Pembro. 200 mg Q3W n=17 Participants On cycle 1, day 1 of the dose escalation phase, participants with advanced solid tumor except non-small cell lung cancer (NSCLC) received 75 mg quavonlimab monotherapy followed by 75 mg quavonlimab in combination with 200 mg pembrolizumab Q3W for cycles 2-5. Participants then received 200 mg pembrolizumab monotherapy Q3W starting on Cycle 6, for up to 35 cycles total (up to approximately 24 months).	Cohort 3: MK-1308 200 mg Q3W + Pembro. 200 mg Q3W n=8 Participants On cycle 1, day 1 of the dose escalation phase, participants with advanced solid tumor except non-small cell lung cancer (NSCLC) received 200 mg quavonlimab monotherapy followed by 200 mg quavonlimab in combination with 200 mg pembrolizumab Q3W for cycles 2-5. Participants then received 200 mg pembrolizumab monotherapy Q3W starting on Cycle 6, for up to 35 cycles total (up to approximately 24 months).	Arm A: MK-1308 25 mg Q3W + Pembro. 200 mg Q3W n=38 Participants On cycle 1, day 1 of the dose confirmation phase and during all subsequent cycles, participants with advanced/metastatic NSCLC received 25 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. Participants were treated for 35 cycles total (up to approximately 24 months).	Arm B: MK-1308 25 mg Q6W + Pembro. 200 mg Q3W n=39 Participants On cycle 1, day 1 of the dose confirmation phase, participants with advanced/metastatic NSCLC received 25 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. On all subsequent cycles, participants received 200 mg pembrolizumab Q3W and 25 mg quavonlimab every 6 weeks (Q6W). Participants were treated for up to 35 cycles total (up to approximately 24 months).	Arm C: MK-1308 75 mg Q6W + Pembro. 200 mg Q3W n=38 Participants On cycle 1, day 1 of the dose confirmation phase, participants with advanced/metastatic NSCLC received 75 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. On all subsequent cycles, participants received 200 mg pembrolizumab Q3W and 75 mg quavonlimab Q6W. Participants were treated for 35 cycles total (up to approximately 24 months).	Arm D: MK-1308 75 mg Q6W + Pembro. 200 mg Q3W n=38 Participants On cycle 1, day 1 of the dose confirmation phase, participants with advanced/metastatic small cell lung cancer (SCLC) received 75 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. On all subsequent cycles, participants received 200 mg pembrolizumab Q3W and 75 mg quavonlimab Q6W. Participants were treated for 35 cycles total (up to approximately 24 months).	Arm E: MK-1308 75 mg Q3W + Pembro. 200 mg Q3W n=14 Participants On cycle 1, day 1 of the dose confirmation phase and during all subsequent cycles, participants with NSCLC received 75 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. Participants were treated for 35 cycles total (up to approximately 24 months).	Arm F: MK-1308 25 mg Q6W + Pembro. 400 mg Q6W Co-admin n=106 Participants On cycle 1, day 1 of the efficacy expansion phase and during all subsequent cycles, participants with programmed cell death protein 1 (PD-1)/programmed cell death ligand 1 (PD-L1) refractory melanoma received 25 mg quavonlimab in combination with 400 mg pembrolizumab. Both quavonlimab and pembrolizumab were administered Q6W for 24 months.	Arm G: MK-1308 25 mg Q6W n=37 Participants On cycle 1, day 1 of the efficacy expansion phase and during all subsequent cycles, participants with PD-1/PD-L1 refractory melanoma received 25 mg quavonlimab Q6W for up to 24 months.	Arm I: MK-1308A Q6W (Co-form) n=27 Participants On cycle 1, day 1 of the coformulation (Co-form) phase and during all subsequent cycles, participants with advanced/metastatic solid tumors received 400 mg pembrolizumab co-formulated with 25 mg quavonlimab (MK-1308A) Q6W for 24 months.	Arm K: MK-1308A Q6W (Co-form) n=20 Participants On cycle 1, day 1 of the coformulation phase and during all subsequent cycles, participants in mainland China with advanced/metastatic solid tumors received 400 mg pembrolizumab co-formulated with 25 mg quavonlimab (MK-1308A) Q6W for 24 months.
Maximum Concentration (Cmax) of Quavonlimab Cycle 1	8.23 μg/mL Geometric Coefficient of Variation 26.1	22.5 μg/mL Geometric Coefficient of Variation 29.8	68.3 μg/mL Geometric Coefficient of Variation 17.2	7.28 μg/mL Geometric Coefficient of Variation 30.6	8.02 μg/mL Geometric Coefficient of Variation 29.5	23.4 μg/mL Geometric Coefficient of Variation 24.3	24.1 μg/mL Geometric Coefficient of Variation 30.1	25.0 μg/mL Geometric Coefficient of Variation 20.6	7.25 μg/mL Geometric Coefficient of Variation 26.4	7.42 μg/mL Geometric Coefficient of Variation 30.4	8.06 μg/mL Geometric Coefficient of Variation 26.5	8.23 μg/mL Geometric Coefficient of Variation 26.7
Maximum Concentration (Cmax) of Quavonlimab Cycle 2	9.41 μg/mL Geometric Coefficient of Variation 20.4	23.5 μg/mL Geometric Coefficient of Variation 25.1	71.9 μg/mL Geometric Coefficient of Variation 29.0	8.58 μg/mL Geometric Coefficient of Variation 22.4	—	—	—	26.3 μg/mL Geometric Coefficient of Variation 24.7	7.65 μg/mL Geometric Coefficient of Variation 25.3	7.22 μg/mL Geometric Coefficient of Variation 29.3	8.17 μg/mL Geometric Coefficient of Variation 26.2	7.99 μg/mL Geometric Coefficient of Variation 29.7
Maximum Concentration (Cmax) of Quavonlimab Cycle 3	9.11 μg/mL Geometric Coefficient of Variation 24.7	23.3 μg/mL Geometric Coefficient of Variation 48.0	88.3 μg/mL Geometric Coefficient of Variation 16.0	7.72 μg/mL Geometric Coefficient of Variation 27.7	6.98 μg/mL Geometric Coefficient of Variation 43.7	22.7 μg/mL Geometric Coefficient of Variation 33.1	24.2 μg/mL Geometric Coefficient of Variation 50.4	27.2 μg/mL Geometric Coefficient of Variation 10.2	7.94 μg/mL Geometric Coefficient of Variation 29.6	6.65 μg/mL Geometric Coefficient of Variation 32.7	7.25 μg/mL Geometric Coefficient of Variation 21.9	7.94 μg/mL Geometric Coefficient of Variation 35.4

SECONDARY outcome

Timeframe: At designated time points up to - Cohorts 1-3: Day 15 Cycle 3, Arms A, B, C, D, E: Day 15 Cycle 3, Arm F, G, I: Day 21 Cycle 3, Arm K: Day 21 Cycle 3. Each cycle is 21 days.

Cmin was defined as the minimum or "trough" concentration of quavonlimab observed after its administration and just prior to the administration of a subsequent dose. Cmin determined by blood samples collected pre-dose and at designated timepoints post-dose are presented. Per protocol, no analysis was planned for the cross over phase. Cmin of quavonlimab is presented. Blood sampling was taken for Cohorts 1-3: Predose and Postdose on Days 1, 8, 15 on Cycles 1, 2 and 3. Arms A, B, C, D, E: Days 1, 8, 15 on Cycles 1, 2, 3. Arms F, G and I: Predose and Postdose on Day 1 and 21 on Cycles 1, 2, 3. Arm K: Days 1, 2, 8, 15, 21 on Cycles 1, 2; Days 1, 21 on Cycle 3. Each cycle is 21 days.

Outcome measures

Outcome measures
Measure	Cohort 1: MK-1308 25 mg Q3W + Pembro. 200 mg Q3W n=13 Participants On cycle 1, day 1 of the dose escalation phase, participants with advanced solid tumors received 25 mg quavonlimab (MK-1308) monotherapy followed by 25 mg quavonlimab in combination with 200 mg pembrolizumab (pembro) every 3 weeks (Q3W) for cycles 2-5. Participants then received 200 mg pembrolizumab monotherapy Q3W starting on Cycle 6, for up to 35 cycles total (up to approximately 24 months).	Cohort 2: MK-1308 75 mg Q3W + Pembro. 200 mg Q3W n=14 Participants On cycle 1, day 1 of the dose escalation phase, participants with advanced solid tumor except non-small cell lung cancer (NSCLC) received 75 mg quavonlimab monotherapy followed by 75 mg quavonlimab in combination with 200 mg pembrolizumab Q3W for cycles 2-5. Participants then received 200 mg pembrolizumab monotherapy Q3W starting on Cycle 6, for up to 35 cycles total (up to approximately 24 months).	Cohort 3: MK-1308 200 mg Q3W + Pembro. 200 mg Q3W n=8 Participants On cycle 1, day 1 of the dose escalation phase, participants with advanced solid tumor except non-small cell lung cancer (NSCLC) received 200 mg quavonlimab monotherapy followed by 200 mg quavonlimab in combination with 200 mg pembrolizumab Q3W for cycles 2-5. Participants then received 200 mg pembrolizumab monotherapy Q3W starting on Cycle 6, for up to 35 cycles total (up to approximately 24 months).	Arm A: MK-1308 25 mg Q3W + Pembro. 200 mg Q3W n=35 Participants On cycle 1, day 1 of the dose confirmation phase and during all subsequent cycles, participants with advanced/metastatic NSCLC received 25 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. Participants were treated for 35 cycles total (up to approximately 24 months).	Arm B: MK-1308 25 mg Q6W + Pembro. 200 mg Q3W n=33 Participants On cycle 1, day 1 of the dose confirmation phase, participants with advanced/metastatic NSCLC received 25 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. On all subsequent cycles, participants received 200 mg pembrolizumab Q3W and 25 mg quavonlimab every 6 weeks (Q6W). Participants were treated for up to 35 cycles total (up to approximately 24 months).	Arm C: MK-1308 75 mg Q6W + Pembro. 200 mg Q3W n=26 Participants On cycle 1, day 1 of the dose confirmation phase, participants with advanced/metastatic NSCLC received 75 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. On all subsequent cycles, participants received 200 mg pembrolizumab Q3W and 75 mg quavonlimab Q6W. Participants were treated for 35 cycles total (up to approximately 24 months).	Arm D: MK-1308 75 mg Q6W + Pembro. 200 mg Q3W n=29 Participants On cycle 1, day 1 of the dose confirmation phase, participants with advanced/metastatic small cell lung cancer (SCLC) received 75 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. On all subsequent cycles, participants received 200 mg pembrolizumab Q3W and 75 mg quavonlimab Q6W. Participants were treated for 35 cycles total (up to approximately 24 months).	Arm E: MK-1308 75 mg Q3W + Pembro. 200 mg Q3W n=10 Participants On cycle 1, day 1 of the dose confirmation phase and during all subsequent cycles, participants with NSCLC received 75 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. Participants were treated for 35 cycles total (up to approximately 24 months).	Arm F: MK-1308 25 mg Q6W + Pembro. 400 mg Q6W Co-admin n=95 Participants On cycle 1, day 1 of the efficacy expansion phase and during all subsequent cycles, participants with programmed cell death protein 1 (PD-1)/programmed cell death ligand 1 (PD-L1) refractory melanoma received 25 mg quavonlimab in combination with 400 mg pembrolizumab. Both quavonlimab and pembrolizumab were administered Q6W for 24 months.	Arm G: MK-1308 25 mg Q6W n=32 Participants On cycle 1, day 1 of the efficacy expansion phase and during all subsequent cycles, participants with PD-1/PD-L1 refractory melanoma received 25 mg quavonlimab Q6W for up to 24 months.	Arm I: MK-1308A Q6W (Co-form) n=21 Participants On cycle 1, day 1 of the coformulation (Co-form) phase and during all subsequent cycles, participants with advanced/metastatic solid tumors received 400 mg pembrolizumab co-formulated with 25 mg quavonlimab (MK-1308A) Q6W for 24 months.	Arm K: MK-1308A Q6W (Co-form) n=16 Participants On cycle 1, day 1 of the coformulation phase and during all subsequent cycles, participants in mainland China with advanced/metastatic solid tumors received 400 mg pembrolizumab co-formulated with 25 mg quavonlimab (MK-1308A) Q6W for 24 months.
Minimum Concentration (Cmin) of Quavonlimab Cycle 1	1.44 μg/mL Interval 0.0 to 2.11	3.29 μg/mL Interval 0.0 to 6.86	8.01 μg/mL Interval 1.51 to 17.8	1.05 μg/mL Interval 0.0 to 1.8	0.00 μg/mL Interval 0.0 to 0.0	0.00 μg/mL Interval 0.0 to 3.44	15.6 μg/mL Interval 6.35 to 35.9	3.20 μg/mL Interval 0.0 to 5.26	0.00 μg/mL Interval 0.0 to 1.65	0.00 μg/mL Interval 0.0 to 1.26	0.00 μg/mL Interval 0.0 to 2.02	0.00 μg/mL Interval 0.0 to 1.32
Minimum Concentration (Cmin) of Quavonlimab Cycle 2	1.75 μg/mL Interval 0.0 to 3.1	2.83 μg/mL Interval 0.0 to 10.3	17.4 μg/mL Interval 1.73 to 19.2	1.17 μg/mL Interval 0.0 to 2.73	—	—	25.2 μg/mL Interval 10.1 to 55.1	3.40 μg/mL Interval 1.35 to 6.32	0.00 μg/mL Interval 0.0 to 8.23	0.00 μg/mL Interval 0.0 to 2.09	0.00 μg/mL Interval 0.0 to 1.68	0.00 μg/mL Interval 0.0 to 1.65
Minimum Concentration (Cmin) of Quavonlimab Cycle 3	—	1.91 μg/mL Interval 1.91 to 1.91	—	1.42 μg/mL Interval 0.0 to 2.86	0.00 μg/mL Interval 0.0 to 0.0	0.00 μg/mL Interval 0.0 to 3.1	29.3 μg/mL Interval 10.4 to 56.7	2.91 μg/mL Interval 2.21 to 5.77	0.00 μg/mL Interval 0.0 to 7.5	0.00 μg/mL Interval 0.0 to 7.2	0.00 μg/mL Interval 0.0 to 2.37	0.00 μg/mL Interval 0.0 to 1.05

