Trial Outcomes & Findings for Perioperative Pembrolizumab (MK-3475) Plus Cystectomy or Perioperative Pembrolizumab Plus Enfortumab Vedotin Plus Cystectomy Versus Cystectomy Alone in Participants Who Are Cisplatin-ineligible or Decline Cisplatin With Muscle-invasive Bladder Cancer (MK-3475-905/KEYNOTE-905/EV-303) (NCT NCT03924895)

Last Updated: 2026-06-30

Results Overview

EFS is defined as the time from randomization to the first occurrence of any of the following events: progression of disease that precludes radical cystectomy + pelvic lymph node dissection (RC + PLND) surgery, failure to undergo RC + PLND surgery in participants with residual disease and any radiographic disease present (biopsy-proven muscle-invasive bladder cancer \[MIBC\] will be considered an event regardless of radiographic findings), gross residual disease left behind at the time of surgery, local or distant recurrence as assessed by imaging and/or biopsy, or death due to any cause.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE3

Target enrollment

595 participants

Primary outcome timeframe

Up to approximately 53 months

Results posted on

2026-06-30

Participant Flow

Participants were randomized in two stages. In Stage 1, the study included two arms, with participants assigned 1:1 to Arm A (pembrolizumab plus surgery) or Arm B (surgery alone). In Stage 2, Arm C (enfortumab vedotin plus pembrolizumab and surgery) was added per Protocol Amendment 2, and participants were randomized 1:1:1 to Arms A, B, and C. As of Protocol Amendment 8, enrollment to Arm A stopped (except in France per ethics committee request), and randomization continued in Arms B and C only.

Participant milestones

Participant milestones
Measure	Arm A: Pembrolizumab + Surgery Participants receive 3 preoperative cycles of pembrolizumab, followed by standard of care surgery, followed by 14 cycles of postoperative pembrolizumab. Each cycle is 21 days.	Arm B: Surgery Alone Participants receive standard of care surgery alone.	Arm C: Enfortumab Vedotin (EV) + Pembrolizumab + Surgery Participants receive 3 preoperative cycles of EV + pembrolizumab, followed by standard of care surgery, followed by 6 cycles of postoperative EV + pembrolizumab, followed by 8 cycles of pembrolizumab alone. Each cycle is 21 days.
Overall Study STARTED	166	259	170
Overall Study Treated	166	236	170
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	166	259	170

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm A: Pembrolizumab + Surgery Participants receive 3 preoperative cycles of pembrolizumab, followed by standard of care surgery, followed by 14 cycles of postoperative pembrolizumab. Each cycle is 21 days.	Arm B: Surgery Alone Participants receive standard of care surgery alone.	Arm C: Enfortumab Vedotin (EV) + Pembrolizumab + Surgery Participants receive 3 preoperative cycles of EV + pembrolizumab, followed by standard of care surgery, followed by 6 cycles of postoperative EV + pembrolizumab, followed by 8 cycles of pembrolizumab alone. Each cycle is 21 days.
Overall Study Death	74	108	37
Overall Study Withdrawal by Subject	3	8	3
Overall Study Ongoing	89	143	130

