Trial Outcomes & Findings for Safety and Efficacy Study of Pembrolizumab (MK-3475) Combined With Lenvatinib (MK-7902/E7080) as First-line Intervention in Adults With Advanced Melanoma (MK-7902-003/E7080-G000-312/LEAP-003)-China Extension Study (NCT NCT04889118)

NCT ID: NCT04889118

Last Updated: 2025-12-23

Results Overview

PFS is defined as the time from date of randomization to the date of the first documentation of progressive disease (PD) or death from any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions is also considered PD. For this study, RECIST 1.1 has been modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 131 participants
• Primary outcome timeframe: Up to approximately 30 months
• Results posted on: 2025-12-23

Participant Flow

The China extension study enrolled 131 participants. 62 participants were randomized in the global portion for MK-7902-003 (NCT03820986) and 69 in the China extension portion

Participant milestones

Measure	Pembrolizumab+Lenvatinib Participants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS lenvatinib 20 mg via oral capsule daily for up to at least 2 years.	Pembrolizumab+Placebo Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS placebo for lenvatinib via oral capsule daily for up to at least 2 years.
Overall Study STARTED	64	67
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	64	67

Reasons for withdrawal

Measure	Pembrolizumab+Lenvatinib Participants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS lenvatinib 20 mg via oral capsule daily for up to at least 2 years.	Pembrolizumab+Placebo Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS placebo for lenvatinib via oral capsule daily for up to at least 2 years.
Overall Study Death	49	47
Overall Study Sponsor Decision	15	20

Baseline Characteristics

Safety and Efficacy Study of Pembrolizumab (MK-3475) Combined With Lenvatinib (MK-7902/E7080) as First-line Intervention in Adults With Advanced Melanoma (MK-7902-003/E7080-G000-312/LEAP-003)-China Extension Study

Baseline characteristics by cohort

Measure	Pembrolizumab+Lenvatinib n=64 Participants Participants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS lenvatinib 20 mg via oral capsule daily for up to at least 2 years.	Pembrolizumab+Placebo n=67 Participants Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS placebo for lenvatinib via oral capsule daily for up to at least 2 years.	Total n=131 Participants Total of all reporting groups
Age, Continuous	56.4 Years STANDARD_DEVIATION 11.7 • n=68 Participants	57.3 Years STANDARD_DEVIATION 13.5 • n=4 Participants	56.9 Years STANDARD_DEVIATION 12.6 • n=219 Participants
Sex: Female, Male Female	26 Participants n=68 Participants	32 Participants n=4 Participants	58 Participants n=219 Participants
Sex: Female, Male Male	38 Participants n=68 Participants	35 Participants n=4 Participants	73 Participants n=219 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=68 Participants	0 Participants n=4 Participants	0 Participants n=219 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	61 Participants n=68 Participants	66 Participants n=4 Participants	127 Participants n=219 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=68 Participants	1 Participants n=4 Participants	4 Participants n=219 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=68 Participants	0 Participants n=4 Participants	0 Participants n=219 Participants
Race (NIH/OMB) Asian	64 Participants n=68 Participants	67 Participants n=4 Participants	131 Participants n=219 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=68 Participants	0 Participants n=4 Participants	0 Participants n=219 Participants
Race (NIH/OMB) Black or African American	0 Participants n=68 Participants	0 Participants n=4 Participants	0 Participants n=219 Participants
Race (NIH/OMB) White	0 Participants n=68 Participants	0 Participants n=4 Participants	0 Participants n=219 Participants
Race (NIH/OMB) More than one race	0 Participants n=68 Participants	0 Participants n=4 Participants	0 Participants n=219 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=68 Participants	0 Participants n=4 Participants	0 Participants n=219 Participants

PRIMARY outcome

Timeframe: Up to approximately 30 months

Population: All randomized China participants, included in the treatment group to which they were randomized.

PFS is defined as the time from date of randomization to the date of the first documentation of progressive disease (PD) or death from any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions is also considered PD. For this study, RECIST 1.1 has been modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ.