SECONDARY outcome

Timeframe: Cohorts 1-3: Predose and day 1 of cycles 2, 3, 5, 6, 7, 9 and every 4 cycles up to 35 cycles. Arms A-E: Predose and day 1 of cycles 1-5, 6, 8 and every 4 cycles up to 35 cycles. Arms F, I, K: Predose and day 1 of cycles 1, 2, 3, 4. Each cycle is 21 days.

Population: Participants with at least one ADA sample available after treatment with pembrolizumab

Non-Treatment emergent (TE) ADA refers to presence of ADAs (as determined by assay) in the absence of treatment with pembrolizumab (i.e., at predose). Evaluable participants (used as the denominator for analysis) are the total number of negative, inconclusive, and positive participants (non-treatment emergent, treatment emergent and treatment boosted). Inconclusive participants are the number of participants with no positive ADA samples present and the drug concentration in the last sample above the drug tolerance level. ADA determined by blood samples collected pre-dose and at designated timepoints post-dose are presented. Per protocol, no analysis was planned for arm G and cross over phase.

Outcome measures

Outcome measures
Measure	Cohort 1: MK-1308 25 mg Q3W + Pembro. 200 mg Q3W n=12 Participants On cycle 1, day 1 of the dose escalation phase, participants with advanced solid tumors received 25 mg quavonlimab (MK-1308) monotherapy followed by 25 mg quavonlimab in combination with 200 mg pembrolizumab (pembro) every 3 weeks (Q3W) for cycles 2-5. Participants then received 200 mg pembrolizumab monotherapy Q3W starting on Cycle 6, for up to 35 cycles total (up to approximately 24 months).	Cohort 2: MK-1308 75 mg Q3W + Pembro. 200 mg Q3W n=13 Participants On cycle 1, day 1 of the dose escalation phase, participants with advanced solid tumor except non-small cell lung cancer (NSCLC) received 75 mg quavonlimab monotherapy followed by 75 mg quavonlimab in combination with 200 mg pembrolizumab Q3W for cycles 2-5. Participants then received 200 mg pembrolizumab monotherapy Q3W starting on Cycle 6, for up to 35 cycles total (up to approximately 24 months).	Cohort 3: MK-1308 200 mg Q3W + Pembro. 200 mg Q3W n=5 Participants On cycle 1, day 1 of the dose escalation phase, participants with advanced solid tumor except non-small cell lung cancer (NSCLC) received 200 mg quavonlimab monotherapy followed by 200 mg quavonlimab in combination with 200 mg pembrolizumab Q3W for cycles 2-5. Participants then received 200 mg pembrolizumab monotherapy Q3W starting on Cycle 6, for up to 35 cycles total (up to approximately 24 months).	Arm A: MK-1308 25 mg Q3W + Pembro. 200 mg Q3W n=36 Participants On cycle 1, day 1 of the dose confirmation phase and during all subsequent cycles, participants with advanced/metastatic NSCLC received 25 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. Participants were treated for 35 cycles total (up to approximately 24 months).	Arm B: MK-1308 25 mg Q6W + Pembro. 200 mg Q3W n=39 Participants On cycle 1, day 1 of the dose confirmation phase, participants with advanced/metastatic NSCLC received 25 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. On all subsequent cycles, participants received 200 mg pembrolizumab Q3W and 25 mg quavonlimab every 6 weeks (Q6W). Participants were treated for up to 35 cycles total (up to approximately 24 months).	Arm C: MK-1308 75 mg Q6W + Pembro. 200 mg Q3W n=37 Participants On cycle 1, day 1 of the dose confirmation phase, participants with advanced/metastatic NSCLC received 75 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. On all subsequent cycles, participants received 200 mg pembrolizumab Q3W and 75 mg quavonlimab Q6W. Participants were treated for 35 cycles total (up to approximately 24 months).	Arm D: MK-1308 75 mg Q6W + Pembro. 200 mg Q3W n=35 Participants On cycle 1, day 1 of the dose confirmation phase, participants with advanced/metastatic small cell lung cancer (SCLC) received 75 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. On all subsequent cycles, participants received 200 mg pembrolizumab Q3W and 75 mg quavonlimab Q6W. Participants were treated for 35 cycles total (up to approximately 24 months).	Arm E: MK-1308 75 mg Q3W + Pembro. 200 mg Q3W n=11 Participants On cycle 1, day 1 of the dose confirmation phase and during all subsequent cycles, participants with NSCLC received 75 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. Participants were treated for 35 cycles total (up to approximately 24 months).	Arm F: MK-1308 25 mg Q6W + Pembro. 400 mg Q6W Co-admin n=103 Participants On cycle 1, day 1 of the efficacy expansion phase and during all subsequent cycles, participants with programmed cell death protein 1 (PD-1)/programmed cell death ligand 1 (PD-L1) refractory melanoma received 25 mg quavonlimab in combination with 400 mg pembrolizumab. Both quavonlimab and pembrolizumab were administered Q6W for 24 months.	Arm G: MK-1308 25 mg Q6W On cycle 1, day 1 of the efficacy expansion phase and during all subsequent cycles, participants with PD-1/PD-L1 refractory melanoma received 25 mg quavonlimab Q6W for up to 24 months.	Arm I: MK-1308A Q6W (Co-form) n=23 Participants On cycle 1, day 1 of the coformulation (Co-form) phase and during all subsequent cycles, participants with advanced/metastatic solid tumors received 400 mg pembrolizumab co-formulated with 25 mg quavonlimab (MK-1308A) Q6W for 24 months.	Arm K: MK-1308A Q6W (Co-form) n=20 Participants On cycle 1, day 1 of the coformulation phase and during all subsequent cycles, participants in mainland China with advanced/metastatic solid tumors received 400 mg pembrolizumab co-formulated with 25 mg quavonlimab (MK-1308A) Q6W for 24 months.
Number of Participants With Pembrolizumab Anti-drug Antibodies (ADAs) Evaluable	12 Participants	13 Participants	5 Participants	36 Participants	39 Participants	37 Participants	35 Participants	11 Participants	103 Participants	—	23 Participants	20 Participants
Number of Participants With Pembrolizumab Anti-drug Antibodies (ADAs) Negative	12 Participants	12 Participants	5 Participants	31 Participants	33 Participants	33 Participants	31 Participants	10 Participants	94 Participants	—	20 Participants	13 Participants
Number of Participants With Pembrolizumab Anti-drug Antibodies (ADAs) Non - TE Neutralizing Antibody (NAB) NEG (Negative)	—	1 Participants	—	—	—	—	—	—	—	—	1 Participants	—
Number of Participants With Pembrolizumab Anti-drug Antibodies (ADAs) TE NAB NEG	—	—	—	4 Participants	4 Participants	3 Participants	4 Participants	1 Participants	3 Participants	—	—	2 Participants
Number of Participants With Pembrolizumab Anti-drug Antibodies (ADAs) TE NAB Positive (POS)	—	—	—	1 Participants	—	1 Participants	—	—	—	—	—	1 Participants
Number of Participants With Pembrolizumab Anti-drug Antibodies (ADAs) Inconclusive	—	—	—	—	2 Participants	—	—	—	5 Participants	—	2 Participants	4 Participants
Number of Participants With Pembrolizumab Anti-drug Antibodies (ADAs) Treatment Boosted (TB) NAB NEG	—	—	—	—	—	—	—	—	1 Participants	—	—	0 Participants

SECONDARY outcome

Timeframe: Cohort 1-3: Predose and day 1 of cycles 2, 3, 5, 6, 7, 9 and every 4 cycles up to 35 cycles. Arms A-E: Predose and day 1 of cycle 1-5, 6, 8 and every 4 cycles up to 35 cycles. Arms F, G, I, K: Predose and day 1 of cycles 1, 2, 3, 4. Each cycle is 21 days.

