Trial Outcomes & Findings for Pembrolizumab/Vibostolimab Coformulation (MK-7684A) or Pembrolizumab/Vibostolimab Coformulation Plus Docetaxel Versus Docetaxel for Metastatic Non Small Cell Lung Cancer (NSCLC) With Progressive Disease After Platinum Doublet Chemotherapy and Immunotherapy (MK-7684A-002, KEYVIBE-002) (NCT NCT04725188)

NCT ID: NCT04725188

Last Updated: 2025-08-15

Results Overview

PFS is defined as the time from randomization to the first documented disease progression (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by BICR is presented.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 255 participants
• Primary outcome timeframe: Up to approximately 21 months
• Results posted on: 2025-08-15

Participant Flow

Participant milestones

Measure	Arm 1: Pembrolizumab/Vibostolimab Coformulation + Docetaxel Participants 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 plus docetaxel 75 mg/m\^2 via IV infusion Q3W. Each cycle was 21 days.	Arm 2: Pembrolizumab/Vibostolimab Coformulation Participants received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via IV infusion Q3W for up to 35 cycles up to approximately 2 years. Each cycle was 21 days.	Arm 3: Placebo + Docetaxel Participants received normal saline placebo via IV infusion Q3W for up to 35 cycles up to approximately 2 years plus docetaxel 75 mg/m\^2 via IV infusion Q3W. Each cycle was 21 days.
Overall Study STARTED	87	83	85
Overall Study Treated	85	83	83
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	87	83	85

Reasons for withdrawal

Measure	Arm 1: Pembrolizumab/Vibostolimab Coformulation + Docetaxel Participants 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 plus docetaxel 75 mg/m\^2 via IV infusion Q3W. Each cycle was 21 days.	Arm 2: Pembrolizumab/Vibostolimab Coformulation Participants received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via IV infusion Q3W for up to 35 cycles up to approximately 2 years. Each cycle was 21 days.	Arm 3: Placebo + Docetaxel Participants received normal saline placebo via IV infusion Q3W for up to 35 cycles up to approximately 2 years plus docetaxel 75 mg/m\^2 via IV infusion Q3W. Each cycle was 21 days.
Overall Study Death	72	69	76
Overall Study Lost to Follow-up	1	0	1
Overall Study Withdrawal by Subject	2	2	1
Overall Study Sponsor Decision	12	12	7

Baseline Characteristics

Pembrolizumab/Vibostolimab Coformulation (MK-7684A) or Pembrolizumab/Vibostolimab Coformulation Plus Docetaxel Versus Docetaxel for Metastatic Non Small Cell Lung Cancer (NSCLC) With Progressive Disease After Platinum Doublet Chemotherapy and Immunotherapy (MK-7684A-002, KEYVIBE-002)