Baseline Characteristics

Perioperative Pembrolizumab (MK-3475) Plus Cystectomy or Perioperative Pembrolizumab Plus Enfortumab Vedotin Plus Cystectomy Versus Cystectomy Alone in Participants Who Are Cisplatin-ineligible or Decline Cisplatin With Muscle-invasive Bladder Cancer (MK-3475-905/KEYNOTE-905/EV-303)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A: Pembrolizumab + Surgery n=166 Participants Participants receive 3 preoperative cycles of pembrolizumab, followed by standard of care surgery, followed by 14 cycles of postoperative pembrolizumab. Each cycle is 21 days.	Arm B: Surgery Alone n=259 Participants Participants receive standard of care surgery alone.	Arm C: Enfortumab Vedotin (EV) + Pembrolizumab + Surgery n=170 Participants Participants receive 3 preoperative cycles of EV + pembrolizumab, followed by standard of care surgery, followed by 6 cycles of postoperative EV + pembrolizumab, followed by 8 cycles of pembrolizumab alone. Each cycle is 21 days.	Total n=595 Participants Total of all reporting groups
Sex: Female, Male Male	130 Participants n=20 Participants	193 Participants n=20 Participants	137 Participants n=40 Participants	460 Participants n=6 Participants
Age, Continuous	71.8 Years STANDARD_DEVIATION 7.9 • n=20 Participants	71.9 Years STANDARD_DEVIATION 7.7 • n=20 Participants	72.1 Years STANDARD_DEVIATION 7.9 • n=40 Participants	71.9 Years STANDARD_DEVIATION 7.8 • n=6 Participants
Sex: Female, Male Female	36 Participants n=20 Participants	66 Participants n=20 Participants	33 Participants n=40 Participants	135 Participants n=6 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=20 Participants	15 Participants n=20 Participants	8 Participants n=40 Participants	26 Participants n=6 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	155 Participants n=20 Participants	231 Participants n=20 Participants	160 Participants n=40 Participants	546 Participants n=6 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	8 Participants n=20 Participants	13 Participants n=20 Participants	2 Participants n=40 Participants	23 Participants n=6 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=20 Participants	1 Participants n=20 Participants	0 Participants n=40 Participants	1 Participants n=6 Participants
Race (NIH/OMB) Asian	16 Participants n=20 Participants	38 Participants n=20 Participants	31 Participants n=40 Participants	85 Participants n=6 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=6 Participants
Race (NIH/OMB) Black or African American	1 Participants n=20 Participants	4 Participants n=20 Participants	2 Participants n=40 Participants	7 Participants n=6 Participants
Race (NIH/OMB) White	148 Participants n=20 Participants	205 Participants n=20 Participants	132 Participants n=40 Participants	485 Participants n=6 Participants
Race (NIH/OMB) More than one race	0 Participants n=20 Participants	7 Participants n=20 Participants	4 Participants n=40 Participants	11 Participants n=6 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=20 Participants	4 Participants n=20 Participants	1 Participants n=40 Participants	6 Participants n=6 Participants
Cisplatin Status Cisplatin-Ineligible	163 Participants n=20 Participants	223 Participants n=20 Participants	142 Participants n=40 Participants	528 Participants n=6 Participants
Cisplatin Status Cisplatin-Eligible but Declined	3 Participants n=20 Participants	36 Participants n=20 Participants	28 Participants n=40 Participants	67 Participants n=6 Participants
Tumor Clinical Stage T2N0	12 Participants n=20 Participants	40 Participants n=20 Participants	30 Participants n=40 Participants	82 Participants n=6 Participants
Tumor Clinical Stage T3/T4aN0	150 Participants n=20 Participants	209 Participants n=20 Participants	133 Participants n=40 Participants	492 Participants n=6 Participants
Tumor Clinical Stage T1-4aN1	4 Participants n=20 Participants	10 Participants n=20 Participants	7 Participants n=40 Participants	21 Participants n=6 Participants
Geographic Region United States (US)	19 Participants n=20 Participants	33 Participants n=20 Participants	21 Participants n=40 Participants	73 Participants n=6 Participants
Geographic Region European Union (EU)	73 Participants n=20 Participants	110 Participants n=20 Participants	78 Participants n=40 Participants	261 Participants n=6 Participants
Geographic Region Most of World (MOW)	74 Participants n=20 Participants	116 Participants n=20 Participants	71 Participants n=40 Participants	261 Participants n=6 Participants

PRIMARY outcome

Timeframe: Up to approximately 53 months

Population: Participants were randomized in two stages. Stage 1 assigned participants 1:1 to Arm A (pembrolizumab plus surgery) or Arm B (surgery alone). Stage 2 added Arm C (enfortumab vedotin plus pembrolizumab and surgery), and participants were randomized 1:1:1 to Arms A, B, and C. The analysis population included all participants randomized in Stage 2 to Arm C or Arm B, regardless of treatment received. Participants were analyzed according to randomized arm.

Outcome measures

Outcome measures
Measure	Arm A: Pembrolizumab + Surgery Participants receive 3 preoperative cycles of pembrolizumab, followed by standard of care surgery, followed by 14 cycles of postoperative pembrolizumab. Each cycle is 21 days.	Arm B: Surgery Alone n=174 Participants Participants receive standard of care surgery alone.	Arm C: Enfortumab Vedotin + Pembrolizumab + Surgery n=170 Participants Participants receive 3 preoperative cycles of enfortumab vedotin + pembrolizumab, followed by standard of care surgery, followed by 6 cycles of postoperative enfortumab vedotin + pembrolizumab, followed by 8 cycles of pembrolizumab alone. Each cycle is 21 days.
Event-Free Survival (EFS) Between Arm C: Enfortumab Vedotin + Pembrolizumab + Surgery and Arm B: Surgery Alone	—	15.7 Months Interval 10.3 to 20.5	NA Months Interval 37.3 to NA=median and upper limit not reached due to insufficient number of participants with an event