Population: Participants with at least one ADA sample available after treatment with quavonlimab

Non-Treatment emergent (TE) ADA refers to presence of ADAs (as determined by assay) in the absence of treatment with quavonlimab (i.e., at predose). Evaluable participants (used as the denominator for analysis) are the total number of negative, inconclusive, and positive participants (non-treatment emergent, treatment emergent and treatment boosted (TB)). Inconclusive participants are the number of participants with no positive ADA samples present and the drug concentration in the last sample above the drug tolerance level. ADA determined by blood samples collected pre-dose and at designated timepoints post-dose are presented. Per protocol, no analysis was planned for the cross over phase.

Outcome measures

Outcome measures
Measure	Cohort 1: MK-1308 25 mg Q3W + Pembro. 200 mg Q3W n=14 Participants On cycle 1, day 1 of the dose escalation phase, participants with advanced solid tumors received 25 mg quavonlimab (MK-1308) monotherapy followed by 25 mg quavonlimab in combination with 200 mg pembrolizumab (pembro) every 3 weeks (Q3W) for cycles 2-5. Participants then received 200 mg pembrolizumab monotherapy Q3W starting on Cycle 6, for up to 35 cycles total (up to approximately 24 months).	Cohort 2: MK-1308 75 mg Q3W + Pembro. 200 mg Q3W n=15 Participants On cycle 1, day 1 of the dose escalation phase, participants with advanced solid tumor except non-small cell lung cancer (NSCLC) received 75 mg quavonlimab monotherapy followed by 75 mg quavonlimab in combination with 200 mg pembrolizumab Q3W for cycles 2-5. Participants then received 200 mg pembrolizumab monotherapy Q3W starting on Cycle 6, for up to 35 cycles total (up to approximately 24 months).	Cohort 3: MK-1308 200 mg Q3W + Pembro. 200 mg Q3W n=8 Participants On cycle 1, day 1 of the dose escalation phase, participants with advanced solid tumor except non-small cell lung cancer (NSCLC) received 200 mg quavonlimab monotherapy followed by 200 mg quavonlimab in combination with 200 mg pembrolizumab Q3W for cycles 2-5. Participants then received 200 mg pembrolizumab monotherapy Q3W starting on Cycle 6, for up to 35 cycles total (up to approximately 24 months).	Arm A: MK-1308 25 mg Q3W + Pembro. 200 mg Q3W n=36 Participants On cycle 1, day 1 of the dose confirmation phase and during all subsequent cycles, participants with advanced/metastatic NSCLC received 25 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. Participants were treated for 35 cycles total (up to approximately 24 months).	Arm B: MK-1308 25 mg Q6W + Pembro. 200 mg Q3W n=39 Participants On cycle 1, day 1 of the dose confirmation phase, participants with advanced/metastatic NSCLC received 25 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. On all subsequent cycles, participants received 200 mg pembrolizumab Q3W and 25 mg quavonlimab every 6 weeks (Q6W). Participants were treated for up to 35 cycles total (up to approximately 24 months).	Arm C: MK-1308 75 mg Q6W + Pembro. 200 mg Q3W n=37 Participants On cycle 1, day 1 of the dose confirmation phase, participants with advanced/metastatic NSCLC received 75 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. On all subsequent cycles, participants received 200 mg pembrolizumab Q3W and 75 mg quavonlimab Q6W. Participants were treated for 35 cycles total (up to approximately 24 months).	Arm D: MK-1308 75 mg Q6W + Pembro. 200 mg Q3W n=35 Participants On cycle 1, day 1 of the dose confirmation phase, participants with advanced/metastatic small cell lung cancer (SCLC) received 75 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. On all subsequent cycles, participants received 200 mg pembrolizumab Q3W and 75 mg quavonlimab Q6W. Participants were treated for 35 cycles total (up to approximately 24 months).	Arm E: MK-1308 75 mg Q3W + Pembro. 200 mg Q3W n=11 Participants On cycle 1, day 1 of the dose confirmation phase and during all subsequent cycles, participants with NSCLC received 75 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. Participants were treated for 35 cycles total (up to approximately 24 months).	Arm F: MK-1308 25 mg Q6W + Pembro. 400 mg Q6W Co-admin n=102 Participants On cycle 1, day 1 of the efficacy expansion phase and during all subsequent cycles, participants with programmed cell death protein 1 (PD-1)/programmed cell death ligand 1 (PD-L1) refractory melanoma received 25 mg quavonlimab in combination with 400 mg pembrolizumab. Both quavonlimab and pembrolizumab were administered Q6W for 24 months.	Arm G: MK-1308 25 mg Q6W n=38 Participants On cycle 1, day 1 of the efficacy expansion phase and during all subsequent cycles, participants with PD-1/PD-L1 refractory melanoma received 25 mg quavonlimab Q6W for up to 24 months.	Arm I: MK-1308A Q6W (Co-form) n=23 Participants On cycle 1, day 1 of the coformulation (Co-form) phase and during all subsequent cycles, participants with advanced/metastatic solid tumors received 400 mg pembrolizumab co-formulated with 25 mg quavonlimab (MK-1308A) Q6W for 24 months.	Arm K: MK-1308A Q6W (Co-form) n=20 Participants On cycle 1, day 1 of the coformulation phase and during all subsequent cycles, participants in mainland China with advanced/metastatic solid tumors received 400 mg pembrolizumab co-formulated with 25 mg quavonlimab (MK-1308A) Q6W for 24 months.
Number of Participants With Quavonlimab Anti-drug Antibodies (ADAs) Evaluable	14 Participants	15 Participants	8 Participants	36 Participants	39 Participants	37 Participants	35 Participants	11 Participants	102 Participants	38 Participants	23 Participants	20 Participants
Number of Participants With Quavonlimab Anti-drug Antibodies (ADAs) Negative	3 Participants	7 Participants	4 Participants	12 Participants	6 Participants	6 Participants	8 Participants	4 Participants	35 Participants	21 Participants	8 Participants	6 Participants
Number of Participants With Quavonlimab Anti-drug Antibodies (ADAs) Inconclusive	—	—	—	—	—	—	1 Participants	—	2 Participants	1 Participants	—	1 Participants
Number of Participants With Quavonlimab Anti-drug Antibodies (ADAs) TB NAB MISSING	—	1 Participants	—	—	—	1 Participants	—	—	3 Participants	2 Participants	—	2 Participants
Number of Participants With Quavonlimab Anti-drug Antibodies (ADAs) TE NAB MISSING	11 Participants	7 Participants	4 Participants	23 Participants	32 Participants	30 Participants	26 Participants	7 Participants	61 Participants	13 Participants	15 Participants	11 Participants
Number of Participants With Quavonlimab Anti-drug Antibodies (ADAs) NON-TE NAB MISSING	—	—	—	1 Participants	1 Participants	—	—	—	1 Participants	1 Participants	—	—

SECONDARY outcome

Timeframe: Up to approximately 72 months

Population: All participants with a baseline scan that demonstrated measurable disease and who were administered at least 1 dose of study intervention.

ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented. Per protocol, no analysis was planned for the cross over phase.

Outcome measures

Outcome measures
Measure	Cohort 1: MK-1308 25 mg Q3W + Pembro. 200 mg Q3W n=14 Participants On cycle 1, day 1 of the dose escalation phase, participants with advanced solid tumors received 25 mg quavonlimab (MK-1308) monotherapy followed by 25 mg quavonlimab in combination with 200 mg pembrolizumab (pembro) every 3 weeks (Q3W) for cycles 2-5. Participants then received 200 mg pembrolizumab monotherapy Q3W starting on Cycle 6, for up to 35 cycles total (up to approximately 24 months).	Cohort 2: MK-1308 75 mg Q3W + Pembro. 200 mg Q3W n=17 Participants On cycle 1, day 1 of the dose escalation phase, participants with advanced solid tumor except non-small cell lung cancer (NSCLC) received 75 mg quavonlimab monotherapy followed by 75 mg quavonlimab in combination with 200 mg pembrolizumab Q3W for cycles 2-5. Participants then received 200 mg pembrolizumab monotherapy Q3W starting on Cycle 6, for up to 35 cycles total (up to approximately 24 months).	Cohort 3: MK-1308 200 mg Q3W + Pembro. 200 mg Q3W n=8 Participants On cycle 1, day 1 of the dose escalation phase, participants with advanced solid tumor except non-small cell lung cancer (NSCLC) received 200 mg quavonlimab monotherapy followed by 200 mg quavonlimab in combination with 200 mg pembrolizumab Q3W for cycles 2-5. Participants then received 200 mg pembrolizumab monotherapy Q3W starting on Cycle 6, for up to 35 cycles total (up to approximately 24 months).	Arm A: MK-1308 25 mg Q3W + Pembro. 200 mg Q3W n=40 Participants On cycle 1, day 1 of the dose confirmation phase and during all subsequent cycles, participants with advanced/metastatic NSCLC received 25 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. Participants were treated for 35 cycles total (up to approximately 24 months).	Arm B: MK-1308 25 mg Q6W + Pembro. 200 mg Q3W n=40 Participants On cycle 1, day 1 of the dose confirmation phase, participants with advanced/metastatic NSCLC received 25 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. On all subsequent cycles, participants received 200 mg pembrolizumab Q3W and 25 mg quavonlimab every 6 weeks (Q6W). Participants were treated for up to 35 cycles total (up to approximately 24 months).	Arm C: MK-1308 75 mg Q6W + Pembro. 200 mg Q3W n=40 Participants On cycle 1, day 1 of the dose confirmation phase, participants with advanced/metastatic NSCLC received 75 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. On all subsequent cycles, participants received 200 mg pembrolizumab Q3W and 75 mg quavonlimab Q6W. Participants were treated for 35 cycles total (up to approximately 24 months).	Arm D: MK-1308 75 mg Q6W + Pembro. 200 mg Q3W n=40 Participants On cycle 1, day 1 of the dose confirmation phase, participants with advanced/metastatic small cell lung cancer (SCLC) received 75 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. On all subsequent cycles, participants received 200 mg pembrolizumab Q3W and 75 mg quavonlimab Q6W. Participants were treated for 35 cycles total (up to approximately 24 months).	Arm E: MK-1308 75 mg Q3W + Pembro. 200 mg Q3W n=14 Participants On cycle 1, day 1 of the dose confirmation phase and during all subsequent cycles, participants with NSCLC received 75 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. Participants were treated for 35 cycles total (up to approximately 24 months).	Arm F: MK-1308 25 mg Q6W + Pembro. 400 mg Q6W Co-admin On cycle 1, day 1 of the efficacy expansion phase and during all subsequent cycles, participants with programmed cell death protein 1 (PD-1)/programmed cell death ligand 1 (PD-L1) refractory melanoma received 25 mg quavonlimab in combination with 400 mg pembrolizumab. Both quavonlimab and pembrolizumab were administered Q6W for 24 months.	Arm G: MK-1308 25 mg Q6W On cycle 1, day 1 of the efficacy expansion phase and during all subsequent cycles, participants with PD-1/PD-L1 refractory melanoma received 25 mg quavonlimab Q6W for up to 24 months.	Arm I: MK-1308A Q6W (Co-form) n=29 Participants On cycle 1, day 1 of the coformulation (Co-form) phase and during all subsequent cycles, participants with advanced/metastatic solid tumors received 400 mg pembrolizumab co-formulated with 25 mg quavonlimab (MK-1308A) Q6W for 24 months.	Arm K: MK-1308A Q6W (Co-form) n=20 Participants On cycle 1, day 1 of the coformulation phase and during all subsequent cycles, participants in mainland China with advanced/metastatic solid tumors received 400 mg pembrolizumab co-formulated with 25 mg quavonlimab (MK-1308A) Q6W for 24 months.
Dose Escalation, Dose Confirmation, Coformulation: ORR as Assessed by Investigator Based on Adjusted RECIST v1.1	0.0 Percentage of participants Interval 0.0 to 23.2	0.0 Percentage of participants Interval 0.0 to 19.5	25.0 Percentage of participants Interval 3.2 to 65.1	32.5 Percentage of participants Interval 18.6 to 49.1	37.5 Percentage of participants Interval 22.7 to 54.2	30.0 Percentage of participants Interval 16.6 to 46.5	15.0 Percentage of participants Interval 5.7 to 29.8	35.7 Percentage of participants Interval 12.8 to 64.9	—	—	10.3 Percentage of participants Interval 2.2 to 27.4	20.0 Percentage of participants Interval 5.7 to 43.7