Baseline characteristics by cohort

Measure	Arm 1: Pembrolizumab/Vibostolimab Coformulation + Docetaxel n=87 Participants Participants 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 plus docetaxel 75 mg/m\^2 via IV infusion Q3W. Each cycle was 21 days.	Arm 2: Pembrolizumab/Vibostolimab Coformulation n=83 Participants Participants received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via IV infusion Q3W for up to 35 cycles up to approximately 2 years. Each cycle was 21 days.	Arm 3: Placebo + Docetaxel n=85 Participants Participants received normal saline placebo via IV infusion Q3W for up to 35 cycles up to approximately 2 years plus docetaxel 75 mg/m\^2 via IV infusion Q3W. Each cycle was 21 days.	Total n=255 Participants Total of all reporting groups
Age, Continuous	64.7 Years STANDARD_DEVIATION 8.8 • n=5 Participants	66.0 Years STANDARD_DEVIATION 7.4 • n=7 Participants	65.8 Years STANDARD_DEVIATION 8.0 • n=5 Participants	65.5 Years STANDARD_DEVIATION 8.1 • n=4 Participants
Sex: Female, Male Female	27 Participants n=5 Participants	23 Participants n=7 Participants	24 Participants n=5 Participants	74 Participants n=4 Participants
Sex: Female, Male Male	60 Participants n=5 Participants	60 Participants n=7 Participants	61 Participants n=5 Participants	181 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	12 Participants n=5 Participants	9 Participants n=7 Participants	6 Participants n=5 Participants	27 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	62 Participants n=5 Participants	68 Participants n=7 Participants	65 Participants n=5 Participants	195 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	13 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants	33 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	11 Participants n=5 Participants	14 Participants n=7 Participants	10 Participants n=5 Participants	35 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) White	62 Participants n=5 Participants	63 Participants n=7 Participants	60 Participants n=5 Participants	185 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	13 Participants n=5 Participants	5 Participants n=7 Participants	14 Participants n=5 Participants	32 Participants n=4 Participants
Programmed Cell Death Ligand 1 (PD-L1) Status at Baseline Tumor proportion score (TPS) ≥50%	15 Participants n=5 Participants	14 Participants n=7 Participants	13 Participants n=5 Participants	42 Participants n=4 Participants
Programmed Cell Death Ligand 1 (PD-L1) Status at Baseline TPS 1-49%	34 Participants n=5 Participants	19 Participants n=7 Participants	35 Participants n=5 Participants	88 Participants n=4 Participants
Programmed Cell Death Ligand 1 (PD-L1) Status at Baseline TPS <1%	37 Participants n=5 Participants	45 Participants n=7 Participants	34 Participants n=5 Participants	116 Participants n=4 Participants
Programmed Cell Death Ligand 1 (PD-L1) Status at Baseline Unknown (Not evaluable due to <100 viable tumor cells)	1 Participants n=5 Participants	5 Participants n=7 Participants	3 Participants n=5 Participants	9 Participants n=4 Participants
Predominant Tumor Histology Squamous	26 Participants n=5 Participants	20 Participants n=7 Participants	34 Participants n=5 Participants	80 Participants n=4 Participants
Predominant Tumor Histology Non-squamous	61 Participants n=5 Participants	63 Participants n=7 Participants	51 Participants n=5 Participants	175 Participants n=4 Participants
Prior Lines of Therapy 1	58 Participants n=5 Participants	49 Participants n=7 Participants	52 Participants n=5 Participants	159 Participants n=4 Participants
Prior Lines of Therapy 2	25 Participants n=5 Participants	28 Participants n=7 Participants	26 Participants n=5 Participants	79 Participants n=4 Participants
Prior Lines of Therapy 3	1 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants	12 Participants n=4 Participants
Prior Lines of Therapy 4	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Prior Lines of Therapy ≥5	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Sequence of Prior Anti-Programmed Cell Death Receptor 1 (PD-1)/PD-L1 Immediate Prior Therapy	72 Participants n=5 Participants	70 Participants n=7 Participants	72 Participants n=5 Participants	214 Participants n=4 Participants
Sequence of Prior Anti-Programmed Cell Death Receptor 1 (PD-1)/PD-L1 Not the Immediate Prior Therapy	15 Participants n=5 Participants	13 Participants n=7 Participants	13 Participants n=5 Participants	41 Participants n=4 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status ECOG = 0	34 Participants n=5 Participants	30 Participants n=7 Participants	32 Participants n=5 Participants	96 Participants n=4 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status ECOG = 1	53 Participants n=5 Participants	53 Participants n=7 Participants	53 Participants n=5 Participants	159 Participants n=4 Participants

PRIMARY outcome

Timeframe: Up to approximately 21 months

Population: All randomized participants

PFS is defined as the time from randomization to the first documented disease progression (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by BICR is presented.

Outcome measures

Measure	Arm 1: Pembrolizumab/Vibostolimab Coformulation + Docetaxel n=87 Participants Participants 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 plus docetaxel 75 mg/m\^2 via IV infusion Q3W. Each cycle was 21 days.	Arm 2: Pembrolizumab/Vibostolimab Coformulation n=83 Participants Participants received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via IV infusion Q3W for up to 35 cycles up to approximately 2 years. Each cycle was 21 days.	Arm 3: Placebo + Docetaxel n=85 Participants Participants received normal saline placebo via IV infusion Q3W for up to 35 cycles up to approximately 2 years plus docetaxel 75 mg/m\^2 via IV infusion Q3W. Each cycle was 21 days.
Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) Assessment	5.6 Months Interval 3.9 to 6.8	2.7 Months Interval 1.8 to 4.0	3.2 Months Interval 2.8 to 5.7

SECONDARY outcome

Timeframe: Up to approximately 21 months

Population: All randomized participants

ORR is defined as the percentage of participants who have a confirmed complete response (CR: Disappearance of all target lesions) or a partial response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The percentage of participants who experience a CR or PR as assessed by BICR based on RECIST 1.1 is presented.

