Trial Outcomes & Findings for A Study of Pembrolizumab/Vibostolimab (MK-7684A) in Relapsed/Refractory Hematological Malignancies (MK-7684A-004, KEYVIBE-004) (NCT NCT05005442)

NCT ID: NCT05005442

Last Updated: 2025-12-17

Results Overview

A DLT is defined as an event with toxicity including the type, severity, time of onset, time of resolution, and the probable association with study treatment that are not due to pre-existing conditions as defined by the Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE 5.0). Percentage of participants who experience a DLT per CTCAE 5.0 are reported.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 192 participants
• Primary outcome timeframe: Up to approximately 6 weeks
• Results posted on: 2025-12-17

Participant Flow

One hundred ninety-two participants were allocated, 1 participant was allocated but did not receive treatment due to worsening of underlying disease. No participants were enrolled into Part 2 of the study (The study was closed with amendment 5 after the last subject completed 35 cycles of the first course of Part 1).

Participant milestones

Measure	Cohort A Pembrolizumab/Vibostolimab Coformulation Participants with classic Hodgkin's lymphoma (cHL) or primary mediastinal B-cell lymphoma (PMBCL) who are relapsed or refractory to at least 1 line of prior therapy (cHL) of at least 2 lines of prior therapies (PMBCL) received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.	Cohort B Pembrolizumab/Vibostolimab Coformulation Participants with cHL or PMBCL who are relapsed or refractory to at least 2 lines of prior therapies (cHL) of at least 3 lines of prior therapies (PMBCL) received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.	Cohort C Pembrolizumab/Vibostolimab Coformulation Participants with relapsed or refractory follicular lymphoma (FL) following at least 2 lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.	Cohort D Pembrolizumab/Vibostolimab Coformulation Participants with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) following at least 2 lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.	Cohort E Pembrolizumab/Vibostolimab Coformulation Participants with relapsed or refractory multiple myeloma (MM) following at least 3 lines of therapy and have exhausted all approved lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.	Cohort F Pembrolizumab/Vibostolimab Coformulation Participants with relapsed or refractory non-Hodgkin's lymphoma (NHL) following at least 2 lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
Overall Study STARTED	42	42	20	30	25	33
Overall Study Treated	42	42	20	30	25	32
Overall Study COMPLETED	0	0	0	0	0	0
Overall Study NOT COMPLETED	42	42	20	30	25	33

Reasons for withdrawal

Measure	Cohort A Pembrolizumab/Vibostolimab Coformulation Participants with classic Hodgkin's lymphoma (cHL) or primary mediastinal B-cell lymphoma (PMBCL) who are relapsed or refractory to at least 1 line of prior therapy (cHL) of at least 2 lines of prior therapies (PMBCL) received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.	Cohort B Pembrolizumab/Vibostolimab Coformulation Participants with cHL or PMBCL who are relapsed or refractory to at least 2 lines of prior therapies (cHL) of at least 3 lines of prior therapies (PMBCL) received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.	Cohort C Pembrolizumab/Vibostolimab Coformulation Participants with relapsed or refractory follicular lymphoma (FL) following at least 2 lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.	Cohort D Pembrolizumab/Vibostolimab Coformulation Participants with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) following at least 2 lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.	Cohort E Pembrolizumab/Vibostolimab Coformulation Participants with relapsed or refractory multiple myeloma (MM) following at least 3 lines of therapy and have exhausted all approved lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.	Cohort F Pembrolizumab/Vibostolimab Coformulation Participants with relapsed or refractory non-Hodgkin's lymphoma (NHL) following at least 2 lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
Overall Study Death	14	10	8	22	13	15
Overall Study Lost to Follow-up	0	2	0	0	1	0
Overall Study Physician Decision	0	0	1	0	2	0
Overall Study Sponsor decision	26	26	10	5	9	12
Overall Study Withdrawal by Subject	2	2	1	3	0	5
Overall Study Site terminated by sponsor	0	2	0	0	0	1

Baseline Characteristics

A Study of Pembrolizumab/Vibostolimab (MK-7684A) in Relapsed/Refractory Hematological Malignancies (MK-7684A-004, KEYVIBE-004)

Baseline characteristics by cohort

Measure	Cohort A Pembrolizumab/Vibostolimab Coformulation n=42 Participants Participants with classic Hodgkin's lymphoma (cHL) or primary mediastinal B-cell lymphoma (PMBCL) who are relapsed or refractory to at least 1 line of prior therapy (cHL) of at least 2 lines of prior therapies (PMBCL) received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.	Cohort B Pembrolizumab/Vibostolimab Coformulation n=42 Participants Participants with cHL or PMBCL who are relapsed or refractory to at least 2 lines of prior therapies (cHL) of at least 3 lines of prior therapies (PMBCL) received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.	Cohort C Pembrolizumab/Vibostolimab Coformulation n=20 Participants Participants with relapsed or refractory follicular lymphoma (FL) following at least 2 lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.	Cohort D Pembrolizumab/Vibostolimab Coformulation n=30 Participants Participants with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) following at least 2 lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.	Cohort E Pembrolizumab/Vibostolimab Coformulation n=25 Participants Participants with relapsed or refractory multiple myeloma (MM) following at least 3 lines of therapy and have exhausted all approved lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.	Cohort F Pembrolizumab/Vibostolimab Coformulation n=33 Participants Participants with relapsed or refractory non-Hodgkin's lymphoma (NHL) following at least 2 lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.	Total n=192 Participants Total of all reporting groups
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=6 Participants	0 Participants n=5 Participants	0 Participants n=5 Participants	0 Participants n=122 Participants	0 Participants n=488 Participants	0 Participants n=182 Participants	0 Participants n=3 Participants
Age, Continuous	41.5 Years STANDARD_DEVIATION 16.5 • n=6 Participants	46.7 Years STANDARD_DEVIATION 17.6 • n=5 Participants	63.6 Years STANDARD_DEVIATION 12.8 • n=5 Participants	60.7 Years STANDARD_DEVIATION 12.7 • n=122 Participants	64.4 Years STANDARD_DEVIATION 10.8 • n=488 Participants	66.0 Years STANDARD_DEVIATION 14.4 • n=182 Participants	55.1 Years STANDARD_DEVIATION 17.7 • n=3 Participants
Sex: Female, Male Female	18 Participants n=6 Participants	16 Participants n=5 Participants	8 Participants n=5 Participants	15 Participants n=122 Participants	15 Participants n=488 Participants	13 Participants n=182 Participants	85 Participants n=3 Participants
Sex: Female, Male Male	24 Participants n=6 Participants	26 Participants n=5 Participants	12 Participants n=5 Participants	15 Participants n=122 Participants	10 Participants n=488 Participants	20 Participants n=182 Participants	107 Participants n=3 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=6 Participants	3 Participants n=5 Participants	3 Participants n=5 Participants	5 Participants n=122 Participants	1 Participants n=488 Participants	3 Participants n=182 Participants	21 Participants n=3 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	36 Participants n=6 Participants	33 Participants n=5 Participants	15 Participants n=5 Participants	22 Participants n=122 Participants	24 Participants n=488 Participants	29 Participants n=182 Participants	159 Participants n=3 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=6 Participants	6 Participants n=5 Participants	2 Participants n=5 Participants	3 Participants n=122 Participants	0 Participants n=488 Participants	1 Participants n=182 Participants	12 Participants n=3 Participants
Race (NIH/OMB) Asian	0 Participants n=6 Participants	0 Participants n=5 Participants	0 Participants n=5 Participants	2 Participants n=122 Participants	2 Participants n=488 Participants	3 Participants n=182 Participants	7 Participants n=3 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=6 Participants	0 Participants n=5 Participants	0 Participants n=5 Participants	0 Participants n=122 Participants	0 Participants n=488 Participants	0 Participants n=182 Participants	0 Participants n=3 Participants
Race (NIH/OMB) Black or African American	4 Participants n=6 Participants	1 Participants n=5 Participants	0 Participants n=5 Participants	1 Participants n=122 Participants	3 Participants n=488 Participants	1 Participants n=182 Participants	10 Participants n=3 Participants
Race (NIH/OMB) White	38 Participants n=6 Participants	35 Participants n=5 Participants	20 Participants n=5 Participants	27 Participants n=122 Participants	20 Participants n=488 Participants	29 Participants n=182 Participants	169 Participants n=3 Participants
Race (NIH/OMB) More than one race	0 Participants n=6 Participants	0 Participants n=5 Participants	0 Participants n=5 Participants	0 Participants n=122 Participants	0 Participants n=488 Participants	0 Participants n=182 Participants	0 Participants n=3 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=6 Participants	6 Participants n=5 Participants	0 Participants n=5 Participants	0 Participants n=122 Participants	0 Participants n=488 Participants	0 Participants n=182 Participants	6 Participants n=3 Participants