SECONDARY outcome

Timeframe: Up to approximately 72 months

Population: Participants who received at least one dose of study intervention who had either a CR or PR.

DOR was defined as the time from first documented evidence of complete response (CR: Disappearance of all target lesions) or confirmed partial response (PR: At least a 30% decrease in the sum of diameters of target lesions) until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by Blinded Independent Central Review (BICR) will be presented. Per protocol, only data for arms F and G were presented for this endpoint.

Outcome measures

Outcome measures
Measure	Cohort 1: MK-1308 25 mg Q3W + Pembro. 200 mg Q3W On cycle 1, day 1 of the dose escalation phase, participants with advanced solid tumors received 25 mg quavonlimab (MK-1308) monotherapy followed by 25 mg quavonlimab in combination with 200 mg pembrolizumab (pembro) every 3 weeks (Q3W) for cycles 2-5. Participants then received 200 mg pembrolizumab monotherapy Q3W starting on Cycle 6, for up to 35 cycles total (up to approximately 24 months).	Cohort 2: MK-1308 75 mg Q3W + Pembro. 200 mg Q3W On cycle 1, day 1 of the dose escalation phase, participants with advanced solid tumor except non-small cell lung cancer (NSCLC) received 75 mg quavonlimab monotherapy followed by 75 mg quavonlimab in combination with 200 mg pembrolizumab Q3W for cycles 2-5. Participants then received 200 mg pembrolizumab monotherapy Q3W starting on Cycle 6, for up to 35 cycles total (up to approximately 24 months).	Cohort 3: MK-1308 200 mg Q3W + Pembro. 200 mg Q3W On cycle 1, day 1 of the dose escalation phase, participants with advanced solid tumor except non-small cell lung cancer (NSCLC) received 200 mg quavonlimab monotherapy followed by 200 mg quavonlimab in combination with 200 mg pembrolizumab Q3W for cycles 2-5. Participants then received 200 mg pembrolizumab monotherapy Q3W starting on Cycle 6, for up to 35 cycles total (up to approximately 24 months).	Arm A: MK-1308 25 mg Q3W + Pembro. 200 mg Q3W On cycle 1, day 1 of the dose confirmation phase and during all subsequent cycles, participants with advanced/metastatic NSCLC received 25 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. Participants were treated for 35 cycles total (up to approximately 24 months).	Arm B: MK-1308 25 mg Q6W + Pembro. 200 mg Q3W On cycle 1, day 1 of the dose confirmation phase, participants with advanced/metastatic NSCLC received 25 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. On all subsequent cycles, participants received 200 mg pembrolizumab Q3W and 25 mg quavonlimab every 6 weeks (Q6W). Participants were treated for up to 35 cycles total (up to approximately 24 months).	Arm C: MK-1308 75 mg Q6W + Pembro. 200 mg Q3W On cycle 1, day 1 of the dose confirmation phase, participants with advanced/metastatic NSCLC received 75 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. On all subsequent cycles, participants received 200 mg pembrolizumab Q3W and 75 mg quavonlimab Q6W. Participants were treated for 35 cycles total (up to approximately 24 months).	Arm D: MK-1308 75 mg Q6W + Pembro. 200 mg Q3W On cycle 1, day 1 of the dose confirmation phase, participants with advanced/metastatic small cell lung cancer (SCLC) received 75 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. On all subsequent cycles, participants received 200 mg pembrolizumab Q3W and 75 mg quavonlimab Q6W. Participants were treated for 35 cycles total (up to approximately 24 months).	Arm E: MK-1308 75 mg Q3W + Pembro. 200 mg Q3W On cycle 1, day 1 of the dose confirmation phase and during all subsequent cycles, participants with NSCLC received 75 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. Participants were treated for 35 cycles total (up to approximately 24 months).	Arm F: MK-1308 25 mg Q6W + Pembro. 400 mg Q6W Co-admin n=111 Participants On cycle 1, day 1 of the efficacy expansion phase and during all subsequent cycles, participants with programmed cell death protein 1 (PD-1)/programmed cell death ligand 1 (PD-L1) refractory melanoma received 25 mg quavonlimab in combination with 400 mg pembrolizumab. Both quavonlimab and pembrolizumab were administered Q6W for 24 months.	Arm G: MK-1308 25 mg Q6W n=40 Participants On cycle 1, day 1 of the efficacy expansion phase and during all subsequent cycles, participants with PD-1/PD-L1 refractory melanoma received 25 mg quavonlimab Q6W for up to 24 months.	Arm I: MK-1308A Q6W (Co-form) On cycle 1, day 1 of the coformulation (Co-form) phase and during all subsequent cycles, participants with advanced/metastatic solid tumors received 400 mg pembrolizumab co-formulated with 25 mg quavonlimab (MK-1308A) Q6W for 24 months.	Arm K: MK-1308A Q6W (Co-form) On cycle 1, day 1 of the coformulation phase and during all subsequent cycles, participants in mainland China with advanced/metastatic solid tumors received 400 mg pembrolizumab co-formulated with 25 mg quavonlimab (MK-1308A) Q6W for 24 months.
Efficacy Expansion: Duration of Response (DOR) as Assessed by BICR Based on Adjusted RECIST v1.1	—	—	—	—	—	—	—	—	NA Months Interval 6.2 to NA = Median and lower limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.	8.6 Months Interval 8.6 to 8.6	—	—

Adverse Events

Cohort 1: MK-1308 25 mg Q3W + Pembro. 200 mg Q3W

Serious events: 2 serious events

Other events: 14 other events

Deaths: 13 deaths

Cohort 2: MK-1308 75 mg Q3W + Pembro. 200 mg Q3W

Serious events: 10 serious events

Other events: 16 other events

Deaths: 18 deaths

Cohort 3: MK-1308 200 mg Q3W + Pembro. 200 mg Q3W

Serious events: 4 serious events

Other events: 8 other events

Deaths: 7 deaths

Arm A: MK-1308 25 mg Q3W + Pembro. 200 mg Q3W

Serious events: 20 serious events

Other events: 38 other events

Deaths: 33 deaths

Arm B: MK-1308 25 mg Q6W + Pembro. 200 mg Q3W

Serious events: 14 serious events

Other events: 38 other events

Deaths: 31 deaths

Arm C: MK-1308 75 mg Q6W + Pembro. 200 mg Q3W

Serious events: 23 serious events

Other events: 38 other events

Deaths: 32 deaths

Arm D: MK-1308 75 mg Q6W + Pembro. 200 mg Q3W

Serious events: 16 serious events

Other events: 37 other events

Deaths: 35 deaths

Arm E: MK-1308 75 mg Q3W + Pembro. 200 mg Q3W

Serious events: 10 serious events

Other events: 13 other events

Deaths: 9 deaths

Arm F: MK-1308 25 mg Q6W + Pembro. 400 mg Q6W Co-admin

Serious events: 31 serious events

Other events: 102 other events

Deaths: 86 deaths

Arm F: MK-1308 25 mg Q6W + Pembro. 400 mg Q6W Co-admin After Crossover

Serious events: 4 serious events

Other events: 17 other events

Deaths: 17 deaths

Arm G: MK-1308 25 mg Q6W

Serious events: 9 serious events

Other events: 31 other events

Deaths: 16 deaths

Arm I: MK-1308A Q6W (Co-form)

Serious events: 15 serious events

Other events: 26 other events

Deaths: 22 deaths

Arm K: MK-1308A Q6W (Co-form)