SECONDARY outcome

Timeframe: Up to approximately 6.75 years

EFS is defined as the time from randomization to the first occurrence of any of the following events: progression of disease that precludes RC surgery or failure to undergo RC surgery in participants with residual disease (biopsy-proven muscle-invasive bladder cancer \[MIBC\] will be considered an event regardless of radiographic findings), gross residual disease left behind at the time of surgery, local or distant recurrence as assessed by imaging and/or biopsy, or death due to any cause.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 7.6 years

OS is defined as the time from randomization to death due to any cause.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 7.6 years

OS is defined as the time from randomization to death due to any cause.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 53 monhts

Pathologic complete response rate is defined as the percentage of participants having pCR. pCR is defined as absence of viable tumor (pT0N0) in examined tissue from RC and PLND, as assessed by blind independent central review (BICR).

Outcome measures

Outcome measures
Measure	Arm A: Pembrolizumab + Surgery Participants receive 3 preoperative cycles of pembrolizumab, followed by standard of care surgery, followed by 14 cycles of postoperative pembrolizumab. Each cycle is 21 days.	Arm B: Surgery Alone n=174 Participants Participants receive standard of care surgery alone.	Arm C: Enfortumab Vedotin + Pembrolizumab + Surgery n=170 Participants Participants receive 3 preoperative cycles of enfortumab vedotin + pembrolizumab, followed by standard of care surgery, followed by 6 cycles of postoperative enfortumab vedotin + pembrolizumab, followed by 8 cycles of pembrolizumab alone. Each cycle is 21 days.
Pathologic Complete Response (pCR) Rate Between Arm C and Arm B	—	8.6 Percentage of Participants Interval 4.9 to 13.8	57.1 Percentage of Participants Interval 49.3 to 64.6

SECONDARY outcome

Timeframe: Up to approximately 5.7 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 6.75 years

DFS is defined as the time from first post-surgery baseline scan until: * local or distant recurrence as assessed by imaging and/or biopsy * Death due to any cause

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 5.7 years

Pathologic downstaging rate is defined as the percentage of participants having pDS. pDS is defined as participants with a tumor classification of \<pT2 (includes pT0, pTis, pTa, pT1) and N0 in examined tissue from RC and PLND.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 53 months

Pathologic downstaging (pDS) is defined as participants with a tumor classification of \<pT2. The pathologic stage \<pT2 includes pT0 (No residual primary tumor found in the tissue examined), pTis (carcinoma in situ; a flat, non-invasive cancer confined to the epithelial lining), pTa (Non-invasive papillary carcinoma limited to the urothelium) pT1 (tumor has invaded the connective tissue beneath the urothelium, but not the muscle layer) and N0 (No cancer found in the examined lymph nodes) in examined tissue from RC and PLND. The \<pT2 category represents a better outcome than participants with residual muscle-invasive disease (pT2 or higher) and/or any nodal involvement (N1/N2). The percentage of participants with pDS is presented.

Outcome measures

Outcome measures
Measure	Arm A: Pembrolizumab + Surgery Participants receive 3 preoperative cycles of pembrolizumab, followed by standard of care surgery, followed by 14 cycles of postoperative pembrolizumab. Each cycle is 21 days.	Arm B: Surgery Alone n=174 Participants Participants receive standard of care surgery alone.	Arm C: Enfortumab Vedotin + Pembrolizumab + Surgery n=170 Participants Participants receive 3 preoperative cycles of enfortumab vedotin + pembrolizumab, followed by standard of care surgery, followed by 6 cycles of postoperative enfortumab vedotin + pembrolizumab, followed by 8 cycles of pembrolizumab alone. Each cycle is 21 days.
Pathologic Downstaging {pDS) Rate Between Arm C and Arm B	—	12.6 Percentage of Participants Interval 8.1 to 18.5	65.9 Percentage of Participants Interval 58.2 to 73.0

SECONDARY outcome

Timeframe: Up to approximately 7.6 years

An AE is defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy can be determined.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 1 year

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 1 year

The number of participants who experience perioperative complications will be presented.