Outcome measures

Measure	Pembrolizumab+Lenvatinib n=64 Participants Participants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS lenvatinib 20 mg via oral capsule daily for up to at least 2 years.	Pembrolizumab+Placebo n=67 Participants Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS placebo for lenvatinib via oral capsule daily for up to at least 2 years.
Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) Per Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)	6.1 Months Interval 4.1 to 8.1	2.0 Months Interval 2.0 to 2.1

PRIMARY outcome

Timeframe: Up to approximately 30 months

Population: All randomized China participants, included in the treatment group to which they were randomized

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

Outcome measures

Measure	Pembrolizumab+Lenvatinib n=64 Participants Participants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS lenvatinib 20 mg via oral capsule daily for up to at least 2 years.	Pembrolizumab+Placebo n=67 Participants Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS placebo for lenvatinib via oral capsule daily for up to at least 2 years.
Overall Survival (OS)	19.9 Months Interval 11.9 to 26.8	17.0 Months Interval 12.7 to 25.7

SECONDARY outcome

Timeframe: Up to approximately 30 months

Population: All randomized China participants, included in the treatment group to which they were randomized.

ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. For this study, RECIST 1.1 has been modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ.

Outcome measures

Measure	Pembrolizumab+Lenvatinib n=64 Participants Participants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS lenvatinib 20 mg via oral capsule daily for up to at least 2 years.	Pembrolizumab+Placebo n=67 Participants Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS placebo for lenvatinib via oral capsule daily for up to at least 2 years.
Objective Response Rate (ORR) as Assessed by BICR Per RECIST 1.1	26.6 Percentage of Participants Interval 16.3 to 39.1	16.4 Percentage of Participants Interval 8.5 to 27.5

SECONDARY outcome

Timeframe: Up to approximately 30 months

Population: Randomized participants who had a confirmed complete or partial response, included in the treatment group to which they were randomized.

For participants who demonstrated CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions), DOR is defined as the date of the first documented evidence of CR or PR until PD or death from any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions is also considered PD. For this study, RECIST 1.1 has been modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ.

Outcome measures

Measure	Pembrolizumab+Lenvatinib n=17 Participants Participants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS lenvatinib 20 mg via oral capsule daily for up to at least 2 years.	Pembrolizumab+Placebo n=11 Participants Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS placebo for lenvatinib via oral capsule daily for up to at least 2 years.
Duration of Response (DOR) as Assessed by BICR Per RECIST 1.1	13.7 Months Interval 4.2 to NA = Upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse	NA Months Interval 6.5 to NA = Median, upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse

SECONDARY outcome

Timeframe: Up to approximately 50 months

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

An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.

Outcome measures

Measure	Pembrolizumab+Lenvatinib n=64 Participants Participants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS lenvatinib 20 mg via oral capsule daily for up to at least 2 years.	Pembrolizumab+Placebo n=67 Participants Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS placebo for lenvatinib via oral capsule daily for up to at least 2 years.
Number of Participants With Adverse Events (AEs)	64 Participants	67 Participants

SECONDARY outcome

Timeframe: Up to approximately 39 months

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

The number of participants who discontinue study treatment due to an AE will be presented.

Outcome measures

Measure	Pembrolizumab+Lenvatinib n=64 Participants Participants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS lenvatinib 20 mg via oral capsule daily for up to at least 2 years.	Pembrolizumab+Placebo n=67 Participants Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS placebo for lenvatinib via oral capsule daily for up to at least 2 years.
Number of Participants Who Discontinue Study Treatment Due to Adverse Events (AEs)	10 Participants	3 Participants