Serious events: 4 serious events

Other events: 16 other events

Deaths: 15 deaths

Serious adverse events

Serious adverse events
Measure	Cohort 1: MK-1308 25 mg Q3W + Pembro. 200 mg Q3W n=14 participants at risk On cycle 1, day 1 of the dose escalation phase, participants with advanced solid tumors received 25 mg quavonlimab (MK-1308) monotherapy followed by 25 mg quavonlimab in combination with 200 mg pembrolizumab (pembro) every 3 weeks (Q3W) for cycles 2-5. Participants then received 200 mg pembrolizumab monotherapy Q3W starting on Cycle 6, for up to 35 cycles total (up to approximately 24 months).	Cohort 2: MK-1308 75 mg Q3W + Pembro. 200 mg Q3W n=17 participants at risk On cycle 1, day 1 of the dose escalation phase, participants with advanced solid tumor except non-small cell lung cancer (NSCLC) received 75 mg quavonlimab monotherapy followed by 75 mg quavonlimab in combination with 200 mg pembrolizumab Q3W for cycles 2-5. Participants then received 200 mg pembrolizumab monotherapy Q3W starting on Cycle 6, for up to 35 cycles total (up to approximately 24 months).	Cohort 3: MK-1308 200 mg Q3W + Pembro. 200 mg Q3W n=8 participants at risk On cycle 1, day 1 of the dose escalation phase, participants with advanced solid tumor except non-small cell lung cancer (NSCLC) received 200 mg quavonlimab monotherapy followed by 200 mg quavonlimab in combination with 200 mg pembrolizumab Q3W for cycles 2-5. Participants then received 200 mg pembrolizumab monotherapy Q3W starting on Cycle 6, for up to 35 cycles total (up to approximately 24 months).	Arm A: MK-1308 25 mg Q3W + Pembro. 200 mg Q3W n=40 participants at risk On cycle 1, day 1 of the dose confirmation phase and during all subsequent cycles, participants with advanced/metastatic NSCLC received 25 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. Participants were treated for 35 cycles total (up to approximately 24 months).	Arm B: MK-1308 25 mg Q6W + Pembro. 200 mg Q3W n=40 participants at risk On cycle 1, day 1 of the dose confirmation phase, participants with advanced/metastatic NSCLC received 25 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. On all subsequent cycles, participants received 200 mg pembrolizumab Q3W and 25 mg quavonlimab every 6 weeks (Q6W). Participants were treated for up to 35 cycles total (up to approximately 24 months).	Arm C: MK-1308 75 mg Q6W + Pembro. 200 mg Q3W n=40 participants at risk On cycle 1, day 1 of the dose confirmation phase, participants with advanced/metastatic NSCLC received 75 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. On all subsequent cycles, participants received 200 mg pembrolizumab Q3W and 75 mg quavonlimab Q6W. Participants were treated for 35 cycles total (up to approximately 24 months).	Arm D: MK-1308 75 mg Q6W + Pembro. 200 mg Q3W n=40 participants at risk On cycle 1, day 1 of the dose confirmation phase, participants with advanced/metastatic small cell lung cancer (SCLC) received 75 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. On all subsequent cycles, participants received 200 mg pembrolizumab Q3W and 75 mg quavonlimab Q6W. Participants were treated for 35 cycles total (up to approximately 24 months).	Arm E: MK-1308 75 mg Q3W + Pembro. 200 mg Q3W n=14 participants at risk On cycle 1, day 1 of the dose confirmation phase and during all subsequent cycles, participants with NSCLC received 75 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. Participants were treated for 35 cycles total (up to approximately 24 months).	Arm F: MK-1308 25 mg Q6W + Pembro. 400 mg Q6W Co-admin n=111 participants at risk On cycle 1, day 1 of the efficacy expansion phase and during all subsequent cycles, participants with programmed cell death protein 1 (PD-1)/programmed cell death ligand 1 (PD-L1) refractory melanoma received 25 mg quavonlimab in combination with 400 mg pembrolizumab. Both quavonlimab and pembrolizumab were administered Q6W for 24 months.	Arm F: MK-1308 25 mg Q6W + Pembro. 400 mg Q6W Co-admin After Crossover n=21 participants at risk Participants who demonstrated radiographically confirmed progressive disease in Arm G and switched over to combination therapy received 25 mg quavonlimab in combination with 400 mg pembrolizumab. Both quavonlimab and pembrolizumab were administered Q6W for 24 months.	Arm G: MK-1308 25 mg Q6W n=40 participants at risk On cycle 1, day 1 of the efficacy expansion phase and during all subsequent cycles, participants with PD-1/PD-L1 refractory melanoma received 25 mg quavonlimab Q6W for up to 24 months.	Arm I: MK-1308A Q6W (Co-form) n=29 participants at risk On cycle 1, day 1 of the coformulation (Co-form) phase and during all subsequent cycles, participants with advanced/metastatic solid tumors received 400 mg pembrolizumab co-formulated with 25 mg quavonlimab (MK-1308A) Q6W for 24 months.	Arm K: MK-1308A Q6W (Co-form) n=20 participants at risk On cycle 1, day 1 of the coformulation phase and during all subsequent cycles, participants in mainland China with advanced/metastatic solid tumors received 400 mg pembrolizumab co-formulated with 25 mg quavonlimab (MK-1308A) Q6W for 24 months.
Endocrine disorders Hypothyroidism	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Eye disorders Retinal detachment	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Injury, poisoning and procedural complications Radiation oesophagitis	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Blood and lymphatic system disorders Anaemia	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	12.5% 1/8 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.7% 3/111 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Blood and lymphatic system disorders Autoimmune haemolytic anaemia	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.90% 1/111 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.1% 1/14 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Blood and lymphatic system disorders Mesenteric lymphadenitis	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.1% 1/14 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Cardiac disorders Acute myocardial infarction	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Cardiac disorders Atrial fibrillation	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.90% 1/111 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Cardiac disorders Atrioventricular block complete	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Cardiac disorders Cardiac arrest	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Cardiac disorders Cardiac failure	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Cardiac disorders Cardiac failure congestive	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.9% 1/17 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Cardiac disorders Cardiogenic shock	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Cardiac disorders Coronary artery disease	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.1% 1/14 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Cardiac disorders Myocardial infarction	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Cardiac disorders Pericarditis	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Cardiac disorders Tachyarrhythmia	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Ear and labyrinth disorders Vestibular disorder	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.90% 1/111 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Endocrine disorders Adrenal insufficiency	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.1% 1/14 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	1.8% 2/111 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Endocrine disorders Hyperthyroidism	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Endocrine disorders Hypophysitis	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.90% 1/111 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	4.8% 1/21 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Gastrointestinal disorders Abdominal pain	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.90% 1/111 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 1/20 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Gastrointestinal disorders Ascites	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	12.5% 1/8 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Gastrointestinal disorders Colitis	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.1% 1/14 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	3.6% 4/111 • Number of events 4 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	3.4% 1/29 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Gastrointestinal disorders Constipation	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Gastrointestinal disorders Diarrhoea	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.7% 3/111 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Gastrointestinal disorders Diverticular perforation	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.90% 1/111 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Gastrointestinal disorders Enterocolitis	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.90% 1/111 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Gastrointestinal disorders Large intestinal obstruction	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Gastrointestinal disorders Large intestine perforation	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.9% 1/17 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Gastrointestinal disorders Nausea	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Gastrointestinal disorders Oesophagitis	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.1% 1/14 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	3.4% 1/29 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Gastrointestinal disorders Subileus	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	4.8% 1/21 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Gastrointestinal disorders Vomiting	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
General disorders Asthenia	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
General disorders Chest pain	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.90% 1/111 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
General disorders Death	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
General disorders Fatigue	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.9% 1/17 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.90% 1/111 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
General disorders General physical health deterioration	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	12.5% 1/8 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
General disorders Incarcerated hernia	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.90% 1/111 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
General disorders Malaise	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.9% 1/17 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
General disorders Pyrexia	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.7% 3/111 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Hepatobiliary disorders Autoimmune hepatitis	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.90% 1/111 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Hepatobiliary disorders Biliary obstruction	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.90% 1/111 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Hepatobiliary disorders Cholangitis	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	3.4% 1/29 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Hepatobiliary disorders Cholecystitis	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.90% 1/111 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	3.4% 1/29 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Hepatobiliary disorders Cholelithiasis	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 1/20 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Hepatobiliary disorders Hepatitis	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Hepatobiliary disorders Hypertransaminasaemia	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Hepatobiliary disorders Immune-mediated hepatitis	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	3.4% 1/29 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 1/20 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Infections and infestations Appendicitis perforated	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.90% 1/111 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Infections and infestations Arthritis infective	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.90% 1/111 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Infections and infestations Bacteraemia	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.9% 1/17 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	12.5% 1/8 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Infections and infestations Bronchopulmonary aspergillosis	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Infections and infestations COVID-19 pneumonia	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Infections and infestations Cellulitis	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.90% 1/111 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Infections and infestations Clostridium difficile infection	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.90% 1/111 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Infections and infestations Encephalitis	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 2/40 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Infections and infestations Herpes zoster	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Infections and infestations Infective exacerbation of bronchiectasis	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.90% 1/111 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Infections and infestations Infective exacerbation of chronic obstructive airways disease	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Infections and infestations Lower respiratory tract infection	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	3.4% 1/29 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Infections and infestations Meningitis	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	3.4% 1/29 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Infections and infestations Oesophageal candidiasis	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Infections and infestations Pneumonia	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	10.0% 4/40 • Number of events 4 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	22.5% 9/40 • Number of events 10 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.5% 3/40 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	21.4% 3/14 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.90% 1/111 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Infections and infestations Pulmonary sepsis	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Infections and infestations Sepsis	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.90% 1/111 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Infections and infestations Septic shock	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 2/40 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Infections and infestations Spinal cord infection	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Infections and infestations Urinary tract infection	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.9% 1/17 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Infections and infestations Urosepsis	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	3.4% 1/29 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Injury, poisoning and procedural complications Animal bite	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	3.4% 1/29 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Injury, poisoning and procedural complications Subdural haemorrhage	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Investigations Alanine aminotransferase increased	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 2/40 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Investigations Aspartate aminotransferase increased	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 2/40 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 1/20 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Investigations Gamma-glutamyltransferase increased	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Investigations Troponin increased	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.90% 1/111 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Metabolism and nutrition disorders Dehydration	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.90% 1/111 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Metabolism and nutrition disorders Diabetic metabolic decompensation	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.90% 1/111 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	3.4% 1/29 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.9% 1/17 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.9% 1/17 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	3.4% 1/29 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Metabolism and nutrition disorders Type 1 diabetes mellitus	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	12.5% 1/8 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.1% 1/14 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.90% 1/111 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 2/40 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Musculoskeletal and connective tissue disorders Osteolysis	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.1% 1/14 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Musculoskeletal and connective tissue disorders Spinal pain	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.90% 1/111 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Musculoskeletal and connective tissue disorders Spinal stenosis	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bowen's disease	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	3.4% 1/29 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine tumour	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.90% 1/111 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Paraneoplastic syndrome	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.9% 1/17 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	3.4% 1/29 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	3.4% 1/29 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Nervous system disorders Autonomic nervous system imbalance	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.9% 1/17 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Nervous system disorders Brain oedema	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.90% 1/111 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Nervous system disorders Cerebral haematoma	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.90% 1/111 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Nervous system disorders Cerebral infarction	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 1/20 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Nervous system disorders Cerebrovascular accident	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Nervous system disorders Guillain-Barre syndrome	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.90% 1/111 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Nervous system disorders Haemorrhage intracranial	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.90% 1/111 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	3.4% 1/29 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Nervous system disorders Metabolic encephalopathy	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.1% 1/14 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Nervous system disorders Seizure	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	3.4% 1/29 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Psychiatric disorders Confusional state	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.90% 1/111 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Psychiatric disorders Delirium	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	3.4% 1/29 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Renal and urinary disorders Acute kidney injury	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.9% 1/17 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	12.5% 1/8 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	1.8% 2/111 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Renal and urinary disorders Haematuria	7.1% 1/14 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Renal and urinary disorders Nephritis	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.1% 1/14 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Renal and urinary disorders Urinary tract obstruction	7.1% 1/14 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Renal and urinary disorders Urinoma	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.1% 1/14 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 2/40 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	4.8% 1/21 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Respiratory, thoracic and mediastinal disorders Lung disorder	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.90% 1/111 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 2/40 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 2/40 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	3.4% 1/29 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	12.5% 1/8 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	12.5% 5/40 • Number of events 5 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	10.0% 4/40 • Number of events 4 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 2/40 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 2/40 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.90% 1/111 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 2/40 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 2/40 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.90% 1/111 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.1% 1/14 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Skin and subcutaneous tissue disorders Rash	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	3.4% 1/29 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Vascular disorders Deep vein thrombosis	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.90% 1/111 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Vascular disorders Embolism	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.9% 1/17 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
General disorders Multiple organ dysfunction syndrome	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	4.8% 1/21 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Hepatobiliary disorders Cholestasis	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	4.8% 1/21 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.