Outcome measures

Measure	Arm 1: Pembrolizumab/Vibostolimab Coformulation + Docetaxel n=87 Participants Participants 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 plus docetaxel 75 mg/m\^2 via IV infusion Q3W. Each cycle was 21 days.	Arm 2: Pembrolizumab/Vibostolimab Coformulation n=83 Participants Participants received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via IV infusion Q3W for up to 35 cycles up to approximately 2 years. Each cycle was 21 days.	Arm 3: Placebo + Docetaxel n=85 Participants Participants received normal saline placebo via IV infusion Q3W for up to 35 cycles up to approximately 2 years plus docetaxel 75 mg/m\^2 via IV infusion Q3W. Each cycle was 21 days.
Objective Response Rate (ORR) Per RECIST 1.1 by BICR Assessment	29.9 Percentage of participants Interval 20.5 to 40.6	6.0 Percentage of participants Interval 2.0 to 13.5	15.3 Percentage of participants Interval 8.4 to 24.7

SECONDARY outcome

Timeframe: Up to approximately 21 months

Population: All randomized participants

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

Outcome measures

Measure	Arm 1: Pembrolizumab/Vibostolimab Coformulation + Docetaxel n=87 Participants Participants 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 plus docetaxel 75 mg/m\^2 via IV infusion Q3W. Each cycle was 21 days.	Arm 2: Pembrolizumab/Vibostolimab Coformulation n=83 Participants Participants received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via IV infusion Q3W for up to 35 cycles up to approximately 2 years. Each cycle was 21 days.	Arm 3: Placebo + Docetaxel n=85 Participants Participants received normal saline placebo via IV infusion Q3W for up to 35 cycles up to approximately 2 years plus docetaxel 75 mg/m\^2 via IV infusion Q3W. Each cycle was 21 days.
Overall Survival (OS)	10.2 Months Interval 8.6 to 14.9	7.5 Months Interval 5.2 to 13.4	8.8 Months Interval 6.4 to 11.1

SECONDARY outcome

Timeframe: Up to approximately 21 months

Population: All randomized participants who demonstrated a confirmed CR or PR

For participants who demonstrate a confirmed CR (Disappearance of all target lesions) or confirmed PR (At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until disease progression (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD. The DOR as assessed by BICR is presented.

Outcome measures

Measure	Arm 1: Pembrolizumab/Vibostolimab Coformulation + Docetaxel n=26 Participants Participants 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 plus docetaxel 75 mg/m\^2 via IV infusion Q3W. Each cycle was 21 days.	Arm 2: Pembrolizumab/Vibostolimab Coformulation n=5 Participants Participants received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via IV infusion Q3W for up to 35 cycles up to approximately 2 years. Each cycle was 21 days.	Arm 3: Placebo + Docetaxel n=13 Participants Participants received normal saline placebo via IV infusion Q3W for up to 35 cycles up to approximately 2 years plus docetaxel 75 mg/m\^2 via IV infusion Q3W. Each cycle was 21 days.
Duration of Response (DOR) Per RECIST 1.1 by BICR Assessment	6.5 Months Interval 5.3 to 10.7	NA Months Interval 2.8 to NA=Median DOR not reached at time of data cutoff due to insufficient number of responding participants with relapse NA=DOR upper limit not reached at time of data cutoff due to insufficient number of responding participants with relapse	NA Months Interval 3.0 to NA = Median DOR not reached at time of data cutoff due to insufficient number of responding participants with relapse NA=DOR upper limit not reached at time of data cutoff due to insufficient number of responding participants with relapse

SECONDARY outcome

Timeframe: Up to approximately 39 months

Population: Per protocol, the safety analysis population consisted of all randomized participants who received at least 1 dose of study treatment. Participants are included in the treatment group corresponding to the study treatment they actually received.

An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experienced an AE is reported here.

Outcome measures

Measure	Arm 1: Pembrolizumab/Vibostolimab Coformulation + Docetaxel n=85 Participants Participants 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 plus docetaxel 75 mg/m\^2 via IV infusion Q3W. Each cycle was 21 days.	Arm 2: Pembrolizumab/Vibostolimab Coformulation n=83 Participants Participants received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via IV infusion Q3W for up to 35 cycles up to approximately 2 years. Each cycle was 21 days.	Arm 3: Placebo + Docetaxel n=83 Participants Participants received normal saline placebo via IV infusion Q3W for up to 35 cycles up to approximately 2 years plus docetaxel 75 mg/m\^2 via IV infusion Q3W. Each cycle was 21 days.
Number of Participants Who Experienced an Adverse Event (AE)	85 Participants	76 Participants	82 Participants

SECONDARY outcome

Timeframe: Up to approximately 27 months

Population: Per protocol, the safety analysis population consisted of all randomized participants who received at least 1 dose of study treatment. Participants are included in the treatment group corresponding to the study treatment they actually received.