PRIMARY outcome

Timeframe: Up to approximately 6 weeks

Population: All participants who received at least one dose of study intervention and that finished the DLT evaluation period without a DLT or experienced a DLT in the DLT evaluation period.

A DLT is defined as an event with toxicity including the type, severity, time of onset, time of resolution, and the probable association with study treatment that are not due to pre-existing conditions as defined by the Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE 5.0). Percentage of participants who experience a DLT per CTCAE 5.0 are reported.

Outcome measures

Measure	Cohort A Pembrolizumab/Vibostolimab Coformulation n=42 Participants Participants with classic Hodgkin's lymphoma (cHL) or primary mediastinal B-cell lymphoma (PMBCL) who are relapsed or refractory to at least 1 line of prior therapy (cHL) of at least 2 lines of prior therapies (PMBCL) received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.	Cohort B Pembrolizumab/Vibostolimab Coformulation n=41 Participants Participants with cHL or PMBCL who are relapsed or refractory to at least 2 lines of prior therapies (cHL) of at least 3 lines of prior therapies (PMBCL) received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.	Cohort C Pembrolizumab/Vibostolimab Coformulation n=18 Participants Participants with relapsed or refractory follicular lymphoma (FL) following at least 2 lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.	Cohort D Pembrolizumab/Vibostolimab Coformulation n=20 Participants Participants with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) following at least 2 lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.	Cohort E Pembrolizumab/Vibostolimab Coformulation n=10 Participants Participants with relapsed or refractory multiple myeloma (MM) following at least 3 lines of therapy and have exhausted all approved lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.	Cohort F Pembrolizumab/Vibostolimab Coformulation n=25 Participants Participants with relapsed or refractory non-Hodgkin's lymphoma (NHL) following at least 2 lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
Percentage of Participants With a Dose-Limiting Toxicity (DLT)	4.8 Percentage of Participants Interval 0.8 to 14.2	2.4 Percentage of Participants Interval 0.1 to 10.8	0.0 Percentage of Participants Interval 0.0 to 14.6	5.0 Percentage of Participants Interval 0.3 to 20.8	0.0 Percentage of Participants Interval 0.0 to 23.8	8.0 Percentage of Participants Interval 1.4 to 22.8

PRIMARY outcome

Timeframe: Up to approximately 27 months

Population: All allocated participants who received at least 1 dose of study intervention.

An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. The number of participants who experience an AE are reported.

Outcome measures

Measure	Cohort A Pembrolizumab/Vibostolimab Coformulation n=42 Participants Participants with classic Hodgkin's lymphoma (cHL) or primary mediastinal B-cell lymphoma (PMBCL) who are relapsed or refractory to at least 1 line of prior therapy (cHL) of at least 2 lines of prior therapies (PMBCL) received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.	Cohort B Pembrolizumab/Vibostolimab Coformulation n=42 Participants Participants with cHL or PMBCL who are relapsed or refractory to at least 2 lines of prior therapies (cHL) of at least 3 lines of prior therapies (PMBCL) received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.	Cohort C Pembrolizumab/Vibostolimab Coformulation n=20 Participants Participants with relapsed or refractory follicular lymphoma (FL) following at least 2 lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.	Cohort D Pembrolizumab/Vibostolimab Coformulation n=30 Participants Participants with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) following at least 2 lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.	Cohort E Pembrolizumab/Vibostolimab Coformulation n=25 Participants Participants with relapsed or refractory multiple myeloma (MM) following at least 3 lines of therapy and have exhausted all approved lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.	Cohort F Pembrolizumab/Vibostolimab Coformulation n=32 Participants Participants with relapsed or refractory non-Hodgkin's lymphoma (NHL) following at least 2 lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
Percentage of Participants Who Experienced an Adverse Event (AE)	92.9 Percentage of Participants	97.6 Percentage of Participants	95.0 Percentage of Participants	80.0 Percentage of Participants	80.0 Percentage of Participants	87.5 Percentage of Participants

PRIMARY outcome

Timeframe: Up to approximately 24 months

Population: All allocated participants who received at least 1 dose of study intervention.

An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. The number of participants discontinued from the study treatment due to an AE are reported.