Other adverse events

Other adverse events
Measure	Cohort 1: MK-1308 25 mg Q3W + Pembro. 200 mg Q3W n=14 participants at risk On cycle 1, day 1 of the dose escalation phase, participants with advanced solid tumors received 25 mg quavonlimab (MK-1308) monotherapy followed by 25 mg quavonlimab in combination with 200 mg pembrolizumab (pembro) every 3 weeks (Q3W) for cycles 2-5. Participants then received 200 mg pembrolizumab monotherapy Q3W starting on Cycle 6, for up to 35 cycles total (up to approximately 24 months).	Cohort 2: MK-1308 75 mg Q3W + Pembro. 200 mg Q3W n=17 participants at risk On cycle 1, day 1 of the dose escalation phase, participants with advanced solid tumor except non-small cell lung cancer (NSCLC) received 75 mg quavonlimab monotherapy followed by 75 mg quavonlimab in combination with 200 mg pembrolizumab Q3W for cycles 2-5. Participants then received 200 mg pembrolizumab monotherapy Q3W starting on Cycle 6, for up to 35 cycles total (up to approximately 24 months).	Cohort 3: MK-1308 200 mg Q3W + Pembro. 200 mg Q3W n=8 participants at risk On cycle 1, day 1 of the dose escalation phase, participants with advanced solid tumor except non-small cell lung cancer (NSCLC) received 200 mg quavonlimab monotherapy followed by 200 mg quavonlimab in combination with 200 mg pembrolizumab Q3W for cycles 2-5. Participants then received 200 mg pembrolizumab monotherapy Q3W starting on Cycle 6, for up to 35 cycles total (up to approximately 24 months).	Arm A: MK-1308 25 mg Q3W + Pembro. 200 mg Q3W n=40 participants at risk On cycle 1, day 1 of the dose confirmation phase and during all subsequent cycles, participants with advanced/metastatic NSCLC received 25 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. Participants were treated for 35 cycles total (up to approximately 24 months).	Arm B: MK-1308 25 mg Q6W + Pembro. 200 mg Q3W n=40 participants at risk On cycle 1, day 1 of the dose confirmation phase, participants with advanced/metastatic NSCLC received 25 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. On all subsequent cycles, participants received 200 mg pembrolizumab Q3W and 25 mg quavonlimab every 6 weeks (Q6W). Participants were treated for up to 35 cycles total (up to approximately 24 months).	Arm C: MK-1308 75 mg Q6W + Pembro. 200 mg Q3W n=40 participants at risk On cycle 1, day 1 of the dose confirmation phase, participants with advanced/metastatic NSCLC received 75 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. On all subsequent cycles, participants received 200 mg pembrolizumab Q3W and 75 mg quavonlimab Q6W. Participants were treated for 35 cycles total (up to approximately 24 months).	Arm D: MK-1308 75 mg Q6W + Pembro. 200 mg Q3W n=40 participants at risk On cycle 1, day 1 of the dose confirmation phase, participants with advanced/metastatic small cell lung cancer (SCLC) received 75 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. On all subsequent cycles, participants received 200 mg pembrolizumab Q3W and 75 mg quavonlimab Q6W. Participants were treated for 35 cycles total (up to approximately 24 months).	Arm E: MK-1308 75 mg Q3W + Pembro. 200 mg Q3W n=14 participants at risk On cycle 1, day 1 of the dose confirmation phase and during all subsequent cycles, participants with NSCLC received 75 mg quavonlimab in combination with 200 mg pembrolizumab Q3W. Participants were treated for 35 cycles total (up to approximately 24 months).	Arm F: MK-1308 25 mg Q6W + Pembro. 400 mg Q6W Co-admin n=111 participants at risk On cycle 1, day 1 of the efficacy expansion phase and during all subsequent cycles, participants with programmed cell death protein 1 (PD-1)/programmed cell death ligand 1 (PD-L1) refractory melanoma received 25 mg quavonlimab in combination with 400 mg pembrolizumab. Both quavonlimab and pembrolizumab were administered Q6W for 24 months.	Arm F: MK-1308 25 mg Q6W + Pembro. 400 mg Q6W Co-admin After Crossover n=21 participants at risk Participants who demonstrated radiographically confirmed progressive disease in Arm G and switched over to combination therapy received 25 mg quavonlimab in combination with 400 mg pembrolizumab. Both quavonlimab and pembrolizumab were administered Q6W for 24 months.	Arm G: MK-1308 25 mg Q6W n=40 participants at risk On cycle 1, day 1 of the efficacy expansion phase and during all subsequent cycles, participants with PD-1/PD-L1 refractory melanoma received 25 mg quavonlimab Q6W for up to 24 months.	Arm I: MK-1308A Q6W (Co-form) n=29 participants at risk On cycle 1, day 1 of the coformulation (Co-form) phase and during all subsequent cycles, participants with advanced/metastatic solid tumors received 400 mg pembrolizumab co-formulated with 25 mg quavonlimab (MK-1308A) Q6W for 24 months.	Arm K: MK-1308A Q6W (Co-form) n=20 participants at risk On cycle 1, day 1 of the coformulation phase and during all subsequent cycles, participants in mainland China with advanced/metastatic solid tumors received 400 mg pembrolizumab co-formulated with 25 mg quavonlimab (MK-1308A) Q6W for 24 months.
Injury, poisoning and procedural complications Foot fracture	7.1% 1/14 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.9% 1/17 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	12.5% 1/8 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 2/40 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 2/40 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	3.4% 1/29 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Investigations Alanine aminotransferase increased	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.9% 1/17 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	25.0% 10/40 • Number of events 12 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	12.5% 5/40 • Number of events 5 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	22.5% 9/40 • Number of events 11 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	12.5% 5/40 • Number of events 7 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	42.9% 6/14 • Number of events 10 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	9.0% 10/111 • Number of events 13 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	4.8% 1/21 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	6.9% 2/29 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	15.0% 3/20 • Number of events 4 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Investigations Ammonia increased	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.1% 1/14 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Investigations Aspartate aminotransferase increased	7.1% 1/14 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	17.6% 3/17 • Number of events 4 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	25.0% 2/8 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	22.5% 9/40 • Number of events 9 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	15.0% 6/40 • Number of events 6 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	27.5% 11/40 • Number of events 15 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	10.0% 4/40 • Number of events 6 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	42.9% 6/14 • Number of events 12 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.4% 6/111 • Number of events 9 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	14.3% 3/21 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.5% 3/40 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	10.3% 3/29 • Number of events 4 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	15.0% 3/20 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Investigations Blood alkaline phosphatase increased	14.3% 2/14 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.9% 1/17 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	25.0% 2/8 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 2/40 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	14.3% 2/14 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.4% 6/111 • Number of events 6 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	19.0% 4/21 • Number of events 5 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.5% 3/40 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	6.9% 2/29 • Number of events 4 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 1/20 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Injury, poisoning and procedural complications Fall	14.3% 2/14 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 2/40 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.1% 1/14 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Blood and lymphatic system disorders Anaemia	7.1% 1/14 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	11.8% 2/17 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	25.0% 2/8 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.5% 3/40 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	20.0% 8/40 • Number of events 9 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	12.5% 5/40 • Number of events 5 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	14.3% 2/14 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	9.9% 11/111 • Number of events 12 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	19.0% 4/21 • Number of events 4 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	20.0% 8/40 • Number of events 9 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	10.3% 3/29 • Number of events 4 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	25.0% 5/20 • Number of events 13 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Blood and lymphatic system disorders Eosinophilia	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.9% 1/17 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.90% 1/111 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	9.5% 2/21 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.5% 3/40 • Number of events 4 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.7% 3/111 • Number of events 4 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	14.3% 3/21 • Number of events 4 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.5% 3/40 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Blood and lymphatic system disorders Neutropenia	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	12.5% 1/8 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Cardiac disorders Tachycardia	7.1% 1/14 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.1% 1/14 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Ear and labyrinth disorders Vertigo	7.1% 1/14 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.9% 1/17 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 2/40 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.90% 1/111 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Endocrine disorders Adrenal insufficiency	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.9% 1/17 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.5% 3/40 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	10.0% 4/40 • Number of events 4 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	10.0% 4/40 • Number of events 4 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.90% 1/111 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Endocrine disorders Hyperthyroidism	21.4% 3/14 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.9% 1/17 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	37.5% 3/8 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	10.0% 4/40 • Number of events 4 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.5% 3/40 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 2/40 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	17.5% 7/40 • Number of events 7 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.1% 1/14 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.7% 3/111 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Endocrine disorders Hypophysitis	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.1% 1/14 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Endocrine disorders Hypothyroidism	21.4% 3/14 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	17.6% 3/17 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	12.5% 5/40 • Number of events 5 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	22.5% 9/40 • Number of events 9 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	20.0% 8/40 • Number of events 8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	20.0% 8/40 • Number of events 8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.1% 1/14 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.7% 3/111 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	4.8% 1/21 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	15.0% 3/20 • Number of events 4 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Eye disorders Lacrimation increased	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.9% 1/17 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.1% 1/14 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.90% 1/111 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Eye disorders Vision blurred	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	3.4% 1/29 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	10.0% 2/20 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Gastrointestinal disorders Abdominal distension	14.3% 2/14 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.9% 1/17 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	1.8% 2/111 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	4.8% 1/21 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	3.4% 1/29 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 1/20 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Gastrointestinal disorders Abdominal pain	14.3% 2/14 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.9% 1/17 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	12.5% 1/8 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 2/40 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 2/40 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.1% 1/14 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	11.7% 13/111 • Number of events 13 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	4.8% 1/21 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.5% 3/40 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	3.4% 1/29 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	10.0% 2/20 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	12.5% 1/8 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	10.0% 4/40 • Number of events 4 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	8.1% 9/111 • Number of events 9 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	6.9% 2/29 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Gastrointestinal disorders Aphthous ulcer	7.1% 1/14 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Gastrointestinal disorders Ascites	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.9% 1/17 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Gastrointestinal disorders Colitis	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.1% 1/14 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	1.8% 2/111 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Gastrointestinal disorders Constipation	21.4% 3/14 • Number of events 4 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	17.6% 3/17 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	12.5% 1/8 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	10.0% 4/40 • Number of events 4 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	10.0% 4/40 • Number of events 4 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	12.5% 5/40 • Number of events 5 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	10.0% 4/40 • Number of events 4 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	21.4% 3/14 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	12.6% 14/111 • Number of events 17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	9.5% 2/21 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	10.0% 4/40 • Number of events 4 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	13.8% 4/29 • Number of events 4 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	10.0% 2/20 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Gastrointestinal disorders Dental caries	7.1% 1/14 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Gastrointestinal disorders Diarrhoea	21.4% 3/14 • Number of events 4 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	11.8% 2/17 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	37.5% 3/8 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	22.5% 9/40 • Number of events 18 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.5% 3/40 • Number of events 7 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	22.5% 9/40 • Number of events 15 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	25.0% 10/40 • Number of events 22 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	21.4% 3/14 • Number of events 6 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	24.3% 27/111 • Number of events 37 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	19.0% 4/21 • Number of events 4 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.5% 3/40 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	6.9% 2/29 • Number of events 4 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	15.0% 3/20 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Gastrointestinal disorders Diarrhoea haemorrhagic	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.1% 1/14 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Gastrointestinal disorders Dry mouth	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	11.8% 2/17 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	12.5% 1/8 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 2/40 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 2/40 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 2/40 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	14.3% 2/14 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	8.1% 9/111 • Number of events 9 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	3.4% 1/29 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 1/20 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Gastrointestinal disorders Dyspepsia	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 2/40 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.5% 3/40 • Number of events 4 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	1.8% 2/111 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Gastrointestinal disorders Gingival pain	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.1% 1/14 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Gastrointestinal disorders Haematochezia	7.1% 1/14 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.90% 1/111 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Gastrointestinal disorders Inguinal hernia	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.9% 1/17 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Gastrointestinal disorders Nausea	7.1% 1/14 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	37.5% 3/8 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	25.0% 10/40 • Number of events 17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	12.5% 5/40 • Number of events 5 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 2/40 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	25.0% 10/40 • Number of events 16 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	18.9% 21/111 • Number of events 24 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	10.0% 4/40 • Number of events 4 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	3.4% 1/29 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Gastrointestinal disorders Obstruction gastric	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.9% 1/17 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Gastrointestinal disorders Small intestinal obstruction	7.1% 1/14 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Gastrointestinal disorders Vomiting	14.3% 2/14 • Number of events 4 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	29.4% 5/17 • Number of events 5 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	25.0% 2/8 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	12.5% 5/40 • Number of events 9 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	10.0% 4/40 • Number of events 4 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.5% 3/40 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	15.0% 6/40 • Number of events 6 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	3.6% 4/111 • Number of events 4 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	4.8% 1/21 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 2/40 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	3.4% 1/29 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
General disorders Asthenia	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.9% 1/17 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	25.0% 2/8 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	10.0% 4/40 • Number of events 5 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 2/40 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	10.0% 4/40 • Number of events 4 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.1% 1/14 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	11.7% 13/111 • Number of events 15 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	28.6% 6/21 • Number of events 6 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	10.0% 4/40 • Number of events 4 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	17.2% 5/29 • Number of events 5 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 1/20 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