An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinued study treatment due to an AE is reported here.

Outcome measures

Measure	Arm 1: Pembrolizumab/Vibostolimab Coformulation + Docetaxel n=85 Participants Participants 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 plus docetaxel 75 mg/m\^2 via IV infusion Q3W. Each cycle was 21 days.	Arm 2: Pembrolizumab/Vibostolimab Coformulation n=83 Participants Participants received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via IV infusion Q3W for up to 35 cycles up to approximately 2 years. Each cycle was 21 days.	Arm 3: Placebo + Docetaxel n=83 Participants Participants received normal saline placebo via IV infusion Q3W for up to 35 cycles up to approximately 2 years plus docetaxel 75 mg/m\^2 via IV infusion Q3W. Each cycle was 21 days.
Number of Participants Who Discontinued Study Treatment Due to an AE	42 Participants	12 Participants	24 Participants

Adverse Events

Pembrolizumab/Vibostolimab Coformulation + Docetaxel

Serious events: 48 serious events

Other events: 83 other events

Deaths: 74 deaths

Pembrolizumab/Vibostolimab Coformulation

Serious events: 26 serious events

Other events: 67 other events

Deaths: 70 deaths

Placebo + Docetaxel

Serious events: 37 serious events

Other events: 76 other events

Deaths: 77 deaths

Serious adverse events

Measure	Pembrolizumab/Vibostolimab Coformulation + Docetaxel n=85 participants at risk Participants 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 plus docetaxel 75 mg/m\^2 via IV infusion Q3W. Each cycle was 21 days.	Pembrolizumab/Vibostolimab Coformulation n=83 participants at risk Participants received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via IV infusion Q3W for up to 35 cycles up to approximately 2 years. Each cycle was 21 days.	Placebo + Docetaxel n=83 participants at risk Participants received normal saline placebo via IV infusion Q3W for up to 35 cycles up to approximately 2 years plus docetaxel 75 mg/m\^2 via IV infusion Q3W. Each cycle was 21 days.
Blood and lymphatic system disorders Anaemia	3.5% 3/85 • Number of events 4 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	1.2% 1/83 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	2.4% 2/83 • Number of events 2 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Blood and lymphatic system disorders Febrile neutropenia	3.5% 3/85 • Number of events 5 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	3.6% 3/83 • Number of events 3 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Cardiac disorders Acute myocardial infarction	1.2% 1/85 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Cardiac disorders Atrial fibrillation	1.2% 1/85 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Cardiac disorders Cardiac arrest	0.00% 0/85 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	1.2% 1/83 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Cardiac disorders Cardiac failure	2.4% 2/85 • Number of events 2 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Cardiac disorders Myocardial infarction	0.00% 0/85 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	1.2% 1/83 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Cardiac disorders Pericardial effusion	1.2% 1/85 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	1.2% 1/83 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Endocrine disorders Adrenal insufficiency	1.2% 1/85 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Endocrine disorders Hypophysitis	2.4% 2/85 • Number of events 2 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Endocrine disorders Hypothyroidism	0.00% 0/85 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	1.2% 1/83 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Eye disorders Retinal detachment	1.2% 1/85 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Gastrointestinal disorders Constipation	0.00% 0/85 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	1.2% 1/83 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Gastrointestinal disorders Diarrhoea	3.5% 3/85 • Number of events 4 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	1.2% 1/83 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	2.4% 2/83 • Number of events 3 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Gastrointestinal disorders Gastritis	2.4% 2/85 • Number of events 2 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Gastrointestinal disorders Gastrointestinal disorder	1.2% 1/85 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Gastrointestinal disorders Gastrointestinal toxicity	0.00% 0/85 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	1.2% 1/83 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Gastrointestinal disorders Immune-mediated enterocolitis	1.2% 1/85 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Gastrointestinal disorders Intestinal haemorrhage	1.2% 1/85 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Gastrointestinal disorders Intestinal perforation	0.00% 0/85 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	1.2% 1/83 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Gastrointestinal disorders Segmental diverticular colitis	0.00% 0/85 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	1.2% 1/83 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
General disorders Death	1.2% 1/85 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	1.2% 1/83 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	2.4% 2/83 • Number of events 2 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
General disorders Fatigue	1.2% 1/85 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	1.2% 1/83 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
General disorders General physical health deterioration	1.2% 1/85 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	1.2% 1/83 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
General disorders Oedema peripheral	2.4% 2/85 • Number of events 2 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
General disorders Performance status decreased	1.2% 1/85 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
General disorders Pyrexia	1.2% 1/85 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	1.2% 1/83 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