Outcome measures

Measure	Cohort A Pembrolizumab/Vibostolimab Coformulation n=42 Participants Participants with classic Hodgkin's lymphoma (cHL) or primary mediastinal B-cell lymphoma (PMBCL) who are relapsed or refractory to at least 1 line of prior therapy (cHL) of at least 2 lines of prior therapies (PMBCL) received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.	Cohort B Pembrolizumab/Vibostolimab Coformulation n=42 Participants Participants with cHL or PMBCL who are relapsed or refractory to at least 2 lines of prior therapies (cHL) of at least 3 lines of prior therapies (PMBCL) received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.	Cohort C Pembrolizumab/Vibostolimab Coformulation n=20 Participants Participants with relapsed or refractory follicular lymphoma (FL) following at least 2 lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.	Cohort D Pembrolizumab/Vibostolimab Coformulation n=30 Participants Participants with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) following at least 2 lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.	Cohort E Pembrolizumab/Vibostolimab Coformulation n=25 Participants Participants with relapsed or refractory multiple myeloma (MM) following at least 3 lines of therapy and have exhausted all approved lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.	Cohort F Pembrolizumab/Vibostolimab Coformulation n=32 Participants Participants with relapsed or refractory non-Hodgkin's lymphoma (NHL) following at least 2 lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
Percentage of Participants Who Discontinued Study Treatment Due to an AE	19.0 Percentage of Participants	4.8 Percentage of Participants	15.0 Percentage of Participants	13.3 Percentage of Participants	4.0 Percentage of Participants	12.5 Percentage of Participants

SECONDARY outcome

Timeframe: Up to approximately 37 months

Population: All participants who have received at least one dose of study intervention and had ORR measured by Lugano 2014 Classification.

ORR for Cohorts A-D and F was assessed based on the Lugano 2014 Classification. ORR is defined as the percentage of the participants who had complete response (CR) or partial response (PR) and was evaluated using computed tomography (CT) and positron emission tomography (PET)-CT. CR is complete metabolic (no/minimal fluorodeoxyglucose [FDG] uptake) and radiologic response (target lesions regress to ≤5 cm in longest transverse diameter of a lesion) and no new lesions. PR is partial metabolic (moderate/high FDG uptake) and radiologic response (≥50% decrease in sum of product diameters for multiple lesions of up to 6 target measurable nodes and extranodal sites, no increase in lesions, and spleen regressed by >50% in length beyond normal). ORR for Cohorts A-D and F is presented. Cohort E is presented separately.

Outcome measures

Measure	Cohort A Pembrolizumab/Vibostolimab Coformulation n=42 Participants Participants with classic Hodgkin's lymphoma (cHL) or primary mediastinal B-cell lymphoma (PMBCL) who are relapsed or refractory to at least 1 line of prior therapy (cHL) of at least 2 lines of prior therapies (PMBCL) received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.	Cohort B Pembrolizumab/Vibostolimab Coformulation n=42 Participants Participants with cHL or PMBCL who are relapsed or refractory to at least 2 lines of prior therapies (cHL) of at least 3 lines of prior therapies (PMBCL) received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.	Cohort C Pembrolizumab/Vibostolimab Coformulation n=20 Participants Participants with relapsed or refractory follicular lymphoma (FL) following at least 2 lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.	Cohort D Pembrolizumab/Vibostolimab Coformulation n=30 Participants Participants with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) following at least 2 lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.	Cohort E Pembrolizumab/Vibostolimab Coformulation Participants with relapsed or refractory multiple myeloma (MM) following at least 3 lines of therapy and have exhausted all approved lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.	Cohort F Pembrolizumab/Vibostolimab Coformulation n=32 Participants Participants with relapsed or refractory non-Hodgkin's lymphoma (NHL) following at least 2 lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
Objective Response Rate (ORR) as Assessed by Lugano 2014 Classification (Cohorts A-D & F)	64.3 Percentage of Participants Interval 48.0 to 78.4	35.7 Percentage of Participants Interval 21.6 to 52.0	15.0 Percentage of Participants Interval 3.2 to 37.9	16.7 Percentage of Participants Interval 5.6 to 34.7	—	18.8 Percentage of Participants Interval 7.2 to 36.4

SECONDARY outcome

Timeframe: Up to approximately 37 months

Population: All participants who have received at least one dose of study intervention and had ORR measured by the 2016 IMWG Response Criteria.

ORR for Cohort E was measured by 2016 IMWG Response Criteria. ORR is defined as the percentage of the participants with either a stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) according to the International Myeloma Working Group (IMWG) Response Criteria. CR = negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND <5% plasmacytomas in the bone marrow; sCR=stringent complete response, CR as above PLUS normal serum free light-chain (FLC) assay ratio and absence of clonal cells in bone marrow; VGPR = serum and urine M-component detectable by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-component plus urine M-component <100 mg/24 hr; PR = ≥50% reduction of serum Mprotein and reduction in 24-hour urinary M-protein by ≥90% or to <200 mg/24 hours. The ORR for Cohort E is presented. Cohorts A-D and F were presented in a previous outcome measure.

Outcome measures

Measure	Cohort A Pembrolizumab/Vibostolimab Coformulation Participants with classic Hodgkin's lymphoma (cHL) or primary mediastinal B-cell lymphoma (PMBCL) who are relapsed or refractory to at least 1 line of prior therapy (cHL) of at least 2 lines of prior therapies (PMBCL) received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.	Cohort B Pembrolizumab/Vibostolimab Coformulation Participants with cHL or PMBCL who are relapsed or refractory to at least 2 lines of prior therapies (cHL) of at least 3 lines of prior therapies (PMBCL) received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.	Cohort C Pembrolizumab/Vibostolimab Coformulation Participants with relapsed or refractory follicular lymphoma (FL) following at least 2 lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.	Cohort D Pembrolizumab/Vibostolimab Coformulation Participants with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) following at least 2 lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.	Cohort E Pembrolizumab/Vibostolimab Coformulation n=25 Participants Participants with relapsed or refractory multiple myeloma (MM) following at least 3 lines of therapy and have exhausted all approved lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.	Cohort F Pembrolizumab/Vibostolimab Coformulation Participants with relapsed or refractory non-Hodgkin's lymphoma (NHL) following at least 2 lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
ORR as Assessed by the 2016 International Myeloma Working Group (IMWG) Response Criteria (Cohort E)	—	—	—	—	0.0 Percentage of Participants Interval 0.0 to 13.7	—

SECONDARY outcome

Timeframe: Up to approximately 37 months

Population: All participants who have received at least one dose of study intervention and had a response measured by measured by Lugano 2014 Classification.

For participants who demonstrate a confirmed complete response (CR) or partial response (PR), DOR is defined as the time from CR or PR to documented disease progression or death. Participants are assessed using computed tomography (CT) and positron emission tomography (PET)- CT and response was evaluated based on the Lugano 2014 Classification (Cheson et al, Journal of Clinical Oncology, 2014). CR is complete metabolic (no/minimal fluorodeoxyglucose [FDG] uptake) and radiologic response (target lesions regress to ≤5 cm in longest transverse diameter of a lesion) and no new lesions. PR is partial metabolic (moderate/high FDG uptake) and radiologic response (≥50% decrease in sum of product diameters (SPD) for multiple lesions of up to 6 target measurable nodes and extranodal sites, no increase in lesions, and spleen regressed by >50% in length beyond normal). DOR for Cohorts A-D and F are presented. Cohort E is presented separately.