General disorders Catheter site pain	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.9% 1/17 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
General disorders Chest discomfort	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.90% 1/111 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	6.9% 2/29 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
General disorders Chest pain	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.9% 1/17 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 2/40 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.5% 3/40 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 2/40 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.7% 3/111 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	14.3% 3/21 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	6.9% 2/29 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 1/20 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
General disorders Chills	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.9% 1/17 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.90% 1/111 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	6.9% 2/29 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
General disorders Early satiety	7.1% 1/14 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.9% 1/17 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
General disorders Fatigue	50.0% 7/14 • Number of events 7 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	17.6% 3/17 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	25.0% 2/8 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	22.5% 9/40 • Number of events 13 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	22.5% 9/40 • Number of events 12 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	15.0% 6/40 • Number of events 8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	27.5% 11/40 • Number of events 12 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	28.6% 4/14 • Number of events 5 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	23.4% 26/111 • Number of events 28 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	4.8% 1/21 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	15.0% 6/40 • Number of events 6 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	31.0% 9/29 • Number of events 9 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	10.0% 2/20 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
General disorders General physical health deterioration	7.1% 1/14 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.9% 1/17 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.90% 1/111 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
General disorders Influenza like illness	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.9% 1/17 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	12.5% 1/8 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 2/40 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 2/40 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 2/40 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	1.8% 2/111 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
General disorders Localised oedema	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.9% 1/17 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 1/20 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
General disorders Malaise	7.1% 1/14 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	14.3% 2/14 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	4.8% 1/21 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
General disorders Mucosal inflammation	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.9% 1/17 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.90% 1/111 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
General disorders Oedema peripheral	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.9% 1/17 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	25.0% 2/8 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	12.5% 5/40 • Number of events 7 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.1% 1/14 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.2% 8/111 • Number of events 12 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 1/20 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
General disorders Pyrexia	7.1% 1/14 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.9% 1/17 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	10.0% 4/40 • Number of events 4 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	10.0% 4/40 • Number of events 5 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	12.5% 5/40 • Number of events 10 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.5% 3/40 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	28.6% 4/14 • Number of events 7 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	8.1% 9/111 • Number of events 12 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	9.5% 2/21 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 2/40 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	10.3% 3/29 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Hepatobiliary disorders Hepatitis	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.1% 1/14 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	1.8% 2/111 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Hepatobiliary disorders Hypertransaminasaemia	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	12.5% 1/8 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Hepatobiliary disorders Immune-mediated hepatitis	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	12.5% 1/8 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Immune system disorders Contrast media allergy	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.5% 3/40 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	3.4% 1/29 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Immune system disorders Drug hypersensitivity	7.1% 1/14 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.90% 1/111 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Immune system disorders Hypersensitivity	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.9% 1/17 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Infections and infestations Cellulitis	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	12.5% 1/8 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.90% 1/111 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	3.4% 1/29 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Infections and infestations Conjunctivitis	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	12.5% 1/8 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.90% 1/111 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Infections and infestations Cystitis	7.1% 1/14 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Infections and infestations Gingivitis	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.9% 1/17 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Infections and infestations Herpes zoster	7.1% 1/14 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.90% 1/111 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	3.4% 1/29 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Infections and infestations Infection	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.1% 1/14 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Infections and infestations Nasopharyngitis	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	12.5% 1/8 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 2/40 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.90% 1/111 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Infections and infestations Oral candidiasis	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.9% 1/17 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Infections and infestations Oral herpes	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.9% 1/17 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	1.8% 2/111 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Infections and infestations Pneumonia	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.5% 3/40 • Number of events 5 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	1.8% 2/111 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	3.4% 1/29 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Infections and infestations Sinusitis	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.1% 1/14 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.90% 1/111 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	6.9% 2/29 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Infections and infestations Tinea infection	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.1% 1/14 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Infections and infestations Upper respiratory tract infection	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.9% 1/17 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	12.5% 1/8 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 2/40 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	12.5% 5/40 • Number of events 5 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	12.5% 5/40 • Number of events 7 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	12.5% 5/40 • Number of events 6 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.7% 3/111 • Number of events 4 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	15.0% 3/20 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Infections and infestations Urinary tract infection	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.5% 3/40 • Number of events 7 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 2/40 • Number of events 8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.5% 3/40 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	6.3% 7/111 • Number of events 8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	6.9% 2/29 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Injury, poisoning and procedural complications Animal bite	7.1% 1/14 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Injury, poisoning and procedural complications Dental restoration failure	7.1% 1/14 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Investigations Blood bilirubin increased	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.9% 1/17 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	25.0% 2/8 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 4 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	1.8% 2/111 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Investigations Blood corticotrophin increased	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	12.5% 1/8 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.90% 1/111 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Investigations Blood creatinine increased	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	12.5% 1/8 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.5% 3/40 • Number of events 5 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 2/40 • Number of events 4 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 2/40 • Number of events 4 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	14.3% 2/14 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.90% 1/111 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	3.4% 1/29 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	10.0% 2/20 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Investigations Blood lactate dehydrogenase increased	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	12.5% 1/8 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.7% 3/111 • Number of events 4 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	4.8% 1/21 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	3.4% 1/29 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Investigations C-reactive protein increased	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.4% 6/111 • Number of events 7 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	4.8% 1/21 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.5% 3/40 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Investigations Cortisol increased	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	12.5% 1/8 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Investigations Gamma-glutamyltransferase increased	14.3% 2/14 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.9% 1/17 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	25.0% 2/8 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.5% 3/40 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.1% 1/14 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	3.6% 4/111 • Number of events 4 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	14.3% 3/21 • Number of events 4 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	10.0% 4/40 • Number of events 4 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	10.3% 3/29 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 1/20 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Investigations Lipase increased	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	12.5% 1/8 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.7% 3/111 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	14.3% 3/21 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 2/40 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Investigations Lymphocyte count decreased	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.9% 1/17 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	12.5% 1/8 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Investigations Neutrophil count decreased	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 2/40 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	10.0% 2/20 • Number of events 4 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Investigations Platelet count decreased	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.9% 1/17 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	12.5% 1/8 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.1% 1/14 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.90% 1/111 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 1/20 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Investigations Weight decreased	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	17.6% 3/17 • Number of events 4 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	12.5% 1/8 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	12.5% 5/40 • Number of events 5 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	10.0% 4/40 • Number of events 4 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.5% 3/40 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	17.5% 7/40 • Number of events 7 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	28.6% 4/14 • Number of events 4 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.4% 6/111 • Number of events 6 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	9.5% 2/21 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	3.4% 1/29 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 1/20 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Investigations White blood cell count decreased	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	12.5% 1/8 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	15.0% 3/20 • Number of events 7 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Metabolism and nutrition disorders Decreased appetite	35.7% 5/14 • Number of events 5 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	17.6% 3/17 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	37.5% 3/8 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	32.5% 13/40 • Number of events 15 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	30.0% 12/40 • Number of events 13 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	20.0% 8/40 • Number of events 10 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	17.5% 7/40 • Number of events 8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.1% 1/14 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	16.2% 18/111 • Number of events 19 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	9.5% 2/21 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 2/40 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	6.9% 2/29 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	10.0% 2/20 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Metabolism and nutrition disorders Dehydration	7.1% 1/14 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.9% 1/17 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	12.5% 1/8 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	10.0% 4/40 • Number of events 10 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 2/40 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.5% 3/40 • Number of events 4 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.1% 1/14 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.90% 1/111 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	3.4% 1/29 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Metabolism and nutrition disorders Glucose tolerance impaired	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	12.5% 1/8 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.5% 3/40 • Number of events 4 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.7% 3/111 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	17.5% 7/40 • Number of events 8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 2/40 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	28.6% 4/14 • Number of events 9 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	4.5% 5/111 • Number of events 5 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	4.8% 1/21 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.5% 3/40 • Number of events 4 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 2/40 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	10.0% 4/40 • Number of events 5 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	12.5% 5/40 • Number of events 7 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	21.4% 3/14 • Number of events 4 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.5% 3/40 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	14.3% 2/14 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	1.8% 2/111 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 1/20 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	12.5% 1/8 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 2/40 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 2/40 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 2/40 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	14.3% 2/14 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.4% 6/111 • Number of events 6 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	4.8% 1/21 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	3.4% 1/29 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	15.0% 3/20 • Number of events 8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 2/40 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	14.3% 2/14 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	1.8% 2/111 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.1% 1/14 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 1/20 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Metabolism and nutrition disorders Hypokalaemia	7.1% 1/14 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	11.8% 2/17 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	25.0% 2/8 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	10.0% 4/40 • Number of events 5 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 2/40 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	12.5% 5/40 • Number of events 10 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	14.3% 2/14 • Number of events 5 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	4.5% 5/111 • Number of events 5 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	4.8% 1/21 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	20.0% 4/20 • Number of events 8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	12.5% 1/8 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 2/40 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 2/40 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	10.0% 4/40 • Number of events 4 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	14.3% 2/14 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	6.9% 2/29 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	11.8% 2/17 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	12.5% 1/8 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 2/40 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 2/40 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 2/40 • Number of events 4 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 2/40 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.1% 1/14 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	1.8% 2/111 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	4.8% 1/21 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 1/20 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Metabolism and nutrition disorders Hypophagia	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	12.5% 1/8 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.5% 3/40 • Number of events 5 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.1% 1/14 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	1.8% 2/111 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 2/40 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Musculoskeletal and connective tissue disorders Arthralgia	14.3% 2/14 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	11.8% 2/17 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	12.5% 1/8 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	10.0% 4/40 • Number of events 4 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	15.0% 6/40 • Number of