Adverse Events

Pembrolizumab+Lenvatinib

Serious events: 14 serious events

Other events: 64 other events

Deaths: 49 deaths

Pembrolizumab + Placebo

Serious events: 12 serious events

Other events: 66 other events

Deaths: 47 deaths

Serious adverse events

Measure	Pembrolizumab+Lenvatinib n=64 participants at risk Participants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS lenvatinib 20 mg via oral capsule daily for up to at least 2 years.	Pembrolizumab + Placebo n=67 participants at risk Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS placebo for lenvatinib via oral capsule daily for up to at least 2 years.
Cardiac disorders Acute myocardial infarction	1.6% 1/64 • Number of events 1 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	0.00% 0/67 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Cardiac disorders Cardiac arrest	1.6% 1/64 • Number of events 1 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	0.00% 0/67 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Gastrointestinal disorders Colitis	1.6% 1/64 • Number of events 1 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	0.00% 0/67 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Gastrointestinal disorders Haemorrhoids	0.00% 0/64 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	1.5% 1/67 • Number of events 1 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Gastrointestinal disorders Pancreatitis	1.6% 1/64 • Number of events 1 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	0.00% 0/67 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Hepatobiliary disorders Cholecystitis	1.6% 1/64 • Number of events 2 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	0.00% 0/67 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Infections and infestations COVID-19 pneumonia	0.00% 0/64 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	1.5% 1/67 • Number of events 1 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Infections and infestations Gastroenteritis	1.6% 1/64 • Number of events 1 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	0.00% 0/67 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Infections and infestations Pneumonia	1.6% 1/64 • Number of events 1 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	0.00% 0/67 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Infections and infestations Upper respiratory tract infection	1.6% 1/64 • Number of events 1 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	0.00% 0/67 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Infections and infestations Urinary tract infection	3.1% 2/64 • Number of events 2 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	0.00% 0/67 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Injury, poisoning and procedural complications Traumatic fracture	0.00% 0/64 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	1.5% 1/67 • Number of events 1 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Investigations Aspartate aminotransferase increased	0.00% 0/64 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	1.5% 1/67 • Number of events 1 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Investigations Lipase increased	0.00% 0/64 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	1.5% 1/67 • Number of events 1 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Investigations Platelet count decreased	1.6% 1/64 • Number of events 1 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	0.00% 0/67 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/64 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	1.5% 1/67 • Number of events 1 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Musculoskeletal and connective tissue disorders Myositis	1.6% 1/64 • Number of events 1 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	0.00% 0/67 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Musculoskeletal and connective tissue disorders Pain in extremity	1.6% 1/64 • Number of events 1 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	0.00% 0/67 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 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) Paraneoplastic syndrome	0.00% 0/64 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	1.5% 1/67 • Number of events 1 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Nervous system disorders Cerebral infarction	0.00% 0/64 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	1.5% 1/67 • Number of events 1 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Nervous system disorders Immune-mediated encephalitis	0.00% 0/64 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	1.5% 1/67 • Number of events 1 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Renal and urinary disorders Renal failure	0.00% 0/64 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	1.5% 1/67 • Number of events 2 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/64 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	1.5% 1/67 • Number of events 1 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Respiratory, thoracic and mediastinal disorders Immune-mediated lung disease	0.00% 0/64 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	1.5% 1/67 • Number of events 1 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.00% 0/64 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	1.5% 1/67 • Number of events 1 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Skin and subcutaneous tissue disorders Eczema	1.6% 1/64 • Number of events 1 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	0.00% 0/67 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Skin and subcutaneous tissue disorders Rash	1.6% 1/64 • Number of events 1 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	0.00% 0/67 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.