Outcome measures

Measure	Cohort A Pembrolizumab/Vibostolimab Coformulation n=27 Participants Participants with classic Hodgkin's lymphoma (cHL) or primary mediastinal B-cell lymphoma (PMBCL) who are relapsed or refractory to at least 1 line of prior therapy (cHL) of at least 2 lines of prior therapies (PMBCL) received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.	Cohort B Pembrolizumab/Vibostolimab Coformulation n=15 Participants Participants with cHL or PMBCL who are relapsed or refractory to at least 2 lines of prior therapies (cHL) of at least 3 lines of prior therapies (PMBCL) received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.	Cohort C Pembrolizumab/Vibostolimab Coformulation n=3 Participants Participants with relapsed or refractory follicular lymphoma (FL) following at least 2 lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.	Cohort D Pembrolizumab/Vibostolimab Coformulation n=5 Participants Participants with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) following at least 2 lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.	Cohort E Pembrolizumab/Vibostolimab Coformulation Participants with relapsed or refractory multiple myeloma (MM) following at least 3 lines of therapy and have exhausted all approved lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.	Cohort F Pembrolizumab/Vibostolimab Coformulation n=6 Participants Participants with relapsed or refractory non-Hodgkin's lymphoma (NHL) following at least 2 lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
Duration of Response (DOR) as Assessed by Lugano 2014 Classification (Cohorts A-D & F)	5.4 Months Interval 2.9 to 11.0	3.0 Months Interval 2.8 to 10.2	2.8 Months Interval 2.8 to NA = upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.	NA Months Interval 2.9 to NA = Median and upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.	—	3.4 Months Interval 1.6 to NA = 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 37 months

Population: All participants who have received at least one dose of study intervention and had a response measured by measured by 2016 IMWG Response Criteria. No participants met the pre-specified analysis criteria for DOR in Cohort E (i.e., no participants with a response) and therefore DOR is unavailable for Cohort E.

DOR is defined as the time from CR or PR to documented disease progression or death. DOR for Cohort E was measured by the 2016 IMWG Response Criteria with response criteria defined as participants with either a stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR). CR = negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND <5% plasmacytomas in the bone marrow; sCR=CR as above PLUS normal serum free light-chain (FLC) assay ratio and absence of clonal cells in bone marrow; VGPR = serum and urine M-component detectable by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-component plus urine M-component <100 mg/24 hr; PR = ≥50% reduction of serum Mprotein and reduction in 24-hour urinary M-protein by ≥90% or to <200 mg/24 hours. The DOR for Cohort E is presented. Cohorts A-D and F were presented in a previous outcome measure.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 37 months

Population: All participants who have received at least one dose of study intervention and were evaluated using Lugano 2014 Classification.

DCR is % of participants who had tumor response per response criteria or have stable disease (SD) for ≥ 12 weeks before any evidence of progressive disease (PD). CR or PR were evaluated with CT and PET-CT. CR: complete metabolic (no/minimal FDG uptake) and radiologic response (target lesions regress to ≤5 cm in longest transverse diameter of a lesion) and no new lesions. PR: partial metabolic (moderate/high FDG uptake) and radiologic response (≥50% decrease in sum of product diameters for multiple lesions of up to 6 target measurable nodes and extranodal sites, no increase in lesions, and spleen regressed by >50% in length beyond normal). SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. DCR for Cohorts A-D & F are presented. Cohort E is presented in a separate outcome measure.

Outcome measures

Measure	Cohort A Pembrolizumab/Vibostolimab Coformulation n=42 Participants Participants with classic Hodgkin's lymphoma (cHL) or primary mediastinal B-cell lymphoma (PMBCL) who are relapsed or refractory to at least 1 line of prior therapy (cHL) of at least 2 lines of prior therapies (PMBCL) received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.	Cohort B Pembrolizumab/Vibostolimab Coformulation n=42 Participants Participants with cHL or PMBCL who are relapsed or refractory to at least 2 lines of prior therapies (cHL) of at least 3 lines of prior therapies (PMBCL) received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.	Cohort C Pembrolizumab/Vibostolimab Coformulation n=20 Participants Participants with relapsed or refractory follicular lymphoma (FL) following at least 2 lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.	Cohort D Pembrolizumab/Vibostolimab Coformulation n=30 Participants Participants with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) following at least 2 lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.	Cohort E Pembrolizumab/Vibostolimab Coformulation Participants with relapsed or refractory multiple myeloma (MM) following at least 3 lines of therapy and have exhausted all approved lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.	Cohort F Pembrolizumab/Vibostolimab Coformulation n=32 Participants Participants with relapsed or refractory non-Hodgkin's lymphoma (NHL) following at least 2 lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
Disease Control Rate (DCR) as Assessed by Lugano 2014 Classification (Cohorts A-D & F)	73.8 Percentage of Participants Interval 58.0 to 86.1	59.5 Percentage of Participants Interval 43.3 to 74.4	25.0 Percentage of Participants Interval 8.7 to 49.1	16.7 Percentage of Participants Interval 5.6 to 34.7	—	31.3 Percentage of Participants Interval 16.1 to 50.0

SECONDARY outcome

Timeframe: Up to approximately 37 months

Population: All participants who have received at least one dose of study intervention and were evaluated using 2016 IMWG Response Criteria.

DCR: percentage of participants who have achieved tumor response or have shown SD for at least 12 weeks before any evidence of PD per IMWG response criteria 2016. Response criteria are defined as participants with either a sCR, CR, VGPR, or PR. CR = negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND <5% plasmacytomas in the bone marrow; sCR=CR as above PLUS normal serum FLC assay ratio and absence of clonal cells in bone marrow; VGPR = serum and urine M-component detectable by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-component plus urine M-component <100 mg/24 hr; PR = ≥50% reduction of serum Mprotein and reduction in 24-hour urinary M-protein by ≥90% or to <200 mg/24 hours. SD = Not meeting criteria for CR, VGPR, PR, or PD. PD as defined by prespecified 2016 IMWG response criteria. DCR for Cohort E is presented. Cohorts A-D and F were presented in a previous outcome measure.