events 11 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	17.5% 7/40 • Number of events 11 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	10.0% 4/40 • Number of events 4 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.1% 1/14 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	12.6% 14/111 • Number of events 17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	14.3% 3/21 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.5% 3/40 • Number of events 4 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	3.4% 1/29 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 1/20 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Musculoskeletal and connective tissue disorders Back pain	21.4% 3/14 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.9% 1/17 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	12.5% 1/8 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 2/40 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	10.0% 4/40 • Number of events 4 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	14.3% 2/14 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	8.1% 9/111 • Number of events 9 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	14.3% 3/21 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	3.4% 1/29 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 1/20 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Musculoskeletal and connective tissue disorders Joint range of motion decreased	7.1% 1/14 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.1% 1/14 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.90% 1/111 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Musculoskeletal and connective tissue disorders Muscle rigidity	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.1% 1/14 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.90% 1/111 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Musculoskeletal and connective tissue disorders Muscular weakness	7.1% 1/14 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	12.5% 1/8 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 2/40 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.5% 3/40 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.90% 1/111 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 2/40 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 2/40 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.90% 1/111 • Number of events 4 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	4.8% 1/21 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	6.9% 2/29 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	7.1% 1/14 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 2/40 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.7% 3/111 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Musculoskeletal and connective tissue disorders Myalgia	7.1% 1/14 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.9% 1/17 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 2/40 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	12.5% 5/40 • Number of events 6 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 2/40 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	3.6% 4/111 • Number of events 4 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	9.5% 2/21 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 2/40 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	3.4% 1/29 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Musculoskeletal and connective tissue disorders Pain in extremity	7.1% 1/14 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 2/40 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 2/40 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.1% 1/14 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	8.1% 9/111 • Number of events 9 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	9.5% 2/21 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 2/40 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	3.4% 1/29 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Musculoskeletal and connective tissue disorders Synovial cyst	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	12.5% 1/8 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Seborrhoeic keratosis	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.9% 1/17 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.90% 1/111 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	3.4% 1/29 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	21.4% 3/14 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	11.8% 2/17 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	12.5% 1/8 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 2/40 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.1% 1/14 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	3.4% 1/29 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Nervous system disorders Ataxia	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.9% 1/17 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Nervous system disorders Dizziness	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	12.5% 5/40 • Number of events 5 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	12.5% 5/40 • Number of events 7 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	14.3% 2/14 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	6.3% 7/111 • Number of events 7 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	9.5% 2/21 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Nervous system disorders Dysaesthesia	7.1% 1/14 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Nervous system disorders Headache	7.1% 1/14 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	11.8% 2/17 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	17.5% 7/40 • Number of events 7 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.5% 3/40 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	12.5% 5/40 • Number of events 5 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.5% 3/40 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	14.3% 2/14 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	12.6% 14/111 • Number of events 15 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	14.3% 3/21 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.5% 3/40 • Number of events 4 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	6.9% 2/29 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Nervous system disorders Hypoaesthesia	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	12.5% 1/8 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.1% 1/14 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Nervous system disorders Neuralgia	7.1% 1/14 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Nervous system disorders Neuropathy peripheral	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.5% 3/40 • Number of events 4 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	1.8% 2/111 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Nervous system disorders Presyncope	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	11.8% 2/17 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.90% 1/111 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Nervous system disorders Seizure	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.9% 1/17 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Nervous system disorders Somnolence	7.1% 1/14 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.90% 1/111 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Psychiatric disorders Confusional state	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.9% 1/17 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.90% 1/111 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Psychiatric disorders Depression	7.1% 1/14 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 2/40 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 2/40 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	3.4% 1/29 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Psychiatric disorders Insomnia	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	15.0% 6/40 • Number of events 8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	12.5% 5/40 • Number of events 5 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 2/40 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 2/40 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	14.3% 2/14 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.2% 8/111 • Number of events 8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	4.8% 1/21 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	10.3% 3/29 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 1/20 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Renal and urinary disorders Acute kidney injury	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	10.0% 4/40 • Number of events 4 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Renal and urinary disorders Dysuria	7.1% 1/14 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.1% 1/14 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.90% 1/111 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	3.4% 1/29 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Renal and urinary disorders Haematuria	14.3% 2/14 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.1% 1/14 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.90% 1/111 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	10.0% 2/20 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Renal and urinary disorders Hydronephrosis	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	12.5% 1/8 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Renal and urinary disorders Nephrolithiasis	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	12.5% 1/8 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Renal and urinary disorders Pollakiuria	7.1% 1/14 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Renal and urinary disorders Renal colic	7.1% 1/14 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Renal and urinary disorders Urinary tract inflammation	7.1% 1/14 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Renal and urinary disorders Urinary tract pain	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.1% 1/14 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Reproductive system and breast disorders Gynaecomastia	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.9% 1/17 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Reproductive system and breast disorders Vulvovaginal burning sensation	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	12.5% 1/8 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Respiratory, thoracic and mediastinal disorders Chylothorax	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.9% 1/17 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Respiratory, thoracic and mediastinal disorders Cough	7.1% 1/14 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	17.6% 3/17 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	12.5% 1/8 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	12.5% 5/40 • Number of events 7 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	12.5% 5/40 • Number of events 5 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	10.0% 4/40 • Number of events 4 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	15.0% 6/40 • Number of events 7 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	9.0% 10/111 • Number of events 10 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	3.4% 1/29 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 2/40 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.1% 1/14 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.7% 3/111 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	3.4% 1/29 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Respiratory, thoracic and mediastinal disorders Dyspnoea	7.1% 1/14 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	17.6% 3/17 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	17.5% 7/40 • Number of events 7 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	17.5% 7/40 • Number of events 9 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	17.5% 7/40 • Number of events 7 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	12.5% 5/40 • Number of events 5 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	14.3% 2/14 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	8.1% 9/111 • Number of events 9 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	3.4% 1/29 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Respiratory, thoracic and mediastinal disorders Hypercapnia	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.1% 1/14 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.1% 1/14 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.9% 1/17 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 2/40 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	10.0% 4/40 • Number of events 4 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.7% 3/111 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	3.4% 1/29 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Respiratory, thoracic and mediastinal disorders Pleural effusion	7.1% 1/14 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	10.0% 4/40 • Number of events 5 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	10.0% 4/40 • Number of events 4 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 2/40 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.90% 1/111 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	3.4% 1/29 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Respiratory, thoracic and mediastinal disorders Pneumonitis	7.1% 1/14 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	15.0% 6/40 • Number of events 8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.5% 3/40 • Number of events 4 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	10.0% 4/40 • Number of events 5 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.1% 1/14 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.90% 1/111 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	3.4% 1/29 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.9% 1/17 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.5% 3/40 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	12.5% 5/40 • Number of events 6 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 2/40 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	10.0% 4/40 • Number of events 5 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	14.3% 2/14 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 2/40 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.5% 3/40 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	6.9% 2/29 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.9% 1/17 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 2/40 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 2/40 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.1% 1/14 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	3.6% 4/111 • Number of events 4 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.9% 1/17 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.90% 1/111 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.5% 3/40 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	11.8% 2/17 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Skin and subcutaneous tissue disorders Pruritus	14.3% 2/14 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	35.3% 6/17 • Number of events 8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	30.0% 12/40 • Number of events 15 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	25.0% 10/40 • Number of events 15 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	27.5% 11/40 • Number of events 12 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	37.5% 15/40 • Number of events 20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	35.7% 5/14 • Number of events 6 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	34.2% 38/111 • Number of events 42 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	9.5% 2/21 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	22.5% 9/40 • Number of events 9 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	37.9% 11/29 • Number of events 11 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	40.0% 8/20 • Number of events 10 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Skin and subcutaneous tissue disorders Rash	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	23.5% 4/17 • Number of events 6 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	12.5% 1/8 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	27.5% 11/40 • Number of events 12 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	35.0% 14/40 • Number of events 16 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	32.5% 13/40 • Number of events 14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	10.0% 4/40 • Number of events 6 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	42.9% 6/14 • Number of events 7 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	18.0% 20/111 • Number of events 25 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 2/40 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	27.6% 8/29 • Number of events 8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	15.0% 3/20 • Number of events 4 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Skin and subcutaneous tissue disorders Rash maculo-papular	21.4% 3/14 • Number of events 4 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	11.8% 2/17 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	12.5% 5/40 • Number of events 5 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.5% 3/40 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	15.0% 6/40 • Number of events 10 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	20.0% 8/40 • Number of events 8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.1% 1/14 • Number of events 6 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.7% 3/111 • Number of events 4 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	3.4% 1/29 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Skin and subcutaneous tissue disorders Rash papular	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.1% 1/14 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	11.8% 2/17 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.1% 1/14 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.90% 1/111 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	4.8% 1/21 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.9% 1/17 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.2% 8/111 • Number of events 12 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	3.4% 1/29 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Skin and subcutaneous tissue disorders Vitiligo	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.1% 1/14 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.4% 6/111 • Number of events 7 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	9.5% 2/21 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Vascular disorders Deep vein thrombosis	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.1% 1/14 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Vascular disorders Hypertension	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.9% 1/17 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	4.5% 5/111 • Number of events 5 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	3.4% 1/29 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Vascular disorders Hypotension	7.1% 1/14 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.9% 1/17 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 2/40 • Number of events 3 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	12.5% 5/40 • Number of events 5 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.5% 3/40 • Number of events 4 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	7.1% 1/14 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	1.8% 2/111 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/21 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Blood and lymphatic system disorders Thrombocytosis	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	9.5% 2/21 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Investigations Amylase increased	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.90% 1/111 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	9.5% 2/21 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	5.0% 2/40 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	3.4% 1/29 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour haemorrhage	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/17 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/8 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/40 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/14 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/111 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	9.5% 2/21 • Number of events 2 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	2.5% 1/40 • Number of events 1 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/29 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.	0.00% 0/20 • Up to approximately 77 months Analysis population for all-cause mortality consists of all allocated participants. Analysis population for safety consists of all participants who received at least one dose of study intervention.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme LLC

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee If publication activity was not directed by the Sponsor, the investigator agreed to submit all manuscripts or abstracts to the Sponsor before submission. This allowed the Sponsor to protect proprietary information and to provide comments.
Publication restrictions are in place

Restriction type: OTHER