Outcome measures

Outcome data not reported

Adverse Events

Arm A: Pembrolizumab + Surgery

Serious events: 107 serious events

Other events: 143 other events

Deaths: 76 deaths

Arm B: Surgery Alone

Serious events: 94 serious events

Other events: 94 other events

Deaths: 111 deaths

Arm C: EV + Pembrolizumab + Surgery

Serious events: 97 serious events

Other events: 163 other events

Deaths: 38 deaths

Serious adverse events

Other adverse events

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 is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments. Authorship will be determined by mutual agreement and in line with ICMJE authorship requirements.
Publication restrictions are in place

Restriction type: OTHER

Serious adverse events
Measure	Arm A: Pembrolizumab + Surgery n=163 participants at risk Participants receive 3 preoperative cycles of pembrolizumab, followed by standard of care surgery, followed by 14 cycles of postoperative pembrolizumab. Each cycle is 21 days.	Arm B: Surgery Alone n=242 participants at risk Participants receive standard of care surgery alone	Arm C: EV + Pembrolizumab + Surgery n=167 participants at risk Participants receive 3 preoperative cycles of EV + pembrolizumab, followed by standard of care surgery, followed by 6 cycles of postoperative EV + pembrolizumab, followed by 8 cycles of pembrolizumab alone. Each cycle is 21 days.
Blood and lymphatic system disorders Anaemia	0.61% 1/163 • Number of events 1 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.83% 2/242 • Number of events 2 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	1.2% 2/167 • Number of events 2 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/163 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/242 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.60% 1/167 • Number of events 1 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Blood and lymphatic system disorders Leukocytosis	0.61% 1/163 • Number of events 1 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/242 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/167 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Blood and lymphatic system disorders Thrombocytopenia	0.61% 1/163 • Number of events 1 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/242 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/167 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Cardiac disorders Acute myocardial infarction	0.00% 0/163 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/242 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	1.2% 2/167 • Number of events 2 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Cardiac disorders Arteriosclerosis coronary artery	0.61% 1/163 • Number of events 1 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/242 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/167 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Cardiac disorders Atrial fibrillation	1.2% 2/163 • Number of events 2 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.41% 1/242 • Number of events 1 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.60% 1/167 • Number of events 1 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Cardiac disorders Atrial flutter	0.61% 1/163 • Number of events 1 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/242 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/167 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Cardiac disorders Cardiac arrest	0.61% 1/163 • Number of events 1 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/242 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.60% 1/167 • Number of events 1 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Cardiac disorders Cardiac failure acute	0.61% 1/163 • Number of events 1 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.41% 1/242 • Number of events 1 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/167 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Cardiac disorders Cardiac failure congestive	1.2% 2/163 • Number of events 2 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/242 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/167 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Cardiac disorders Cardiac flutter	0.61% 1/163 • Number of events 1 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/242 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/167 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Cardiac disorders Cardio-respiratory arrest	0.00% 0/163 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.41% 1/242 • Number of events 1 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/167 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Cardiac disorders Myocardial infarction	0.61% 1/163 • Number of events 1 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.41% 1/242 • Number of events 1 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.60% 1/167 • Number of events 1 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Cardiac disorders Myocarditis	1.8% 3/163 • Number of events 3 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/242 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.60% 1/167 • Number of events 1 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Cardiac disorders Pericarditis	0.61% 1/163 • Number of events 1 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/242 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/167 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Endocrine disorders Adrenal insufficiency	1.2% 2/163 • Number of events 2 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/242 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.60% 1/167 • Number of events 1 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Endocrine disorders Hypothyroidism	0.00% 0/163 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/242 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.60% 1/167 • Number of events 1 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Eye disorders Epiretinal membrane	0.00% 0/163 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/242 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.60% 1/167 • Number of events 1 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Eye disorders Ocular myasthenia	0.61% 1/163 • Number of events 1 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/242 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/167 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Eye disorders Vision blurred	0.00% 0/163 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/242 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.60% 1/167 • Number of events 1 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Abdominal hernia	0.00% 0/163 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.41% 1/242 • Number of events 1 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.60% 1/167 • Number of events 1 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Abdominal pain	1.2% 2/163 • Number of events 2 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.41% 1/242 • Number of events 1 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.60% 1/167 • Number of events 1 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Abdominal strangulated hernia	0.61% 1/163 • Number of events 1 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/242 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/167 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Anal fissure	0.00% 0/163 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/242 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.60% 1/167 • Number of events 1 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Autoimmune colitis	0.00% 0/163 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/242 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.60% 1/167 • Number of events 1 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Colitis	0.61% 1/163 • Number of events 1 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/242 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/167 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Constipation	0.61% 1/163 • Number of events 1 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.83% 2/242 • Number of events 2 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	1.2% 2/167 • Number of events 2 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Diarrhoea	0.61% 1/163 • Number of events 2 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.41% 1/242 • Number of events 1 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	2.4% 4/167 • Number of events 4 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Duodenal stenosis	0.00% 0/163 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/242 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.60% 1/167 • Number of events 1 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Duodenal ulcer	1.8% 3/163 • Number of events 3 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/242 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/167 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.00% 0/163 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.41% 1/242 • Number of events 1 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/167 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Enterocele	0.61% 1/163 • Number of events 1 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/242 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/167 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Enterocolitis	0.61% 1/163 • Number of events 1 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/242 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/167 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Enterocutaneous fistula	0.00% 0/163 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.41% 1/242 • Number of events 1 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.60% 1/167 • Number of events 1 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Gastritis	0.00% 0/163 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.41% 1/242 • Number of events 1 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/167 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/163 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/242 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.60% 1/167 • Number of events 1 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Ileal perforation	0.00% 0/163 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/242 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.60% 1/167 • Number of events 1 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Ileus	1.2% 2/163 • Number of events 2 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	1.2% 3/242 • Number of events 3 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.60% 1/167 • Number of events 1 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Ileus paralytic	0.61% 1/163 • Number of events 1 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.41% 1/242 • Number of events 1 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/167 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.