Other adverse events

Measure	Pembrolizumab+Lenvatinib n=64 participants at risk Participants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS lenvatinib 20 mg via oral capsule daily for up to at least 2 years.	Pembrolizumab + Placebo n=67 participants at risk Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS placebo for lenvatinib via oral capsule daily for up to at least 2 years.
Blood and lymphatic system disorders Anaemia	23.4% 15/64 • Number of events 22 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	28.4% 19/67 • Number of events 25 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Endocrine disorders Hyperthyroidism	15.6% 10/64 • Number of events 10 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	16.4% 11/67 • Number of events 13 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Endocrine disorders Hypothyroidism	73.4% 47/64 • Number of events 86 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	22.4% 15/67 • Number of events 16 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Gastrointestinal disorders Abdominal pain upper	10.9% 7/64 • Number of events 8 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	3.0% 2/67 • Number of events 3 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Gastrointestinal disorders Constipation	7.8% 5/64 • Number of events 7 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	7.5% 5/67 • Number of events 5 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Gastrointestinal disorders Diarrhoea	40.6% 26/64 • Number of events 37 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	1.5% 1/67 • Number of events 1 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Gastrointestinal disorders Gingival pain	7.8% 5/64 • Number of events 5 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	0.00% 0/67 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Gastrointestinal disorders Gingival swelling	6.2% 4/64 • Number of events 4 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	0.00% 0/67 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Gastrointestinal disorders Mouth ulceration	10.9% 7/64 • Number of events 10 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	0.00% 0/67 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Gastrointestinal disorders Nausea	9.4% 6/64 • Number of events 6 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	10.4% 7/67 • Number of events 7 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Gastrointestinal disorders Toothache	12.5% 8/64 • Number of events 10 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	1.5% 1/67 • Number of events 1 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Gastrointestinal disorders Vomiting	14.1% 9/64 • Number of events 14 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	0.00% 0/67 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
General disorders Asthenia	6.2% 4/64 • Number of events 4 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	6.0% 4/67 • Number of events 4 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
General disorders Pyrexia	9.4% 6/64 • Number of events 8 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	6.0% 4/67 • Number of events 6 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Infections and infestations COVID-19	10.9% 7/64 • Number of events 8 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	11.9% 8/67 • Number of events 8 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Infections and infestations Pneumonia	6.2% 4/64 • Number of events 4 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	0.00% 0/67 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Infections and infestations Sinusitis	0.00% 0/64 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	6.0% 4/67 • Number of events 4 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Infections and infestations Urinary tract infection	7.8% 5/64 • Number of events 11 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	14.9% 10/67 • Number of events 11 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Investigations Alanine aminotransferase increased	39.1% 25/64 • Number of events 40 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	32.8% 22/67 • Number of events 29 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Investigations Amylase increased	7.8% 5/64 • Number of events 6 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	9.0% 6/67 • Number of events 10 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Investigations Aspartate aminotransferase increased	46.9% 30/64 • Number of events 45 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	25.4% 17/67 • Number of events 19 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Investigations Bilirubin conjugated increased	10.9% 7/64 • Number of events 16 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	11.9% 8/67 • Number of events 17 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Investigations Blood alkaline phosphatase increased	9.4% 6/64 • Number of events 9 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	7.5% 5/67 • Number of events 15 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Investigations Blood bilirubin increased	25.0% 16/64 • Number of events 28 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	23.9% 16/67 • Number of events 36 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Investigations Blood bilirubin unconjugated increased	9.4% 6/64 • Number of events 12 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	4.5% 3/67 • Number of events 3 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Investigations Blood creatine phosphokinase increased	15.6% 10/64 • Number of events 10 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	20.9% 14/67 • Number of events 20 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Investigations Blood creatinine increased	14.1% 9/64 • Number of events 16 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	10.4% 7/67 • Number of events 15 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Investigations Blood glucose increased	14.1% 9/64 • Number of events 9 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	7.5% 5/67 • Number of events 6 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Investigations Blood lactate dehydrogenase increased	43.8% 28/64 • Number of events 65 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	25.4% 17/67 • Number of events 23 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Investigations Blood thyroid stimulating hormone increased	15.6% 10/64 • Number of events 13 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	4.5% 3/67 • Number of events 3 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Investigations Blood urea increased	15.6% 10/64 • Number of events 14 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	10.4% 7/67 • Number of events 18 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Investigations C-reactive protein increased	10.9% 7/64 • Number of events 20 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	16.4% 11/67 • Number of events 20 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Investigations Electrocardiogram ST-T change	7.8% 5/64 • Number of events 5 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	10.4% 7/67 • Number of events 8 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Investigations Gamma-glutamyltransferase increased	40.6% 26/64 • Number of events 50 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	26.9% 18/67 • Number of events 24 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Investigations Lipase increased	23.4% 15/64 • Number of events 24 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	6.0% 4/67 • Number of events 4 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Investigations Lymphocyte count decreased	6.2% 4/64 • Number of events 11 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	3.0% 2/67 • Number of events 2 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Investigations Neutrophil count decreased	17.2% 11/64 • Number of events 36 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	6.0% 4/67 • Number of events 4 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Investigations Platelet count