Outcome measures

Measure	Cohort A Pembrolizumab/Vibostolimab Coformulation Participants with classic Hodgkin's lymphoma (cHL) or primary mediastinal B-cell lymphoma (PMBCL) who are relapsed or refractory to at least 1 line of prior therapy (cHL) of at least 2 lines of prior therapies (PMBCL) received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.	Cohort B Pembrolizumab/Vibostolimab Coformulation Participants with cHL or PMBCL who are relapsed or refractory to at least 2 lines of prior therapies (cHL) of at least 3 lines of prior therapies (PMBCL) received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.	Cohort C Pembrolizumab/Vibostolimab Coformulation Participants with relapsed or refractory follicular lymphoma (FL) following at least 2 lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.	Cohort D Pembrolizumab/Vibostolimab Coformulation Participants with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) following at least 2 lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.	Cohort E Pembrolizumab/Vibostolimab Coformulation n=25 Participants Participants with relapsed or refractory multiple myeloma (MM) following at least 3 lines of therapy and have exhausted all approved lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.	Cohort F Pembrolizumab/Vibostolimab Coformulation Participants with relapsed or refractory non-Hodgkin's lymphoma (NHL) following at least 2 lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
DCR as Assessed by 2016 IMWG Response Criteria (Cohort E)	—	—	—	—	16.0 Percentage of Participants Interval 4.5 to 36.1	—

SECONDARY outcome

Timeframe: Predose at Cycles 1, 3, 7, 11, 15, 19, 23, 27 and 31. Cycle = 3 weeks

Population: All participants who received at least one dose of intervention and had data for the corresponding cycle.

Ctrough is the lowest concentration reached by a drug before the next dose is administered. Blood samples collected predose were used to determine Ctrough of Vibostolimab.

Outcome measures

Measure	Cohort A Pembrolizumab/Vibostolimab Coformulation n=35 Participants Participants with classic Hodgkin's lymphoma (cHL) or primary mediastinal B-cell lymphoma (PMBCL) who are relapsed or refractory to at least 1 line of prior therapy (cHL) of at least 2 lines of prior therapies (PMBCL) received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.	Cohort B Pembrolizumab/Vibostolimab Coformulation n=40 Participants Participants with cHL or PMBCL who are relapsed or refractory to at least 2 lines of prior therapies (cHL) of at least 3 lines of prior therapies (PMBCL) received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.	Cohort C Pembrolizumab/Vibostolimab Coformulation n=18 Participants Participants with relapsed or refractory follicular lymphoma (FL) following at least 2 lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.	Cohort D Pembrolizumab/Vibostolimab Coformulation n=18 Participants Participants with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) following at least 2 lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.	Cohort E Pembrolizumab/Vibostolimab Coformulation n=25 Participants Participants with relapsed or refractory multiple myeloma (MM) following at least 3 lines of therapy and have exhausted all approved lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.	Cohort F Pembrolizumab/Vibostolimab Coformulation n=25 Participants Participants with relapsed or refractory non-Hodgkin's lymphoma (NHL) following at least 2 lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
Lowest Plasma Concentration (Ctrough) of Vibostolimab Cycle 31	31.7 ug/mL Interval 2.43 to 413.0	31.6 ug/mL Interval 6.13 to 163.0	—	38.0 ug/mL Interval 1.57 to 923.0	—	—
Lowest Plasma Concentration (Ctrough) of Vibostolimab Cycle 1	8.06 ug/mL Interval 6.71 to 9.68	9.86 ug/mL Interval 8.22 to 11.8	10.0 ug/mL Interval 6.61 to 15.3	9.64 ug/mL Interval 7.24 to 12.9	9.86 ug/mL Interval 6.52 to 14.9	9.52 ug/mL Interval 6.95 to 13.0
Lowest Plasma Concentration (Ctrough) of Vibostolimab Cycle 3	15.3 ug/mL Interval 12.4 to 18.8	17.0 ug/mL Interval 13.3 to 21.6	22.6 ug/mL Interval 13.5 to 38.0	14.5 ug/mL Interval 7.55 to 27.9	17.9 ug/mL Interval 5.07 to 63.3	20.2 ug/mL Interval 15.8 to 25.9
Lowest Plasma Concentration (Ctrough) of Vibostolimab Cycle 19	34.8 ug/mL Interval 21.6 to 56.2	24.2 ug/mL Interval 13.8 to 42.6	—	31.1 ug/mL Interval 5.49 to 176.0	—	—
Lowest Plasma Concentration (Ctrough) of Vibostolimab Cycle 23	36.5 ug/mL Interval 24.2 to 55.2	24.8 ug/mL Interval 15.2 to 40.3	—	51.5 ug/mL Confidence interval cannot be calculated when N=1.	—	—
Lowest Plasma Concentration (Ctrough) of Vibostolimab Cycle 27	40.6 ug/mL Interval 22.8 to 72.4	19.3 ug/mL Interval 9.23 to 40.4	—	48.9 ug/mL Interval 8.42 to 284.0	—	—
Lowest Plasma Concentration (Ctrough) of Vibostolimab Cycle 7	21.0 ug/mL Interval 17.1 to 25.8	19.5 ug/mL Interval 14.9 to 25.5	38.1 ug/mL Interval 6.15 to 236.0	25.8 ug/mL Interval 5.19 to 129.0	—	22.1 ug/mL Interval 14.1 to 34.7
Lowest Plasma Concentration (Ctrough) of Vibostolimab Cycle 11	22.6 ug/mL Interval 16.6 to 30.8	24.2 ug/mL Interval 16.3 to 35.8	28.9 ug/mL Interval 0.251 to 3330.0	40.7 ug/mL Interval 40.1 to 41.4	—	—
Lowest Plasma Concentration (Ctrough) of Vibostolimab Cycle 15	26.2 ug/mL Interval 17.0 to 40.6	25.6 ug/mL Interval 17.4 to 37.8	—	40.6 ug/mL Interval 7.65 to 216.0	—	—

SECONDARY outcome

Timeframe: Postdose: after end of infusion (up to ~10 minutes) at Cycles 1 and 8. Cycle = 3 weeks

Population: All participants who received at least one dose of intervention and had data for the corresponding cycle.

Cmax is the maximum concentration of the drug observed in plasma. Blood samples collected post dose were used to determine Cmax of Vibostolimab.

Outcome measures

Measure	Cohort A Pembrolizumab/Vibostolimab Coformulation n=37 Participants Participants with classic Hodgkin's lymphoma (cHL) or primary mediastinal B-cell lymphoma (PMBCL) who are relapsed or refractory to at least 1 line of prior therapy (cHL) of at least 2 lines of prior therapies (PMBCL) received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.	Cohort B Pembrolizumab/Vibostolimab Coformulation n=38 Participants Participants with cHL or PMBCL who are relapsed or refractory to at least 2 lines of prior therapies (cHL) of at least 3 lines of prior therapies (PMBCL) received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.	Cohort C Pembrolizumab/Vibostolimab Coformulation n=17 Participants Participants with relapsed or refractory follicular lymphoma (FL) following at least 2 lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.	Cohort D Pembrolizumab/Vibostolimab Coformulation n=26 Participants Participants with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) following at least 2 lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.	Cohort E Pembrolizumab/Vibostolimab Coformulation n=24 Participants Participants with relapsed or refractory multiple myeloma (MM) following at least 3 lines of therapy and have exhausted all approved lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.	Cohort F Pembrolizumab/Vibostolimab Coformulation n=28 Participants Participants with relapsed or refractory non-Hodgkin's lymphoma (NHL) following at least 2 lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
Maximum Concentration (Cmax) of Vibostolimab Cycle 1	85.8 ug/mL Interval 65.4 to 113.0	85.4 ug/mL Interval 70.0 to 104.0	42.6 ug/mL Interval 35.2 to 51.5	64.2 ug/mL Interval 54.2 to 76.1	53.2 ug/mL Interval 45.7 to 61.9	55.2 ug/mL Interval 44.2 to 69.0
Maximum Concentration (Cmax) of Vibostolimab Cycle 8	84.8 ug/mL Interval 69.9 to 103.0	75.8 ug/mL Interval 61.5 to 93.5	112 ug/mL Interval 22.8 to 552.0	77.4 ug/mL Interval 46.4 to 129.0	—	80.9 ug/mL Interval 58.4 to 112.0