General disorders Sudden death	1.2% 1/85 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Hepatobiliary disorders Bile duct stone	1.2% 1/85 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Hepatobiliary disorders Cholangitis	0.00% 0/85 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	1.2% 1/83 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Hepatobiliary disorders Hepatitis	0.00% 0/85 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	1.2% 1/83 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Immune system disorders Hypersensitivity	1.2% 1/85 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Infections and infestations Abdominal sepsis	1.2% 1/85 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Infections and infestations Bacteraemia	0.00% 0/85 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	1.2% 1/83 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Infections and infestations Bronchitis	0.00% 0/85 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	1.2% 1/83 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Infections and infestations COVID-19	3.5% 3/85 • Number of events 3 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	1.2% 1/83 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	1.2% 1/83 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Infections and infestations COVID-19 pneumonia	0.00% 0/85 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	2.4% 2/83 • Number of events 2 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Infections and infestations Cellulitis	1.2% 1/85 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Infections and infestations Clostridium difficile colitis	0.00% 0/85 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	1.2% 1/83 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Infections and infestations Cystitis	1.2% 1/85 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Infections and infestations Device related bacteraemia	1.2% 1/85 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Infections and infestations Diverticulitis intestinal perforated	0.00% 0/85 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	1.2% 1/83 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Infections and infestations Enterococcal infection	1.2% 1/85 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Infections and infestations Gastroenteritis	1.2% 1/85 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Infections and infestations Herpes zoster	1.2% 1/85 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Infections and infestations Infectious pleural effusion	0.00% 0/85 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	1.2% 1/83 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Infections and infestations Influenza	1.2% 1/85 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Infections and infestations Large intestine infection	1.2% 1/85 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Infections and infestations Lower respiratory tract infection	0.00% 0/85 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	1.2% 1/83 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Infections and infestations Neutropenic sepsis	1.2% 1/85 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	1.2% 1/83 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Infections and infestations Oral candidiasis	1.2% 1/85 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Infections and infestations Pneumonia	8.2% 7/85 • Number of events 9 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	3.6% 3/83 • Number of events 3 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	12.0% 10/83 • Number of events 11 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Infections and infestations Pneumonia aspiration	0.00% 0/85 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	1.2% 1/83 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Infections and infestations Pneumonia escherichia	0.00% 0/85 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	1.2% 1/83 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Infections and infestations Respiratory syncytial virus infection	0.00% 0/85 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	1.2% 1/83 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Infections and infestations Respiratory tract infection	0.00% 0/85 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	1.2% 1/83 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Infections and infestations Sepsis	0.00% 0/85 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	1.2% 1/83 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Infections and infestations Septic shock	3.5% 3/85 • Number of events 3 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Infections and infestations Staphylococcal infection	0.00% 0/85 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	1.2% 1/83 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Infections and infestations Subperiosteal abscess	1.2% 1/85 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Infections and infestations Urinary tract infection	0.00% 0/85 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	1.2% 1/83 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Infections and infestations Urosepsis	1.2% 1/85 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/85 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	1.2% 1/83 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Injury, poisoning and procedural complications Hip fracture	3.5% 3/85 • Number of events 3 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Injury, poisoning and procedural complications Humerus fracture	1.2% 1/85 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Injury, poisoning and procedural complications Procedural complication	0.00% 0/85 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	1.2% 1/83 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.00% 0/85 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	1.2% 1/83 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Investigations Neutrophil count decreased	2.4% 2/85 • Number of events 2 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	1.2% 1/83 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Investigations Platelet count decreased	0.00% 0/85 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	1.2% 1/83 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Investigations White blood cell count decreased	0.00% 0/85 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	1.2% 1/83 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/85 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	1.2% 1/83 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Metabolism and nutrition disorders Dehydration	2.4% 2/85 • Number of events 2 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Metabolism and nutrition disorders Electrolyte imbalance	0.00% 0/85 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	1.2% 1/83 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/85 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	1.2% 1/83 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Metabolism and nutrition disorders Hypokalaemia	1.2% 1/85 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Metabolism and nutrition disorders Hypophagia	1.2% 1/85 