Other adverse events
Measure	Arm A: Pembrolizumab + Surgery n=163 participants at risk Participants receive 3 preoperative cycles of pembrolizumab, followed by standard of care surgery, followed by 14 cycles of postoperative pembrolizumab. Each cycle is 21 days.	Arm B: Surgery Alone n=242 participants at risk Participants receive standard of care surgery alone	Arm C: EV + Pembrolizumab + Surgery n=167 participants at risk Participants receive 3 preoperative cycles of EV + pembrolizumab, followed by standard of care surgery, followed by 6 cycles of postoperative EV + pembrolizumab, followed by 8 cycles of pembrolizumab alone. Each cycle is 21 days.
Blood and lymphatic system disorders Anaemia	30.1% 49/163 • Number of events 54 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	11.2% 27/242 • Number of events 28 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	30.5% 51/167 • Number of events 67 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Blood and lymphatic system disorders Neutropenia	2.5% 4/163 • Number of events 4 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/242 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	9.6% 16/167 • Number of events 26 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Endocrine disorders Hyperthyroidism	11.7% 19/163 • Number of events 20 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/242 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	4.8% 8/167 • Number of events 8 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Endocrine disorders Hypothyroidism	16.6% 27/163 • Number of events 28 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/242 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	13.8% 23/167 • Number of events 26 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Eye disorders Dry eye	1.8% 3/163 • Number of events 3 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/242 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	6.0% 10/167 • Number of events 10 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Eye disorders Lacrimation increased	0.00% 0/163 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/242 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	9.6% 16/167 • Number of events 18 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Abdominal pain	7.4% 12/163 • Number of events 12 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	6.6% 16/242 • Number of events 16 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	9.6% 16/167 • Number of events 18 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Constipation	14.1% 23/163 • Number of events 27 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	7.4% 18/242 • Number of events 20 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	26.3% 44/167 • Number of events 53 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Diarrhoea	14.1% 23/163 • Number of events 26 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	2.9% 7/242 • Number of events 7 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	32.3% 54/167 • Number of events 95 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Dry mouth	1.8% 3/163 • Number of events 3 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.41% 1/242 • Number of events 1 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	10.8% 18/167 • Number of events 18 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Nausea	12.9% 21/163 • Number of events 22 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	6.6% 16/242 • Number of events 18 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	25.7% 43/167 • Number of events 52 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Vomiting	5.5% 9/163 • Number of events 10 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	3.3% 8/242 • Number of events 9 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	9.0% 15/167 • Number of events 16 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
General disorders Asthenia	13.5% 22/163 • Number of events 24 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	2.1% 5/242 • Number of events 5 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	16.2% 27/167 • Number of events 31 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
General disorders Fatigue	16.0% 26/163 • Number of events 32 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	5.0% 12/242 • Number of events 12 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	32.3% 54/167 • Number of events 62 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
General disorders Oedema peripheral	6.7% 11/163 • Number of events 11 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	1.7% 4/242 • Number of events 5 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	9.6% 16/167 • Number of events 18 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
General disorders Pyrexia	11.0% 18/163 • Number of events 19 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	2.5% 6/242 • Number of events 6 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	10.8% 18/167 • Number of events 23 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Infections and infestations COVID-19	8.6% 14/163 • Number of events 15 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/242 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	3.0% 5/167 • Number of events 5 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Infections and infestations Urinary tract infection	20.2% 33/163 • Number of events 45 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	2.5% 6/242 • Number of events 6 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	15.6% 26/167 • Number of events 42 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Injury, poisoning and procedural complications Procedural pain	7.4% 12/163 • Number of events 12 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	6.2% 15/242 • Number of events 15 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	5.4% 9/167 • Number of events 9 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Investigations Alanine aminotransferase increased	8.6% 14/163 • Number of events 