Adverse Events

COHORT A

Serious events: 17 serious events

Other events: 35 other events

Deaths: 14 deaths

COHORT B

Serious events: 11 serious events

Other events: 39 other events

Deaths: 10 deaths

COHORT C

Serious events: 8 serious events

Other events: 15 other events

Deaths: 9 deaths

COHORT D

Serious events: 11 serious events

Other events: 21 other events

Deaths: 24 deaths

COHORT E

Serious events: 8 serious events

Other events: 16 other events

Deaths: 14 deaths

COHORT F

Serious events: 13 serious events

Other events: 24 other events

Deaths: 15 deaths

Serious adverse events

Measure	COHORT A n=42 participants at risk Participants with classic Hodgkin's lymphoma (cHL) or primary mediastinal B-cell lymphoma (PMBCL) who are relapsed or refractory to at least 1 line of prior therapy (cHL) of at least 2 lines of prior therapies (PMBCL) received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.	COHORT B n=42 participants at risk Participants with cHL or PMBCL who are relapsed or refractory to at least 2 lines of prior therapies (cHL) of at least 3 lines of prior therapies (PMBCL) received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.	COHORT C n=20 participants at risk Participants with relapsed or refractory follicular lymphoma (FL) following at least 2 lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.	COHORT D n=30 participants at risk Participants with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) following at least 2 lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.	COHORT E n=25 participants at risk Participants with relapsed or refractory multiple myeloma (MM) following at least 3 lines of therapy and have exhausted all approved lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.	COHORT F n=32 participants at risk Participants with relapsed or refractory non-Hodgkin's lymphoma (NHL) following at least 2 lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
Blood and lymphatic system disorders Anaemia	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/30 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	4.0% 1/25 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/32 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	2.4% 1/42 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/30 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/25 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/32 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Blood and lymphatic system disorders Lymphadenopathy	2.4% 1/42 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/30 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/25 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/32 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Blood and lymphatic system disorders Neutropenia	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	3.3% 1/30 • Number of events 2 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/25 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/32 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/30 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	4.0% 1/25 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	3.1% 1/32 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Cardiac disorders Acute cardiac event	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	3.3% 1/30 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/25 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/32 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Cardiac disorders Arrhythmia	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/30 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	4.0% 1/25 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/32 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Cardiac disorders Atrial fibrillation	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	2.4% 1/42 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	3.3% 1/30 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/25 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/32 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Cardiac disorders Cardiac failure acute	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/30 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/25 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	3.1% 1/32 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Cardiac disorders Myocarditis	2.4% 1/42 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/30 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/25 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/32 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Congenital, familial and genetic disorders Pyloric stenosis	2.4% 1/42 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/30 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/25 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/32 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Congenital, familial and genetic disorders Tracheo-oesophageal fistula	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/30 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/25 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	3.1% 1/32 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Endocrine disorders Thyroiditis	2.4% 1/42 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/30 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/25 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/32 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Abdominal pain	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/30 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/25 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	3.1% 1/32 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Constipation	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/30 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/25 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	3.1% 1/32 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Dyspepsia	2.4% 1/42 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/30 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/25 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/32 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Gastric haemorrhage	2.4% 1/42 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/30 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/25 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/32 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Ileus	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/30 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/25 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	3.1% 1/32 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Immune-mediated gastritis	2.4% 1/42 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/30 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/25 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/32 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Nausea	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/30 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/25 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	3.1% 1/32 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Oesophageal haemorrhage	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/30 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/25 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	3.1% 1/32 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
General disorders Asthenia	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/30 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/25 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	3.1% 1/32 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
General disorders Pyrexia	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	5.0% 1/20 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/30 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/25 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/32 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Hepatobiliary disorders Cholecystitis	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	2.4% 1/42 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/30 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/25 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/32 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Immune system disorders Cytokine release syndrome	2.4% 1/42 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/30 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/25 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/32 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Immune system disorders Infusion related hypersensitivity reaction	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	2.4% 1/42 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/30 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/25 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/32 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Acute hepatitis B	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/30 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/25 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	3.1% 1/32 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Aspergillus infection	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	2.4% 1/42 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/30 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/25 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/32 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations COVID-19	2.4% 1/42 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	2.4% 1/42 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	10.0% 2/20 • Number of events 3 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/30 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/25 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	3.1% 1/32 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations COVID-19 pneumonia	2.4% 1/42 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	5.0% 1/20 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	3.3% 1/30 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/25 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	3.1% 1/32 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Cellulitis	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	5.0% 1/20 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	3.3% 1/30 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/25 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/32 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Device related infection	2.4% 1/42 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/30 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/25 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	3.1% 1/32 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Encephalitis	4.8% 2/42 • Number of events 2 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/30 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/25 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/32 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Gastroenteritis	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/30 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/25 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	3.1% 1/32 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Infection	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/30 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	4.0% 1/25 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/32 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Parainfluenzae virus infection	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/30 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	4.0% 1/25 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	3.1% 1/32 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Pneumonia	2.4% 1/42 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	4.8% 2/42 • Number of events 2 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/30 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	8.0% 2/25 • Number of events 2 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	6.2% 2/32 • Number of events 2 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Post-acute COVID-19 syndrome	2.4% 1/42 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/30 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/25 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/32 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Pyelonephritis	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	3.3% 1/30 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/25 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/32 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Sepsis	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	3.3% 1/30 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/25 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	3.1% 1/32 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Soft tissue infection	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/30 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/25 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	3.1% 1/32 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Upper respiratory tract infection	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	3.3% 1/30 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/25 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/32 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Vascular device infection	2.4% 1/42 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/30 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/25 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/32 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Wound infection	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	3.3% 1/30 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/25 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/32 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Injury, poisoning and procedural complications Limb injury	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	2.4% 1/42 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/30 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/25 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/32 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Investigations Platelet count decreased	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	3.3% 1/30 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/25 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/32 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Metabolism and nutrition disorders Dehydration	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/30 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/25 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	3.1% 1/32 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	6.7% 2/30 • Number of events 2 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/25 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/32 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/30 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	4.0% 1/25 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/32 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Musculoskeletal and connective tissue disorders Myositis	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	5.0% 1/20 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/30 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/25 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/32 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Nervous system disorders Neurological symptom	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/30 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	4.0% 1/25 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/32 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) High-grade B-cell lymphoma	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	2.4% 1/42 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/30 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/25 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/32 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leydig cell tumour of the testis	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/30 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/25 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	3.1% 1/32 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/30 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	4.0% 1/25 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/32 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Nervous system disorders Neurotoxicity	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/30 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/25 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	3.1% 1/32 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Nervous system disorders Seizure	2.4% 1/42 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/30 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/25 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/32 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Renal and urinary disorders Acute kidney injury	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	3.3% 1/30 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/25 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	6.2% 2/32 • Number of events 2 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Renal and urinary disorders Hydronephrosis	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/30 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/25 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	3.1% 1/32 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Renal and urinary disorders Nephritis	2.4% 1/42 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/30 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/25 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/32 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Renal and urinary disorders Renal failure	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	5.0% 1/20 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/30 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/25 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/32 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Renal and urinary disorders Urinary retention	2.4% 1/42 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/30 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/25 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/32 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Reproductive system and breast disorders Benign prostatic hyperplasia	2.4% 1/42 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/30 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/25 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/32 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/30 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	4.0% 1/25 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/32 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Oesophagobronchial fistula	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/30 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/25 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	3.1% 1/32 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Pneumonitis	4.8% 2/42 • Number of events 2 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/30 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/25 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/32 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	5.0% 1/20 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/30 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/25 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/32 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Skin and subcutaneous tissue disorders Drug eruption	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	2.4% 1/42 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/30 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/25 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/32 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Skin and subcutaneous tissue disorders Rash	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	3.3% 1/30 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/25 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/32 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Skin and subcutaneous tissue disorders Toxic epidermal necrolysis	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	5.0% 1/20 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	3.3% 1/30 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/25 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/32 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Skin and subcutaneous tissue disorders Urticaria	2.4% 1/42 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	2.4% 1/42 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	3.3% 1/30 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/25 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/32 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Vascular disorders Embolism	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	3.3% 1/30 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/25 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/32 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.