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/85 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	1.2% 1/83 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Musculoskeletal and connective tissue disorders Back pain	1.2% 1/85 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Musculoskeletal and connective tissue disorders Osteolysis	0.00% 0/85 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	1.2% 1/83 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Musculoskeletal and connective tissue disorders Osteoporotic fracture	1.2% 1/85 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Musculoskeletal and connective tissue disorders Pain in extremity	1.2% 1/85 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	1.2% 1/83 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Musculoskeletal and connective tissue disorders Pathological fracture	1.2% 1/85 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer fatigue	0.00% 0/85 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	1.2% 1/83 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour compression	0.00% 0/85 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	1.2% 1/83 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour haemorrhage	0.00% 0/85 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	1.2% 1/83 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/85 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	1.2% 1/83 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Nervous system disorders Brain stem stroke	0.00% 0/85 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	1.2% 1/83 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Nervous system disorders Cerebrovascular accident	1.2% 1/85 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	1.2% 1/83 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Nervous system disorders Dizziness	0.00% 0/85 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	1.2% 1/83 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Nervous system disorders Epilepsy	1.2% 1/85 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Nervous system disorders Hyperaesthesia	1.2% 1/85 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Nervous system disorders Lethargy	1.2% 1/85 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Nervous system disorders Occipital neuralgia	0.00% 0/85 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	1.2% 1/83 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Nervous system disorders Peripheral sensorimotor neuropathy	1.2% 1/85 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Nervous system disorders Polyneuropathy	1.2% 1/85 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Renal and urinary disorders Acute kidney injury	1.2% 1/85 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Renal and urinary disorders Ureterolithiasis	0.00% 0/85 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	1.2% 1/83 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	1.2% 1/85 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	1.2% 1/85 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	1.2% 1/85 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	1.2% 1/85 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	1.2% 1/83 • Number of events 3 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	2.4% 2/83 • Number of events 2 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Respiratory, thoracic and mediastinal disorders Dyspnoea	2.4% 2/85 • Number of events 2 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	1.2% 1/83 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	1.2% 1/83 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/85 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	2.4% 2/83 • Number of events 2 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Respiratory, thoracic and mediastinal disorders Immune-mediated lung disease	1.2% 1/85 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	2.4% 2/85 • Number of events 2 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Respiratory, thoracic and mediastinal disorders Malignant pleural effusion	0.00% 0/85 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	1.2% 1/83 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/85 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	1.2% 1/83 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	2.4% 2/83 • Number of events 2 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Respiratory, thoracic and mediastinal disorders Pneumonitis	1.2% 1/85 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	1.2% 1/83 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/85 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	1.2% 1/83 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	1.2% 1/83 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	2.4% 2/85 • Number of events 2 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	1.2% 1/83 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	2.4% 2/83 • Number of events 2 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.2% 1/85 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	1.2% 1/83 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Skin and subcutaneous tissue disorders Dermatitis	1.2% 1/85 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Skin and subcutaneous tissue disorders Drug eruption	2.4% 2/85 • Number of events 2 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Skin and subcutaneous tissue disorders Lichenification	1.2% 1/85 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Skin and subcutaneous tissue disorders Rash morbilliform	1.2% 1/85 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Skin and subcutaneous tissue disorders Skin toxicity	1.2% 1/85 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Surgical and medical procedures Euthanasia	1.2% 1/85 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	1.2% 1/83 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Vascular disorders Deep vein thrombosis	0.00% 0/85 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	1.2% 1/83 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Vascular disorders Hypotension	1.2% 1/85 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Vascular disorders Hypovolaemic shock	1.2% 1/85 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Vascular disorders Orthostatic hypotension	0.00% 0/85 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	1.2% 1/83 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Vascular disorders Superior vena cava occlusion	1.2% 1/85 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Vascular disorders Superior vena cava syndrome	0.00% 0/85 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	2.4% 2/83 • Number of events 2 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.