15 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	1.2% 3/242 • Number of events 3 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	19.2% 32/167 • Number of events 38 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Investigations Aspartate aminotransferase increased	9.8% 16/163 • Number of events 17 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.83% 2/242 • Number of events 2 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	24.0% 40/167 • Number of events 43 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Investigations Blood alkaline phosphatase increased	6.1% 10/163 • Number of events 12 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.83% 2/242 • Number of events 2 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	4.2% 7/167 • Number of events 9 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Investigations Blood creatinine increased	13.5% 22/163 • Number of events 25 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	3.3% 8/242 • Number of events 8 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	11.4% 19/167 • Number of events 23 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Investigations Weight decreased	11.0% 18/163 • Number of events 18 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	4.5% 11/242 • Number of events 11 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	19.8% 33/167 • Number of events 35 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Metabolism and nutrition disorders Decreased appetite	14.1% 23/163 • Number of events 30 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	3.7% 9/242 • Number of events 9 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	28.1% 47/167 • Number of events 55 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Metabolism and nutrition disorders Hyperglycaemia	4.9% 8/163 • Number of events 10 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.83% 2/242 • Number of events 2 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	12.0% 20/167 • Number of events 24 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Metabolism and nutrition disorders Hyperkalaemia	8.6% 14/163 • Number of events 17 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.41% 1/242 • Number of events 1 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	6.0% 10/167 • Number of events 14 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Metabolism and nutrition disorders Hypokalaemia	9.8% 16/163 • Number of events 21 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	3.3% 8/242 • Number of events 9 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	8.4% 14/167 • Number of events 21 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Metabolism and nutrition disorders Hypomagnesaemia	2.5% 4/163 • Number of events 4 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	2.1% 5/242 • Number of events 5 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	5.4% 9/167 • Number of events 12 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Metabolism and nutrition disorders Hyponatraemia	4.9% 8/163 • Number of events 9 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.41% 1/242 • Number of events 1 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	7.2% 12/167 • Number of events 13 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Musculoskeletal and connective tissue disorders Arthralgia	4.3% 7/163 • Number of events 9 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.41% 1/242 • Number of events 1 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	6.0% 10/167 • Number of events 13 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Musculoskeletal and connective tissue disorders Back pain	5.5% 9/163 • Number of events 11 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.41% 1/242 • Number of events 1 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	3.0% 5/167 • Number of events 5 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	3.1% 5/163 • Number of events 5 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	4.5% 11/242 • Number of events 11 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	9.6% 16/167 • Number of events 16 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Nervous system disorders Dizziness	3.7% 6/163 • Number of events 9 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/242 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	7.2% 12/167 • Number of events 16 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Nervous system disorders Dysgeusia	3.1% 5/163 • Number of events 6 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/242 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	28.1% 47/167 • Number of events 58 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Nervous system disorders Neuropathy peripheral	0.00% 0/163 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/242 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	10.2% 17/167 • Number of events 18 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Nervous system disorders Paraesthesia	1.2% 2/163 • Number of events 2 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/242 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	6.6% 11/167 • Number of events 14 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/163 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.41% 1/242 • Number of events 1 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	13.8% 23/167 • Number of events 23 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Nervous system disorders Taste disorder	0.00% 0/163 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/242 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	6.6% 11/167 • Number of events 11 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Psychiatric disorders Insomnia	1.8% 3/163 • Number of events 3 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	3.3% 8/242 • Number of events 9 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	10.8% 18/167 • Number of events 18 • Up to approximately 69 months All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.