Other adverse events

Measure	COHORT A n=42 participants at risk Participants with classic Hodgkin's lymphoma (cHL) or primary mediastinal B-cell lymphoma (PMBCL) who are relapsed or refractory to at least 1 line of prior therapy (cHL) of at least 2 lines of prior therapies (PMBCL) received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.	COHORT B n=42 participants at risk Participants with cHL or PMBCL who are relapsed or refractory to at least 2 lines of prior therapies (cHL) of at least 3 lines of prior therapies (PMBCL) received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.	COHORT C n=20 participants at risk Participants with relapsed or refractory follicular lymphoma (FL) following at least 2 lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.	COHORT D n=30 participants at risk Participants with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) following at least 2 lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.	COHORT E n=25 participants at risk Participants with relapsed or refractory multiple myeloma (MM) following at least 3 lines of therapy and have exhausted all approved lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.	COHORT F n=32 participants at risk Participants with relapsed or refractory non-Hodgkin's lymphoma (NHL) following at least 2 lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
Blood and lymphatic system disorders Anaemia	11.9% 5/42 • Number of events 7 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	11.9% 5/42 • Number of events 6 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	5.0% 1/20 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	16.7% 5/30 • Number of events 5 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	28.0% 7/25 • Number of events 8 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	12.5% 4/32 • Number of events 5 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Blood and lymphatic system disorders Eosinophilia	7.1% 3/42 • Number of events 3 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	2.4% 1/42 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	3.3% 1/30 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	8.0% 2/25 • Number of events 2 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/32 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Blood and lymphatic system disorders Neutropenia	9.5% 4/42 • Number of events 8 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	15.0% 3/20 • Number of events 3 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	13.3% 4/30 • Number of events 4 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	4.0% 1/25 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	15.6% 5/32 • Number of events 5 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Blood and lymphatic system disorders Thrombocytopenia	2.4% 1/42 • Number of events 3 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	5.0% 1/20 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	6.7% 2/30 • Number of events 3 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	12.0% 3/25 • Number of events 3 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	12.5% 4/32 • Number of events 4 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Cardiac disorders Sinus tachycardia	4.8% 2/42 • Number of events 2 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/30 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	8.0% 2/25 • Number of events 4 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/32 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Endocrine disorders Hypothyroidism	19.0% 8/42 • Number of events 13 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	7.1% 3/42 • Number of events 3 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	3.3% 1/30 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/25 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/32 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	2.4% 1/42 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	5.0% 1/20 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/30 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/25 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	6.2% 2/32 • Number of events 2 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Constipation	4.8% 2/42 • Number of events 2 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	4.8% 2/42 • Number of events 2 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	10.0% 2/20 • Number of events 2 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	3.3% 1/30 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	4.0% 1/25 • Number of events 2 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	6.2% 2/32 • Number of events 3 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Diarrhoea	16.7% 7/42 • Number of events 7 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	9.5% 4/42 • Number of events 5 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	13.3% 4/30 • Number of events 4 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/25 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	9.4% 3/32 • Number of events 3 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Nausea	9.5% 4/42 • Number of events 4 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	2.4% 1/42 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	10.0% 2/20 • Number of events 2 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/30 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	8.0% 2/25 • Number of events 2 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	15.6% 5/32 • Number of events 5 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Gastrointestinal disorders Vomiting	2.4% 1/42 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/30 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	4.0% 1/25 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	6.2% 2/32 • Number of events 2 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
General disorders Chills	2.4% 1/42 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	9.5% 4/42 • Number of events 4 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	10.0% 2/20 • Number of events 2 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/30 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	4.0% 1/25 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/32 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
General disorders Fatigue	7.1% 3/42 • Number of events 3 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	14.3% 6/42 • Number of events 6 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	5.0% 1/20 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	6.7% 2/30 • Number of events 2 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	16.0% 4/25 • Number of events 4 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/32 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
General disorders Hyperthermia	7.1% 3/42 • Number of events 3 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/30 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/25 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/32 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
General disorders Influenza like illness	7.1% 3/42 • Number of events 4 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/30 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/25 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/32 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
General disorders Pyrexia	19.0% 8/42 • Number of events 8 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	16.7% 7/42 • Number of events 10 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	13.3% 4/30 • Number of events 8 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	12.0% 3/25 • Number of events 4 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	12.5% 4/32 • Number of events 6 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations COVID-19	9.5% 4/42 • Number of events 4 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	16.7% 7/42 • Number of events 8 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	10.0% 2/20 • Number of events 2 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	3.3% 1/30 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/25 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/32 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Pneumonia	2.4% 1/42 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	7.1% 3/42 • Number of events 3 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	6.7% 2/30 • Number of events 2 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/25 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	3.1% 1/32 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Upper respiratory tract infection	14.3% 6/42 • Number of events 7 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	7.1% 3/42 • Number of events 3 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/30 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	12.0% 3/25 • Number of events 5 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	3.1% 1/32 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Infections and infestations Urinary tract infection	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	3.3% 1/30 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	8.0% 2/25 • Number of events 2 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	3.1% 1/32 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Injury, poisoning and procedural complications Infusion related reaction	7.1% 3/42 • Number of events 3 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	4.8% 2/42 • Number of events 3 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/30 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	4.0% 1/25 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	3.1% 1/32 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Investigations Alanine aminotransferase increased	11.9% 5/42 • Number of events 5 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	7.1% 3/42 • Number of events 3 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	6.7% 2/30 • Number of events 4 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	8.0% 2/25 • Number of events 2 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	3.1% 1/32 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Investigations Aspartate aminotransferase increased	11.9% 5/42 • Number of events 6 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	7.1% 3/42 • Number of events 3 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	6.7% 2/30 • Number of events 2 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	4.0% 1/25 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	3.1% 1/32 • Number of events 2 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Investigations Blood alkaline phosphatase increased	2.4% 1/42 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	3.3% 1/30 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	12.0% 3/25 • Number of events 3 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/32 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Investigations Blood bilirubin increased	4.8% 2/42 • Number of events 5 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/30 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/25 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	