Other adverse events

Measure	Pembrolizumab/Vibostolimab Coformulation + Docetaxel n=85 participants at risk Participants 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 plus docetaxel 75 mg/m\^2 via IV infusion Q3W. Each cycle was 21 days.	Pembrolizumab/Vibostolimab Coformulation n=83 participants at risk Participants received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via IV infusion Q3W for up to 35 cycles up to approximately 2 years. Each cycle was 21 days.	Placebo + Docetaxel n=83 participants at risk Participants received normal saline placebo via IV infusion Q3W for up to 35 cycles up to approximately 2 years plus docetaxel 75 mg/m\^2 via IV infusion Q3W. Each cycle was 21 days.
Blood and lymphatic system disorders Anaemia	35.3% 30/85 • Number of events 35 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	14.5% 12/83 • Number of events 13 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	33.7% 28/83 • Number of events 30 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Endocrine disorders Hyperthyroidism	5.9% 5/85 • Number of events 6 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	2.4% 2/83 • Number of events 2 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	2.4% 2/83 • Number of events 2 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Endocrine disorders Hypothyroidism	9.4% 8/85 • Number of events 10 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	3.6% 3/83 • Number of events 3 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	1.2% 1/83 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Eye disorders Lacrimation increased	8.2% 7/85 • Number of events 7 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	6.0% 5/83 • Number of events 5 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Gastrointestinal disorders Abdominal pain	7.1% 6/85 • Number of events 7 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	2.4% 2/83 • Number of events 2 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	7.2% 6/83 • Number of events 6 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Gastrointestinal disorders Constipation	23.5% 20/85 • Number of events 28 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	7.2% 6/83 • Number of events 6 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	10.8% 9/83 • Number of events 9 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Gastrointestinal disorders Diarrhoea	36.5% 31/85 • Number of events 52 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	12.0% 10/83 • Number of events 12 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	27.7% 23/83 • Number of events 33 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Gastrointestinal disorders Nausea	28.2% 24/85 • Number of events 38 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	13.3% 11/83 • Number of events 12 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	26.5% 22/83 • Number of events 26 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Gastrointestinal disorders Stomatitis	16.5% 14/85 • Number of events 23 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	1.2% 1/83 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	6.0% 5/83 • Number of events 7 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Gastrointestinal disorders Vomiting	14.1% 12/85 • Number of events 16 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	4.8% 4/83 • Number of events 5 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	13.3% 11/83 • Number of events 16 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
General disorders Asthenia	30.6% 26/85 • Number of events 38 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	18.1% 15/83 • Number of events 16 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	28.9% 24/83 • Number of events 28 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
General disorders Chest pain	2.4% 2/85 • Number of events 2 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	4.8% 4/83 • Number of events 4 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	7.2% 6/83 • Number of events 6 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
General disorders Fatigue	30.6% 26/85 • Number of events 39 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	12.0% 10/83 • Number of events 10 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	27.7% 23/83 • Number of events 26 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
General disorders Mucosal inflammation	7.1% 6/85 • Number of events 10 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	1.2% 1/83 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	3.6% 3/83 • Number of events 3 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
General disorders Oedema peripheral	20.0% 17/85 • Number of events 21 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	3.6% 3/83 • Number of events 3 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	9.6% 8/83 • Number of events 9 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
General disorders Pyrexia	8.2% 7/85 • Number of events 7 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	6.0% 5/83 • Number of events 7 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	13.3% 11/83 • Number of events 15 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Infections and infestations COVID-19	15.3% 13/85 • Number of events 14 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	7.2% 6/83 • Number of events 6 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	8.4% 7/83 • Number of events 7 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Infections and infestations Pneumonia	5.9% 5/85 • Number of events 5 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	7.2% 6/83 • Number of events 6 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	7.2% 6/83 • Number of events 7 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Investigations Amylase increased	3.5% 3/85 • Number of events 3 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	6.0% 5/83 • Number of events 8 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	1.2% 1/83 • Number of events 2 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Investigations Blood creatinine increased	5.9% 5/85 • Number of events 5 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	2.4% 2/83 • Number of events 2 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Investigations Lipase increased	2.4% 2/85 • Number of events 3 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	6.0% 5/83 • Number of events 8 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	1.2% 1/83 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Investigations Neutrophil count decreased	16.5% 14/85 • Number of events 25 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	18.1% 15/83 • Number of events 24 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Investigations Weight decreased	16.5% 14/85 • Number of events 16 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	4.8% 4/83 • Number of events 4 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	13.3% 11/83 • Number of events 12 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Metabolism