decreased	21.9% 14/64 • Number of events 23 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	4.5% 3/67 • Number of events 5 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Investigations Red blood cells urine positive	12.5% 8/64 • Number of events 14 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	7.5% 5/67 • Number of events 7 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Investigations Serum amyloid A protein increased	9.4% 6/64 • Number of events 13 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	13.4% 9/67 • Number of events 12 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Investigations Urinary occult blood positive	15.6% 10/64 • Number of events 18 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	17.9% 12/67 • Number of events 24 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Investigations Urobilinogen urine increased	6.2% 4/64 • Number of events 4 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	0.00% 0/67 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Investigations Weight decreased	56.2% 36/64 • Number of events 49 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	22.4% 15/67 • Number of events 18 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Investigations White blood cell count decreased	18.8% 12/64 • Number of events 33 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	7.5% 5/67 • Number of events 10 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Investigations White blood cells urine positive	18.8% 12/64 • Number of events 34 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	10.4% 7/67 • Number of events 19 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Metabolism and nutrition disorders Decreased appetite	28.1% 18/64 • Number of events 20 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	16.4% 11/67 • Number of events 11 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Metabolism and nutrition disorders Hypercholesterolaemia	51.6% 33/64 • Number of events 75 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	19.4% 13/67 • Number of events 28 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Metabolism and nutrition disorders Hyperglycaemia	42.2% 27/64 • Number of events 53 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	13.4% 9/67 • Number of events 17 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Metabolism and nutrition disorders Hyperkalaemia	6.2% 4/64 • Number of events 6 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	1.5% 1/67 • Number of events 1 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Metabolism and nutrition disorders Hypertriglyceridaemia	65.6% 42/64 • Number of events 111 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	37.3% 25/67 • Number of events 46 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Metabolism and nutrition disorders Hyperuricaemia	40.6% 26/64 • Number of events 51 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	22.4% 15/67 • Number of events 26 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Metabolism and nutrition disorders Hypoalbuminaemia	32.8% 21/64 • Number of events 35 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	16.4% 11/67 • Number of events 16 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Metabolism and nutrition disorders Hypocalcaemia	17.2% 11/64 • Number of events 16 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	6.0% 4/67 • Number of events 7 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Metabolism and nutrition disorders Hypochloraemia	10.9% 7/64 • Number of events 7 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	9.0% 6/67 • Number of events 7 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Metabolism and nutrition disorders Hypokalaemia	23.4% 15/64 • Number of events 21 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	11.9% 8/67 • Number of events 11 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Metabolism and nutrition disorders Hyponatraemia	23.4% 15/64 • Number of events 19 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	16.4% 11/67 • Number of events 14 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Metabolism and nutrition disorders Hypoproteinaemia	7.8% 5/64 • Number of events 5 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	3.0% 2/67 • Number of events 2 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Musculoskeletal and connective tissue disorders Arthralgia	10.9% 7/64 • Number of events 8 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	4.5% 3/67 • Number of events 3 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Musculoskeletal and connective tissue disorders Myalgia	6.2% 4/64 • Number of events 5 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	0.00% 0/67 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 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) Cancer pain	3.1% 2/64 • Number of events 2 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	6.0% 4/67 • Number of events 4 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Nervous system disorders Dizziness	6.2% 4/64 • Number of events 4 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	6.0% 4/67 • Number of events 5 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Nervous system disorders Headache	7.8% 5/64 • Number of events 6 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	3.0% 2/67 • Number of events 2 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Renal and urinary disorders Haematuria	9.4% 6/64 • Number of events 10 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	7.5% 5/67 • Number of events 6 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Renal and urinary disorders Proteinuria	71.9% 46/64 • Number of events 103 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	46.3% 31/67 • Number of events 58 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Respiratory, thoracic and mediastinal disorders Cough	7.8% 5/64 • Number of events 6 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	3.0% 2/67 • Number of events 2 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Respiratory, thoracic and mediastinal disorders Dysphonia	7.8% 5/64 • Number of events 5 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	0.00% 0/67 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Skin and subcutaneous tissue disorders Leukoderma	3.1% 2/64 • Number of events 2 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	6.0% 4/67 • Number of events 4 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	28.1% 18/64 • Number of events 20 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	1.5% 1/67 • Number of events 1 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Skin and subcutaneous tissue disorders Pruritus	7.8% 5/64 • Number of events 5 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	16.4% 11/67 • Number of events 11 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Skin and subcutaneous tissue disorders Rash	17.2% 11/64 • Number of events 14 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	11.9% 8/67 • Number of events 8 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Skin and subcutaneous tissue disorders Skin depigmentation	9.4% 6/64 • Number of events 6 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	3.0% 2/67 • Number of events 2 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Skin and subcutaneous tissue disorders Skin hypopigmentation	3.1% 2/64 • Number of events 2 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	7.5% 5/67 • Number of events 5 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
Vascular disorders Hypertension	64.1% 41/64 • Number of events 57 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.	11.9% 8/67 • Number of events 10 • Up to approximately 51 months The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. The population for SAE and other AEs includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA V25.1 preferred terms 'Neoplasm progression' , 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme LLC

Phone: 1-800-672-6372

Email: ClinicalTrialsDisclosure@msd.com

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.
• Publication restrictions are in place

Restriction type: OTHER