6.2% 2/32 • Number of events 2 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Investigations Blood creatinine increased	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	5.0% 1/20 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	10.0% 3/30 • Number of events 3 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	16.0% 4/25 • Number of events 4 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	6.2% 2/32 • Number of events 2 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Investigations Blood thyroid stimulating hormone increased	7.1% 3/42 • Number of events 5 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	2.4% 1/42 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	5.0% 1/20 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/30 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	4.0% 1/25 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	12.5% 4/32 • Number of events 4 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Investigations C-reactive protein increased	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	3.3% 1/30 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/25 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	6.2% 2/32 • Number of events 2 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Investigations Lymphocyte count decreased	2.4% 1/42 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/30 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	12.0% 3/25 • Number of events 4 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/32 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Investigations Neutrophil count decreased	2.4% 1/42 • Number of events 5 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	6.7% 2/30 • Number of events 2 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/25 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/32 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Investigations Platelet count decreased	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	7.1% 3/42 • Number of events 3 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	10.0% 2/20 • Number of events 2 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/30 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	4.0% 1/25 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/32 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Investigations Weight decreased	9.5% 4/42 • Number of events 4 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/30 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	4.0% 1/25 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/32 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Metabolism and nutrition disorders Decreased appetite	4.8% 2/42 • Number of events 3 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	4.8% 2/42 • Number of events 2 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/30 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	16.0% 4/25 • Number of events 4 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	3.1% 1/32 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	2.4% 1/42 • Number of events 3 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	6.7% 2/30 • Number of events 3 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	16.0% 4/25 • Number of events 4 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/32 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	5.0% 1/20 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	3.3% 1/30 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	4.0% 1/25 • Number of events 2 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	9.4% 3/32 • Number of events 3 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Metabolism and nutrition disorders Hypernatraemia	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/30 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	8.0% 2/25 • Number of events 2 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/32 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/30 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	12.0% 3/25 • Number of events 3 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	3.1% 1/32 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Metabolism and nutrition disorders Hypokalaemia	2.4% 1/42 • Number of events 2 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	9.5% 4/42 • Number of events 5 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	6.7% 2/30 • Number of events 2 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/25 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	3.1% 1/32 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Musculoskeletal and connective tissue disorders Arthralgia	7.1% 3/42 • Number of events 3 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	4.8% 2/42 • Number of events 3 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	3.3% 1/30 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	8.0% 2/25 • Number of events 3 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	3.1% 1/32 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Musculoskeletal and connective tissue disorders Back pain	4.8% 2/42 • Number of events 3 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	4.8% 2/42 • Number of events 2 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	10.0% 2/20 • Number of events 2 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	3.3% 1/30 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	8.0% 2/25 • Number of events 2 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/32 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/30 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	8.0% 2/25 • Number of events 2 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	3.1% 1/32 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Musculoskeletal and connective tissue disorders Muscle spasms	9.5% 4/42 • Number of events 4 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/30 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/25 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/32 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/30 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	8.0% 2/25 • Number of events 2 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/32 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Nervous system disorders Dizziness	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/30 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	8.0% 2/25 • Number of events 2 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	3.1% 1/32 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Nervous system disorders Headache	7.1% 3/42 • Number of events 4 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	9.5% 4/42 • Number of events 4 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	5.0% 1/20 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/30 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/25 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	3.1% 1/32 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Psychiatric disorders Insomnia	9.5% 4/42 • Number of events 4 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	2.4% 1/42 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/30 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	4.0% 1/25 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/32 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Cough	9.5% 4/42 • Number of events 4 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	4.8% 2/42 • Number of events 2 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	5.0% 1/20 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	3.3% 1/30 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	8.0% 2/25 • Number of events 2 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	12.5% 4/32 • Number of events 4 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Pneumonitis	7.1% 3/42 • Number of events 5 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/30 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/25 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	3.1% 1/32 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	2.4% 1/42 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/30 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	4.0% 1/25 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	6.2% 2/32 • Number of events 2 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/30 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	12.0% 3/25 • Number of events 3 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/32 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Skin and subcutaneous tissue disorders Eczema	2.4% 1/42 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	7.1% 3/42 • Number of events 3 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/20 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	3.3% 1/30 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/25 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	3.1% 1/32 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Skin and subcutaneous tissue disorders Pruritus	31.0% 13/42 • Number of events 14 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	19.0% 8/42 • Number of events 13 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	5.0% 1/20 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	6.7% 2/30 • Number of events 2 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	4.0% 1/25 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	21.9% 7/32 • Number of events 7 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Skin and subcutaneous tissue disorders Rash	2.4% 1/42 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	11.9% 5/42 • Number of events 5 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	5.0% 1/20 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	6.7% 2/30 • Number of events 2 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/25 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	9.4% 3/32 • Number of events 3 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Skin and subcutaneous tissue disorders Rash maculo-papular	4.8% 2/42 • Number of events 2 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	4.8% 2/42 • Number of events 2 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	10.0% 2/20 • Number of events 2 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	3.3% 1/30 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	0.00% 0/25 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	3.1% 1/32 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Vascular disorders Hypertension	0.00% 0/42 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	2.4% 1/42 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	5.0% 1/20 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	3.3% 1/30 • Number of events 1 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	4.0% 1/25 • Number of events 3 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.	6.2% 2/32 • Number of events 2 • Up to ~37 months. All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.

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. Authorship will be determined by mutual agreement and in line with International Committee of Medical Journal Editors (ICMJE) authorship requirements.
• Publication restrictions are in place

Restriction type: OTHER