and nutrition disorders Decreased appetite	24.7% 21/85 • Number of events 28 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	13.3% 11/83 • Number of events 11 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	22.9% 19/83 • Number of events 25 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Metabolism and nutrition disorders Hyperglycaemia	7.1% 6/85 • Number of events 9 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	2.4% 2/83 • Number of events 2 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	3.6% 3/83 • Number of events 5 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Metabolism and nutrition disorders Hypokalaemia	8.2% 7/85 • Number of events 7 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	3.6% 3/83 • Number of events 3 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	4.8% 4/83 • Number of events 5 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Metabolism and nutrition disorders Hypomagnesaemia	5.9% 5/85 • Number of events 6 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	2.4% 2/83 • Number of events 2 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	2.4% 2/83 • Number of events 2 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Musculoskeletal and connective tissue disorders Arthralgia	18.8% 16/85 • Number of events 22 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	3.6% 3/83 • Number of events 3 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	13.3% 11/83 • Number of events 15 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Musculoskeletal and connective tissue disorders Myalgia	10.6% 9/85 • Number of events 14 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	1.2% 1/83 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	7.2% 6/83 • Number of events 7 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Musculoskeletal and connective tissue disorders Pain in extremity	5.9% 5/85 • Number of events 9 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	2.4% 2/83 • Number of events 2 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	6.0% 5/83 • Number of events 7 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Nervous system disorders Dysgeusia	14.1% 12/85 • Number of events 13 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	8.4% 7/83 • Number of events 9 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Nervous system disorders Headache	5.9% 5/85 • Number of events 5 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	3.6% 3/83 • Number of events 4 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	3.6% 3/83 • Number of events 3 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Nervous system disorders Neuropathy peripheral	16.5% 14/85 • Number of events 15 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	8.4% 7/83 • Number of events 7 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Nervous system disorders Paraesthesia	4.7% 4/85 • Number of events 5 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	1.2% 1/83 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	7.2% 6/83 • Number of events 7 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Psychiatric disorders Insomnia	9.4% 8/85 • Number of events 8 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	4.8% 4/83 • Number of events 4 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	3.6% 3/83 • Number of events 3 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Respiratory, thoracic and mediastinal disorders Cough	15.3% 13/85 • Number of events 15 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	6.0% 5/83 • Number of events 5 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	13.3% 11/83 • Number of events 12 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Respiratory, thoracic and mediastinal disorders Dyspnoea	23.5% 20/85 • Number of events 22 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	16.9% 14/83 • Number of events 15 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	16.9% 14/83 • Number of events 14 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Respiratory, thoracic and mediastinal disorders Haemoptysis	4.7% 4/85 • Number of events 4 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	3.6% 3/83 • Number of events 3 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	6.0% 5/83 • Number of events 5 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Skin and subcutaneous tissue disorders Alopecia	28.2% 24/85 • Number of events 24 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	2.4% 2/83 • Number of events 2 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	24.1% 20/83 • Number of events 21 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Skin and subcutaneous tissue disorders Dry skin	8.2% 7/85 • Number of events 9 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	2.4% 2/83 • Number of events 2 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	3.6% 3/83 • Number of events 3 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Skin and subcutaneous tissue disorders Eczema	8.2% 7/85 • Number of events 7 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	2.4% 2/83 • Number of events 2 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Skin and subcutaneous tissue disorders Nail disorder	7.1% 6/85 • Number of events 6 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	4.8% 4/83 • Number of events 4 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Skin and subcutaneous tissue disorders Nail toxicity	1.2% 1/85 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	0.00% 0/83 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	6.0% 5/83 • Number of events 5 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	4.7% 4/85 • Number of events 4 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	1.2% 1/83 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	6.0% 5/83 • Number of events 5 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Skin and subcutaneous tissue disorders Pruritus	36.5% 31/85 • Number of events 51 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	20.5% 17/83 • Number of events 21 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	4.8% 4/83 • Number of events 5 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Skin and subcutaneous tissue disorders Rash	25.9% 22/85 • Number of events 28 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	18.1% 15/83 • Number of events 17 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	8.4% 7/83 • Number of events 8 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Vascular disorders Hypertension	5.9% 5/85 • Number of events 6 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	3.6% 3/83 • Number of events 3 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.	1.2% 1/83 • Number of events 1 • Up to approximately 39 months All-cause mortality included all randomized participants. Serious and other AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.

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 The investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
• Publication restrictions are in place

Restriction type: OTHER